Trial Outcomes & Findings for Evaluation of Ovarian Morphology and Function in Overweight Women During Weight Loss (NCT NCT01785719)

Last Updated: 2025-02-03

Results Overview

Participants with irregular menstrual cycles at baseline were categorized as "responders" or "non-responders" based on any changes they experienced in menstrual cyclicity over the course of the intervention. "Responders" were defined as participants who shifted towards a more favorable menstrual cycle status over the course of the intervention. "Non-responders" were defined as participants who experienced no change or a shift to a less favorable menstrual cycle status over the course of the intervention. Menstrual cycle status categories were defined as "Amenorrhea" (mean cycle length\>90 days; least favorable), "Oligomenorrhea" (mean cycle length 36-90 days; unfavorable), and "Regular" (mean cycle length 21-35 days; most favorable). All participants with regular menstrual cycles at baseline maintained regular cycles over the course of the intervention and were therefore not included in this analysis.

Recruitment status

COMPLETED

Study phase

Target enrollment

79 participants

Primary outcome timeframe

Up to 7 months

Results posted on

2025-02-03

Participant Flow

Women ages 18-38 with BMI \>25 kg/m\*m with regular menstrual cycles or irregular menstrual cycles (with or without PCOS). No use of hormonal contraception, fertility therapy, or insulin-sensitizing medication in the 3 months prior to enrollment. All participants completed 4-week baseline evaluation. Participants enrolled before 2018 completed a 12-week hypocaloric dietary intervention. The study was amended in 2018 to increase the duration of the intervention to 24 weeks.

Most participants experienced a lag between enrollment and the start of baseline due to scheduling, med washout, and/or stage of menstrual cycle. Some participants were lost to follow-up during this time. Additionally, the first 2 weeks of baseline were used to assess ovarian ultrasound image quality and vein status to confirm eligibility. Participants were excluded if we could not achieve consistent high quality ovarian ultrasound images and/or successful venipuncture in the first 2 weeks.

Participant milestones

Participant milestones
Measure	Irregular Cycles (With or Without Additional Features of PCOS) Individuals with irregular menstrual cycles at baseline with or without additional features of PCOS. Irregular menstrual cycles were defined as mean cycle length \>35 days over the past year, based on self-reported menstrual cycle dates at enrollment.	Regular Cycles Individuals with regular menstrual cycles at baseline. Regular menstrual cycles were defined as mean cycle length 21-35 days over the past year, based on self-reported menstrual cycle dates at enrollment.
4-week Baseline Evaluation STARTED	42	37
4-week Baseline Evaluation COMPLETED	34	24
4-week Baseline Evaluation NOT COMPLETED	8	13
Hypocaloric Dietary Intervention STARTED	34	24
Hypocaloric Dietary Intervention COMPLETED	30	18
Hypocaloric Dietary Intervention NOT COMPLETED	4	6
6-month Post-intervention Follow-up STARTED	30	18
6-month Post-intervention Follow-up COMPLETED	18	14
6-month Post-intervention Follow-up NOT COMPLETED	12	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Irregular Cycles (With or Without Additional Features of PCOS) Individuals with irregular menstrual cycles at baseline with or without additional features of PCOS. Irregular menstrual cycles were defined as mean cycle length \>35 days over the past year, based on self-reported menstrual cycle dates at enrollment.	Regular Cycles Individuals with regular menstrual cycles at baseline. Regular menstrual cycles were defined as mean cycle length 21-35 days over the past year, based on self-reported menstrual cycle dates at enrollment.
4-week Baseline Evaluation Physician Decision	1	0
4-week Baseline Evaluation Withdrawal by Subject	1	2
4-week Baseline Evaluation Lost to Follow-up	0	1
4-week Baseline Evaluation Pregnancy	0	2
4-week Baseline Evaluation Poor vein access and/or ultrasound image quality	4	8
4-week Baseline Evaluation Exclusionary medication	2	0
Hypocaloric Dietary Intervention Adverse Event	1	0
Hypocaloric Dietary Intervention Physician Decision	1	0
Hypocaloric Dietary Intervention Withdrawal by Investigator - Poor Compliance	1	2
Hypocaloric Dietary Intervention Research Restrictions (COVID)	1	2
Hypocaloric Dietary Intervention Poor vein access and/or ultrasound image quality	0	1
Hypocaloric Dietary Intervention Participant initiated an exclusionary medication.	0	1
6-month Post-intervention Follow-up Lost to Follow-up	12	2
6-month Post-intervention Follow-up Pregnancy	0	1
6-month Post-intervention Follow-up Exclusionary medication	0	1

