Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer

Healthy Subject Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04211766
• Other study ID #: RG1006100
• Secondary ID: NCI-2019-07435RG
• Status: Completed
• Phase: N/A
• Start date: January 5, 2021
• Est. completion date: August 16, 2022

Study information

• Verified date: April 2024
• Source: Fred Hutchinson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 16, 2022
• Est. primary completion date: August 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subject

Intervention

Dietary Supplement:
• Dietary Fiber
Given fiber supplement
• Fish Oil
Given fish oil supplement

Other:
• Comparator
Given fiber supplement placebo
• Comparator
Given fish oil supplement placebo (corn oil)

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Cancer Institute (NCI), Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in mRNA Expression Profiles in the Exfoliome	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.	End of each intervention period
Secondary	Compliance	Serum Phospholipids - Eicosapentaenoic acid (EPA), concentration	Average at the end of each intervention period