Trial Outcomes & Findings for Multicultural Healthy Diet to Reduce Cognitive Decline (NCT NCT03240406)

NCT ID: NCT03240406

Last Updated: 2024-12-12

Results Overview

Change in global composite cognition score (standardized unit) is computed as the average of the three domain-specific Z-scores of the participant's performance on three ambulatory cognitive assessments: visuospatial working memory (Dot Grid Memory), processing speed (Symbol Search), and short-term associative memory binding (Color Shapes Task) at 9 months post baseline (Burst 1). Z-scores are centered at a population mean of "0" (i.e., a Z-score of "0" signifies that the data point(s) is equal to the population mean at study baseline for all three tasks in the composite average; positive Z-score group values indicate the number of standard deviations the data point(s) is above the mean and negative Z-score group values indicate the number of standard deviations the data point(s) is below the mean). Mean change in global composite Z-score from baseline will be reported by study arm. Increase in composite Z-scores from baseline are associated with improved cognition.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 393 participants
• Primary outcome timeframe: Baseline (Burst 1) and 9 months (Burst 2)
• Results posted on: 2024-12-12

Participant Flow

During the Covid-19 pandemic, collection of biospecimens and anthropometry data in-person was halted from 3/12/2020 to 7/16/2020; screening visits were administered via Zoom instead of in-person. Group and telephone sessions related to intervention and comparison activities continued via Zoom and telephone during this hiatus and until the end of the study. Recruitment slowed during the pandemic and follow-up was extended to allow all participants to meet their primary endpoint milestone

Of 393 enrolled patients, 290 met eligibility criteria for randomization and were randomized into the study. For this study, Burst time intervals are as follows: Baseline (Burst 1), 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-baseline Completion of this study was defined as the first of the following: the completion of all activities through: 1. Burst 4 (27 months post-baseline) OR 2. August 30, 2023.

Participant milestones

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Burst 1 (Baseline) STARTED	144	146
Burst 1 (Baseline) COMPLETED	144	146
Burst 1 (Baseline) NOT COMPLETED	0	0
Burst 2 (9 Months) STARTED	144	146
Burst 2 (9 Months) COMPLETED	126	129
Burst 2 (9 Months) NOT COMPLETED	18	17
Burst 3 (18 Months) STARTED	122	126
Burst 3 (18 Months) COMPLETED	98	93
Burst 3 (18 Months) NOT COMPLETED	24	33
Burst 4 (27 Months) STARTED	77	72
Burst 4 (27 Months) COMPLETED	57	57
Burst 4 (27 Months) NOT COMPLETED	20	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multicultural Healthy Diet to Reduce Cognitive Decline

Baseline characteristics by cohort

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.	Total n=290 Participants Total of all reporting groups
Age, Continuous	53.3 years STANDARD_DEVIATION 7.2 • n=5 Participants	54.0 years STANDARD_DEVIATION 7.0 • n=7 Participants	53.7 years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	115 Participants n=5 Participants	115 Participants n=7 Participants	230 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	31 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	60 Participants n=5 Participants	58 Participants n=7 Participants	118 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	84 Participants n=5 Participants	88 Participants n=7 Participants	172 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	63 Participants n=5 Participants	67 Participants n=7 Participants	130 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants	32 Participants n=7 Participants	66 Participants n=5 Participants
Race (NIH/OMB) More than one race	28 Participants n=5 Participants	33 Participants n=7 Participants	61 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	144 participants n=5 Participants	146 participants n=7 Participants	290 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Participants completing at least 18 sessions for the primary three domains at Bursts 1 or 2 were analyzed. Missing and non-compliant data were multiply imputed using multivariate imputation by chained equations (MICE).

Change in global composite cognition score (standardized unit) is computed as the average of the three domain-specific Z-scores of the participant's performance on three ambulatory cognitive assessments: visuospatial working memory (Dot Grid Memory), processing speed (Symbol Search), and short-term associative memory binding (Color Shapes Task) at 9 months post baseline (Burst 1). Z-scores are centered at a population mean of "0" (i.e., a Z-score of "0" signifies that the data point(s) is equal to the population mean at study baseline for all three tasks in the composite average; positive Z-score group values indicate the number of standard deviations the data point(s) is above the mean and negative Z-score group values indicate the number of standard deviations the data point(s) is below the mean). Mean change in global composite Z-score from baseline will be reported by study arm. Increase in composite Z-scores from baseline are associated with improved cognition.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Change in Mean Global Composite Cognition Score From Baseline	0.2 Z-score Standard Deviation 0.8	0.2 Z-score Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1 (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

DII score was determined by an algorithm that summarized the inflammatory potential of the diet. The DII score represents a weighted sum of the self-reported quantities of 28 foods, each translated into Z-scores using a global comparative database consisting of data from 11 countries by subtracting from the individual's self-report value the mean of the global database, then dividing by the standard deviation (SD). Z-scores are centered at a population mean of "0" (i.e., a Z-score of "0" signifies that the data point(s) is = to the population mean at study baseline for all 3 tasks in the composite average; positive and negative Z-score group values indicate the number of SD the data point(s) is above or below the mean, respectively). For this study, possible scoring range for 28 food parameters was -8 to 8 based on ref: Hebert JR, et.al., Perspective: The Dietary Inflammatory Index (DII®): Adv Nutr. 2019;10:185-95. Higher Z-score values are indicative of a more pro-inflammatory diet.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Dietary Inflammatory Index (DII) Score Burst 1 (Baseline)	1.10 Z-score Standard Deviation 1.85	1.17 Z-score Standard Deviation 1.83
Dietary Inflammatory Index (DII) Score Burst 2 (9 Months)	0.70 Z-score Standard Deviation 2.01	1.38 Z-score Standard Deviation 1.76