Baseline Characteristics

Evaluation of Ovarian Morphology and Function in Overweight Women During Weight Loss

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Irregular Cycles (With or Without Additional Features of PCOS) n=30 Participants Participants who completed the hypocaloric dietary intervention\* and reported irregular menstrual cycles at baseline. Irregular menstrual cycles were defined as mean cycle length \>35 days over the past year, based on self-reported menstrual cycle dates at enrollment. \*Participants enrolled before 2018 completed a 12-week dietary intervention and participants enrolled 2018 and later completed a 24-week dietary intervention.	Regular Cycles n=18 Participants Participants who completed the hypocaloric dietary intervention\* and reported regular menstrual cycles at baseline. Regular menstrual cycles were defined as mean cycle length 21-35 days over the past year, based on self-reported menstrual cycle dates at enrollment. \*Participants enrolled before 2018 completed a 12-week dietary intervention and participants enrolled 2018 and later completed a 24-week dietary intervention.	Total n=48 Participants Total of all reporting groups
Age, Continuous	28 years STANDARD_DEVIATION 5 • n=5 Participants	31 years STANDARD_DEVIATION 3 • n=7 Participants	29 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	18 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	17 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	16 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	18 participants n=7 Participants	48 participants n=5 Participants
Body Mass Index	37 kg/m*m STANDARD_DEVIATION 6 • n=5 Participants	37 kg/m*m STANDARD_DEVIATION 7 • n=7 Participants	37 kg/m*m STANDARD_DEVIATION 6 • n=5 Participants
Menstrual Cycle Length	84 days STANDARD_DEVIATION 67 • n=5 Participants	30 days STANDARD_DEVIATION 2 • n=7 Participants	65 days STANDARD_DEVIATION 59 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 7 months

Population: This table includes outcome data for all participants who completed either the 12-wk or 24-wk hypocaloric dietary intervention, depending on year of enrollment (participants pre-2018 completed 12 weeks, participants 2018 and later completed 24 weeks). Irregular menstrual cycles were defined as mean cycle length \>35 days over the past year, based on self-reported menstrual cycle dates at enrollment.

Outcome measures

Outcome measures
Measure	Irregular Cycles (With or Without Additional Features of PCOS) n=30 Participants Participants who completed the hypocaloric dietary intervention\* and reported irregular menstrual cycles at baseline. Irregular menstrual cycles were defined as mean cycle length \>35 days over the past year, based on self-reported menstrual cycle dates at enrollment. \*Participants enrolled before 2018 completed a 12-week dietary intervention and participants enrolled 2018 and later completed a 24-week dietary intervention.	Regular Cycles Participants who completed the hypocaloric dietary intervention\* and reported regular menstrual cycles at baseline. Regular menstrual cycles were defined as mean cycle length 21-35 days over the past year, based on self-reported menstrual cycle dates at enrollment. \*Participants enrolled before 2018 completed a 12-week dietary intervention and participants enrolled 2018 and later completed a 24-week dietary intervention.
Change From Baseline Ovulatory/Menstrual Function Responders	12 Participants	—
Change From Baseline Ovulatory/Menstrual Function Non-Responders	18 Participants	—

SECONDARY outcome

Timeframe: Up to 7 months

Change in follicle number per ovary (FNPO) from baseline to the end of a hypocaloric dietary intervention. Ovarian images were collected using 3D transvaginal ultrasonography and were assessed for morphological endpoints by trained raters using the 2D offline grid method. FNPO was calculated by summing all 2-9 mm follicles in each ovary. Left and right FNPO were averaged for each participant before baseline to post-intervention changes were calculated.

