ProAlgaZyme Novel Algae Infusion: Applications in Metabolic Syndrome

Health Enhancement Products

Status

Completed

Conditions

Metabolic Syndrome X

Treatments

Drug: ProAlgaZyme

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00489333

087/2006

H-0001-01

Details and patient eligibility

About

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.

Full 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]

Enrollment

52 patients

Sex

All

Ages

25 to 60 years old

Volunteers

No Healthy Volunteers

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.