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

NCT ID: NCT01690312

Last Updated: 2014-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-02-28

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.

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Fish Oil

Intervention Type: DIETARY_SUPPLEMENT

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 \[3080 mg of DHA+EPA\].

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.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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 \[3080 mg of DHA+EPA\].

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biodroga Inc.

INDUSTRY

Sponsor Role: collaborator

University of Guelph

OTHER

Sponsor Role: collaborator

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alison Duncan, Ph.D., R.D.

Role: PRINCIPAL_INVESTIGATOR

University of Guelph

Locations

Nutrasource Diagnostics Inc.

Guelph, Ontario, Canada

Countries

Canada

Other Identifiers

150038

Identifier Type: OTHER

Identifier Source: secondary_id

11-09-002

Identifier Type: -

Identifier Source: org_study_id