Outcome measures

Outcome measures
Measure	Irregular Cycles (With or Without Additional Features of PCOS) n=30 Participants Participants who completed the hypocaloric dietary intervention\* and reported irregular menstrual cycles at baseline. Irregular menstrual cycles were defined as mean cycle length \>35 days over the past year, based on self-reported menstrual cycle dates at enrollment. \*Participants enrolled before 2018 completed a 12-week dietary intervention and participants enrolled 2018 and later completed a 24-week dietary intervention.	Regular Cycles n=18 Participants Participants who completed the hypocaloric dietary intervention\* and reported regular menstrual cycles at baseline. Regular menstrual cycles were defined as mean cycle length 21-35 days over the past year, based on self-reported menstrual cycle dates at enrollment. \*Participants enrolled before 2018 completed a 12-week dietary intervention and participants enrolled 2018 and later completed a 24-week dietary intervention.
Change From Baseline Follicle Number Per Ovary	-5 Follicle number per ovary Standard Deviation 14	-9 Follicle number per ovary Standard Deviation 11

SECONDARY outcome

Timeframe: Up to 7 months

Change in reproductive hormones from baseline to the end of a hypocaloric dietary intervention. Blood samples were collected in the morning after an overnight fast during the early follicular phase as confirmed by the absence of a dominant follicle or corpus luteum on ultrasound. Hormones reported include: * Total testosterone: Evaluated by the Brigham Research Assay Core (Harvard) using liquid chromatography tandem mass-spectrometry. Results are reported in ng/dL. * Anti-Müllerian hormone (AMH): Evaluated using the Motive Biosciences (formerly Ansh Labs) picoAMH ELISA. Results are reported in ng/mL

Outcome measures

Outcome measures
Measure	Irregular Cycles (With or Without Additional Features of PCOS) n=30 Participants Participants who completed the hypocaloric dietary intervention\* and reported irregular menstrual cycles at baseline. Irregular menstrual cycles were defined as mean cycle length \>35 days over the past year, based on self-reported menstrual cycle dates at enrollment. \*Participants enrolled before 2018 completed a 12-week dietary intervention and participants enrolled 2018 and later completed a 24-week dietary intervention.	Regular Cycles n=18 Participants Participants who completed the hypocaloric dietary intervention\* and reported regular menstrual cycles at baseline. Regular menstrual cycles were defined as mean cycle length 21-35 days over the past year, based on self-reported menstrual cycle dates at enrollment. \*Participants enrolled before 2018 completed a 12-week dietary intervention and participants enrolled 2018 and later completed a 24-week dietary intervention.
Change From Baseline Reproductive Hormones Change in Total testosterone (ng/dL)	20 ng/dL Standard Deviation 52	-5 ng/dL Standard Deviation 8
Change From Baseline Reproductive Hormones Change in AMH (ng/dL)	0.32 ng/dL Standard Deviation 2.77	-0.38 ng/dL Standard Deviation 2.91

SECONDARY outcome

Timeframe: Up to 7 months

Change in metabolic status from baseline to the end of a hypocaloric dietary intervention. HOMA-IR (Homeostasis Model Assessment of Insulin Resistance) was used as an indicator of metabolic status. HOMA-IR uses fasting blood glucose and insulin values to approximate insulin resistance. Blood glucose and insulin were measured in the morning after an overnight fast during the early follicular phase as confirmed by the absence of a dominant follicle or corpus luteum on ultrasound. HOMA-IR was calculated by multiplying blood glucose (mg/dL) by insulin (mIU/mL) and dividing by 405. A higher HOMA-IR score is indicative of increased insulin resistance.

