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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
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 \[3080 mg of DHA+EPA\].
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.
Nutrasource Diagnostics Inc.
Guelph, Ontario, Canada
Triglyceride [TG]
Fasted and postprandial samples will be drawn (hourly up to 6 hours).
Time frame: 0 and 4 weeks
Glucose
Fasted and postprandial samples will be drawn (every 30 minutes up to 2 hours).
Time frame: 0 and 4 weeks
Insulin
Fasted and postprandial samples will be drawn (every 30 minutes up to 2 hours).
Time frame: 0 and 4 weeks
Total cholesterol [TC]
A fasted blood sample will be taken.
Time frame: 0 and 4 weeks
High-density lipoprotein [HDL]
A fasted blood sample will be taken.
Time frame: 0 and 4 weeks
Low-density lipoprotein [LDL]
A fasted blood sample will be taken.
Time frame: 0 and 4 weeks
Very low-density lipoprotein [VLDL]
A fasted blood sample will be taken.
Time frame: 0 and 4 weeks
Lipoprotein A
A fasted blood sample will be taken.
Time frame: 0 and 4 weeks
Intermediate-density lipoprotein [IDL]
A fasted blood sample will be taken.
Time frame: 0 and 4 weeks
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Remnant Lipoproteins
A fasted blood sample will be taken.
Time frame: 0 and 4 weeks
High-sensitivity C-Reactive Protein [hs-CRP]
A fasted blood sample will be taken.
Time frame: 0 and 4 weeks
Homocysteine
A fasted blood sample will be taken.
Time frame: 0 and 4 weeks
Essential Fatty Acid Profile
A fasted blood sample will be taken.
Time frame: 0 and 4 weeks
Apolipoprotein B
A fasted blood sample will be taken.
Time frame: 0 and 4 weeks
Apolipoprotein A-1
A fasted blood sample will be taken.
Time frame: 0 and 4 weeks