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

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.

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Dietary supplement: Fish Oil; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Guelph, Ontario, Canada, N1G 0B4
      • Nutrasource Diagnostics Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 (Dietary Supplement - 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.	Dietary supplement: Fish 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].
Experimental: 2 (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.	Dietary supplement: Placebo; 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.

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

Collaborators and Investigators

• Sponsor: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
• Collaborators: University of Guelph; Biodroga Inc.
• Investigators: Principal Investigator: Alison Duncan, Ph.D., R.D., University of Guelph

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: September 10, 2012
• First Submitted That Met QC Criteria: September 18, 2012
• First Posted (Estimate): September 21, 2012

Study Record Updates

• Last Update Posted (Estimate): February 7, 2014
• Last Update Submitted That Met QC Criteria: February 6, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Insulin; Humans; Cardiovascular Disease; DHA; Fish Oil; Statins; Glucose; Triglycerides; Post-Prandial; Homocysteine; EPA; Lipoproteins; Fasted; Apolipoprotein B; High-DHA; Total cholesterol [TC]; 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]; Essential Fatty Acid Profile; Apolipoprotein A-1
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 11-09-002; 150038 (Health Canada)