Outcome measures

Outcome measures
Measure	Irregular Cycles (With or Without Additional Features of PCOS) n=30 Participants Participants who completed the hypocaloric dietary intervention\* and reported irregular menstrual cycles at baseline. Irregular menstrual cycles were defined as mean cycle length \>35 days over the past year, based on self-reported menstrual cycle dates at enrollment. \*Participants enrolled before 2018 completed a 12-week dietary intervention and participants enrolled 2018 and later completed a 24-week dietary intervention.	Regular Cycles n=18 Participants Participants who completed the hypocaloric dietary intervention\* and reported regular menstrual cycles at baseline. Regular menstrual cycles were defined as mean cycle length 21-35 days over the past year, based on self-reported menstrual cycle dates at enrollment. \*Participants enrolled before 2018 completed a 12-week dietary intervention and participants enrolled 2018 and later completed a 24-week dietary intervention.
Change From Baseline Metabolic Status (HOMA-IR)	-1.3 HOMA-IR score Standard Deviation 2.5	-0.9 HOMA-IR score Standard Deviation 0.8

SECONDARY outcome

Timeframe: Up to 7 months

Change in total percent body fat from baseline to the end of a hypocaloric dietary intervention. Body fat was measured using the Hologic Discovery A Dual X-Ray Absorptiometry (DXA) Scanner.

Outcome measures

Outcome measures
Measure	Irregular Cycles (With or Without Additional Features of PCOS) n=30 Participants Participants who completed the hypocaloric dietary intervention\* and reported irregular menstrual cycles at baseline. Irregular menstrual cycles were defined as mean cycle length \>35 days over the past year, based on self-reported menstrual cycle dates at enrollment. \*Participants enrolled before 2018 completed a 12-week dietary intervention and participants enrolled 2018 and later completed a 24-week dietary intervention.	Regular Cycles n=18 Participants Participants who completed the hypocaloric dietary intervention\* and reported regular menstrual cycles at baseline. Regular menstrual cycles were defined as mean cycle length 21-35 days over the past year, based on self-reported menstrual cycle dates at enrollment. \*Participants enrolled before 2018 completed a 12-week dietary intervention and participants enrolled 2018 and later completed a 24-week dietary intervention.
Change From Baseline Total Percent Body Fat	-1.8 Percent body fat Standard Deviation 1.6	-1.6 Percent body fat Standard Deviation 4.3

SECONDARY outcome

Timeframe: Up to 7 months

Change ovarian volume (cm\^3) from baseline to the end of a hypocaloric dietary intervention. Ovarian images were collected using 3D transvaginal ultrasonography and were assessed for morphological endpoints by trained raters using the 2D offline grid method. Ovarian volume was calculated using a modified formula for a prolate ellipsoid. Left and right ovarian volumes were averaged for each participant before baseline to post-intervention changes were calculated.

Outcome measures

Outcome measures
Measure	Irregular Cycles (With or Without Additional Features of PCOS) n=30 Participants Participants who completed the hypocaloric dietary intervention\* and reported irregular menstrual cycles at baseline. Irregular menstrual cycles were defined as mean cycle length \>35 days over the past year, based on self-reported menstrual cycle dates at enrollment. \*Participants enrolled before 2018 completed a 12-week dietary intervention and participants enrolled 2018 and later completed a 24-week dietary intervention.	Regular Cycles n=18 Participants Participants who completed the hypocaloric dietary intervention\* and reported regular menstrual cycles at baseline. Regular menstrual cycles were defined as mean cycle length 21-35 days over the past year, based on self-reported menstrual cycle dates at enrollment. \*Participants enrolled before 2018 completed a 12-week dietary intervention and participants enrolled 2018 and later completed a 24-week dietary intervention.
Change From Baseline Ovarian Volume	-1.9 cm^3 Standard Deviation 2.8	0.9 cm^3 Standard Deviation 2.0

SECONDARY outcome

Timeframe: Up to 7 months

Change in FAI from baseline to the end of a hypocaloric dietary intervention. Blood samples were collected in the morning after an overnight fast during the early follicular phase as confirmed by the absence of a dominant follicle or corpus luteum on ultrasound. Free Androgen Index (FAI) is the ratio of total testosterone to sex hormone binding globulin (SHBG), indicating the amount of active testosterone in the blood. SHBG was evaluated by the Cornell Human Nutrition Chemistry Service Laboratory using Immulite 2000 immunoassay. FAI levels of 5 or higher are indicative of PCOS.

