The Beans to Enrich the Gut Microbiome vs. Obesity's Negative Effects (BE GONE) Trial
2 other identifiers
interventional
71
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2016
CompletedFirst Posted
Study publicly available on registry
July 25, 2016
CompletedStudy Start
First participant enrolled
July 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
April 15, 2026
April 1, 2026
10.7 years
July 18, 2016
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes in Stool 16S rRNA Gene Profiles
The primary outcome measures will be intra- and inter-individual changes in stool 16S rRNA gene profiles at baseline, week 4 and week 8 for each cross-over period.
Baseline to week 8
Changes in Blood Markers and Metabolites
The primary outcome measures will be intra- and inter-individual changes in blood makers and metabolites at baseline, week 8 for each cross-over period.
Baseline to week 8
Study Arms (2)
Regular Diet + Beans, Then Regular Diet - Beans
EXPERIMENTALRegular Diet - Beans, Then Regular Diet + Beans
ACTIVE COMPARATORInterventions
Participants follow their normal diet (not including beans for 8 weeks)
Participants add 1/2 cup of canned beans per day to their diets for the first 2 weeks. This is increased to 1 cup per day for the following 6 weeks of the study.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (2)
Zhang X, Irajizad E, Hoffman KL, Fahrmann JF, Li F, Seo YD, Browman GJ, Dennison JB, Vykoukal J, Luna PN, Siu W, Wu R, Murage E, Ajami NJ, McQuade JL, Wargo JA, Long JP, Do KA, Lampe JW, Basen-Engquist KM, Okhuysen PC, Kopetz S, Hanash SM, Petrosino JF, Scheet P, Daniel CR. Modulating a prebiotic food source influences inflammation and immune-regulating gut microbes and metabolites: insights from the BE GONE trial. EBioMedicine. 2023 Dec;98:104873. doi: 10.1016/j.ebiom.2023.104873. Epub 2023 Nov 30.
PMID: 38040541RESULTZhang X, Browman G, Siu W, Basen-Engquist KM, Hanash SM, Hoffman KL, Okhuysen PC, Scheet P, Petrosino JF, Kopetz S, Daniel CR. The BE GONE trial study protocol: a randomized crossover dietary intervention of dry beans targeting the gut microbiome of overweight and obese patients with a history of colorectal polyps or cancer. BMC Cancer. 2019 Dec 18;19(1):1233. doi: 10.1186/s12885-019-6400-z.
PMID: 31852462RESULT
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carrie Daniel-MacDougall, PHD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2016
First Posted
July 25, 2016
Study Start
July 25, 2016
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
April 15, 2026
Record last verified: 2026-04