Clinical trial NCT04211766: Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer
Official title: Diet and the Colonic Exfoliome: A Novel, Non-Invasive Approach to Testing Interventions in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subject
Keywords: Colon
Rectum
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Texas A&M University
First posted: 2019-12-26
Enrollment: 38
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Feasibility and Retention for a Trial With Daily Doses of 35 g of Fiber and 6.2 g of EPA +DHA (and Corresponding Comparators)
timeFrame: Baseline to completion of the 2 study time periods
Secondary outcomes:
measure: Number of Differentially Expressed Exfoliome Genes at p<0.01
timeFrame: End of Fiber Plus Fish Oil Supplementation vs end of Comparator
measure: Compliance
timeFrame: Average at the end of each intervention period
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Johanna Lampe
role: PRINCIPAL_INVESTIGATOR
References: