Metabolic Syndrome X
Conditions
Keywords
ProAlgaZyme, Metabolic syndrome, Inflammation, Cardiovascular, hsCRP, Lipids, Algae
Brief summary
The purpose of this study is to compare the effects of supplementation with ProAlgaZyme (a novel fermentation product of a freshwater algae ecosystem) vs. placebo on Metabolic Syndrome and indicators of cardiovascular health including: body weight and fat, blood lipids, inflammatory markers such as hsCRP, blood pressure and fasting blood glucose.
Detailed description
Metabolic syndrome, a set of symptoms strongly associated with increased risk for both cardiovascular disease and diabetes, is generally linked to obesity and has become a serious problem in many industrialized countries. Agents that aid in weight loss or help to normalize blood lipids or inflammation may reduce the risk of metabolic syndrome and therefore, reduce the risk of cardiovascular disease and diabetes. This study is a single-center, double-blind, placebo-controlled, parallel design, to evaluate the effects of ProAlgaZyme (4 fl. oz. daily) on metabolic syndrome and markers of cardiovascular health including blood lipids, inflammatory markers and anthropometric measurements. Comparisons: ProAlgaZyme vs. placebo \[Time frame: 10 weeks\]
Interventions
DRUGProAlgaZyme
Sponsors
University of Yaounde
Health Enhancement Products, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Participants must meet 3 of the following criteria: * BMI ≥30 kg/m2 * HDL Cholesterol of \<40 * Triglycerides \>150 mg/dl * Fasting blood glucose \>100 mg/dl * Blood pressure \>130/85 mm Hg * Total Cholesterol of \>200 mg/dl * LDL Cholesterol of \>160 mg/dl * Interleukin 6 (IL-6) \>5pg/mL
Exclusion criteria
* Morbidly obese: BMI \>40 kg/m2 * Taking any cholesterol-lowering medications 30 days prior to the start of enrollment and during the course of the study. * Enrolled in another clinical study in the past 6 months. * Pregnant, actively infected, on medication that interfered with healing (for example, steroids), were inflicted with systemic disease such as AIDS, HIV, active hepatitis or active malignancy (clinical signs within the past 5 years), or suffered from diabetes mellitus requiring daily insulin management.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting Blood Glucose | 10 weeks |
| hsCRP | 10 weeks |
| Lipids (total cholesterol, triglycerides HDL-C, LDL-C) | 10 weeks |
| Anthropometric measurements (weight/BMI, % body fat, blood pressure) | 10 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Insulin | 10 weeks |
| Interleukin-6 (IL-6) | 10 weeks |
| TNF-alpha | 10 weeks |
| RBC Sedimentation Rate | 10 weeks |
Countries
Cameroon
Outcome results
None listed