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1 (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Energy-adjusted DII score was determined by an algorithm that summarized the inflammatory potential of the diet. This score represents a weighted sum of self-reported quantities of 28 foods per 1000 kilocalories of consumption that were then translated into Z-scores using a global comparative database of data from 11 countries by subtracting from the individual's self-report value the mean of the global database, then dividing by the SD. Z-scores are centered at a population mean of 0 (i.e., a Z-score of 0 signifies that the data point is = to the population mean at study baseline for all 3 tasks in the composite average; positive and negative Z-score group values indicate the number of SD the data point is above or below the mean, respectively). For this study, possible scoring range for 28 food parameters was -8 to 8 based on ref: Hebert JR, et.al., Perspective: The Dietary Inflammatory Index (DII®): Adv Nutr. 2019;10:185-95. Higher values are indicative of a more inflammatory diet.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Energy-Adjusted DII Score Burst 1 (Baseline)	-0.30 Z-score Standard Deviation 1.96	-0.30 Z-score Standard Deviation 2.03
Energy-Adjusted DII Score Burst 2 (9 Months)	-0.98 Z-score Standard Deviation 2.16	-0.09 Z-score Standard Deviation 2.03

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: Burst 1, MHD (N=13); Burst 1, Comparison (N=12). Burst 2, MHD (N=36), Burst 2, Comparison (N=44).

Blood sera specimens were collected and processed at Baseline and 9-months post-intervention and shipped to University of Minnesota Advanced Research & Diagnostic Laboratory (ARDL) for total folate analysis by a validated serum folate assay. Mean total folate levels are summarized by study arm and reported in nmol/L. The lower limit of detection (LLOD) for mean total folate is 4.54 nmol/L and the upper limit of detection (ULOD) 90.8 nmol/L. Increase in this biomarker from baseline for MHD participants indicates possible adherence to an MHD dietary pattern such as eating more green leafy vegetables.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=131 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=134 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Total Serum Folate Levels Burst 1 (Baseline)	35.93 nmol/L Standard Deviation 17.19	34.72 nmol/L Standard Deviation 15.74
Total Serum Folate Levels Burst 2 (9 months)	35.26 nmol/L Standard Deviation 17.8	35.01 nmol/L Standard Deviation 15.78

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: Burst 1, MHD (N=7); Burst 1, Comparison (N=6). Burst 2, MHD (N=31), Burst 2, Comparison (N=38).

Blood plasma specimens were collected and processed at Baseline and 9-months post-intervention and shipped to University of Minnesota ARDL for α-tocopherol analysis by an HPLC method. α-Tocopherols were measured with a diode array detector equipped HPLC system. Mean α-tocopherol levels are summarized by study arm and reported in mcg/mL. There are no reference ranges for this biomarker from this laboratory (other than non-negative values). Increase in this biomarker from baseline for MHD participants indicates possible adherence to an MHD dietary pattern.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=137 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=140 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
α-Tocopherol Levels Burst 1 (Baseline)	11.39 mcg/mL Standard Deviation 3.49	11.02 mcg/mL Standard Deviation 2.94
α-Tocopherol Levels Burst 2 (9 Months)	11.45 mcg/mL Standard Deviation 3.73	11.26 mcg/mL Standard Deviation 3.56

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: Burst 1, MHD (N=7); Burst 1, Comparison (N=6). Burst 2, MHD (N=31), Burst 2, Comparison (N=38).

Blood plasma specimens were collected and processed at Baseline and 9-months post-intervention from a sub-sample and shipped to University of Minnesota ARDL lab for α-carotenoid analysis by an HPLC method. α-Carotenoids were measured with a diode array detector equipped HPLC system. Mean α-carotenoid levels are summarized by study arm and reported in mcg/mL. There are no reference ranges for this biomarker (other than non-negative values). Increase in this biomarker from baseline for MHD participants indicates possible adherence to an MHD dietary pattern.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=137 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=140 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
α-Carotenoid Levels Burst 1 (Baseline)	0.04 mcg/mL Standard Deviation 0.04	0.04 mcg/mL Standard Deviation 0.03
α-Carotenoid Levels Burst 2 (9 Months)	0.04 mcg/mL Standard Deviation 0.04	0.04 mcg/mL Standard Deviation 0.06

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: Burst 1, MHD (N=10); Burst 1, Comparison (N=7). Burst 2, MHD (N=33), Burst 2, Comparison (N=40).

Blood sera specimens were collected and processed at Baseline and 9-months post-intervention and shipped to University of Minnesota ARDL laboratory for Vitamin B12 analysis by a validated Vitamin B12 assay. Mean Vitamin B12 levels are summarized by study arm and reported in pg/mL. Reference ranges for this biomarker are: 232-1245 pg/mL and LLOD is 100 pg/mL. Increase in this biomarker from baseline for MHD participants indicates possible adherence to an MHD dietary pattern.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=134 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=139 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Vitamin B12 Levels Burst 1 (Baseline)	736.78 pg/mL Standard Deviation 513.94	712.89 pg/mL Standard Deviation 445.71
Vitamin B12 Levels Burst 2 (9 Months)	718.23 pg/mL Standard Deviation 522.58	716.22 pg/mL Standard Deviation 417.64

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=61); MHD, Burst 2 (N=52). Comparison, Burst 1 (N=61); Comparison, Burst 2 (N=52). For the Fatty Acid Profile Outcome Measure only a subset of samples were analyzed due to cost.

