Trial Outcomes & Findings for Impacts of Lentils on Metabolism and Inflammation (NCT NCT04283448)

Results Overview

Area under the curve for serum triglyceride concentration calculated from 0 - 5 hours post consumption of a meal containing 50 g of fat. Value reported as the change from baseline to 12 weeks post intervention (Value at 12 weeks minus value at baseline).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

12 weeks

Results posted on

2024-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	Lentil 0.66 cups lentils Dietary Lentil: Participants in the Lentil arm of the study will consume midday meals containing 0.66 cups of lentils seven days per week for 12 weeks.	Control 0.0 cups lentils Control: Participants in the Control arm of the study will consume midday meals containing 0.00 cups of lentils seven days per week for 12 weeks.
Overall Study STARTED	20	18
Overall Study COMPLETED	20	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impacts of Lentils on Metabolism and Inflammation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lentil n=20 Participants 0.66 cups lentils Dietary Lentil: Participants in the Lentil arm of the study will consume midday meals containing 0.66 cups of lentils seven days per week for 12 weeks.	Control n=18 Participants 0.0 cups lentils Control: Participants in the Control arm of the study will consume midday meals containing 0.00 cups of lentils seven days per week for 12 weeks.	Total n=38 Participants Total of all reporting groups
Age, Continuous	50.65 years STANDARD_DEVIATION 11.52 • n=5 Participants	43.20 years STANDARD_DEVIATION 14.01 • n=7 Participants	47.11 years STANDARD_DEVIATION 13.14 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	17 Participants n=7 Participants	35 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	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	18 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Area under the curve for serum triglyceride concentration calculated from 0 - 5 hours post consumption of a meal containing 50 g of fat. Value reported as the change from baseline to 12 weeks post intervention (Value at 12 weeks minus value at baseline).

Outcome measures

Outcome measures
Measure	Lentil n=20 Participants 0.66 cups lentils Dietary Lentil: Participants in the Lentil arm of the study will consume midday meals containing 0.66 cups of lentils seven days per week for 12 weeks.	Control n=18 Participants 0.0 cups lentils Control: Participants in the Control arm of the study will consume midday meals containing 0.00 cups of lentils seven days per week for 12 weeks.
Change in Postprandial Serum Triglyceride	-0.1 mmol*hr/L Standard Deviation 1.5	0.2 mmol*hr/L Standard Deviation 1.8

PRIMARY outcome

Timeframe: 12 weeks

Area under the curve for serum glucose concentration calculated from 0 - 5 hours post consumption of a meal containing 50 g of fat. Value reported as the change from baseline to 12 weeks post intervention (Value at 12 weeks minus value at baseline)

Outcome measures

Outcome measures
Measure	Lentil n=20 Participants 0.66 cups lentils Dietary Lentil: Participants in the Lentil arm of the study will consume midday meals containing 0.66 cups of lentils seven days per week for 12 weeks.	Control n=18 Participants 0.0 cups lentils Control: Participants in the Control arm of the study will consume midday meals containing 0.00 cups of lentils seven days per week for 12 weeks.
Change in Postprandial Serum Glucose	-0.7 mmol*hr/L Standard Deviation 1.4	0.1 mmol*hr/L Standard Deviation 1.8

PRIMARY outcome

Timeframe: 12 weeks

Area under the curve for inflammatory cytokine (tumor necrosis factor-alpha, interleukin-(IL)1beta, IL-6, IL-10, IL-17, IL-23, interferon-gamma, and granulocyte macrophage-colony stimulating factor) concentration calculated from 0 - 5 hours post consumption of a meal containing 50 g of fat. Value reported as the change in AUC for each cytokine from baseline to 12 weeks post intervention (Value at 12 weeks minus value at baseline).

