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Completed

NCT Number: NCT04211766

Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer

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.

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Key information

Conditions

Healthy Subject

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary fiber

Dietary Supplement

Given fiber supplement

Other names: Fiber

Fish Oil

Dietary Supplement

Given fish oil supplement

Other names: Oil, Fish, Seafood Oil

Comparator

Other

Given fiber supplement placebo

Other names: placebo therapy, PLCB, sham therapy

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Number of Differentially Expressed Exfoliome Genes at p<0.01

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

    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.

  2. Compliance

    Time frame: Average at the end of each intervention period

    Serum Phospholipids - Eicosapentaenoic acid (EPA), concentration

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • Texas A&M University

Registry information

Official study title

Diet and the Colonic Exfoliome: A Novel, Non-Invasive Approach to Testing Interventions in Humans

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 26, 2019
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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