ProAlgaZyme Novel Algae Infusion: Applications in Metabolic Syndrome

Study Overview
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Brief Summary
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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
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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]

Official Title
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The Effects of ProAlgaZyme Novel Algae Infusion vs. Placebo on Metabolic Syndrome and Markers of Cardiovascular Health

Conditions
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Metabolic Syndrome X

Intervention / Treatment
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* Drug: ProAlgaZyme


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ProAlgaZyme|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hsCRP |  | 10 weeks | 
| Lipids (total cholesterol, triglycerides HDL-C, LDL-C) |  | 10 weeks | 
| Anthropometric measurements (weight/BMI, % body fat, blood pressure) |  | 10 weeks | 
| Fasting Blood Glucose |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin |  | 10 weeks | 
| Interleukin-6 (IL-6) |  | 10 weeks | 
| TNF-alpha |  | 10 weeks | 
| RBC Sedimentation Rate |  | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ProAlgaZyme, Metabolic syndrome, Inflammation, Cardiovascular, hsCRP, Lipids, Algae