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Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04211766
Collaborator
National Cancer Institute (NCI) (NIH), Texas A&M University (Other)
30
Enrollment
1
Location
2
Arms
23.8
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Dietary Fiber
  • Dietary Supplement: Fish Oil
  • Other: Placebo
  • Other: Placebo
 Phase 1

Detailed Description

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Diet and the Colonic Exfoliome: A Novel, Non-Invasive Approach to Testing Interventions in Humans
Actual Study Start Date :
Jan 5, 2021
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group I (supplemental fiber and fat followed by placebo)

Participants receive a fiber supplement daily and a fish oil supplement PO daily on days 1-30. Participants enter a washout period for at least 60 days and then crossover to Group II.

Dietary Supplement: Dietary Fiber
Given fiber supplement
Other Names:
  • Fiber

    • Dietary Supplement: Fish Oil
    Given fish oil supplement
    Other Names:
  • Oil, Fish
  • Seafood Oil

    • Other: Placebo
    Given fiber supplement placebo
    Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

    • Other: Placebo
    Given fish oil supplement placebo (corn oil)
    Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

    		•
    Active Comparator: Group II (placebo followed by supplemental fiber and fat)

    Participants receive a fiber supplement placebo daily and a fish oil supplement placebo daily on days 1-30. Participants enter a washout period for at least 60 days and then crossover to Group I.

    Dietary Supplement: Dietary Fiber
    Given fiber supplement
    Other Names:
  • Fiber

    • Dietary Supplement: Fish Oil
    Given fish oil supplement
    Other Names:
  • Oil, Fish
  • Seafood Oil

    • Other: Placebo
    Given fiber supplement placebo
    Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

    • Other: Placebo
    Given fish oil supplement placebo (corn oil)
    Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in mRNA expression profiles in the exfoliome [Baseline to 2 years]

      Poly A+ RNA will be isolated from exfoliated cells in stool, and libraries generated from stool RNA will be sequenced on an Illumina HiSeq 2500 platform.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fred Hutch/University of Washington Cancer Consortium Seattle Washington United States 98109

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Johanna Lampe, Fred Hutch/University of Washington Cancer Consortium

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Fred Hutchinson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04211766
    Other Study ID Numbers:
    • RG1006100
    • NCI-2019-07435
    • RG1006100
    • R21CA245456
    • 10327
    First Posted:
    Dec 26, 2019
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fred Hutchinson Cancer Center
    Colon
    Rectum

    Study Results

    No Results Posted as of Jul 22, 2022