Status:
COMPLETED
Legume Diet Satiety Pilot Study
Lead Sponsor:
Emory University
Conditions:
Obesity
Colorectal Carcinoma
Eligibility:
MALE
40-70 years
Phase:
NA
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 die...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02269631
Start Date
December 1 2014
End Date
December 1 2017
Last Update
January 25 2019
Active Locations (2)
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1
Morehouse
Atlanta, Georgia, United States, 30310
2
Emory ACTSI
Atlanta, Georgia, United States, 30322