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Effects of Fish Oil on the Colon Mucosa

NCT01860352 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-03-01

No results posted yet for this study

Summary

The purpose of this study is to see what effects the dietary supplement called Omega-3 or "Fish Oil" and it has on your colon, if any. Omega-3 (Fish Oil) is available in many forms (pills, capsules, liquid) in grocery stores, health food/vitamin stores and drug stores and from eating fish. We would like to learn if different amounts of Fish Oil specifically chosen for you individually change your colon tissue (large intestine). We hope that Fish Oil may be useful in the future as something that may help to prevent colon cancer, but we don't have any research in humans that shows that yet. We have to do this study first to see if Fish Oil effects the colon. One type of Fish Oil is has been approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of heart disease. We are going to test a different Fish Oil supplement made by a company called Nordic Naturals.

The colon lining or "mucosa" comes in contact with all the undigested things we eat or drink as it passes out to waste (stool). Animal studies suggest that fish oil may help the colon lining by reducing colon polyps and therefore colon cancer. We think this happens through chemical changes in the colon lining and also in the blood. The chemicals that we are looking at are called "fatty acids". We want to see if taking different amounts fish oil chosen for you changes these chemicals (fatty acids) in your colon or your blood. We will assign you a personal "low dose" of fish oil to take for 2 weeks, followed by a "high dose, or maximum" dose for 2 weeks. We will calculate your basal Metabolic Rate (BMR) from your height, weight, age and assess your activity factor. We have a table that then tells us your target low and high dose. Then, based on your blood samples, we figure out which target dose is the one for you that will change these chemicals (fatty acids) by about ½ (50%). We will check how well this process worked by collecting small pieces of colon tissue (biopsies) of the colon before any fish oil and after all the fish oil is consumed. We will also use blood samples to test for these fatty acids and a few others. We are going to collect diet information at several times throughout the study so we can see if the food you eat makes a difference too.

We hope to learn a lot about how fatty acids are metabolized (broken down or used) in the colon directly in combination with Omega-3 supplements.

Conditions

  • Physiological Effects of Fish Oil

Interventions

DIETARY_SUPPLEMENT

Fish OIl

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-02-29
Completion
2016-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01860352 on ClinicalTrials.gov