N/A
Completed N=35
Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer
Healthy Subject
Source: ClinicalTrials.gov NCT04211766 ↗
Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Feasibility and Retention for a Trial With Daily Doses of 35 g of Fiber and 6.2 g of EPA +DHA (and Corresponding Comparators) — 14; 15; 1; 1 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility and Retention for a Trial With Daily Doses of 35 g of Fiber and 6.2 g of EPA +DHA (and Corresponding Comparators) |
14; 15; 1; 1; 4; 0 | — |
| SECONDARY Number of Differentially Expressed Exfoliome Genes at p<0.01 |
10; 2; 988 | — |
| SECONDARY Compliance |
43.9; 3.6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04211766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.