Clinical trial · Interventional
Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer
Diet and the Colonic Exfoliome: A Novel, Non-Invasive Approach to Testing Interventions in Humans
NCT04211766CI-TRIAL-00081116completedN/AResults postedClinicalTrials.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 trial studies how fiber and fish oil supplements affect the metabolism and activities of colon cells in healthy individuals. Diet is an important risk factor for colorectal cancer, and several dietary components important in colorectal cancer prevention are modified by gut microbial metabolism. Giving fiber and fish oil supplements may inhibit the growth of gut cells and ultimately reduce risk of colorectal cancer.
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 |
|---|---|---|---|
| Healthy Subject | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparator | Other | — | UNRESOLVED |
| Dietary Fiber | Dietary Supplement | — | UNRESOLVED |
| Fish Oil | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cross-over Randomization 1: Fiber plus Fish Oil followed by Comparator
- description
- Participants first received a fiber supplement and a fish oil supplement PO daily for 30 days (Period 1). Participants entered a washout period for at least 60 days. For period 2 they received similarly packaged comparator (maltodextrin and corn oil)
- interventionNames
- Dietary Supplement: Dietary Fiber
- Dietary Supplement: Fish Oil
- Other: Comparator
- type
- EXPERIMENTAL
- label
- Cross-over Randomization 2: Comparator followed by Fiber plus Fish Oil
- description
- Participants first received the comparator (maltodextrin and corn oil) supplement PO daily for 30 days (Period 1). Participants enter a washout period for at least 60 days. For period 2 they received the fiber supplement and a fish oil supplement
- interventionNames
- Dietary Supplement: Dietary Fiber
- Dietary Supplement: Fish Oil
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Healthy * Normal-overweight (body mass index \[BMI\] of 18-30 kg/m\^2) * Women will be postmenopausal, with no menstrual period in 12 months * Non-smoking * Consume fiber intakes of less than \< 20 g/d * White blood cell count 3,000-11,000/mm\^3 * Platelet count 100,000-400,000 mm\^3 * Hematocrit 33-50% (women); 36-50% (men) * Bilirubin 0.2-1.3 mg/dL * Aspartate aminotransferase (AST) 0-35 U/L * Alanine aminotransferase (ALT) 0-40 U/L * Alkaline phosphatase 20-125 U/L * Creatinine =\< 1.2 mg/dL * Potassium 3.5-5.0 mmol/L Exclusion Criteria: * Chronic medical illness, history of gastrointestinal disorders (e.g., ulcerative colitis, Crohn disease, celiac sprue, hereditary nonpolyposis colorectal cancer \[HNPCC\], familial adenomatous polyposis, pancreatic disease, previous gastrointestinal resection, radiation or chemotherapy, and cancer (other than non-melanoma skin cancer) * Weight change greater than 4.5 kg within past year * Oral or intravenous (IV) antibiotic use within the past 3 months * Regular use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) * Smoking or use of cannabis products * Known allergy to fish * Intention to relocate out of study area within next 4 months
References
Publications (1)
- DERIVEDFan YY, Salinas ML, Mullens DA, Davidson LA, Goldsby JS, Ivanov IV, Jayaraman A, Cai JJ, Levy L, Hullar MA, Navarro SL, Lampe JW, Chapkin RS. Pesco-Vegetarian Food Components Promote Colonocyte Ferroptosis in Preclinical Mouse Models and a Randomized Crossover Trial in Healthy Human Adults. J Nutr. 2026 Feb;156(2):101287. doi: 10.1016/j.tjnut.2025.101287. Epub 2025 Dec 27. PMID 41461276