Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer

NCT04211766 | Completed Results

• 4 other identifiers: RG1006100NCI-2019-07435R21CA24545610327
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subject

Keywords

Colon; Rectum

Outcome Measures

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)

  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.

  Baseline to completion of the 2 study time periods

Secondary Outcomes (2)

• Number of Differentially Expressed Exfoliome Genes at p<0.01

  End of Fiber Plus Fish Oil Supplementation vs end of Comparator

• Compliance

  Average at the end of each intervention period

Study Arms (2)

Cross-over Randomization 1: Fiber plus Fish Oil followed by Comparator

EXPERIMENTAL

Participants first received a fiber supplement and a fish oil supplement PO daily for 30 days (Period 1). Participants entered a washout period for at least 60 days. For period 2 they received similarly packaged comparator (maltodextrin and corn oil)

Dietary Supplement: Dietary Fiber; Dietary Supplement: Fish Oil; Other: Comparator

Cross-over Randomization 2: Comparator followed by Fiber plus Fish Oil

EXPERIMENTAL

Participants first received the comparator (maltodextrin and corn oil) supplement PO daily for 30 days (Period 1). Participants enter a washout period for at least 60 days. For period 2 they received the fiber supplement and a fish oil supplement

Dietary Supplement: Dietary Fiber; Dietary Supplement: Fish Oil; Other: Comparator

Interventions

Dietary Fiber DIETARY_SUPPLEMENT

Given fiber supplement

Also known as: Fiber

Cross-over Randomization 1: Fiber plus Fish Oil followed by Comparator; Cross-over Randomization 2: Comparator followed by Fiber plus Fish Oil

Fish Oil DIETARY_SUPPLEMENT

Given fish oil supplement

Also known as: Oil, Fish, Seafood Oil

Cross-over Randomization 1: Fiber plus Fish Oil followed by Comparator; Cross-over Randomization 2: Comparator followed by Fiber plus Fish Oil

Comparator OTHER

Given fiber supplement placebo

Also known as: placebo therapy, PLCB, sham therapy

Cross-over Randomization 1: Fiber plus Fish Oil followed by Comparator; Cross-over Randomization 2: Comparator followed by Fiber plus Fish Oil

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Fan YY, Salinas ML, Mullens DA, Davidson LA, Goldsby JS, Ivanov IV, Jayaraman A, Cai JJ, Levy L, Hullar MA, Navarro SL, Lampe JW, Chapkin RS. Pesco-Vegetarian Food Components Promote Colonocyte Froptosis in Preclinical Mouse Models and a Randomized Crossover Trial in Healthy Human Adults. J Nutr. 2025 Dec 27:101287. doi: 10.1016/j.tjnut.2025.101287. Online ahead of print.

  PMID: 41461276 DERIVED

MeSH Terms

Interventions

Dietary Fiber; Fish Oils

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Oils; Lipids

Limitations and Caveats

This is a pilot study with limited funding (R21 mechanism) thus sample size is small.

Results Point of Contact

• Title: Dr. Johanna Lampe
• Organization: Fred Hutchinson Cancer Center

JLampe@fredhutch.org

(206) 667-6580

Study Officials

• Johanna Lampe

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: December 26, 2019
• Study Start: January 5, 2021
• Primary Completion: August 16, 2022
• Study Completion: August 16, 2022
• Last Updated: September 27, 2024
• Results First Posted: October 17, 2023

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)