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| ID | Type | Description | Link |
|---|---|---|---|
| 150038 | Other Identifier | Health Canada |
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| Name | Class |
|---|---|
| Biodroga Inc. | INDUSTRY |
| University of Guelph | OTHER |
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The objective of this study is to determine the acute and chronic [4-week] effects of a high-DHA fish oil supplement on fasting and post-prandial (post-meal) biomarkers of cardiovascular disease risk, in adults on Statin therapy.
This study involves fasted and post-prandial components.
Fasted Study:
Participants will provide fasting blood samples pre-and post-intervention [4-week administration of supplement or placebo] in Treatment Period I. Participants will again provide fasting blood samples pre-and post-intervention [4-week administration of supplement or placebo, opposite to Treatment Period I] during Treatment Period II.
There will be a 4-week washout period during the two Treatment Periods.
Post-prandial study:
Participants will also complete a post-prandial study pre-and post-intervention during each Treatment Period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 (Dietary Supplement - Fish Oil) | Experimental | On Day 1 & Day 29, the researcher will obtain anthropometric measurements as specified in the study protocol. A venous catheter will be inserted and a fasted blood sample will be drawn, which will be analyzed for study primary and secondary endpoints. Participants will consume a Breakfast Meal (which will represent t0) and will have blood drawn at a total of 7 time points. Blood samples drawn at30, t60, t120, and t180 will be analyzed for glucose and insulin; blood samples drawn at t60, t120, t180, t240, t300 and t360 will be analyzed for triglycerides. Upon completion of the 6 hour blood draw period, the venous catheter will be removed. On Day 15, the researcher will obtain anthropometric measurements as specified in the study protocol. |
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| 2 (Placebo) | Experimental | On Day 1 & Day 29, the researcher will obtain anthropometric measurements as specified in the study protocol. A venous catheter will be inserted and a fasted blood sample will be drawn, which will be analyzed for study primary and secondary endpoints. Participants will consume a Breakfast Meal (which will represent t0) and will have blood drawn at a total of 7 time points. Blood samples drawn at30, t60, t120, and t180 will be analyzed for glucose and insulin; blood samples drawn at t60, t120, t180, t240, t300 and t360 will be analyzed for triglycerides. Upon completion of the 6 hour blood draw period, the venous catheter will be removed. On Day 15, the researcher will obtain anthropometric measurements as specified in the study protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish Oil | Dietary Supplement | On Day 1 and Day 15, participants will receive a 2-week supply of study supplements and will be instructed to consume 4 capsules per day. Each capsule contains 1000 mg of fish oil [620 mg of DHA and 150 mg of EPA], providing a total daily dosage of 4000 mg of fish oil [3080 mg of DHA+EPA]. |
| Measure | Description | Time Frame |
|---|---|---|
| Triglyceride [TG] | Fasted and postprandial samples will be drawn (hourly up to 6 hours). | 0 and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose | Fasted and postprandial samples will be drawn (every 30 minutes up to 2 hours). | 0 and 4 weeks |
| Insulin | Fasted and postprandial samples will be drawn (every 30 minutes up to 2 hours). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Duncan, Ph.D., R.D. | University of Guelph | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutrasource Diagnostics Inc. | Guelph | Ontario | N1G 0B4 | Canada |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| C564708 | Huntington Disease-Like 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
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| Placebo | Dietary Supplement | On Day 1 and Day 15, participants will receive a 2-week supply of study supplements and will be instructed to consume 4 capsules per day. Each capsule contains 1000 mg of olive oil, providing a total daily dosage of 4000 mg of olive oil. |
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| 0 and 4 weeks |
| Total cholesterol [TC] | A fasted blood sample will be taken. | 0 and 4 weeks |
| High-density lipoprotein [HDL] | A fasted blood sample will be taken. | 0 and 4 weeks |
| Low-density lipoprotein [LDL] | A fasted blood sample will be taken. | 0 and 4 weeks |
| Very low-density lipoprotein [VLDL] | A fasted blood sample will be taken. | 0 and 4 weeks |
| Lipoprotein A | A fasted blood sample will be taken. | 0 and 4 weeks |
| Intermediate-density lipoprotein [IDL] | A fasted blood sample will be taken. | 0 and 4 weeks |
| Remnant Lipoproteins | A fasted blood sample will be taken. | 0 and 4 weeks |
| High-sensitivity C-Reactive Protein [hs-CRP] | A fasted blood sample will be taken. | 0 and 4 weeks |
| Homocysteine | A fasted blood sample will be taken. | 0 and 4 weeks |
| Essential Fatty Acid Profile | A fasted blood sample will be taken. | 0 and 4 weeks |
| Apolipoprotein B | A fasted blood sample will be taken. | 0 and 4 weeks |
| Apolipoprotein A-1 | A fasted blood sample will be taken. | 0 and 4 weeks |