N/A N=35 Randomized Double-blind Prevention

Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer

Healthy Subject

Bottom Line

View on ClinicalTrials.gov: NCT04211766 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2023

Primary outcome: 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 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Dietary Fiber (Dietary_supplement); Fish Oil (Dietary_supplement); Comparator (Other)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Fred Hutchinson Cancer Center
Primary completion: Aug 2022

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	—

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.

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

View full record on ClinicalTrials.gov →

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.