Clinical Study to Assess High-DHA Fish Oil on Biomarkers of Cardiovascular Disease Risk in Adults on Statin Therapy

Study Overview
=================
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.

Official Title
-----------------
Clinical Study to Assess the Acute and Chronic Effects of a High-DHA Fish Oil on Fasting and Post-Prandial Biomarkers of Cardiovascular Disease Risk in Adults on Statin Therapy.

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Fish Oil
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 (Dietary Supplement - Fish Oil)<br>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. | Dietary Supplement: Fish Oil<br>* 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].<br>|
| Experimental: 2 (Placebo)<br>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. | Dietary Supplement: Placebo<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride [TG] | Fasted and postprandial samples will be drawn (hourly up to 6 hours). | 0 and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Statins, Humans, Cardiovascular Disease, 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