Healthy Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Dose Ranging Study to Evaluate the Pharmacokinetics, Safety and Effects of NutriterraTM in Healthy Adult Subjects
The blood lipid profile plays a role in health and disease states and is affected by many
genetic and lifestyle factors. On the more extreme side, hyperlipidemia (a condition
characterized by hypertriglyceridemia, hypercholesteremia, or both) is a risk factor for
coronary heart disease (CHD) 1. CHD is the most common form of cardiovascular disease (CVD);
it is characterized by arterial obstructions or blockages, and is a leading cause of heart
attacks and strokes 2. Specifically, blood lipids including triglycerides (TG), total
cholesterol (TC), low density lipoprotein-cholesterol (LDL-C), and the ratio of TC: high
density lipoprotein (HDL) cholesterol, are key modifiable risk factors for CHD.
Hyperlipidemia is thought to be caused or promoted by sedentary lifestyle, obesity, or
uncontrolled type 2 diabetes 2. Therefore, lifestyle factors, like the modification of
dietary lipids to maintain a healthy blood lipid profile are warranted.
There are many beneficial effects of omega-3 fatty acids in terms of cardiovascular disease
and the nervous system in general, as well as emerging research on DHA supplementation in
acute brain and spinal cord injury. Demand for dietary omega-3's, either through increased
fish consumption or through DHA supplementation, is expected to increase, particularly as the
baby boomer population adds to the ranks of senior citizens concerned about and/or
susceptible to health issues such as dementia and Alzheimer's Disease. Availability of EPA
and DHA in circulation is an important parameter in understanding biologic properties of
fatty acids.
The purpose of this study is to evaluate the pharmacokinetic characteristics of ascending
doses of NutriterraTM, as measured by plasma levels of total EPA, DHA, DPA and ALA under fed
conditions. In addition, after a two-week (minimum) washout period, subjects will take
product for 16 weeks to evaluate effects on cardiovascular markers as a measure of efficacy.
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