Blood plasma specimens were collected and processed at Baseline and 9-months follow-up for a sub-sample and shipped to University of Minnesota ARDL laboratory for total fatty acid analysis by a gas chromatography method. Fatty acids are expressed as a percent of total fatty acids. Fatty acids are compared with each sample rather than measured against a standard and the range of percentage values for each fatty acid is 0-100%. Mean percentage plasma levels of the following fatty acids will be summarized by study arm for Burst 2: Sum of monounsaturated fatty acids (n=6); Long chain saturated fatty acids (fatty acids with 20 or more carbons (n=3)); EPA (eicosapentaenoic acid); DHA (docosahexaenoic acid); n3 DPA (omega three docosapentaenoic acid).

Monounsaturated fat is a composite of 6 fatty acids: 16:1n7 cis, 17:1n7T, 18:1n9 cis,18:1n7 cis, 20:1n9, and 24:1n9 Long chain saturated fat is a composite of 3 fatty acids: 22:0, 23:0, and 24:0

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=83 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=94 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Fatty Acid Profile Monounsaturated Fat at Burst 1 (Baseline)	10.76 % of total fatty acid Standard Deviation 1.30	11.09 % of total fatty acid Standard Deviation 1.67
Fatty Acid Profile Monounsaturated Fat at Burst 2 (9 Months)	10.91 % of total fatty acid Standard Deviation 1.44	10.96 % of total fatty acid Standard Deviation 1.58
Fatty Acid Profile Long-chain Saturated Fat at Burst 1 (Baseline)	2.14 % of total fatty acid Standard Deviation 0.38	2.12 % of total fatty acid Standard Deviation 0.45
Fatty Acid Profile Long-chain Saturated Fat at Burst 2 (9 Months)	2.15 % of total fatty acid Standard Deviation 0.41	2.23 % of total fatty acid Standard Deviation 0.42
Fatty Acid Profile EPA at Burst 1 (Baseline)	0.98 % of total fatty acid Standard Deviation 1.24	0.90 % of total fatty acid Standard Deviation 0.45
Fatty Acid Profile EPA at Burst 2 (9 Months)	1.01 % of total fatty acid Standard Deviation 0.90	0.85 % of total fatty acid Standard Deviation 0.44
Fatty Acid Profile DHA at Burst 1 (Baseline)	3.67 % of total fatty acid Standard Deviation 1.09	3.65 % of total fatty acid Standard Deviation 1.30
Fatty Acid Profile DHA at Burst 2 (9 Months)	3.77 % of total fatty acid Standard Deviation 1.41	3.48 % of total fatty acid Standard Deviation 1.05
Fatty Acid Profile n3 DPA at Burst 1 (Baseline)	1.10 % of total fatty acid Standard Deviation 0.18	1.09 % of total fatty acid Standard Deviation 0.21
Fatty Acid Profile n3 DPA at Burst 2 (9 Months)	1.07 % of total fatty acid Standard Deviation 0.17	1.07 % of total fatty acid Standard Deviation 0.18

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: Burst 1, MHD: (N=10); Burst 1, Comparison: (N=7). Burst 2, MHD: (N=33); Burst 2, Comparison: (N=40)

Serum specimens were collected and processed at Baseline and 9-months follow-up and shipped to University of Minnesota ARDL laboratory for analysis on Roche Cobas 8000 Chemistry Analyzer. Mean serum sodium levels are summarized by study arm and reported in mmol/L. Reference range is 136-145 mmol/L and the lower LOD is 80 mmol/L. Decreased serum sodium levels from baseline may indicate dehydration.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=134 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=139 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Serum Sodium Burst 1 (Baseline)	139.88 mmol/L Standard Deviation 1.88	139.89 mmol/L Standard Deviation 1.91
Serum Sodium Burst 2 (9 Months)	140.24 mmol/L Standard Deviation 2.4	140.11 mmol/L Standard Deviation 1.99

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Total Moisture obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Total moisture from diet was captured by the MOIS variable field within the ASA24. This field is quantified in grams (g) of water. Possible results values are limited to values > 0 (i.e., positive values). Basic descriptive statistics were used to summarize data by arm.ASA-2018 and 2020

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Total Moisture Burst 1 (Baseline)	1821 g Standard Deviation 840	1812 g Standard Deviation 791
Self-reported Diet Components and Food Groups: Total Moisture Burst 2 (9 Months)	1943 g Standard Deviation 959	1790 g Standard Deviation 815

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1 (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2, (N=22).

Energy obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Total energy from diet was captured by the KCAL variable field within the ASA24. This field represents kilocalories (kcal) of energy. Possible results values are to values > 500kcal. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Energy Burst 1 (Baseline)	1622.31 kcal Standard Deviation 574.26	1608.62 kcal Standard Deviation 518
Self-reported Diet Components and Food Groups: Energy Burst 2 (9 Months)	1545.25 kcal Standard Deviation 552.32	1560.3 kcal Standard Deviation 532.73

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1 (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2, (N=22).

Protein obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Protein from the diet was captured by the PROT variable field within the ASA24. This field represents grams (g) of protein consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Protein Burst 1 (Baseline)	73.92 g Standard Deviation 27.21	73.31 g Standard Deviation 23.62
Self-reported Diet Components and Food Groups: Protein Burst 2 (9 Months)	73.42 g Standard Deviation 24.5	70.09 g Standard Deviation 27.31

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Total Intact fruits and fruit juices obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Total Intact fruit and fruit juice consumption from the diet was captured by the F_TOTAL variable field within the ASA24. This field represents total fruit consumption in cup equivalents (cup eq). Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Total Intact Fruits + Fruit Juices Burst 1 (Baseline)	0.85 cup eq Standard Deviation 0.91	0.77 cup eq Standard Deviation 0.78
Self-reported Diet Components and Food Groups: Total Intact Fruits + Fruit Juices Burst 2 (9 Months)	0.95 cup eq Standard Deviation 0.92	0.68 cup eq Standard Deviation 0.76

