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

March 9, 2016 updated by: University of Manitoba
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Participants must meet the following criteria to be eligible for participation in the study:

  1. Male, or non-pregnant, non-lactating premenopausal female, ≥18 and ≤50 years of age;
  2. Normal blood lipid profile (total cholesterol <5.2 mmol/L, LDL-cholesterol <3.4 mmol/L, HDL-cholesterol >0.9 mmol/L, triglycerides <1.7 mmol/L), plasma creatinine <1.5× upper limit of normal (ULN) where the normal range is 50-97 µmol/L, and glycated hemoglobin <6%; aspartate transaminase (AST) <2× ULN where the normal range is 10 - 32 U/L, and alanine transaminase (ALT) <2× ULN where the normal range is <25 U/L;
  3. Blood pressure <140/90;
  4. Body mass index (BMI) of 18 to 28;
  5. Stable regime if taking vitamin and mineral/dietary/herbal supplements for the past 1 months and while participating in the study;
  6. Willing to maintain a stable level of activity while participating in the study;
  7. Willing to maintain dietary routine and to refrain from consuming omega-3 supplements or omega-3 rich foods (>0.3 grams ALA/serving, or >0.1 grams EPA + DHA/serving) from acceptance into the study until the final study visit;
  8. Females must have normal menses and can be on birth control;
  9. Agrees to not donate blood while participating in the study and for 2 months after participation in the study.
  10. Willing to comply with the protocol requirements and procedures;
  11. Willing to provide informed consent.

Exclusion Criteria:

Participants will be excluded if they have any of the following:

  1. Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system, or a disease condition that has required or currently requires medical treatment;
  2. Taking any prescribed medication, regular use of acetylsalicylic acid (e.g. Aspirin), ibuprofen (e.g. Advil) or acetaminophen (e.g. Tylenol) within the last 3 months;
  3. Allergy or sensitivity to any of the study product ingredients, such as flax, flax oil, or marine source oils such as fish or shellfish.
  4. Cigarette/cigar smoking or use of tobacco products within the past 12 months or during the study;
  5. Body weight has not been stable (±3 kg) over the past 6 months;
  6. Consumption of >15 alcoholic beverages per week (according to Canada's Low-Risk Alcohol Drinking Guidelines, 2012) within the last 3 months or while participating in the study;
  7. Current (within the past 30 days) bacterial, viral or fungal infection;
  8. Unable to obtain blood sample at the screening and/or week 0 visit.
  9. Donated or had blood collected in the 2 months prior to participation the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Flax Oil
Flax oil 4 grams of ALA per day for 28 days (4 weeks).
Dietary supplement: Flax Oil
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).
Other Names:
  • Now Brand Organic Flax Oil
Active Comparator: Fish Oil
Fish oil at a dose of 4 grams DHA + 0.8 grams EPA per day for 28 days (4 weeks).
Dietary supplement: Fish Oil
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 Names:
  • Carlson DHA Gems

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma oxylipin concentrations over time
Time Frame: 28 Days
A fasting venous blood sample will be obtained from the participant on Days 0, 1, 3, 7, 14 and 28 of each 'Supplementation Phase' for the assessment of plasma oxylipin profile.
28 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatty Acid Composition Over Time
Time Frame: 28 Days
A fasting venous blood sample will be obtained from the participant on Days 0, 1, 3, 7, 14 and 28 of each 'Supplementation Phase' for the assessment of fatty acid composition.
28 Days
Assessment of Markers of Metabolism, Oxidative Stress & Inflammation Over Time
Time Frame: 28 Days
A fasting venous blood sample will be obtained from the participant at Day 0, 1, 3, 7, 14 and 28 of each Supplementation Phase for assessment of markers of markers of metabolism, oxidative stress and inflammation.
28 Days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Blood Lipids Day 0 vs. Day 28
Time Frame: 28 Days
At the Day 0 and 28 visits, additional blood fasting venous blood will be obtained from the participant for measurement of total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides.
28 Days
Comparison of Serum Oxylipins vs. Plasma Oxylipins
Time Frame: 28 Days
At the Day 0 and 28 visits a fasting venous blood will be obtained for comparison of oxylipins in clotted (serum) versus unclotted (plasma) samples.
28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

Canadian Institutes of Health Research (CIHR)
Manitoba Health Research Council

Investigators

  • Principal Investigator: Carla Taylor, PhD, University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

December 11, 2014

First Submitted That Met QC Criteria

December 15, 2014

First Posted (Estimate)

December 16, 2014

Study Record Updates

Last Update Posted (Estimate)

March 10, 2016

Last Update Submitted That Met QC Criteria

March 9, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B2014:036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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