Clinical trial · Interventional
The Beans to Enrich the Gut Microbiome vs. Obesity's Negative Effects (BE GONE) Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Prevention | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Navy Beans (Canned) | Other | — | UNRESOLVED |
| Regular Diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Regular Diet + Beans, Then Regular Diet - Beans
- interventionNames
- Other: Regular Diet
- Other: Navy Beans (Canned)
- type
- ACTIVE_COMPARATOR
- label
- Regular Diet - Beans, Then Regular Diet + Beans
- interventionNames
- Other: Regular Diet
- Other: Navy Beans (Canned)
Primary outcomes (2)
- measure
- Changes in Stool 16S rRNA Gene Profiles
- timeFrame
- Baseline to week 8
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult men and women 30+ years of age 2. Meet criteria for overweight or obesity via BMI or waist size 3. Underwent colonoscopy screening within the past 10 years 4. 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 5. English-speaking and reside in the greater Houston/outlying areas and/or willing to travel for study-related visits at MD Anderson 6. Ability to complete web-based dietary assessments twice per week 7. Willingness to provide stool samples and undergo venipuncture 8. Willingness to consume/avoid beans as instructed during the 16 weeks from randomization Exclusion Criteria: 1. Antibiotic use in the past month and unable/unwilling to be deferred to a later recruitment date 2. Current smoker 3. Heavy drinker (defined as more than 14 drinks per week) 4. Currently taking exclusionary prescription medications (including cytokines, immunosuppressive agents, chemopreventive drugs, bile acid sequestrants/selective cholesterol absorption inhibitors) 5. Regularly taking anti flatulence medications, probiotics and/or fiber supplements and unable/unwilling to discontinue for the purpose of the study 6. Major dietary restrictions relevant to the intervention 7. Hereditary colorectal cancer syndromes 8. Pregnant or lactating or planning to become pregnant
References
Publications (2)
- RESULTZhang 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 38040541
- RESULTZhang 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 31852462