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Dark Green Vegetables obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Dark green vegetable consumption from the diet was captured by the V_DRKGR variable field within the ASA24. This field represents dark green vegetable consumption in cup equivalents (cup eq). Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Dark Green Vegetables Burst 1 (Baseline)	0.3 cup eq Standard Deviation 0.33	0.33 cup eq Standard Deviation 0.34
Self-reported Diet Components and Food Groups: Dark Green Vegetables Burst 2 (9 Months)	0.43 cup eq Standard Deviation 0.45	0.28 cup eq Standard Deviation 0.28

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Total fats obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Total fats from the diet, which consisted of total saturated fatty acids, total monounsaturated fatty acids, and total polyunsaturated fatty acids, was captured by the TFAT variable field within the ASA24. This field represents grams (g) of total fats consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Total Fats Burst 1 (Baseline)	67.3 g Standard Deviation 26.52	66.71 g Standard Deviation 25.45
Self-reported Diet Components and Food Groups: Total Fats Burst 2 (9 Months)	65.69 g Standard Deviation 29.13	66.77 g Standard Deviation 25.4

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Solid fats obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Solid fats from the diet was captured by the DISCFAT_SOL variable field within the ASA24. This field represents grams (g) of solid fats consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Solid Fats Burst 1 (Baseline)	26.84 g Standard Deviation 15.44	26.77 g Standard Deviation 14.68
Self-reported Diet Components and Food Groups: Solid Fats Burst 2 (9 Months)	23.14 g Standard Deviation 15.44	26.93 g Standard Deviation 14.48

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Carbohydrates obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Carbohydrates from the diet was captured by the CARB variable field within the ASA24. This field represents grams (g) of carbohydrates consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Carbohydrates Burst 2 (Baseline)	181.11 g Standard Deviation 74.37	176.49 g Standard Deviation 66.03
Self-reported Diet Components and Food Groups: Carbohydrates Burst 2 (9 Months)	169.66 g Standard Deviation 71.27	169.23 g Standard Deviation 67.2

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Total Folate from food obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Total Folate from food was captured by the FF variable field within the ASA24. This field represents micrograms (mcg) of total folate from food consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Total Folate From Food Burst 1 (Baseline)	199.05 mcg Standard Deviation 93.83	197.56 mcg Standard Deviation 93.23
Self-reported Diet Components and Food Groups: Total Folate From Food Burst 2 (9 Months)	224.17 mcg Standard Deviation 110.14	181.69 mcg Standard Deviation 83.24

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Non-food Folate obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Non-food Folate was captured by the FDFE variable field within the ASA24. This field represents micrograms (mcg) of Non-food Folate consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Non-food Folate Burst 1 (Baseline)	125.15 mcg Standard Deviation 86.02	130.78 mcg Standard Deviation 108.64
Self-reported Diet Components and Food Groups: Non-food Folate Burst 2 (9 Months)	109.97 mcg Standard Deviation 80.89	127.73 mcg Standard Deviation 98.76

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Vitamin B-12 obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Vitamin B-12 was captured by the VB12 variable field within the ASA24. This field represents micrograms (mcg) of Vitamin B-12 consumed (including supplemental sources). Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Vitamin B-12 Burst 1 (Baseline)	4.25 mcg Standard Deviation 2.59	4.21 mcg Standard Deviation 2.64
Self-reported Diet Components and Food Groups: Vitamin B-12 Burst 2 (9 Months)	4.18 mcg Standard Deviation 2.63	4.06 mcg Standard Deviation 2.43

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Alpha Carotene obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Alpha Carotene from the diet was captured by the ACAR variable field within the ASA24. This field represents micrograms (mcg) of Alpha Carotene consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Alpha Carotene Burst 1 (Baseline)	568.66 mcg Standard Deviation 900.88	448.66 mcg Standard Deviation 676.44
Self-reported Diet Components and Food Groups: Alpha Carotene Burst 2 (9 Months)	586.56 mcg Standard Deviation 858.46	392.19 mcg Standard Deviation 626.37

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Beta Carotene obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Beta Carotene from the diet was captured by the BCAR variable field within the ASA24. This field represents micrograms (mcg) of Beta Carotene consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Beta Carotene Burst 1 (Baseline)	3464.67 mcg Standard Deviation 3758.65	3389.68 mcg Standard Deviation 4072.72
Self-reported Diet Components and Food Groups: Beta Carotene Burst 2 (9 Months)	4040.06 mcg Standard Deviation 3887.57	2948.25 mcg Standard Deviation 2823.76

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Retinol obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Retinol from the diet was captured by the RET variable field within the ASA24. This field represents micrograms (mcg) of Retinol consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Retinol Burst 1 (Baseline)	327.45 mcg Standard Deviation 210.72	317.48 mcg Standard Deviation 190.29
Self-reported Diet Components and Food Groups: Retinol Burst 2 (9 Months)	302.99 mcg Standard Deviation 181.71	318.97 mcg Standard Deviation 210.58

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Beta Cryptoxanthin obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Beta Cryptoxanthin from the diet was captured by the CRYP variable field within the ASA24. This field represents micrograms (mcg) of Beta Cryptoxanthin consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Beta Cryptoxanthin Burst 1 (Baseline)	96.49 mcg Standard Deviation 166.36	57.57 mcg Standard Deviation 84.37
Self-reported Diet Components and Food Groups: Beta Cryptoxanthin Burst 2 (9 Months)	81.28 mcg Standard Deviation 111.66	57.41 mcg Standard Deviation 63.53

