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NCT01860352 · ClinicalTrials.gov registry record · Phase 1
Effects of Fish Oil on the Colon Mucosa
A Phase 1 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT01860352: Completed Phase 1 study, sponsored by University of Michigan.
NCT01860352 is a Phase 1 study that has completed, run by University of Michigan. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01860352, a Phase 1 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
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 f
Primary Outcome
Quantitate the amount of PGE2 in colon mucosa before and after 5 months of Fish Oil
Interventions
- DIETARY_SUPPLEMENT Fish OIl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2013-05 |
| Est. Completion | 2016-10 |
| Phase | Phase 1 |
What the finished NCT01860352 record still lists
NCT01860352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 1 intervention - of which Fish OIl is the first listed.
NCT01860352 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01860352 about?
NCT01860352 is a clinical study titled "Effects of Fish Oil on the Colon Mucosa". 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 ...
What is the current status of trial NCT01860352?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2013-05. Estimated completion is 2016-10.
What interventions are being tested in trial NCT01860352?
The interventions under investigation include: Fish OIl (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01860352?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01860352's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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