Whole Body Energy MetabolismNCT02092649
Effects of 12 Weeks of Omega 3 Supplementation on Resting Metabolic Rate
A study testing Omega-3 Complete in people with Whole Body Energy Metabolism, run by University of Guelph at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Whole Body Energy Metabolism
- What is being tested?
- Omega-3 Complete
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 - 30 years of age.
- Must currently practice a consistent diet and exercise regimen, and maintain this throughout the duration of the study.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Whole Body Energy Metabolism
- Being tested
- Omega-3 Complete, Placebo Pill
- Keywords
- Omega-3, Resting metabolic rate, Eicosapentaenoic acid, Docosahexaenoic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 CompleteDietary supplement
Placebo PillDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Resting Metabolic Rate From Baseline
Percent change in resting metabolic rate
Measured: Baseline, 6 weeks, 12 weeks
Secondary outcomes (5)
Change in Maximum Oxygen Consumption From Baseline
Measured: Baseline, 12 weeks
Change in Whole Body Resting Fat Oxidation From Baseline
Measured: Baseline, 6 weeks, 12 weeks
Change in Whole Body Resting Carbohydrate Oxidation From Baseline
Measured: Baseline, 6 weeks, 12 weeks
Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days
Measured: Baseline, 6 weeks, 12 weeks
Change in Fasted Blood Triglyceride Concentration From Baseline
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Whole Body Energy MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence Spriet, University of Guelph
- Investigators
- Lawrence L Spriet, PhD, Principal investigator, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092649
- Sponsor's protocol ID
- 14JA044
- Status last verified
- Dec 2015
- First submitted
- 17 Mar 2014
- Last updated
- 6 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 28212390
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 12 Weeks of Omega 3 Supplementation on Resting Metabolic Rate
- ClinicalTrials.gov ID
- NCT02092649
- Acronym / sponsor ID
- 14JA044
- Conditions
- Whole Body Energy Metabolism
- Keywords
- Omega-3, Resting metabolic rate, Eicosapentaenoic acid, Docosahexaenoic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Posted 6 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 Complete | Experimental | Dietary Supplement: Omega-3 CompleteOral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks. |
| Placebo Pill | Placebo comparator | Dietary Supplement: Placebo PillOral 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 - 30 years of age.
- Must currently practice a consistent diet and exercise regimen, and maintain this throughout the duration of the study.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 Complete | Dietary supplement | Omega-3 Complete |
| Placebo Pill | Dietary supplement | Placebo Pill |
Primary outcome
Change in Resting Metabolic Rate From Baseline
Time frame: Baseline, 6 weeks, 12 weeks
Percent change in resting metabolic rate
5 secondary outcomes
Change in Maximum Oxygen Consumption From Baseline
Time frame: Baseline, 12 weeks
Change in Whole Body Resting Fat Oxidation From Baseline
Time frame: Baseline, 6 weeks, 12 weeks
Change in Whole Body Resting Carbohydrate Oxidation From Baseline
Time frame: Baseline, 6 weeks, 12 weeks
Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days
Time frame: Baseline, 6 weeks, 12 weeks
Change in Fasted Blood Triglyceride Concentration From Baseline
Time frame: Baseline, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28212390Jannas-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence L Spriet, PhD principal investigator
University of Guelph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 Complete in people with Whole Body Energy Metabolism, run by University of Guelph at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Resting Metabolic Rate From Baseline (time frame: Baseline, 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02092649, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2016.