Metabolic Syndrome XFOHSNCT02042274
Efficacy Study Regarding the Beneficial Effects of Omega-3 Fatty Acids on Cardiometabolic Health
A study testing Fish oil supplement in people with Metabolic Syndrome X, run by University of Guelph at 1 site in Canada.
Trial summary
Fish oil supplements (which are rich in omega-3 fatty acids) have been shown to provide cardiometabolic benefits to individuals of all ages. Specifically, the daily consumption of fish oil supplements has been reported to reduce blood triglyceride levels, and influence glucose homeostasis and whole-body inflammation. 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
- Metabolic Syndrome X
- What is being tested?
- Fish oil supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to Feb 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
- between 18-25 years old
- male
- good general health
Who cannot join
- currently taking a fish oil supplement
- currently taking an omega-3 supplement
- currently consuming a diet high in omega-3 (high in ALA, EPA, or DHA)
- not able to maintain a consistent lifestyle routine throughout the study duration
- have an allergy which would prevent them from taking a fish oil pill
- schedule conflict with study visits
- overweight or obese
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Guelph - Human Nutraceutical Research Unit
Guelph, Ontario, N1G2W1
About this study
Official title: Omega-3 Fatty Acids and Genes Interact to Influence Cardiometabolic Health.
Fish oil supplements (which are rich in omega-3 fatty acids) have been shown to provide cardiometabolic benefits to individuals of all ages. Specifically, the daily consumption of fish oil supplements has been reported to reduce blood triglyceride levels, and influence glucose homeostasis and whole-body inflammation. However, recent evidence highlights important gaps in our understanding with respect to the impact of fish oil supplements on health; specifically, not everyone responds to these supplements in the same manner. The goal of this research is to explore how an individual's genetic make-up may modify their response to fish oil supplements.
Read the detailed description
The typical Western diet is now recognized to have insufficient amounts of omega-3 fatty acids (in particular EPA and DHA). These fatty acids have several known health benefits, including improvements in heart health, metabolic syndrome, and inflammation. These benefits occur because omega-3 fatty acids can regulate a myriad of cellular functions. In order to increase the levels of these omega-3 fatty acids in the body, individuals must either consume more marine products or take an omega-3 rich dietary supplement, such as fish oil. While fish oil supplements are commonly consumed by people, it is now recognized that not everyone responds to these supplements in the same manner. Therefore this study aims to improve our understanding of why people respond differently to the same dietary supplement. The goals of this research will be accomplished using a number of approaches:
- The investigators will examine how fish oil supplementation leads to an enrichment of EPA and DHA in various cells throughout the body (erythrocytes, adipose tissue, etc).
- The investigators will determine the dynamic changes in EPA and DHA incorporation into different cell-types during distinct phases of our dietary intervention study (e.g. during supplementation and subsequent wash out periods).
- The investigators will study how fish oil supplements influence various blood markers of cardiometabolic health (e.g. triglycerides, cholesterol, glucose, C-reactive protein, etc) and whether this is modulated by an individual's genotype.
- Conditions
- Metabolic Syndrome X
- Being tested
- Fish oil supplement
- Keywords
- Fish oil, EPA, DHA, fatty acids, genetic variation, gene expression
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oil supplementDietary supplement
Also called Jamieson Omega-3 complete supplements, Ocean Nutrition MEG-3 supplements
Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period.
| Study group | Role | What they receive |
|---|---|---|
| Fish oil supplement | Experimental | Fish oil supplements providing up to 3g per day of EPA and DHA Receives: Dietary Supplement: Fish oil supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Triglyceride
Blood triglycerides were measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.
Measured: Baseline, 3 months, 5 months
Secondary outcomes (1)
Blood Glucose
Blood glucose levels measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.
Measured: Baseline, 3 months, 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startOct 2012
- Primary completionMar 2013
- Study completionFeb 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 Metabolic Syndrome XStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David M Mutch, University of Guelph
- Investigators
- David M Mutch, PhD, Principal investigator, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042274
- Sponsor's protocol ID
- Fish Oil and Health Study
- Other IDs
- 12JL006
- Acronym
- FOHS
- Status last verified
- Feb 2017
- First submitted
- 20 Jan 2014
- Last updated
- 5 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Roke K, Mutch DM. The role of FADS1/2 polymorphisms on cardiometabolic markers and fatty acid profiles in young adults consuming fish oil supplements. Nutrients. 2014 Jun 16;6(6):2290-304. doi: 10.3390/nu6062290.
