Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy Subject

Intervention / Treatment
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* Dietary Supplement: Dietary Fiber
* Dietary Supplement: Fish Oil
* Other: Comparator
* Other: Comparator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cross-over Randomization 1: Fiber plus Fish Oil followed by Comparator<br>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<br>* Given fiber supplement<br>* Other names: Fiber;Dietary Supplement: Fish Oil<br>* Given fish oil supplement<br>* Other names: Seafood Oil;Other: Comparator<br>* Given fiber supplement placebo<br>* Other names: sham therapy;Other: Comparator<br>* Given fish oil supplement placebo (corn oil)<br>* Other names: sham therapy;|
| Experimental: Cross-over Randomization 2: Comparator followed by Fiber plus Fish Oil<br>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<br>* Given fiber supplement<br>* Other names: Fiber;Dietary Supplement: Fish Oil<br>* Given fish oil supplement<br>* Other names: Seafood Oil;Other: Comparator<br>* Given fiber supplement placebo<br>* Other names: sham therapy;Other: Comparator<br>* Given fish oil supplement placebo (corn oil)<br>* Other names: sham therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and Retention for a Trial With Daily Doses of 35 gr of Fiber and 6.2 oz of Fish Oil (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 | 
| 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 period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colon, Rectum