Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer

Fred Hutchinson Cancer Center38 enrolled

Overview

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.

Participants are randomized to receive two dietary interventions in assigned random order. They either receive the dietary fiber supplement and fish oil supplement orally (PO) daily or they receive a fiber control and corn oil supplement daily for 30 days during the first intervention period. Then they enter a washout period for 60 days when they do not receive any treatment. After that they complete the second intervention period during which they receive the other intervention.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Healthy Subject

Interventions

Dietary FiberDIETARY_SUPPLEMENT

Given fiber supplement

Fish OilDIETARY_SUPPLEMENT

Given fish oil supplement

ComparatorOTHER

Given fiber supplement placebo

Comparator

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Outcomes

Primary Outcomes

Feasibility and Retention for a Trial With Daily Doses of 35 g of Fiber and 6.2 g of EPA +DHA (and Corresponding Comparators)

This grant is an R21 with the intent to provide preliminary data to propose a trial with a larger sample size and adequate statistical power.

Time frame: Baseline to completion of the 2 study time periods

Secondary Outcomes

Number of Differentially Expressed Exfoliome Genes at p<0.01

Poly A+ RNA was isolated from exfoliated cells in stool, and libraries generated from stool RNA and sequenced on an Illumina HiSeq 2500 platform. Intestinal exfoliome gene sequencing data from the end of each intervention period were analyzed using differential expression (DE) analysis. Count data were aligned, and sample libraries were filtered and normalized; 25,118 detected features were filtered to keep any feature with \>20 cpm in 73% of samples in at least one of the groups; this resulted in 1000 genes. DE analysis between Fiber Plus Fish Oil Supplement vs the Comparator at the end time point was performed using edgeR with a paired design (Robinson et al, Bioinformatics 2010;26:139). Data are presented as number of DE genes significant at p \< 0.01 (without multiple test correction). Upregulated genes indicate higher gene expression with Fiber Plus Fish Oil vs the Comparator and downregulated genes indicate lower gene expression with Fiber Plus Fish Oil vs the Comparator.

Time frame: End of Fiber Plus Fish Oil Supplementation vs end of Comparator

Compliance

Serum Phospholipids - Eicosapentaenoic acid (EPA), concentration

Time frame: Average at the end of each intervention period

Data from ClinicalTrials.gov

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