Legume Diet Satiety Pilot Study

January 24, 2019 updated by: Terry Hartman, Emory University

Legume Diet Satiety and Weight Loss Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30310
        • Morehouse
      • Atlanta, Georgia, United States, 30322
        • Emory ACTSI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
Device: Smartpill
to assess how long food takes to pass through the digestive system
Behavioral: Control diet group
no legumes in lunch or dinner meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Weight
Time Frame: 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.
Baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric Emptying Time
Time Frame: 8 weeks
Compare the effects of the high-legume and control diets on gastric emptying time
8 weeks
Change in Plasma Insulin Level (Biomarker of Appetite Regulation)
Time Frame: 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.
Baseline to 8 weeks
Energy Intake
Time Frame: 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.
Baseline to 8 weeks
Satiety
Time Frame: Time course response at baseline and 8 weeks
Use self-reported satiety questionnaire to compare short-term responses to test meals.
Time course response at baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

October 17, 2014

First Submitted That Met QC Criteria

October 20, 2014

First Posted (Estimate)

October 21, 2014

Study Record Updates

Last Update Posted (Actual)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 24, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00075830

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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