Outcome measures

Outcome measures
Measure	Lentil n=20 Participants 0.66 cups lentils Dietary Lentil: Participants in the Lentil arm of the study will consume midday meals containing 0.66 cups of lentils seven days per week for 12 weeks.	Control n=18 Participants 0.0 cups lentils Control: Participants in the Control arm of the study will consume midday meals containing 0.00 cups of lentils seven days per week for 12 weeks.
Change in Postprandial Serum Inflammatory Cytokines tumor necrosis factor-alpha	-7.59 pg*hr/ml Standard Deviation 21.85	3.07 pg*hr/ml Standard Deviation 9.37
Change in Postprandial Serum Inflammatory Cytokines IL-1beta	-4.06 pg*hr/ml Standard Deviation 9.94	1.09 pg*hr/ml Standard Deviation 3.92
Change in Postprandial Serum Inflammatory Cytokines IL-6	-12.42 pg*hr/ml Standard Deviation 31.92	0.09 pg*hr/ml Standard Deviation 3.93
Change in Postprandial Serum Inflammatory Cytokines IL-10	-43.64 pg*hr/ml Standard Deviation 133.11	8.69 pg*hr/ml Standard Deviation 38.50
Change in Postprandial Serum Inflammatory Cytokines IL-17	-27.07 pg*hr/ml Standard Deviation 83.07	13.82 pg*hr/ml Standard Deviation 31.64
Change in Postprandial Serum Inflammatory Cytokines IL-23	-234.36 pg*hr/ml Standard Deviation 941.87	122.67 pg*hr/ml Standard Deviation 731.23
Change in Postprandial Serum Inflammatory Cytokines interferon-gamma	-27.20 pg*hr/ml Standard Deviation 438.32	6.99 pg*hr/ml Standard Deviation 434.06
Change in Postprandial Serum Inflammatory Cytokines granulocyte macrophage-colony stimulating factor	-24.35 pg*hr/ml Standard Deviation 67.97	-77.16 pg*hr/ml Standard Deviation 482.39

PRIMARY outcome

Timeframe: 12 weeks

Concentration of HDL, LDL, TG, and glucose in the serum after an overnight fast. Value reported as the change in value from baseline to 12 weeks post intervention (Value at 12 weeks minus value at baseline).

Outcome measures

Outcome measures
Measure	Lentil n=20 Participants 0.66 cups lentils Dietary Lentil: Participants in the Lentil arm of the study will consume midday meals containing 0.66 cups of lentils seven days per week for 12 weeks.	Control n=18 Participants 0.0 cups lentils Control: Participants in the Control arm of the study will consume midday meals containing 0.00 cups of lentils seven days per week for 12 weeks.
Change in Fasting Serum Lipids and Glucose Cholesterol	-0.11 mmol/L Standard Deviation 0.50	0.36 mmol/L Standard Deviation 0.43
Change in Fasting Serum Lipids and Glucose HDL	-0.07 mmol/L Standard Deviation 0.15	0.10 mmol/L Standard Deviation 0.14
Change in Fasting Serum Lipids and Glucose LDL	-0.03 mmol/L Standard Deviation 0.43	0.30 mmol/L Standard Deviation 0.36
Change in Fasting Serum Lipids and Glucose Triglyceride	-0.06 mmol/L Standard Deviation 0.73	-0.21 mmol/L Standard Deviation 0.54
Change in Fasting Serum Lipids and Glucose Glucose	-0.06 mmol/L Standard Deviation 0.34	-0.05 mmol/L Standard Deviation 0.44

PRIMARY outcome

Timeframe: 12 weeks

Concentration of inflammatory cytokines (tumor necrosis factor-alpha, interleukin-(IL)1beta, IL-6, IL-10, IL-17, IL-23, interferon-gamma, and granulocyte macrophage-colony stimulating factor) in the serum after an overnight fast. Value reported as the change from baseline to 12 weeks post intervention (Value at 12 weeks minus value at baseline)

