Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer

NCT ID: NCT04211766

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-05
• Study Completion Date: 2022-08-16

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.

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.

Conditions

Healthy Subject

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

Dietary Fiber

Intervention Type: DIETARY_SUPPLEMENT

Given fiber supplement

Fish Oil

Intervention Type: DIETARY_SUPPLEMENT

Given fish oil supplement

Comparator

Intervention Type: OTHER

Given fiber supplement placebo

Comparator

Intervention Type: OTHER

Given fish oil supplement placebo (corn oil)

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

Group Type: EXPERIMENTAL

Dietary Fiber

Intervention Type: DIETARY_SUPPLEMENT

Given fiber supplement

Fish Oil

Intervention Type: DIETARY_SUPPLEMENT

Given fish oil supplement

Comparator

Intervention Type: OTHER

Given fiber supplement placebo

Comparator

Intervention Type: OTHER

Given fish oil supplement placebo (corn oil)

Interventions

Dietary Fiber

Given fiber supplement

Intervention Type: DIETARY_SUPPLEMENT

Fish Oil

Given fish oil supplement

Intervention Type: DIETARY_SUPPLEMENT

Comparator

Given fiber supplement placebo

Intervention Type: OTHER

Comparator

Given fish oil supplement placebo (corn oil)

Intervention Type: OTHER

Other Intervention Names

Fiber; Oil, Fish; Seafood Oil; placebo therapy; PLCB; sham therapy; placebo therapy; PLCB; sham therapy

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Texas A&M University

OTHER

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Johanna Lampe

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johanna Lampe

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2019-07435

Identifier Type: REGISTRY

Identifier Source: secondary_id

RG1006100

Identifier Type: OTHER

Identifier Source: secondary_id

R21CA245456

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10327

Identifier Type: OTHER

Identifier Source: secondary_id

RG1006100

Identifier Type: -

Identifier Source: org_study_id