Cardiovascular Disease
Conditions
Keywords
Humans, Cardiovascular Disease, Statins, Fish Oil, DHA, EPA, High-DHA, Triglycerides, Total cholesterol [TC], Lipoproteins, High-density lipoprotein [HDL2, HDL3], Low-density lipoprotein [LDL1+2+3+4], Lipoprotein A [Lp(a)], Intermediate-density lipoprotein (IDL), Very low-density lipoprotein (VLDL1+2, VLDL3), Remnant Lipoproteins, High-sensitivity C-Reactive Protein [hs-CRP], Homocysteine, Essential Fatty Acid Profile, Apolipoprotein B, Apolipoprotein A-1, Glucose, Insulin, Fasted, Post-Prandial
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTFish Oil
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 \[3080 mg of DHA+EPA\].
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
Biodroga Inc.
University of Guelph
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Be an adult between the ages of 18 and 70; * Be a male or a post-menopausal female who has gone a minimum of one year since their last menses; * Be taking Statin medication at a stable dose for a minimum of four weeks prior to study commencement \[and whom have reached a target LDL level\]; * Have elevated fasting triglyceride levels \[greater than 1.5 mmol/L but less than 5.7 mmol/L\]; * Have fasting blood glucose levels below the study cut-off \[less than 7.0 mmol/L\]; * Have a Body Mass Index (BMI) less than 35.0 * Be taking natural health products BUT agree to cease consumption during the study period and a 4-week pre-study washout prior to study commencement. Study participants will be allowed to consume a daily multivitamin if they have been doing so at a stable dose for a minimum of three months prior to study commencement.
Exclusion criteria
* Be younger than 18 years of age or older than 70 years of age; * Be an adult pre- or peri-menopausal female; * Not have taken Statin medication at a stable dose for a minimum of 4 weeks prior to study commencement; * Have fasting triglyceride levels outside of study limits\[ie/ less than 1.5 mmol/L or greater than 5.7 mmol/L\]; * Have elevated fasting blood glucose levels \[greater or equal to 7.0 mmol/L\]; * Have high blood pressure \[greater than 140/100\] * Have a Body Mass Index (BMI) equal to or greater than 35.0 * Have a pre-existing cardiovascular disease or illness, including angina, myocardial infarction, stroke, intermittent claudication or transient ischemic attack; * Have a known allergy to fish and/or fish oil, olive oil, soy or Vitamin E; * Be taking natural health products but are unwilling to cease consumption during the study period and a 4-week pre-study washout prior to study commencement; * Consume more than two (2) fish meals on a weekly basis * Consume excessive amounts of alcohol on a weekly basis \[more than 10 alcoholic drinks per week\]; * Anticipate or have planned surgery during the course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Triglyceride [TG] | 0 and 4 weeks | Fasted and postprandial samples will be drawn (hourly up to 6 hours). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Remnant Lipoproteins | 0 and 4 weeks | A fasted blood sample will be taken. |
| Glucose | 0 and 4 weeks | Fasted and postprandial samples will be drawn (every 30 minutes up to 2 hours). |
| Insulin | 0 and 4 weeks | Fasted and postprandial samples will be drawn (every 30 minutes up to 2 hours). |
| Total cholesterol [TC] | 0 and 4 weeks | A fasted blood sample will be taken. |
| High-density lipoprotein [HDL] | 0 and 4 weeks | A fasted blood sample will be taken. |
| Low-density lipoprotein [LDL] | 0 and 4 weeks | A fasted blood sample will be taken. |
| Intermediate-density lipoprotein [IDL] | 0 and 4 weeks | A fasted blood sample will be taken. |
| Lipoprotein A | 0 and 4 weeks | A fasted blood sample will be taken. |
| High-sensitivity C-Reactive Protein [hs-CRP] | 0 and 4 weeks | A fasted blood sample will be taken. |
| Homocysteine | 0 and 4 weeks | A fasted blood sample will be taken. |
| Essential Fatty Acid Profile | 0 and 4 weeks | A fasted blood sample will be taken. |
| Apolipoprotein B | 0 and 4 weeks | A fasted blood sample will be taken. |
| Apolipoprotein A-1 | 0 and 4 weeks | A fasted blood sample will be taken. |
| Very low-density lipoprotein [VLDL] | 0 and 4 weeks | A fasted blood sample will be taken. |
Countries
Canada
Outcome results
None listed