Trial Outcomes & Findings for Legume Diet Satiety Pilot Study (NCT NCT02269631)
NCT ID: NCT02269631
Last Updated: 2019-01-25
Results Overview
Evaluate the effects of a high-legume diet compared to a control diet with a similar macronutrient profile on weight change in a randomized controlled feeding study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Baseline to 8 weeks
Results posted on
2019-01-25
Participant Flow
Participant milestones
| Measure |
Legume Diet Group
Meals will include approximately 1 ½ cups of cooked legumes, such as pinto, baked and navy beans as part of your 2 daily main dishes (lunch and dinner) and additional foods and snacks, preferably from the recommended healthy foods list. The smartpill will be administered at the end of the study.
Legume diet group: about 1 1/2 cups of legumes included in lunch and dinner meals
Smartpill: to assess how long food takes to pass through the digestive system
legumes: about 1 1/2 cups of legumes included in lunch and dinner meals
|
Control Diet Group
Meals will be healthy, typical American foods (without legumes) for 2 daily main dishes and additional foods and snacks, preferably from the recommended healthy foods list.The smartpill will be administered at the end of the study.
Control diet group: no legumes in lunch or dinner meals
Smartpill: to assess how long food takes to pass through the digestive system
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
|
Overall Study
COMPLETED
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Legume Diet Satiety Pilot Study
Baseline characteristics by cohort
| Measure |
Legume Diet Group
n=7 Participants
Meals will include approximately 1 ½ cups of cooked legumes, such as pinto, baked and navy beans as part of your 2 daily main dishes (lunch and dinner) and additional foods and snacks, preferably from the recommended healthy foods list. The smartpill will be administered at the end of the study.
Legume diet group: about 1 1/2 cups of legumes included in lunch and dinner meals
Smartpill: to assess how long food takes to pass through the digestive system
legumes: about 1 1/2 cups of legumes included in lunch and dinner meals
|
Control Diet Group
n=5 Participants
Meals will be healthy, typical American foods (without legumes) for 2 daily main dishes and additional foods and snacks, preferably from the recommended healthy foods list.The smartpill will be administered at the end of the study.
Control diet group: no legumes in lunch or dinner meals
Smartpill: to assess how long food takes to pass through the digestive system
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 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
|
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
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksEvaluate the effects of a high-legume diet compared to a control diet with a similar macronutrient profile on weight change in a randomized controlled feeding study.
Outcome measures
| Measure |
Legume Diet Group
n=7 Participants
Meals will include approximately 1 ½ cups of cooked legumes, such as pinto, baked and navy beans as part of your 2 daily main dishes (lunch and dinner) and additional foods and snacks, preferably from the recommended healthy foods list. The smartpill will be administered at the end of the study.
Legume diet group: about 1 1/2 cups of legumes included in lunch and dinner meals
Smartpill: to assess how long food takes to pass through the digestive system
legumes: about 1 1/2 cups of legumes included in lunch and dinner meals
|
Control Diet Group
n=5 Participants
Meals will be healthy, typical American foods (without legumes) for 2 daily main dishes and additional foods and snacks, preferably from the recommended healthy foods list.The smartpill will be administered at the end of the study.
Control diet group: no legumes in lunch or dinner meals
Smartpill: to assess how long food takes to pass through the digestive system
|
|---|---|---|
|
Change in Weight
|
9.2 lbs
Interval 5.3 to 18.7
|
6.6 lbs
Interval 6.2 to 11.4
|
SECONDARY outcome
Timeframe: 8 weeksCompare the effects of the high-legume and control diets on gastric emptying time
Outcome measures
| Measure |
Legume Diet Group
n=7 Participants
Meals will include approximately 1 ½ cups of cooked legumes, such as pinto, baked and navy beans as part of your 2 daily main dishes (lunch and dinner) and additional foods and snacks, preferably from the recommended healthy foods list. The smartpill will be administered at the end of the study.
Legume diet group: about 1 1/2 cups of legumes included in lunch and dinner meals
Smartpill: to assess how long food takes to pass through the digestive system
legumes: about 1 1/2 cups of legumes included in lunch and dinner meals
|
Control Diet Group
n=5 Participants
Meals will be healthy, typical American foods (without legumes) for 2 daily main dishes and additional foods and snacks, preferably from the recommended healthy foods list.The smartpill will be administered at the end of the study.
Control diet group: no legumes in lunch or dinner meals
Smartpill: to assess how long food takes to pass through the digestive system
|
|---|---|---|
|
Gastric Emptying Time
|
25.8 hours
Interval 20.8 to 56.8
|
53.8 hours
Interval 9.3 to 95.4
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksCompare the effects of the high-legume and control diets on plasma insulin level in a meal response time (30 min) course experiment.
Outcome measures
| Measure |
Legume Diet Group
n=7 Participants
Meals will include approximately 1 ½ cups of cooked legumes, such as pinto, baked and navy beans as part of your 2 daily main dishes (lunch and dinner) and additional foods and snacks, preferably from the recommended healthy foods list. The smartpill will be administered at the end of the study.
Legume diet group: about 1 1/2 cups of legumes included in lunch and dinner meals
Smartpill: to assess how long food takes to pass through the digestive system
legumes: about 1 1/2 cups of legumes included in lunch and dinner meals
|
Control Diet Group
n=5 Participants
Meals will be healthy, typical American foods (without legumes) for 2 daily main dishes and additional foods and snacks, preferably from the recommended healthy foods list.The smartpill will be administered at the end of the study.
Control diet group: no legumes in lunch or dinner meals
Smartpill: to assess how long food takes to pass through the digestive system
|
|---|---|---|
|
Change in Plasma Insulin Level (Biomarker of Appetite Regulation)
|
-9.9 mg/dl
Interval -75.0 to 55.0
|
5.9 mg/dl
Interval -58.0 to 70.0
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: Data were collected but not analyzed due to a lack of funding.
Compare the effects of the high-legume and control diets on self-reported dietary intake measured by telephone 24-hour dietary recalls.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time course response at baseline and 8 weeksPopulation: Data were collected but not analyzed due to a lack of funding.
Use self-reported satiety questionnaire to compare short-term responses to test meals.
Outcome measures
Outcome data not reported
Adverse Events
Legume Diet Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Diet Group
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
Hartman, Terry Professor, SPH Epidemiology
Emory Unioversity
Phone: 404-727-8713
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place