Gender Effects of Dietary Omega-3 Fatty Acids From Plant and Marine Sources on Oxylipins in Healthy Humans — OXGEN-2014  

Healthy Clinical Trial

Official title: Gender Effects of Dietary Omega-3 Fatty Acids From Plant and Marine Sources on Oxylipins in Healthy Humans

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a single site, double-blind, randomized, crossover study designed to compare the effects of dietary omega-3 fatty acids from flax oil versus fish oil supplementation on oxylipin profiles over time (0 to 4 weeks) and between healthy males and females.

Recruitment will consist of a total of six (6) male and six (6) female participants. Participants will be recruited through advertisement from the local community. The study will be conducted at the Asper Centre for Clinical Research, St. Boniface Hospital. Participants will be asked to provide written informed consent prior to participation in the study. Participants who have provided written consent will be asked to attend an in-patient visit to provide a fasting blood sample. Should the participant be eligible to participate, they will be scheduled for a minimum 6 week Run-in Period, a 4 week Supplementation Phase, a minimum 6 week Wash-out Period and then a second 4 week Supplementation Phase; each Supplementation Phase will have 6 in-person visits (0, 1, 3, 7, 14 and 28 days) to obtain fasting blood and urine samples and for completion of the Study Checklist. During each 4 week Supplementation Phase, participants will consume capsules containing flax oil and at a dose of 4 grams of ALA/day, or capsules containing fish oil and at a dose of 4 grams DHA + 0.8 grams EPA/day. A 3-Day Food Record and Activity Questionnaire will be completed before the Day 0 visit and during week 3 of each Supplementation Phase.

Provision of flax oil or fish oil in capsules will allow this study to be double-blinded. Blinding will reduce potential bias during data collection and evaluation of study endpoints. Both the research team and the participant are blinded from the time of randomization and for the duration of the study. Randomization will be used to avoid bias in the assignment; to increase the likelihood that known and unknown participant characteristics are evenly balanced across the various test groups; and to enhance the validity of statistical comparisons across test groups. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT02317588
• Study type: Interventional
• Source: University of Manitoba
• Status: Completed
• Phase: Phase 1
• Start date: December 2014
• Completion date: February 2016