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| ID | Type | Description | Link |
|---|---|---|---|
| 12JL006 | Other Identifier | University of Guelph |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fish oil supplement | Experimental | Fish oil supplements providing up to 3g per day of EPA and DHA |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish oil supplement | Dietary Supplement | Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood Triglyceride | Blood triglycerides were measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period. | Baseline, 3 months, 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Glucose | Blood glucose levels measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period. | Baseline, 3 months, 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David M Mutch, PhD | University of Guelph | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Guelph - Human Nutraceutical Research Unit | Guelph | Ontario | N1G2W1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24936800 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fish Oil Supplement | Fish oil supplements providing up to 3g per day of EPA and DHA Fish oil supplement: Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period. Measurements are made at three time points: Baseline (Day 0 - before beginning fish oil supplementation), 3 months (Day 90 - after fish oil supplementation), and 5 months (Day 150 - 2 month washout). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fish Oil | Fish oil supplements providing up to 3g per day of EPA and DHA, for 90 days. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Triglyceride | Blood triglycerides were measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period. | Healthy adults, ranging in age from 18-65 years. | Posted | Mean | Standard Deviation | mmol/L | Baseline, 3 months, 5 months |
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Through study completion (total of 5 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fish Oil Supplement | Fish oil supplements providing up to 3g per day of EPA and DHA Fish oil supplement: Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Mutch, Associate Professor | University of Guelph | 519-824-4120 | 53322 | dmutch@uoguelph.ca |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Subjects were recruited through a poster campaign at the University of Guelph campus. | Count of Participants | Participants |
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| Triglycerides | Mean | Standard Deviation | mmol/L |
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| Secondary | Blood Glucose | Blood glucose levels measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period. | Posted | Mean | Standard Deviation | mmol/L | Baseline, 3 months, 5 months |
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| 0 |
| 12 |
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| 12 |
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| D009750 |
| Nutritional and Metabolic Diseases |
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| Measurements |
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