Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subject
• Intervention / Treatment: Dietary supplement: Dietary Fiber; Dietary supplement: Fish Oil; Other: Comparator; Other: Comparator

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cross-over Randomization 1: Fiber plus Fish Oil followed by Comparator; 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; Given fiber supplement; Other Names: Fiber; Dietary supplement: Fish Oil; Given fish oil supplement; Other Names: Oil, Fish; Seafood Oil; Other: Comparator; Given fiber supplement placebo; Other Names: placebo therapy; PLCB; sham therapy; Other: Comparator; Given fish oil supplement placebo (corn oil); Other Names: placebo therapy; PLCB; sham therapy
Experimental: Cross-over Randomization 2: Comparator followed by Fiber plus Fish Oil; 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; Given fiber supplement; Other Names: Fiber; Dietary supplement: Fish Oil; Given fish oil supplement; Other Names: Oil, Fish; Seafood Oil; Other: Comparator; Given fiber supplement placebo; Other Names: placebo therapy; PLCB; sham therapy; Other: Comparator; Given fish oil supplement placebo (corn oil); Other Names: placebo therapy; PLCB; sham therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance	Serum Phospholipids - Eicosapentaenoic acid (EPA), concentration	Average at the end of each intervention period
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.	End of Fiber Plus Fish Oil Supplementation vs end of Comparator

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI); Texas A&M University
• Investigators: Principal Investigator: Johanna Lampe, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2021
• Primary Completion (Actual): August 16, 2022
• Study Completion (Actual): August 16, 2022

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: December 23, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Colon; Rectum
• Other Study ID Numbers: RG1006100 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); 10327 (Other Identifier: CTEP); NCI-2019-07435 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R21CA245456 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No