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Lycopene obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Lycopene from the diet was captured by the LYCO variable field within the ASA24. This field represents micrograms (mcg) of Lycopene consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Lycopene Burst 1 (Baseline)	3905.68 mcg Standard Deviation 5106.71	3558.21 mcg Standard Deviation 3819.37
Self-reported Diet Components and Food Groups: Lycopene Burst 2 (9 Months)	3685.28 mcg Standard Deviation 4671.61	3244.35 mcg Standard Deviation 2902.16

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Lutein + Zeaxanthin obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Lutein + Zeaxanthin from the diet was captured by the LZ variable field within the ASA24. This field represents micrograms (mcg) of Lutein + Zeaxanthin consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Lutein + Zeaxanthin Burst 1 (Baseline)	2885.48 mcg Standard Deviation 3661.72	2765.1 mcg Standard Deviation 4110.87
Self-reported Diet Components and Food Groups: Lutein + Zeaxanthin Burst 2 (9 Months)	3570.56 mcg Standard Deviation 4028.1	2609.09 mcg Standard Deviation 3357.6

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Alpha Tocopherol (Vitamin E) obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Alpha Tocopherol from the diet was captured by the ATOC variable field within the ASA24. This field represents micrograms (mg) of Alpha Tocopherol consumed (including from supplemental sources). Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Alpha Tocopherol (Vitamin E) Burst 1 (Baseline)	7.48 mg Standard Deviation 3.07	7.59 mg Standard Deviation 3.87
Self-reported Diet Components and Food Groups: Alpha Tocopherol (Vitamin E) Burst 2 (9 Months)	8.69 mg Standard Deviation 5.34	7.34 mg Standard Deviation 3.41

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Seafood high in n-3 fatty acids obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Seafood high in n-3 fatty acids from the diet was captured by the M_FISH_HI variable field within the ASA24. This field represents ounce equivalents (oz eq) of Seafood high in n-3 fatty acids consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Seafood High in n-3 Fatty Acids Burst 1 (Baseline)	0.58 oz eq Standard Deviation 0.94	0.44 oz eq Standard Deviation 0.92
Self-reported Diet Components and Food Groups: Seafood High in n-3 Fatty Acids Burst 2 (9 Months)	0.56 oz eq Standard Deviation 1.06	0.44 oz eq Standard Deviation 0.9

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

EPA (P205) obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. EPA (P205) from the diet was captured by the P205 variable field within the ASA24. This field represents grams (g) of EPA (P205) consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: EPA (P205) Burst 1 (Baseline)	0.07 g Standard Deviation 0.01	0.06 g Standard Deviation 0.08
Self-reported Diet Components and Food Groups: EPA (P205) Burst 2 (9 Months)	0.07 g Standard Deviation 0.08	0.05 g Standard Deviation 0.07

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

DHA (P226) obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. DHA (P226) from the diet was captured by the P226 variable field within the ASA24. This field represents grams (g) of DHA (P226) consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: DHA (P226) Burst 1 (Baseline)	0.14 g Standard Deviation 0.17	0.12 g Standard Deviation 0.16
Self-reported Diet Components and Food Groups: DHA (P226) Burst 2 (9 Months)	0.13 g Standard Deviation 0.16	0.1 g Standard Deviation 0.12

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

DPA (P225) obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. DPA (P225) from the diet was captured by the P225 variable field within the ASA24. This field represents grams (g) of DPA (P225) consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: DPA (P225) Burst 1 (Baseline)	0.03 g Standard Deviation 0.03	0.03 g Standard Deviation 0.03
Self-reported Diet Components and Food Groups: DPA (P225) Burst 2 (9 Months)	0.03 g Standard Deviation 0.03	0.02 g Standard Deviation 0.02

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Beans and peas (Legumes) consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Legumes information from the diet was captured by the V_LEGUMES variable field within the ASA24. This field represents cup equivalents (cup eq) of legumes consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Beans and Peas (Legumes) Burst 1 (Baseline)	0.12 cup eq Standard Deviation 0.17	0.1 cup eq Standard Deviation 0.16
Self-reported Diet Components and Food Groups: Beans and Peas (Legumes) Burst 2 (9 Months)	0.14 cup eq Standard Deviation 0.22	0.09 cup eq Standard Deviation 0.14

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Whole grains consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Whole grains information from the diet was captured by the G_WHOLE variable field within the ASA24. This field represents ounce equivalents (oz eq) of whole grains consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Whole Grains Burst 1 (Baseline)	0.75 oz eq Standard Deviation 0.76	0.85 oz eq Standard Deviation 0.93
Self-reported Diet Components and Food Groups: Whole Grains Burst 2 (9 Months)	1.06 oz eq Standard Deviation 1.17	0.90 oz eq Standard Deviation 1.01

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Cured meats consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Cured meats information from the diet was captured by the PF_CUREDMEAT variable field within the ASA24. This field represents ounce equivalents (oz eq) of cured meats consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Cured Meats Burst 1 (Baseline)	0.74 oz eq Standard Deviation 0.93	0.64 oz eq Standard Deviation 0.83
Self-reported Diet Components and Food Groups: Cured Meats Burst 2 (9 Months)	0.63 oz eq Standard Deviation 0.82	0.76 oz eq Standard Deviation 0.95

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Poultry consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Poultry information from the diet was captured by the PF_POULT variable field within the ASA24. This field represents ounce equivalents (oz eq) of poultry consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Poultry Burst 1 (Baseline)	1.82 oz eq Standard Deviation 1.65	1.89 oz eq Standard Deviation 1.64
Self-reported Diet Components and Food Groups: Poultry Burst 2 (9 Months)	1.79 oz eq Standard Deviation 1.56	1.82 oz eq Standard Deviation 1.54

