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

Cardiovascular Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690312
• Other study ID #: 11-09-002
• Secondary ID: 150038
• Status: Completed
• Phase: N/A
• First received: September 10, 2012
• Last updated: February 6, 2014
• Start date: September 2012
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Nutrasource Diagnostics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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].
• 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.

Locations

Country	Name	City	State
Canada	Nutrasource Diagnostics Inc.	Guelph	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Nutrasource Diagnostics Inc.	Biodroga Inc., University of Guelph

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triglyceride [TG]	Fasted and postprandial samples will be drawn (hourly up to 6 hours).	0 and 4 weeks	No
Secondary	Glucose	Fasted and postprandial samples will be drawn (every 30 minutes up to 2 hours).	0 and 4 weeks	No
Secondary	Insulin	Fasted and postprandial samples will be drawn (every 30 minutes up to 2 hours).	0 and 4 weeks	No
Secondary	Total cholesterol [TC]	A fasted blood sample will be taken.	0 and 4 weeks	No
Secondary	High-density lipoprotein [HDL]	A fasted blood sample will be taken.	0 and 4 weeks	No
Secondary	Low-density lipoprotein [LDL]	A fasted blood sample will be taken.	0 and 4 weeks	No
Secondary	Very low-density lipoprotein [VLDL]	A fasted blood sample will be taken.	0 and 4 weeks	No
Secondary	Lipoprotein A	A fasted blood sample will be taken.	0 and 4 weeks	No
Secondary	Intermediate-density lipoprotein [IDL]	A fasted blood sample will be taken.	0 and 4 weeks	No
Secondary	Remnant Lipoproteins	A fasted blood sample will be taken.	0 and 4 weeks	No
Secondary	High-sensitivity C-Reactive Protein [hs-CRP]	A fasted blood sample will be taken.	0 and 4 weeks	No
Secondary	Homocysteine	A fasted blood sample will be taken.	0 and 4 weeks	No
Secondary	Essential Fatty Acid Profile	A fasted blood sample will be taken.	0 and 4 weeks	No
Secondary	Apolipoprotein B	A fasted blood sample will be taken.	0 and 4 weeks	No
Secondary	Apolipoprotein A-1	A fasted blood sample will be taken.	0 and 4 weeks	No