Clinical trial NCT01690312: Clinical Study to Assess High-DHA Fish Oil on Biomarkers of Cardiovascular Disease Risk in Adults on Statin Therapy
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Humans
Cardiovascular Disease
Statins
Fish Oil
DHA
EPA
High-DHA
Triglycerides
Total cholesterol [TC]
Lipoproteins
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]
Homocysteine
Essential Fatty Acid Profile
Apolipoprotein B
Apolipoprotein A-1
Glucose
Insulin
Fasted
Post-Prandial
Lead sponsor: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Sponsor class: NETWORK
Collaborators: name: Biodroga Inc.
name: University of Guelph
First posted: 2012-09-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Triglyceride [TG]
timeFrame: 0 and 4 weeks
Secondary outcomes:
measure: Glucose
timeFrame: 0 and 4 weeks
measure: Insulin
timeFrame: 0 and 4 weeks
measure: Total cholesterol [TC]
timeFrame: 0 and 4 weeks
measure: High-density lipoprotein [HDL]
timeFrame: 0 and 4 weeks
measure: Low-density lipoprotein [LDL]
timeFrame: 0 and 4 weeks
measure: Very low-density lipoprotein [VLDL]
timeFrame: 0 and 4 weeks
measure: Lipoprotein A
timeFrame: 0 and 4 weeks
measure: Intermediate-density lipoprotein [IDL]
timeFrame: 0 and 4 weeks
measure: Remnant Lipoproteins
timeFrame: 0 and 4 weeks
measure: High-sensitivity C-Reactive Protein [hs-CRP]
timeFrame: 0 and 4 weeks
measure: Homocysteine
timeFrame: 0 and 4 weeks
measure: Essential Fatty Acid Profile
timeFrame: 0 and 4 weeks
measure: Apolipoprotein B
timeFrame: 0 and 4 weeks
measure: Apolipoprotein A-1
timeFrame: 0 and 4 weeks
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Nutrasource Diagnostics Inc.
state: Ontario
Study officials:
affiliation: University of Guelph
name: Alison Duncan, Ph.D., R.D.
role: PRINCIPAL_INVESTIGATOR
References: