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

Nutrasource

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Dietary Supplement: Fish Oil; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT01690312

150038 (Other Identifier)

11-09-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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36 participants in 2 patient groups

1 (Dietary Supplement - Fish Oil)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fish Oil

2 (Placebo)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Placebo