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Legume Diet Satiety Pilot Study

Primary Purpose

Obesity, Colorectal Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Legume diet group
Control diet group
Smartpill
legumes
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Weight loss, Epidemiology, Nutrition

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Morehouse
  • Emory ACTSI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Legume diet group

Control diet group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in Weight
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

Gastric Emptying Time
Compare the effects of the high-legume and control diets on gastric emptying time
Change in Plasma Insulin Level (Biomarker of Appetite Regulation)
Compare the effects of the high-legume and control diets on plasma insulin level in a meal response time (30 min) course experiment.
Energy Intake
Compare the effects of the high-legume and control diets on self-reported dietary intake measured by telephone 24-hour dietary recalls.
Satiety
Use self-reported satiety questionnaire to compare short-term responses to test meals.

Full Information

First Posted
October 17, 2014
Last Updated
January 24, 2019
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT02269631
Brief Title
Legume Diet Satiety Pilot Study
Official Title
Legume Diet Satiety and Weight Loss Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Colorectal Carcinoma
Keywords
Weight loss, Epidemiology, Nutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Legume diet group
Arm Type
Experimental
Arm 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.
Arm Title
Control diet group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Legume diet group
Intervention Description
about 1 1/2 cups of legumes included in lunch and dinner meals
Intervention Type
Behavioral
Intervention Name(s)
Control diet group
Intervention Description
no legumes in lunch or dinner meals
Intervention Type
Device
Intervention Name(s)
Smartpill
Intervention Description
to assess how long food takes to pass through the digestive system
Intervention Type
Other
Intervention Name(s)
legumes
Intervention Description
about 1 1/2 cups of legumes included in lunch and dinner meals
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
Title
Gastric Emptying Time
Description
Compare the effects of the high-legume and control diets on gastric emptying time
Time Frame
8 weeks
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
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
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry J Hartman, PhD, MPH, RD
Organizational Affiliation
Rollins School of Public Health, Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Morehouse
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30310
Country
United States
Facility Name
Emory ACTSI
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

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Legume Diet Satiety Pilot Study

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