Clinical trial · Interventional
Fiber-rich Foods to Treat Obesity and Prevent Colon Cancer
NCT04780477CI-TRIAL-00122982active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study tests whether a high-fiber diet based on legumes, such as dry beans, can lead to sustained reductions in obesity and colon cancer risk in persons at highest risk, namely overweight or obese, post-polypectomy patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Healthy American Diet | Dietary Supplement | — | UNRESOLVED |
| High Fiber Diet Featuring Legumes (HLD) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- High Fiber Diet Featuring Legumes (HLD)
- description
- Participants randomized to the high fiber diet featuring legumes (HLD) will add approximately 30 grams of dietary fiber per day from legume dishes, ensuring a total intake of approximately 50 grams of dietary fiber per day.
- interventionNames
- Dietary Supplement: High Fiber Diet Featuring Legumes (HLD)
- type
- ACTIVE_COMPARATOR
- label
- Healthy American Diet Control Arm
- description
- Participants randomized to the healthy American diet control arm will receive pre-portioned meal replacement entrées with legumes replaced by lean chicken or meat.
- interventionNames
- Dietary Supplement: Healthy American Diet
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * free-living adults 40 to 75 years old * BMI 25-40 kg/m\^2 * able to provide documentation confirming a colonoscopy within 3 years that found ≥1 adenoma \>0.5 cm or a sessile serrated polyp (any) * English speaking * ambulatory, able to pick up food, participate in clinical exams and laboratory tests * able to provide informed consent Exclusion Criteria: * serious and/or unstable medical condition as deemed by study physician * history of colorectal cancer, bowel resection, polyposis syndrome, or inflammatory bowel disease * smoked regularly in the past year * dietary restrictions substantially limiting compliance (e.g., must be willing to be randomized to either diet) * planning on substantially changing usual exercise behavior in the next 6 months * regular or recent use of prescription medication that may alter inflammation markers or gut function as deemed by study physician * pregnant women, breast feeding women, or women planning pregnancy within the year of active study participation
References
Publications (1)
- DERIVEDHartman TJ, Christie J, Wilson A, Ziegler TR, Methe B, Flanders WD, Rolls BJ, Loye Eberhart B, Li JV, Huneault H, Cousineau B, Perez MR, O'Keefe SJD. Fibre-rich Foods to Treat Obesity and Prevent Colon Cancer trial study protocol: a randomised clinical trial of fibre-rich legumes targeting the gut microbiome, metabolome and gut transit time of overweight and obese patients with a history of noncancerous adenomatous polyps. BMJ Open. 2024 Feb 5;14(2):e081379. doi: 10.1136/bmjopen-2023-081379. PMID 38316601