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
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Fish Oil

• 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

Arm && Interventions

Group	Intervention	Description
2 (Placebo)	Placebo	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.
1 (Dietary Supplement - Fish Oil)	Fish Oil	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.

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
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.
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.
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