Outcome measures

Outcome measures
Measure	Lentil n=20 Participants 0.66 cups lentils Dietary Lentil: Participants in the Lentil arm of the study will consume midday meals containing 0.66 cups of lentils seven days per week for 12 weeks.	Control n=18 Participants 0.0 cups lentils Control: Participants in the Control arm of the study will consume midday meals containing 0.00 cups of lentils seven days per week for 12 weeks.
Change in Fasting Inflammatory Cytokines interferon-gamma	9.69 pg/ml Standard Deviation 143.72	11.67 pg/ml Standard Deviation 85.84
Change in Fasting Inflammatory Cytokines tumor necrosis factor-alpha	1.47 pg/ml Standard Deviation 4.17	-0.76 pg/ml Standard Deviation 1.88
Change in Fasting Inflammatory Cytokines IL-1beta	0.65 pg/ml Standard Deviation 2.05	0.04 pg/ml Standard Deviation 0.78
Change in Fasting Inflammatory Cytokines IL-6	2.20 pg/ml Standard Deviation 5.52	0.26 pg/ml Standard Deviation 1.79
Change in Fasting Inflammatory Cytokines IL-10	3.46 pg/ml Standard Deviation 12.93	0.62 pg/ml Standard Deviation 12.72
Change in Fasting Inflammatory Cytokines IL-17	3.56 pg/ml Standard Deviation 12.62	-0.84 pg/ml Standard Deviation 4.93
Change in Fasting Inflammatory Cytokines IL-23	-28.54 pg/ml Standard Deviation 527.21	-12.27 pg/ml Standard Deviation 129.2
Change in Fasting Inflammatory Cytokines granulocyte macrophage-colony stimulating factor	3.00 pg/ml Standard Deviation 24.99	-4.53 pg/ml Standard Deviation 17.42

SECONDARY outcome

Timeframe: 12 weeks

Change in % Body Fat from baseline to 12 weeks post intervention (Value at 12 weeks minus value at baseline)

Outcome measures

Outcome measures
Measure	Lentil n=20 Participants 0.66 cups lentils Dietary Lentil: Participants in the Lentil arm of the study will consume midday meals containing 0.66 cups of lentils seven days per week for 12 weeks.	Control n=18 Participants 0.0 cups lentils Control: Participants in the Control arm of the study will consume midday meals containing 0.00 cups of lentils seven days per week for 12 weeks.
Change in Body Fat Composition	-1.2 percentage of Body Fat Standard Deviation 6.4	0.55 percentage of Body Fat Standard Deviation 1.9

SECONDARY outcome

Timeframe: 12 weeks

Change in the quantity of adipose tissue located within the abdominal compartment from baseline to 12 weeks post intervention (Value at 12 weeks minus value at baseline)

Outcome measures

Outcome measures
Measure	Lentil n=20 Participants 0.66 cups lentils Dietary Lentil: Participants in the Lentil arm of the study will consume midday meals containing 0.66 cups of lentils seven days per week for 12 weeks.	Control n=18 Participants 0.0 cups lentils Control: Participants in the Control arm of the study will consume midday meals containing 0.00 cups of lentils seven days per week for 12 weeks.
Change in Visceral Adipose Tissue	0.08 Liters Standard Deviation 0.92	0.17 Liters Standard Deviation 0.63

SECONDARY outcome

Timeframe: 12 weeks

Change in BMI (kg/m\^2) from baseline to 12 weeks post intervention (Value at 12 weeks minus value at baseline).

Outcome measures

Outcome measures
Measure	Lentil n=20 Participants 0.66 cups lentils Dietary Lentil: Participants in the Lentil arm of the study will consume midday meals containing 0.66 cups of lentils seven days per week for 12 weeks.	Control n=18 Participants 0.0 cups lentils Control: Participants in the Control arm of the study will consume midday meals containing 0.00 cups of lentils seven days per week for 12 weeks.
Change in Body Mass Index (BMI)	-0.43 kg of mass per meter of height squared Standard Deviation 1.21	-0.02 kg of mass per meter of height squared Standard Deviation 0.96

SECONDARY outcome

Timeframe: 12 weeks

Ratings of hunger, fullness, satiety, satisfaction, desire to eat, and desire to consume additional food in response to mid-day meal consumption during the 12-week intervention. Ratings were scored on a scale of 0 to 10 with 0 representing no feelings of hunger, fullness, satiety, satisfaction, desire to eat, or consume additional food and 10 representing maximal feelings of hunger, fullness, satiety, satisfaction, desire to eat, or consume additional food. Reported values represent the average from all survey responses collected over the duration of the 12-week intervention period.

