The Beans to Enrich the Gut Microbiome vs. Obesity's Negative Effects (BE GONE) Trial (NCT02843425) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Beans to Enrich the Gut Microbiome vs. Obesity's Negative Effects (BE GONE) Trial
United States71 participantsStarted 2016-07-25
Plain-language summary
You are being asked to take part in this study because either you are a survivor who has a previous history of colorectal cancer or an MD Anderson patient who had a precancerous colorectal polyp or you have a previous history of colorectal cancer, and you have a current adult body mass index (BMI) score of 25 or higher.
The BMI score is used as an indicator of the level of body fat, based on height and weight.
The goal of this clinical research study is to learn if eating canned, pre-cooked beans can help improve the levels of healthy bacteria in the digestive system and reduce the effects of obesity on cancer risk.
This is an investigational study.
Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.
Who can participate
Age range30 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adult men and women 30+ years of age
✓. Meet criteria for overweight or obesity via BMI or waist size
✓. Underwent colonoscopy screening within the past 10 years
✓. History of pathology-confirmed precancerous polyp of the colon or rectum; OR Colorectal cancer survivor who has completed treatment with adequate maintenance of bowel length (eligible: hemicolectomy or low anterior resection; ineligible: total or near total colectomy, greater than 10 cm of small bowel resection) and normalized bowel habits
✓. English-speaking and reside in the greater Houston/outlying areas and/or willing to travel for study-related visits at MD Anderson
✓. Ability to complete web-based dietary assessments twice per week
✓. Willingness to provide stool samples and undergo venipuncture
✓. Willingness to consume/avoid beans as instructed during the 16 weeks from randomization
. Antibiotic use in the past month and unable/unwilling to be deferred to a later recruitment date
✕. Current smoker
✕. Heavy drinker (defined as more than 14 drinks per week)
✕. Currently taking exclusionary prescription medications (including cytokines, immunosuppressive agents, chemopreventive drugs, bile acid sequestrants/selective cholesterol absorption inhibitors)
✕. Regularly taking anti flatulence medications, probiotics and/or fiber supplements and unable/unwilling to discontinue for the purpose of the study
✕. Major dietary restrictions relevant to the intervention
✕. Hereditary colorectal cancer syndromes
✕. Pregnant or lactating or planning to become pregnant