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Nuts and seeds consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Nuts and seeds information from the diet was captured by the PF_NUTSDS variable field within the ASA24. This field represents ounce equivalents (oz eq) of nuts and seeds consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Nuts and Seeds Burst 1 (Baseline)	0.57 oz eq Standard Deviation 0.91	0.58 oz eq Standard Deviation 0.94
Self-reported Diet Components and Food Groups: Nuts and Seeds Burst 2 (9 Months)	0.82 oz eq Standard Deviation 1.43	0.56 oz eq Standard Deviation 0.88

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Cheeses consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Cheese information from the diet was captured by the D_CHEESE variable field within the ASA24. This field represents cup equivalents (cup eq) of cheeses consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Cheeses Burst 1 (Baseline)	0.58 cup eq Standard Deviation 0.48	0.62 cup eq Standard Deviation 0.6
Self-reported Diet Components and Food Groups: Cheeses Burst 2 (9 Months)	0.51 cup eq Standard Deviation 0.54	0.54 cup eq Standard Deviation 0.48

SECONDARY outcome

Timeframe: Baseline (Burst 1) and 9 months (Burst 2)

Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).

Added sugars consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Added sugars information from the diet was captured by the ADD_SUGARS variable field within the ASA24. This field represents tablespoon equivalents (tsp eq) of added sugars consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Self-reported Diet Components and Food Groups: Added Sugars Burst 1 (Baseline)	10.06 tsp eq Standard Deviation 7.57	9.91 tsp eq Standard Deviation 6.79
Self-reported Diet Components and Food Groups: Added Sugars Burst 2 (9 Months)	7.91 tsp eq Standard Deviation 6.02	9.31 tsp eq Standard Deviation 6.89

SECONDARY outcome

Timeframe: Baseline (Burst 1), and 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-intervention

Population: Missing data: MHD, Burst 1, (N=4); MHD, Burst 2 (N=29); MHD, Burst 3 (N=24); MHD, Burst 4 (N=20). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=31); Comparison, Burst 3 (N=34); Comparison, Burst 4 (N=15).

Symbol Search Task Performance is an ambulatory cognitive assessment of processing speed/attention. The task is administered 5 times daily throughout each 7-day measurement Burst (Baseline, 9 months, 18 months, 27 months). Mean response time in milliseconds (ms) for accurate trials will be determined and reported. Possible values ranges for Symbol Search Task Performance are >0 ms (i.e., positive values). Lower Symbol Search Task Performance values in mean response time are indicative of improvement in cognitive processing.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=140 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Symbol Search Task Performance Burst 3 (18 months)	1,845.0 ms Standard Deviation 465.6	1,825.6 ms Standard Deviation 470.7
Symbol Search Task Performance Burst 1 (Baseline)	1,874.7 ms Standard Deviation 474.3	1,846.4 ms Standard Deviation 466.3
Symbol Search Task Performance Burst 2 (9 months)	1,854.4 ms Standard Deviation 537.5	1,800.5 ms Standard Deviation 457.8
Symbol Search Task Performance Burst 4 (27 months)	1,765.2 ms Standard Deviation 529.3	1,812.0 ms Standard Deviation 445.0

SECONDARY outcome

Timeframe: Baseline (Burst 1), and 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-intervention

Population: Missing data: MHD, Burst 1, (N=4); MHD, Burst 2 (N=29); MHD, Burst 3 (N=24); MHD, Burst 4 (N=20). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=31); Comparison, Burst 3 (N=34); Comparison, Burst 4 (N=15).

Grid Memory Task Performance is an ambulatory cognitive assessment of visuospatial working memory. The task is administered 5 times daily throughout each 7-day measurement Burst (Baseline, 9 months, 18 months, 27 months). The mean error distance (pixel Euclidean distance, represented in pixels) of the red dots between study and recall arrays will be quantified and reported based on the completion of 4 trials. Possible value ranges for pixels are >0 (i.e., positive values). Lower pixel values are indicative of improved short-term recall and visuospatial working memory.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=140 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Grid Memory Task Performance Burst 1 (Baseline)	34.0 pixels Standard Deviation 15.6	35.2 pixels Standard Deviation 15.3
Grid Memory Task Performance Burst 2 (9 months)	29.0 pixels Standard Deviation 14.7	30.4 pixels Standard Deviation 15.4
Grid Memory Task Performance Burst 3 (18 months)	26.8 pixels Standard Deviation 15.5	31.6 pixels Standard Deviation 15.8
Grid Memory Task Performance Burst 4 (27 months)	25.6 pixels Standard Deviation 15.7	27.4 pixels Standard Deviation 16.3

SECONDARY outcome

Timeframe: Baseline (Burst 1), and 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-intervention

Population: Missing data: MHD, Burst 1, (N=4); MHD, Burst 2 (N=29); MHD, Burst 3 (N=24); MHD, Burst 4 (N=20). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=31); Comparison, Burst 3 (N=34); Comparison, Burst 4 (N=15).

Color Shapes Task Performance is an ambulatory cognitive assessment of short-term associative visual memory. The task is administered 5 times daily throughout each 7-day measurement Burst. The task had 2 conditions, signal present and signal absent. Hit rate represents the proportion of trials where participants correctly responded that signal was present. False alarm rate represents the proportion of trials where a signal was absent where participants incorrectly responded that a signal was present. Corrected Recognition Score represents the overall sensitivity to the signal and is calculated by subtracting the False alarm rate from the Hit rate and is summarized by study arm as described in Hakun, et.al., (2024). Mobile Monitoring of Cognitive Change (M2C2): High-Frequency Assessments and Protocol Reporting Guidelines. Possible ranges for Corrected Recognition Score are -1 to 1. Higher Corrected Recognition Rate values are indicative of better short term associative memory-binding.

