Metabolic Syndrome Clinical Trial
Official title:
The Effects of ProAlgaZyme Novel Algae Infusion on HDL Cholesterol and C-Reactive Protein in Individuals With Metabolic Syndrome
The purpose of this study is to determine the effectiveness of ProAlgaZyme in increasing levels of HDL 'good' cholesterol and decreasing total cholesterol and C-reactive protein in patients with Metabolic Syndrome.
Cardiovascular disease (CVD) is the most common cause of mortality in the United States. In
1988, Reaven, et al. published findings that indicate a majority of individuals who
developed CVD had multiple concurrent risk factors including dyslipidemia, hypertension, and
hyperglycemia. Reaven, et al., defined this cluster of risk factors as Syndrome X and
hypothesized that insulin resistance was the underlying factor in its development. Over
time, metabolic syndrome has been used as a more meaningful term and additional risk factors
have been associated with its diagnosis (Grundy, et al. 2004). Metabolic syndrome is an
increasingly prevalent problem in the United States and other westernized nations. It is
estimated that approximately 50 million Americans have metabolic syndrome. The risk factors
linked to metabolic syndrome include:
- Abdominal obesity
- Atherogenic dyslipidemia (high triglycerides, low HDL cholesterol and high LDL
cholesterol)
- Elevated blood pressure
- Insulin resistance with or without glucose intolerance
- Pro-thrombotic state (e.g., high fibrinogen or plasminogen activator inhibitor-1 in the
blood)
- Pro-inflammatory state [e.g. elevated C-reactive protein (CRP)in the blood]
The management goals for metabolic syndrome include reducing the risk for developing CVD and
type 2 diabetes. Therefore, therapy is directed at reducing LDL cholesterol, blood pressure
and glucose as well as increasing HDL cholesterol levels. Additional interventions to
control blood pressure and lipids provide the next line of treatment for patients with
metabolic syndrome.
ProAlgaZyme, a novel fermentation product of a freshwater algae ecosystem, will be evaluated
in this trial for its effects on circulating lipids. According to the sponsor, ProAlgaZyme
is expected to increase the circulating levels of HDL cholesterol while lowering total
cholesterol and CRP. ProAlgaZyme was previously tested in a double blind, placebo
controlled, pilot trial in 60 subjects with metabolic syndrome (30 subjects per arm),
conducted at the University of Yaoundé, Cameroon. Statistically significant (p < 0.05 or
better) improvements were seen in total cholesterol, HDL-C and C-reactive protein when
compared to placebo. (In Press - Lipids in Health and Disease)
The present study will evaluate the effect of ProAlgaZyme versus placebo on blood lipids and
hsCRP in subjects who meet the criteria for Metabolic Syndrome.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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