Legume Diet Satiety Pilot Study



Status:Completed
Conditions:Colorectal Cancer, Obesity Weight Loss
Therapuetic Areas:Endocrinology, Oncology
Healthy:No
Age Range:40 - 70
Updated:1/27/2019
Start Date:December 2014
End Date:December 2017

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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.

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.

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)
We found this trial at
2
sites
Atlanta, Georgia 30310
Phone: 404-752-1500
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Atlanta, Georgia 30322
Phone: 404-727-7351
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Atlanta, GA
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