Clinical trial NCT02269631: Legume Diet Satiety Pilot Study
Official title: Legume Diet Satiety and Weight Loss Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Colorectal Carcinoma
Keywords: Weight loss
Epidemiology
Nutrition
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 12
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Change in Weight
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Gastric Emptying Time
timeFrame: 8 weeks
measure: Change in Plasma Insulin Level (Biomarker of Appetite Regulation)
timeFrame: Baseline to 8 weeks
measure: Energy Intake
timeFrame: Baseline to 8 weeks
measure: Satiety
timeFrame: Time course response at baseline and 8 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Morehouse
state: Georgia
city: Atlanta
country: United States
facility: Emory ACTSI
state: Georgia
Study officials:
affiliation: Rollins School of Public Health, Emory University
name: Terry J Hartman, PhD, MPH, RD
role: PRINCIPAL_INVESTIGATOR
References: