NCT02092649

Brief Summary

Fatty acids are the main components of the cell membranes. It has been demonstrated that diet can alter the characteristics and function of many membranes in the body, which has an effect on cardiovascular and metabolic health. Over the last two decades there has been a substantial rise in the research of the effects of Omega 3 polyunsaturated fatty acids on bodily function. There are two fatty acids that are of particular interest to researchers, eicosapentanoic acid (EPA) and docosahexanoic acid (DHA). These fatty acids have unique unsaturated structures, and their incorporation into biological membranes seems to generate important and positive physiological effects. The body is unable to synthesize these fatty acids in high concentrations to elicit significant effects, so they must be obtained through diet in food or via supplementation. It has been suggested that EPA and DHA supplementation increases resting metabolic rate (RMR) in humans, in part by increasing the use of fat as a fuel during rest. There are a limited number of studies examining the effects of Omega 3 supplementation on RMR. Some have found an increase in RMR while others have found no change. These studies have some limitations, as that they have either used a small sample size, a low omega fatty acid dose and/or short supplementation periods. Due to the variable results, the investigators will improve the reliability of the RMR measurements by making measures on each subject during two consecutive days at each time point that it is measured (0, 6 and 12 weeks). Therefore, the purpose of this study is to determine the effects of 12 weeks of omega 3 supplementation (3 g/d) on healthy young adults vs. the supplementation of a placebo. The researchers hypothesize that EPA and DHA supplementation will result in an increase in RMR and fat oxidation in some subjects and not in others. The duplicate RMR measures will determine the prevalence and magnitude of the omega 3 supplementation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1 year until next milestone

Results Posted

Study results publicly available

January 6, 2016

Completed
Last Updated

January 6, 2016

Status Verified

December 1, 2015

Enrollment Period

7 months

First QC Date

March 17, 2014

Results QC Date

June 1, 2015

Last Update Submit

December 1, 2015

Conditions

Keywords

Omega-3Resting metabolic rateEicosapentaenoic acidDocosahexaenoic acid

Outcome Measures

Primary Outcomes (1)

  • Change in Resting Metabolic Rate From Baseline

    Percent change in resting metabolic rate

    Baseline, 6 weeks, 12 weeks

Secondary Outcomes (5)

  • Change in Maximum Oxygen Consumption From Baseline

    Baseline, 12 weeks

  • Change in Whole Body Resting Fat Oxidation From Baseline

    Baseline, 6 weeks, 12 weeks

  • Change in Whole Body Resting Carbohydrate Oxidation From Baseline

    Baseline, 6 weeks, 12 weeks

  • Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days

    Baseline, 6 weeks, 12 weeks

  • Change in Fasted Blood Triglyceride Concentration From Baseline

    Baseline, 12 weeks

Study Arms (2)

Omega-3 Complete

EXPERIMENTAL

Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.

Dietary Supplement: Omega-3 Complete

Placebo Pill

PLACEBO COMPARATOR

Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.

Dietary Supplement: Placebo Pill

Interventions

Omega-3 CompleteDIETARY_SUPPLEMENT
Omega-3 Complete
Placebo PillDIETARY_SUPPLEMENT
Placebo Pill

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age.
  • Must currently practice a consistent diet and exercise regimen, and maintain this throughout the duration of the study.

You may not qualify if:

  • Current or previous supplementation with omega-3's.
  • Average fish intake greater than two times per week.
  • Taken any medications, have any medical condition, and hospitalization or surgeries.
  • Allergy to fish/fish oil, , (rosemary extract, ascorbyl palmitate, or natural tocopherols).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Guelph

Guelph, Ontario, N1G 2W1, Canada

Location

Related Publications (1)

  • Jannas-Vela S, Roke K, Boville S, Mutch DM, Spriet LL. Lack of effects of fish oil supplementation for 12 weeks on resting metabolic rate and substrate oxidation in healthy young men: A randomized controlled trial. PLoS One. 2017 Feb 17;12(2):e0172576. doi: 10.1371/journal.pone.0172576. eCollection 2017.

Results Point of Contact

Title
Sebastian Jannas-Vela MSc
Organization
University of Guelph

Study Officials

  • Lawrence L Spriet, PhD

    University of Guelph

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 20, 2014

Study Start

April 1, 2014

Primary Completion

November 1, 2014

Study Completion

January 1, 2015

Last Updated

January 6, 2016

Results First Posted

January 6, 2016

Record last verified: 2015-12

Locations