Outcome measures

Outcome measures
Measure	Lentil n=20 Participants 0.66 cups lentils Dietary Lentil: Participants in the Lentil arm of the study will consume midday meals containing 0.66 cups of lentils seven days per week for 12 weeks.	Control n=18 Participants 0.0 cups lentils Control: Participants in the Control arm of the study will consume midday meals containing 0.00 cups of lentils seven days per week for 12 weeks.
Perceptions of Hunger, Fullness, Satiety, and Satisfaction After Mid-day Meal During the Intervention Hunger (lower scores indicate low hunger after consuming meal)	3.6 units on a scale (0=lowest, 10=highest) Standard Deviation 2.0	3.9 units on a scale (0=lowest, 10=highest) Standard Deviation 2.1
Perceptions of Hunger, Fullness, Satiety, and Satisfaction After Mid-day Meal During the Intervention Fullness (lower scores indicate low fullness after consuming meal)	6.3 units on a scale (0=lowest, 10=highest) Standard Deviation 2.3	6.2 units on a scale (0=lowest, 10=highest) Standard Deviation 2.0
Perceptions of Hunger, Fullness, Satiety, and Satisfaction After Mid-day Meal During the Intervention Satisfaction (lower scores indicate low satiety after consuming the meal)	6.2 units on a scale (0=lowest, 10=highest) Standard Deviation 2.1	6.1 units on a scale (0=lowest, 10=highest) Standard Deviation 1.9
Perceptions of Hunger, Fullness, Satiety, and Satisfaction After Mid-day Meal During the Intervention Desire to eat (lower scores indicate little desire to eat more food after consuming the meal)	4.0 units on a scale (0=lowest, 10=highest) Standard Deviation 2.2	4.2 units on a scale (0=lowest, 10=highest) Standard Deviation 2.2
Perceptions of Hunger, Fullness, Satiety, and Satisfaction After Mid-day Meal During the Intervention Amount of food that could be eaten (lower scores indicate that little food is desired)	3.6 units on a scale (0=lowest, 10=highest) Standard Deviation 1.9	4.0 units on a scale (0=lowest, 10=highest) Standard Deviation 2.0

SECONDARY outcome

Timeframe: 12 weeks

Ratings of the gastrointestinal symptoms of bloating, cramping, discomfort, and flatulence over the 12-week intervention. All symptoms were qualitatively ranked as "none", "mild", "moderate", or "severe" by participants. Numerical values were then assigned to all measures using a 4-point scale: (0 = none, 1 = mild, 2 = moderate, 3 = severe). Values reported represent the average from all surveys collected during the 12 week intervention.

Outcome measures

Outcome measures
Measure	Lentil n=20 Participants 0.66 cups lentils Dietary Lentil: Participants in the Lentil arm of the study will consume midday meals containing 0.66 cups of lentils seven days per week for 12 weeks.	Control n=18 Participants 0.0 cups lentils Control: Participants in the Control arm of the study will consume midday meals containing 0.00 cups of lentils seven days per week for 12 weeks.
Gastrointestinal Symptoms of Bloating, Cramping, Discomfort, and Flatulence During the Intervention Flatulence (lower scores indicate less flatulence)	0.9 score on a scale Standard Deviation 0.7	0.8 score on a scale Standard Deviation 0.9
Gastrointestinal Symptoms of Bloating, Cramping, Discomfort, and Flatulence During the Intervention Bloating (lower scores indicate less bloating)	0.6 score on a scale Standard Deviation 0.8	0.7 score on a scale Standard Deviation 0.9
Gastrointestinal Symptoms of Bloating, Cramping, Discomfort, and Flatulence During the Intervention Cramping (lower scores indicate less cramping)	0.2 score on a scale Standard Deviation 0.5	0.3 score on a scale Standard Deviation 0.7
Gastrointestinal Symptoms of Bloating, Cramping, Discomfort, and Flatulence During the Intervention Discomfort (lower scores indicate less abdominal discomfort)	0.3 score on a scale Standard Deviation 0.6	0.4 score on a scale Standard Deviation 0.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Healthy Eating Index (HEI) scores were obtained through DHQ III survey data output from before and after the 12 week intervention. Each category is scored on a scale of 0-5 or 0-10. For components of adequacy, high scores indicate higher intake of each component and are therefore desirable. For components of moderation, high scores indicate lower intake of each component and are therefore desirable. Total possible scores for components of adequacy are as follows: Total Fruits (5), Whole Fruits (5), Total Vegetables (5), Greens and Beans (5), Whole Grains (10), Dairy (10), Total Protein Foods (5), Seafood and Plant Proteins (5), Fatty acids (10). Total possible scores for components of moderation are as follows: Refined Grains (10), Sodium (10), Added sugar (10). Total HEI score is also reported as the sum of all components with a total possible score of 100 indicating healthiest possible diet. All values reported as the change in value from baseline to 12 weeks post intervention.

