CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
Flax Oil +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02317588
NCT02317588Phase 1Completed
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Gender Effects of Dietary Omega-3 Fatty Acids From Plant and Marine Sources on Oxylipins in Healthy Humans

University of Manitoba·interventional·Posted Dec 16, 2014·Updated Mar 10, 2016

In Brief

A Phase 1 clinical trial evaluating Flax Oil and Fish Oil for Healthy. Completed, enrolled 12 participants across 1 site.

Detailed Summary

This study is single site, double-blind, randomized, cross-over study designed to compare the effects of flax oil and fish oil supplementation on the oxylipin profile in healthy males and females. Eligible participants will complete two (2) Supplementation Phases (flax oil versus fish oil) and will be asked to attend 6 in-person clinic visits (0, 1, 3, 7, 14 and 28 days) for blood and urine collection during each phase. Participants will consume 8 capsules a day for 28 days containing either A) Flax Oil at 4 grams of ALA per day ,in one phase and B) Fish Oil at a dose of 4 grams DHA + 0.8 grams EPA per day in the next phase. Participants will be randomized and blinded and will therefore no know what supplement they are taking in either phase.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
CollaboratorsCanadian Institutes of Health Research (CIHR), Manitoba Health Research Council

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 16, 2014
Enrollment StartDec 1, 2014
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.5 years ago

Interventions

Flax Oildietary

Participants will consume capsules containing flax oil at a dose of 4 grams of ALA per day (8 capsules a day) with a meal for 28 days (4 weeks).

Fish Oildietary

Participants will consume capsules containing fish oil at a dose of 4 grams DHA + 0.8 grams EPA per day (8 capsules) for 28 days (4 weeks).