The purpose of this study is to determine the effects of omega-3 fatty acids in the form of fish oil supplementation (approximately 2 grams per day) on the carotid intima-media (CIMT)progression (primary objective) and 2)(Secondary objective) lipid markers such as LDL, apo-B, and LDL buoyancy, on inflammatory burden as measured by CRP, on oxidative stress as measured by urinary isoprostanes, urine microalbumin/creatinine, and serum adiponectin a fat derived hormone in subjects with metabolic syndrome.
This translational pilot study will have a double-blind, placebo-controlled, parallel design. We will enroll one hundred subjects who meet at least 3 of the 5 criteria for metabolic syndrome as per NCEP guidelines/WHO guidelines and who do not have known cardiovascular disease or diabetes. They will receive either placebo or omega-3 fatty acids in the form of fish oil capsules for a two-year period. Assessment of, C-IMT, serum lipoprotein profile, LDL- buoyancy, adiponectin, CRP, SAA, apolipoprotein B and A-1, fasting glucose, fasting insulin levels, and plasma fatty acids will be measured at baseline, one year, and two years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
100
Total of 1.8 grams of EPA +DHA in the form of fish oil capsules (3/day)
Northwest Lipid Research Clinic (University of Washington Affiliated)
Seattle, Washington, United States
Change in Carotid IMT
Time frame: 1 year, 2 years
Lipid (apolipoproteins and lipid parameters)
Time frame: 1 year, 2 years
hs-CRP & SAA
Time frame: 1 year, 2 years
Glucose
Time frame: 1 year, 2 years
Insulin
Time frame: 1 year, 2 years
adiponectin
Time frame: 1 year, 2 years
urine microalbumin/creatinine
Time frame: 1 year, 2 years
Serum Fatty Acids
Time frame: 1 year, 2 years
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