Outcome measures

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=140 Participants 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 Participants 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Color Shapes Task Performance Burst 1 (Baseline)	0.6 Corrected Recognition Score Standard Deviation 0.2	0.6 Corrected Recognition Score Standard Deviation 0.2
Color Shapes Task Performance Burst 2 (9 months)	0.6 Corrected Recognition Score Standard Deviation 0.2	0.6 Corrected Recognition Score Standard Deviation 0.2
Color Shapes Task Performance Burst 3 (18 months)	0.6 Corrected Recognition Score Standard Deviation 0.2	0.6 Corrected Recognition Score Standard Deviation 0.2
Color Shapes Task Performance Burst 4 (27 months)	0.7 Corrected Recognition Score Standard Deviation 0.2	0.7 Corrected Recognition Score Standard Deviation 0.2

Adverse Events

Anti-inflammatory Dietary Intervention (MHD Arm)

Serious events: 9 serious events

Other events: 73 other events

Deaths: 0 deaths

Usual Diet Plus Self-Care (Comparison Arm)

Serious events: 10 serious events

Other events: 71 other events

Deaths: 0 deaths

Serious adverse events

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 participants at risk 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 participants at risk 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Infections and infestations Hospitalization for COVID-19	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	2.7% 4/146 • Adverse event data was collected every 9 months, up to 27 months total
Surgical and medical procedures Breast Cancer, Surgery and Chemotherapy	0.00% 0/144 • Adverse event data was collected every 9 months, up to 27 months total	2.7% 4/146 • Adverse event data was collected every 9 months, up to 27 months total
Nervous system disorders Hospitalization for Stress	0.00% 0/144 • Adverse event data was collected every 9 months, up to 27 months total	0.68% 1/146 • Adverse event data was collected every 9 months, up to 27 months total
Surgical and medical procedures Treatment for Brain Cancer	0.00% 0/144 • Adverse event data was collected every 9 months, up to 27 months total	0.68% 1/146 • Adverse event data was collected every 9 months, up to 27 months total
Surgical and medical procedures Hospitalization for Stent Placement	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.00% 0/146 • Adverse event data was collected every 9 months, up to 27 months total
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Cancer	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.00% 0/146 • Adverse event data was collected every 9 months, up to 27 months total
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.00% 0/146 • Adverse event data was collected every 9 months, up to 27 months total
Gastrointestinal disorders Pancreatitis	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.00% 0/146 • Adverse event data was collected every 9 months, up to 27 months total
Cardiac disorders Congestive Heart Failure	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.00% 0/146 • Adverse event data was collected every 9 months, up to 27 months total
Renal and urinary disorders Acute Renal Failure	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.00% 0/146 • Adverse event data was collected every 9 months, up to 27 months total
Cardiac disorders Heart Attack, Heart Surgery	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.00% 0/146 • Adverse event data was collected every 9 months, up to 27 months total
Surgical and medical procedures Gastric Bypass Revision	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.00% 0/146 • Adverse event data was collected every 9 months, up to 27 months total
Surgical and medical procedures Emergent Visit for Gastric Bypass	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.00% 0/146 • Adverse event data was collected every 9 months, up to 27 months total

