The objective of this research project is to investigate the ability to affect cardiovascular disease (CVD) risk factors through a novel, easily implemented functional food-based approach. The goal of the proposed project is to evaluate the effect of a range of proprietary products specifically formulated to deliver convenient pre-packaged condition-specific foods to positively impact blood cholesterol levels in statin intolerant and/or statin unwilling participants. The specific aim of this project is to evaluate the changes in serum low-density lipoprotein (LDL)-cholesterol, triglyceride (TG) glucose, insulin and high-sensitivity C-reactive protein (hsCRP) concentrations over a 4 week regimen using healthy tasty foods which are self-selected by a statin intolerant patient group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
60
Mayo Clinic
Rochester, Minnesota, United States
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, Canada
Change in fasting serum lipids (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides)
Time frame: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
Change in fasting serum glucose
Homeostasis model of assessment for insulin resistance (HOMA-IR) index will also be calculated
Time frame: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
Change in fasting insulin
Homeostasis model of assessment for insulin resistance (HOMA-IR) index will also be calculated
Time frame: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
Change in fasting C-reactive protein
Time frame: Baseline (days 1 and 2) and Endpoint (days 29 and 30)
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