ProAlgaZyme Novel Algae Infusion: Applications in Metabolic Syndrome

Health Enhancement Products, Inc.52 enrolled

Overview

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.

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 \[Time frame: 10 weeks\]

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Metabolic Syndrome X

Interventions

ProAlgaZymeDRUG

Eligibility

Sex: ALLMin age: 25 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I

Yaoundé, Cameroon

Outcomes

Primary Outcomes

hsCRP

Time frame: 10 weeks

Lipids (total cholesterol, triglycerides HDL-C, LDL-C)

Time frame: 10 weeks

Anthropometric measurements (weight/BMI, % body fat, blood pressure)

Time frame: 10 weeks

Fasting Blood Glucose

Time frame: 10 weeks

Secondary Outcomes

Insulin

Time frame: 10 weeks

Interleukin-6 (IL-6)

Time frame: 10 weeks

TNF-alpha

Time frame: 10 weeks

RBC Sedimentation Rate

Time frame: 10 weeks

Data from ClinicalTrials.gov

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