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

Not Applicable

Completed

• Conditions: Cardiovascular Disease

• Registration Number: NCT01690312
• Lead Sponsor: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-10
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-21
• Primary Completion: 2013-12
• Status Verified: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-06
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Triglyceride [TG]	0 and 4 weeks	Fasted and postprandial samples will be drawn (hourly up to 6 hours).

Secondary Outcome Measures

Name	Time	Method
High-density lipoprotein [HDL]	0 and 4 weeks	A fasted blood sample will be taken.
Homocysteine	0 and 4 weeks	A fasted blood sample will be taken.
Insulin	0 and 4 weeks	Fasted and postprandial samples will be drawn (every 30 minutes up to 2 hours).
Lipoprotein A	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).
Low-density lipoprotein [LDL]	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.
Remnant Lipoproteins	0 and 4 weeks	A fasted blood sample will be taken.
Apolipoprotein B	0 and 4 weeks	A fasted blood sample will be taken.
Total cholesterol [TC]	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.
Intermediate-density lipoprotein [IDL]	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 A-1	0 and 4 weeks	A fasted blood sample will be taken.

Trial Locations

Locations (1)

Nutrasource Diagnostics Inc.; 🇨🇦 Guelph, Ontario, Canada