PubMed 24936800
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acids and Genes Interact to Influence Cardiometabolic Health.
- ClinicalTrials.gov ID
- NCT02042274
- Acronym / sponsor ID
- FOHS / Fish Oil and Health Study
- Conditions
- Metabolic Syndrome X
- Keywords
- Fish oil, EPA, DHA, fatty acids, genetic variation, gene expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 22 Jan 2014 (estimated)
- Results
- Posted 5 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fish oil supplements (which are rich in omega-3 fatty acids) have been shown to provide cardiometabolic benefits to individuals of all ages. Specifically, the daily consumption of fish oil supplements has been reported to reduce blood triglyceride levels, and influence glucose homeostasis and whole-body inflammation. However, recent evidence highlights important gaps in our understanding with respect to the impact of fish oil supplements on health; specifically, not everyone responds to these supplements in the same manner. The goal of this research is to explore how an individual's genetic make-up may modify their response to fish oil supplements.
Detailed description
The typical Western diet is now recognized to have insufficient amounts of omega-3 fatty acids (in particular EPA and DHA). These fatty acids have several known health benefits, including improvements in heart health, metabolic syndrome, and inflammation. These benefits occur because omega-3 fatty acids can regulate a myriad of cellular functions. In order to increase the levels of these omega-3 fatty acids in the body, individuals must either consume more marine products or take an omega-3 rich dietary supplement, such as fish oil. While fish oil supplements are commonly consumed by people, it is now recognized that not everyone responds to these supplements in the same manner. Therefore this study aims to improve our understanding of why people respond differently to the same dietary supplement. The goals of this research will be accomplished using a number of approaches:
- The investigators will examine how fish oil supplementation leads to an enrichment of EPA and DHA in various cells throughout the body (erythrocytes, adipose tissue, etc).
- The investigators will determine the dynamic changes in EPA and DHA incorporation into different cell-types during distinct phases of our dietary intervention study (e.g. during supplementation and subsequent wash out periods).
- The investigators will study how fish oil supplements influence various blood markers of cardiometabolic health (e.g. triglycerides, cholesterol, glucose, C-reactive protein, etc) and whether this is modulated by an individual's genotype.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fish oil supplement | Experimental | Dietary Supplement: Fish oil supplementFish oil supplements providing up to 3g per day of EPA and DHA |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- between 18-25 years old
- male
- good general health
Key exclusion criteria (7 listed)
- currently taking a fish oil supplement
- currently taking an omega-3 supplement
- currently consuming a diet high in omega-3 (high in ALA, EPA, or DHA)
- not able to maintain a consistent lifestyle routine throughout the study duration
- have an allergy which would prevent them from taking a fish oil pill
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 |
|---|---|---|
| Fish oil supplementAlso: Jamieson Omega-3 complete supplements, Ocean Nutrition MEG-3 supplementsParticipants are instructed to consume fish oil supplements on a daily basis for a 3-month period. | Dietary supplement | Fish oil supplement |
Primary outcome
Blood Triglyceride
Time frame: Baseline, 3 months, 5 months
Blood triglycerides were measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.
1 secondary outcome
Blood Glucose
Time frame: Baseline, 3 months, 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24936800Roke K, Mutch DM. The role of FADS1/2 polymorphisms on cardiometabolic markers and fatty acid profiles in young adults consuming fish oil supplements. Nutrients. 2014 Jun 16;6(6):2290-304. doi: 10.3390/nu6062290.
- Individual participant dataSharing planned: No
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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.
David M Mutch, 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 Fish oil supplement in people with Metabolic Syndrome X, 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 3 inclusion and 7 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 5 Apr 2017. 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. 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 5 Apr 2017). 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?
Blood Triglyceride (time frame: Baseline, 3 months, 5 months). 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 NCT02042274, 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 5 Apr 2017.