Legume Diet Satiety Pilot Study

Obesity Clinical Trial

Official title:

Legume Diet Satiety and Weight Loss Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02269631
• Other study ID #: IRB00075830
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 2017

Study information

• Verified date: January 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms
• Obesity

Intervention

Behavioral:
• Legume diet group
about 1 1/2 cups of legumes included in lunch and dinner meals
• Control diet group
no legumes in lunch or 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

Locations

Country	Name	City	State
United States	Emory ACTSI	Atlanta	Georgia
United States	Morehouse	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 8 weeks
Secondary	Gastric Emptying Time	Compare the effects of the high-legume and control diets on gastric emptying time	8 weeks
Secondary	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.	Baseline to 8 weeks
Secondary	Energy Intake	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
Secondary	Satiety	Use self-reported satiety questionnaire to compare short-term responses to test meals.	Time course response at baseline and 8 weeks