Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer

Fred Hutchinson Cancer Center (FHCC)

Status: Completed

Conditions: Healthy Subject

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04211766

10327 (Other Identifier)

NCI-2019-07435 (Registry Identifier)

RG1006100 (Other Identifier)

R21CA245456 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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38 participants in 2 patient groups

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

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Fish Oil

Other: Comparator

Other: Comparator

Dietary Supplement: Dietary Fiber

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

Experimental group

Description:

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

Treatment:

Dietary Supplement: Fish Oil

Other: Comparator

Other: Comparator

Dietary Supplement: Dietary Fiber