The Effects of ProAlgaZyme on HDL Cholesterol in Individuals With Metabolic Syndrome

• Status: Unknown status
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Health Enhancement Products, Inc.
• Collaborator: MAPS Applied Research Center

Criteria

Inclusion Criteria:

• Body mass index 28-40

• Subjects with at least 3 of the following parameters:

• Elevated waist circumference: Men - Equal to or greater than 40 in (102cm); Women
• Equal to or greater than 35 in (88cm)

• Elevated triglycerides: Equal to or greater than 150 mg/dL

• Reduced HDL ("good") cholesterol: Men - Less than 40 mg/dL; Women - Less than 50 mg/dL

• Elevated blood pressure: Equal to or greater than 130/85 mmHg

• Elevated fasting glucose: Equal to or greater than 100 mg/dL

• Elevated CRP: Equal to or greater than 5 mg/L

• Subjects with ability to comprehend and complete the questionnaires and forms

• Subjects whose schedules permit 4 visits to the study center over the duration of the trial

• Subjects who are likely to comply with study procedures and test article consumption

• Subjects who are likely to abstain from taking unauthorized supplements/medications or participating in any other clinical trial or experimental treatment during this trial

Exclusion Criteria:

• Subjects with uncontrolled hypertension as defined as greater than 180/95 mmHg (subjects may be re-screened after adequate blood pressure control has been maintained)

• Women who are pregnant or lactating, or who are of child-bearing potential and not using an acceptable method of birth control

• Subjects with a history of hepatic or renal disease, insulin dependent diabetes, active cancer, HIV infection or blood dyscrasias

• Current use of lipid-lowering medications, anti-inflammatories such as low-dose aspirin, or herbal therapies known to affect inflammation or blood lipids 8 weeks prior to study entry

• Current use of Metformin

• More than moderate alcohol use (> 14 drinks per week)

• Use of illicit drugs

• Acute coronary syndrome, heart failure, CVA, or coronary intervention within 6 months prior to study

• Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study