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

NCT02317588 | Completed Phase 1

• 1 other identifier: B2014:036
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Oxylipins; Flax oil; Fish oil

Outcome Measures

Primary Outcomes (1)

• Plasma oxylipin concentrations over time

  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 Outcomes (2)

• Fatty Acid Composition Over Time

  28 Days

• Assessment of Markers of Metabolism, Oxidative Stress & Inflammation Over Time

  28 Days

Other Outcomes (2)

• Assessment of Blood Lipids Day 0 vs. Day 28

  28 Days

• Comparison of Serum Oxylipins vs. Plasma Oxylipins

  28 Days

Study Arms (2)

Flax Oil

ACTIVE COMPARATOR

Flax oil 4 grams of ALA per day for 28 days (4 weeks).

Dietary Supplement: Flax Oil

Fish Oil

ACTIVE COMPARATOR

Fish oil at a dose of 4 grams DHA + 0.8 grams EPA per day for 28 days (4 weeks).

Dietary Supplement: Fish Oil

Interventions

Flax Oil DIETARY_SUPPLEMENT

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).

Also known as: Now Brand Organic Flax Oil

Flax Oil

Fish Oil DIETARY_SUPPLEMENT

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).

Also known as: Carlson DHA Gems

Fish Oil

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must meet the following criteria to be eligible for participation in the study:
• Male, or non-pregnant, non-lactating premenopausal female, ≥18 and ≤50 years of age;
• 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;
• Blood pressure \<140/90;
• Body mass index (BMI) of 18 to 28;
• Stable regime if taking vitamin and mineral/dietary/herbal supplements for the past 1 months and while participating in the study;
• Willing to maintain a stable level of activity while participating in the study;
• 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;
• Females must have normal menses and can be on birth control;
• Agrees to not donate blood while participating in the study and for 2 months after participation in the study.
• Willing to comply with the protocol requirements and procedures;
• Willing to provide informed consent.

You may not qualify if:

• Participants will be excluded if they have any of the following:
• 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;
• 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;
• Allergy or sensitivity to any of the study product ingredients, such as flax, flax oil, or marine source oils such as fish or shellfish.
• Cigarette/cigar smoking or use of tobacco products within the past 12 months or during the study;
• Body weight has not been stable (±3 kg) over the past 6 months;
• 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;
• Current (within the past 30 days) bacterial, viral or fungal infection;
• Unable to obtain blood sample at the screening and/or week 0 visit.
• Donated or had blood collected in the 2 months prior to participation the study.

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Manitoba Health Research Council: collaborator

Study Sites (1)

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (22)

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  PMID: 33097936 DERIVED

Related Links

• Canadian Centre for Agri-Food Research in Health and Medicine

MeSH Terms

Interventions

Linseed Oil; Fish Oils

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Carla Taylor, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 16, 2014
• Study Start: December 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 10, 2016

Record last verified: 2016-03

Locations

CA (1)