Gender Effects of Dietary Omega-3 Fatty Acids From Plant and Marine Sources on Oxylipins in Healthy Humans
Condition: Healthy
Study type: Interventional
Phase: Phase 1

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.
    

Detailed 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.
    

Intervention name(s): Flax Oil; Fish Oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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).; 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).
Other intervention name(s): Now Brand Organic Flax Oil; Carlson DHA Gems
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Oxylipins; Flax oil; Fish oil