Outcome measures

Outcome measures
Measure	Lentil n=20 Participants 0.66 cups lentils Dietary Lentil: Participants in the Lentil arm of the study will consume midday meals containing 0.66 cups of lentils seven days per week for 12 weeks.	Control n=18 Participants 0.0 cups lentils Control: Participants in the Control arm of the study will consume midday meals containing 0.00 cups of lentils seven days per week for 12 weeks.
Change in Habitual Diet Total Fruits (0-5 score possible, higher indicating healthier score)	-0.1 HEI Scores from DHQIII Standard Deviation 1.6	-0.8 HEI Scores from DHQIII Standard Deviation 1.5
Change in Habitual Diet Whole Fruits (0-5 score possible, higher indicating healthier score)	-0.1 HEI Scores from DHQIII Standard Deviation 1.6	-0.5 HEI Scores from DHQIII Standard Deviation 1.3
Change in Habitual Diet Total Vegetables (0-5 score possible, higher indicating healthier score)	0.6 HEI Scores from DHQIII Standard Deviation 1.1	0.1 HEI Scores from DHQIII Standard Deviation 1.1
Change in Habitual Diet Green and Beans (0-5 score possible, higher indicating healthier score)	0.8 HEI Scores from DHQIII Standard Deviation 1.1	-0.1 HEI Scores from DHQIII Standard Deviation 1.3
Change in Habitual Diet Whole Grains (0-10 score possible, higher indicating healthier score)	0.4 HEI Scores from DHQIII Standard Deviation 1.8	0.6 HEI Scores from DHQIII Standard Deviation 1.3
Change in Habitual Diet Dairy (0-10 score possible, higher indicating healthier score)	-0.9 HEI Scores from DHQIII Standard Deviation 2.3	-1.1 HEI Scores from DHQIII Standard Deviation 2.0
Change in Habitual Diet Total Protein Foods (0-5 score possible, higher indicating healthier score)	0.3 HEI Scores from DHQIII Standard Deviation 0.5	0.0 HEI Scores from DHQIII Standard Deviation 0.3
Change in Habitual Diet Seafood and Plant Proteins (0-5 score possible, higher indicating healthier score)	0.6 HEI Scores from DHQIII Standard Deviation 0.9	0.3 HEI Scores from DHQIII Standard Deviation 0.9
Change in Habitual Diet Fatty Acids (0-10 score possible, higher indicating healthier score)	0.1 HEI Scores from DHQIII Standard Deviation 2.5	0.4 HEI Scores from DHQIII Standard Deviation 2.3
Change in Habitual Diet Refined Grains (0-10 score possible, higher indicating healthier score)	-0.3 HEI Scores from DHQIII Standard Deviation 2.4	-2.0 HEI Scores from DHQIII Standard Deviation 2.0
Change in Habitual Diet Sodium (0-10 score possible, higher indicating healthier score)	-1.9 HEI Scores from DHQIII Standard Deviation 2.5	-1.5 HEI Scores from DHQIII Standard Deviation 2.5
Change in Habitual Diet Added Sugars (0-10 score possible, higher indicating healthier score)	0.8 HEI Scores from DHQIII Standard Deviation 2.0	0.5 HEI Scores from DHQIII Standard Deviation 1.9
Change in Habitual Diet Saturated Fats (0-10 score possible, higher indicating healthier score)	0.8 HEI Scores from DHQIII Standard Deviation 2.8	0.7 HEI Scores from DHQIII Standard Deviation 2.4
Change in Habitual Diet Total HEI (0-100 score possible, higher indicating healthier)	0.3 HEI Scores from DHQIII Standard Deviation 9.2	-3.5 HEI Scores from DHQIII Standard Deviation 7.9

Adverse Events

Lentil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mary P Miles

Montana State University

Phone: 406 994-6678

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place