Other adverse events

Measure	Anti-inflammatory Dietary Intervention (MHD Arm) n=144 participants at risk 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet, Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential	Usual Diet Plus Self-Care (Comparison Arm) n=146 participants at risk 18 month intervention of usual diet plus self-care modules Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Respiratory, thoracic and mediastinal disorders Respiratory Problems	1.4% 2/144 • Adverse event data was collected every 9 months, up to 27 months total	1.4% 2/146 • Adverse event data was collected every 9 months, up to 27 months total
Nervous system disorders Headache	5.6% 8/144 • Adverse event data was collected every 9 months, up to 27 months total	5.5% 8/146 • Adverse event data was collected every 9 months, up to 27 months total
Vascular disorders High Blood Pressure	13.9% 20/144 • Adverse event data was collected every 9 months, up to 27 months total	12.3% 18/146 • Adverse event data was collected every 9 months, up to 27 months total
Gastrointestinal disorders Periodontal Disease	2.1% 3/144 • Adverse event data was collected every 9 months, up to 27 months total	0.68% 1/146 • Adverse event data was collected every 9 months, up to 27 months total
Musculoskeletal and connective tissue disorders Osteoarthritis, Fibromyalgia/Osteoarthritis, muscular or bone problems	6.9% 10/144 • Adverse event data was collected every 9 months, up to 27 months total	5.5% 8/146 • Adverse event data was collected every 9 months, up to 27 months total
Metabolism and nutrition disorders Obesity	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.00% 0/146 • Adverse event data was collected every 9 months, up to 27 months total
Gastrointestinal disorders Stomach or Bowel Issues	2.1% 3/144 • Adverse event data was collected every 9 months, up to 27 months total	4.8% 7/146 • Adverse event data was collected every 9 months, up to 27 months total
Ear and labyrinth disorders Hearing or Vision Problems	10.4% 15/144 • Adverse event data was collected every 9 months, up to 27 months total	11.6% 17/146 • Adverse event data was collected every 9 months, up to 27 months total
Blood and lymphatic system disorders Blood Circulation or Blood-Related Problems	4.2% 6/144 • Adverse event data was collected every 9 months, up to 27 months total	1.4% 2/146 • Adverse event data was collected every 9 months, up to 27 months total
Cardiac disorders Chest Pain or Irregular Heartbeat	2.8% 4/144 • Adverse event data was collected every 9 months, up to 27 months total	4.1% 6/146 • Adverse event data was collected every 9 months, up to 27 months total
Nervous system disorders Carpal Tunnel	0.00% 0/144 • Adverse event data was collected every 9 months, up to 27 months total	1.4% 2/146 • Adverse event data was collected every 9 months, up to 27 months total
Surgical and medical procedures Knee Replacement	0.00% 0/144 • Adverse event data was collected every 9 months, up to 27 months total	2.1% 3/146 • Adverse event data was collected every 9 months, up to 27 months total
Skin and subcutaneous tissue disorders Dermatitis, Eczema	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.00% 0/146 • Adverse event data was collected every 9 months, up to 27 months total
Immune system disorders Rheumatoid Arthritis, Immune Deficiency Syndrome, Multiple Sclerosis, Scleroderma,Autoimmune Disease	4.2% 6/144 • Adverse event data was collected every 9 months, up to 27 months total	3.4% 5/146 • Adverse event data was collected every 9 months, up to 27 months total
Respiratory, thoracic and mediastinal disorders COPD, Asthma, Emphysema, Chronic Bronchitis, Other Respiratory Problem	4.2% 6/144 • Adverse event data was collected every 9 months, up to 27 months total	4.8% 7/146 • Adverse event data was collected every 9 months, up to 27 months total
Blood and lymphatic system disorders Sickle Cell Disease	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.00% 0/146 • Adverse event data was collected every 9 months, up to 27 months total
Infections and infestations Legionnaires' Pneumonia	0.00% 0/144 • Adverse event data was collected every 9 months, up to 27 months total	0.68% 1/146 • Adverse event data was collected every 9 months, up to 27 months total
Respiratory, thoracic and mediastinal disorders Sleep Apnea	0.00% 0/144 • Adverse event data was collected every 9 months, up to 27 months total	0.68% 1/146 • Adverse event data was collected every 9 months, up to 27 months total
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.00% 0/146 • Adverse event data was collected every 9 months, up to 27 months total
Metabolism and nutrition disorders Diabetes	1.4% 2/144 • Adverse event data was collected every 9 months, up to 27 months total	2.1% 3/146 • Adverse event data was collected every 9 months, up to 27 months total
Surgical and medical procedures Major Surgery	4.2% 6/144 • Adverse event data was collected every 9 months, up to 27 months total	4.1% 6/146 • Adverse event data was collected every 9 months, up to 27 months total
Investigations Cholesterol, High	0.00% 0/144 • Adverse event data was collected every 9 months, up to 27 months total	0.68% 1/146 • Adverse event data was collected every 9 months, up to 27 months total
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary Gland Adenoma	0.00% 0/144 • Adverse event data was collected every 9 months, up to 27 months total	0.68% 1/146 • Adverse event data was collected every 9 months, up to 27 months total
Infections and infestations COVID-19	20.1% 29/144 • Adverse event data was collected every 9 months, up to 27 months total	19.9% 29/146 • Adverse event data was collected every 9 months, up to 27 months total
Ear and labyrinth disorders Vertigo	0.00% 0/144 • Adverse event data was collected every 9 months, up to 27 months total	1.4% 2/146 • Adverse event data was collected every 9 months, up to 27 months total
Endocrine disorders Thyroid Problems	0.00% 0/144 • Adverse event data was collected every 9 months, up to 27 months total	1.4% 2/146 • Adverse event data was collected every 9 months, up to 27 months total
Psychiatric disorders Emotional or Psychiatric Problems	2.1% 3/144 • Adverse event data was collected every 9 months, up to 27 months total	0.68% 1/146 • Adverse event data was collected every 9 months, up to 27 months total
Immune system disorders Human Immunodeficiency Virus (HIV)	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	1.4% 2/146 • Adverse event data was collected every 9 months, up to 27 months total
Infections and infestations Urinary Tract Infections (frequent)	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.00% 0/146 • Adverse event data was collected every 9 months, up to 27 months total
Injury, poisoning and procedural complications Broken Toe	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.00% 0/146 • Adverse event data was collected every 9 months, up to 27 months total
Pregnancy, puerperium and perinatal conditions Pregnant	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.00% 0/146 • Adverse event data was collected every 9 months, up to 27 months total
Injury, poisoning and procedural complications Ankle, Knee Injury	0.00% 0/144 • Adverse event data was collected every 9 months, up to 27 months total	0.68% 1/146 • Adverse event data was collected every 9 months, up to 27 months total
Reproductive system and breast disorders Perimenopause (possible)	0.00% 0/144 • Adverse event data was collected every 9 months, up to 27 months total	0.68% 1/146 • Adverse event data was collected every 9 months, up to 27 months total
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/144 • Adverse event data was collected every 9 months, up to 27 months total	0.68% 1/146 • Adverse event data was collected every 9 months, up to 27 months total
Surgical and medical procedures Hernia Surgery	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.00% 0/146 • Adverse event data was collected every 9 months, up to 27 months total
Hepatobiliary disorders Liver-Related	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.68% 1/146 • Adverse event data was collected every 9 months, up to 27 months total
Injury, poisoning and procedural complications Concussion	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.00% 0/146 • Adverse event data was collected every 9 months, up to 27 months total
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Tumor, benign	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.00% 0/146 • Adverse event data was collected every 9 months, up to 27 months total
Musculoskeletal and connective tissue disorders Gout	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.00% 0/146 • Adverse event data was collected every 9 months, up to 27 months total
Surgical and medical procedures Bilateral Vein Procedure	0.69% 1/144 • Adverse event data was collected every 9 months, up to 27 months total	0.00% 0/146 • Adverse event data was collected every 9 months, up to 27 months total
Renal and urinary disorders Kidney Stones	0.00% 0/144 • Adverse event data was collected every 9 months, up to 27 months total	1.4% 2/146 • Adverse event data was collected every 9 months, up to 27 months total

Additional Information

Dr. Yasmin Mossavar-Rahmani

Albert Einstein College of Medicine

Phone: 718-430-2136

Email: yasmin.mossavar-rahmani@einsteinmed.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place