Legume Diet Satiety Pilot Study

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02269631
• Collaborator: (none)
• Enrollment: 12
• Locations: 2
• Arms: 2
• Duration (Months): 36
• Patients Per Site: 6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This pilot study is designed to test the effects of a high legume (dried bean) diet on hunger and other indicators of health over the course of eight weeks, compared to a more conventional healthy diet.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Colorectal Carcinoma	Behavioral: Legume diet group; Behavioral: Control diet group; Device: Smartpill; Other: legumes	N/A

Detailed Description

The goal of the currently proposed study is to conduct a randomized controlled feeding pilot study within a more diverse population also at high risk for colorectal carcinoma (CRC) to evaluate whether a high-legume diet will result in increased satiety and in turn will facilitate reduced energy intake and weight loss compared to a control diet provided under similar conditions. In addition, explore potential beneficial effects of the high-legume diet on gastric emptying and circulating levels of appetite-regulating hormones and other biomarkers. Dietary behaviors that are even moderately more satiating over time have the potential to enhance weight loss and could lead to a significant public health impact among populations at high risk for colorectal carcinoma (CRC) and other chronic diseases.

Towards the end of the study, the participants will do an additional test, looking at how long food takes to pass through the digestive system using a SmartPill capsule. The SmartPill is a pill about the size of a large multivitamin that can measure pH, pressure, and temperature changes, which it uses to assess where in the digestive tract it is. The participant swallows the pill, and carries around a receiver that is about the size of a deck of cards for the next 3-5 days. The SmartPill is expelled, and the receiver notifies the participant that they can return the receiver to the study personnel.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Legume Diet Satiety and Weight Loss Pilot Study
• Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Legume diet group; about 1 1/2 cups of legumes included in lunch and dinner meals; Device: Smartpill; to assess how long food takes to pass through the digestive system; Other: legumes; about 1 1/2 cups of legumes included in lunch and dinner meals
Active Comparator: 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.	Behavioral: Control diet group; no legumes in lunch or dinner meals; Device: Smartpill; to assess how long food takes to pass through the digestive system

Outcome Measures

Primary Outcome Measures

1. Change in Weight [Baseline to 8 weeks]

   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.

Secondary Outcome Measures

1. Gastric Emptying Time [8 weeks]

   Compare the effects of the high-legume and control diets on gastric emptying time

2. Change in Plasma Insulin Level (Biomarker of Appetite Regulation) [Baseline to 8 weeks]

   Compare the effects of the high-legume and control diets on plasma insulin level in a meal response time (30 min) course experiment.

3. Energy Intake [Baseline to 8 weeks]

   Compare the effects of the high-legume and control diets on self-reported dietary intake measured by telephone 24-hour dietary recalls.

4. Satiety [Time course response at baseline and 8 weeks]

   Use self-reported satiety questionnaire to compare short-term responses to test meals.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• BMI overweight-obese: 25.0-40 kg/m2

• Colonoscopy within the last two years that found ≥1 adenoma

• English speaking

• Ambulatory, able to come to either food distribution site to pick up food and participate in clinical examinations and laboratory tests

Exclusion Criteria:

• Serious medical condition (e.g., cancer, heart disease, kidney disease, diabetes)

• History of CRC, bowel resection, polyposis syndrome, or inflammatory bowel disease

• Smoked regularly in the past year

• Dietary restrictions substantially limiting compliance or vegetarian or Vegan diet

• Planning on changing diet or exercise behavior in the next 6 months

• Regular use of medication that may alter inflammation markers, insulin, glucose, or gut function (i.e. regular use of non-steroidal anti-inflammatory medication, insulin therapy, steroid therapy, or antibiotics)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Morehouse	Atlanta	Georgia	United States	30310
2	Emory ACTSI	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

• Emory University

Investigators

• Principal Investigator: Terry J Hartman, PhD, MPH, RD, Rollins School of Public Health, Emory University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 19, 2015

More Information

Publications

None provided.

• Responsible Party: Terry Hartman, Terry Hartman PhD, MPH, RD, Emory University
• ClinicalTrials.gov Identifier: NCT02269631
• Other Study ID Numbers: IRB00075830
• First Posted: Oct 21, 2014
• Last Update Posted: Jan 25, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by Terry Hartman, Terry Hartman PhD, MPH, RD, Emory University: Weight loss; Epidemiology; Nutrition
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

Participant Flow

Arm/Group Title	Legume Diet Group	Control Diet Group
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	7	5
COMPLETED	7	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Legume Diet Group	Control Diet Group	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	7	5	12
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	6 85.7%	4 80%	10 83.3%
>=65 years	1 14.3%	1 20%	2 16.7%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	7 100%	5 100%	12 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 28.6%	3 60%	5 41.7%
White	5 71.4%	2 40%	7 58.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	7 100%	5 100%	12 100%

Outcome Measures

1. Primary Outcome

Title	Change in Weight
Description	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.
Time Frame	Baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Legume Diet Group	Control Diet Group
Arm/Group Description	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	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
Measure Participants	7	5
Median (Full Range) [lbs]	9.2	6.6

2. Secondary Outcome

Title	Gastric Emptying Time
Description	Compare the effects of the high-legume and control diets on gastric emptying time
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Legume Diet Group	Control Diet Group
Arm/Group Description	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	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
Measure Participants	7	5
Median (Full Range) [hours]	25.8	53.8

3. Secondary Outcome

Title	Change in Plasma Insulin Level (Biomarker of Appetite Regulation)
Description	Compare the effects of the high-legume and control diets on plasma insulin level in a meal response time (30 min) course experiment.
Time Frame	Baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Legume Diet Group	Control Diet Group
Arm/Group Description	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	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
Measure Participants	7	5
Mean (95% Confidence Interval) [mg/dl]	-9.9	5.9

4. Secondary Outcome

Title	Energy Intake
Description	Compare the effects of the high-legume and control diets on self-reported dietary intake measured by telephone 24-hour dietary recalls.
Time Frame	Baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

Data were collected but not analyzed due to a lack of funding.

Arm/Group Title	Legume Diet Group	Control Diet Group
Arm/Group Description	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	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
Measure Participants	0	0

5. Secondary Outcome

Title	Satiety
Description	Use self-reported satiety questionnaire to compare short-term responses to test meals.
Time Frame	Time course response at baseline and 8 weeks

Outcome Measure Data

Analysis Population Description

Data were collected but not analyzed due to a lack of funding.

Arm/Group Title	Legume Diet Group	Control Diet Group
Arm/Group Description	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	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
Measure Participants	0	0

Adverse Events

Time Frame	8 weeks
Arm/Group Title	Legume Diet Group		Control Diet Group
Arm/Group Description	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		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
All Cause Mortality
	Legume Diet Group		Control Diet Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/5 (0%)
Serious Adverse Events
	Legume Diet Group		Control Diet Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Legume Diet Group		Control Diet Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.