Outcome measures

Outcome measures
Measure	Irregular Cycles (With or Without Additional Features of PCOS) n=30 Participants Participants who completed the hypocaloric dietary intervention\* and reported irregular menstrual cycles at baseline. Irregular menstrual cycles were defined as mean cycle length \>35 days over the past year, based on self-reported menstrual cycle dates at enrollment. \*Participants enrolled before 2018 completed a 12-week dietary intervention and participants enrolled 2018 and later completed a 24-week dietary intervention.	Regular Cycles n=18 Participants Participants who completed the hypocaloric dietary intervention\* and reported regular menstrual cycles at baseline. Regular menstrual cycles were defined as mean cycle length 21-35 days over the past year, based on self-reported menstrual cycle dates at enrollment. \*Participants enrolled before 2018 completed a 12-week dietary intervention and participants enrolled 2018 and later completed a 24-week dietary intervention.
Change From Baseline Free Androgen Index (FAI)	2 free androgen index Standard Deviation 9	-1 free androgen index Standard Deviation 1

SECONDARY outcome

Timeframe: Up to 7 months

Change in BMI from baseline to the end of a hypocaloric dietary intervention.

Outcome measures

Outcome measures
Measure	Irregular Cycles (With or Without Additional Features of PCOS) n=30 Participants Participants who completed the hypocaloric dietary intervention\* and reported irregular menstrual cycles at baseline. Irregular menstrual cycles were defined as mean cycle length \>35 days over the past year, based on self-reported menstrual cycle dates at enrollment. \*Participants enrolled before 2018 completed a 12-week dietary intervention and participants enrolled 2018 and later completed a 24-week dietary intervention.	Regular Cycles n=18 Participants Participants who completed the hypocaloric dietary intervention\* and reported regular menstrual cycles at baseline. Regular menstrual cycles were defined as mean cycle length 21-35 days over the past year, based on self-reported menstrual cycle dates at enrollment. \*Participants enrolled before 2018 completed a 12-week dietary intervention and participants enrolled 2018 and later completed a 24-week dietary intervention.
Change From Baseline BMI	-2.8 kg/m^2 Standard Deviation 1.5	-3.8 kg/m^2 Standard Deviation 1.9

Adverse Events

Irregular Cycles (With or Without Additional Features of PCOS)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Regular Cycles

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Irregular Cycles (With or Without Additional Features of PCOS) n=42 participants at risk Participants who completed the hypocaloric dietary intervention\* and reported irregular menstrual cycles at baseline. Irregular menstrual cycles were defined as mean cycle length \>35 days over the past year, based on self-reported menstrual cycle dates at enrollment. \*Participants enrolled before 2018 completed a 12-week dietary intervention and participants enrolled 2018 and later completed a 24-week dietary intervention.	Regular Cycles n=37 participants at risk Participants who completed the hypocaloric dietary intervention\* and reported regular menstrual cycles at baseline. Regular menstrual cycles were defined as mean cycle length 21-35 days over the past year, based on self-reported menstrual cycle dates at enrollment. \*Participants enrolled before 2018 completed a 12-week dietary intervention and participants enrolled 2018 and later completed a 24-week dietary intervention.
Endocrine disorders Fasting blood glucose value of >120 mg/dL	7.1% 3/42 • Number of events 3 • Adverse event data were collected over 13 months (including up to 7 months of baseline and dietary intervention, plus a single follow-up visit 6 months later). All participants who enrolled in the study were considered at risk for adverse events. A systematic approach was used to assess adverse events. During each study visit (2-6 times per week), research team members asked participants whether they were experiencing any adverse symptoms related to the study diet or study procedures. Research team members reviewed fasting blood glucose results and did not proceed with the oral glucose tolerance test if a participant's value exceeded 120 mg/dL.	0.00% 0/37 • Adverse event data were collected over 13 months (including up to 7 months of baseline and dietary intervention, plus a single follow-up visit 6 months later). All participants who enrolled in the study were considered at risk for adverse events. A systematic approach was used to assess adverse events. During each study visit (2-6 times per week), research team members asked participants whether they were experiencing any adverse symptoms related to the study diet or study procedures. Research team members reviewed fasting blood glucose results and did not proceed with the oral glucose tolerance test if a participant's value exceeded 120 mg/dL.
Endocrine disorders 2 hour blood glucose value of 140-199 mg/dL	14.3% 6/42 • Number of events 8 • Adverse event data were collected over 13 months (including up to 7 months of baseline and dietary intervention, plus a single follow-up visit 6 months later). All participants who enrolled in the study were considered at risk for adverse events. A systematic approach was used to assess adverse events. During each study visit (2-6 times per week), research team members asked participants whether they were experiencing any adverse symptoms related to the study diet or study procedures. Research team members reviewed fasting blood glucose results and did not proceed with the oral glucose tolerance test if a participant's value exceeded 120 mg/dL.	2.7% 1/37 • Number of events 1 • Adverse event data were collected over 13 months (including up to 7 months of baseline and dietary intervention, plus a single follow-up visit 6 months later). All participants who enrolled in the study were considered at risk for adverse events. A systematic approach was used to assess adverse events. During each study visit (2-6 times per week), research team members asked participants whether they were experiencing any adverse symptoms related to the study diet or study procedures. Research team members reviewed fasting blood glucose results and did not proceed with the oral glucose tolerance test if a participant's value exceeded 120 mg/dL.
Skin and subcutaneous tissue disorders Hypertrophic scarring at venipuncture site	0.00% 0/42 • Adverse event data were collected over 13 months (including up to 7 months of baseline and dietary intervention, plus a single follow-up visit 6 months later). All participants who enrolled in the study were considered at risk for adverse events. A systematic approach was used to assess adverse events. During each study visit (2-6 times per week), research team members asked participants whether they were experiencing any adverse symptoms related to the study diet or study procedures. Research team members reviewed fasting blood glucose results and did not proceed with the oral glucose tolerance test if a participant's value exceeded 120 mg/dL.	2.7% 1/37 • Number of events 1 • Adverse event data were collected over 13 months (including up to 7 months of baseline and dietary intervention, plus a single follow-up visit 6 months later). All participants who enrolled in the study were considered at risk for adverse events. A systematic approach was used to assess adverse events. During each study visit (2-6 times per week), research team members asked participants whether they were experiencing any adverse symptoms related to the study diet or study procedures. Research team members reviewed fasting blood glucose results and did not proceed with the oral glucose tolerance test if a participant's value exceeded 120 mg/dL.
Metabolism and nutrition disorders Bloating and gastrointestinal discomfort	2.9% 1/34 • Number of events 1 • Adverse event data were collected over 13 months (including up to 7 months of baseline and dietary intervention, plus a single follow-up visit 6 months later). All participants who enrolled in the study were considered at risk for adverse events. A systematic approach was used to assess adverse events. During each study visit (2-6 times per week), research team members asked participants whether they were experiencing any adverse symptoms related to the study diet or study procedures. Research team members reviewed fasting blood glucose results and did not proceed with the oral glucose tolerance test if a participant's value exceeded 120 mg/dL.	0.00% 0/24 • Adverse event data were collected over 13 months (including up to 7 months of baseline and dietary intervention, plus a single follow-up visit 6 months later). All participants who enrolled in the study were considered at risk for adverse events. A systematic approach was used to assess adverse events. During each study visit (2-6 times per week), research team members asked participants whether they were experiencing any adverse symptoms related to the study diet or study procedures. Research team members reviewed fasting blood glucose results and did not proceed with the oral glucose tolerance test if a participant's value exceeded 120 mg/dL.

Additional Information

Marla Lujan, PhD

Cornell University

Phone: (607) 255-3153

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place