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

Status unconfirmed · Not applicable

Conditions studied: Metabolic Syndrome, Hyperlipidemia

In brief

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.

Key facts

Study ID

NCT00518960

Run by

Health Enhancement Products, Inc.

People needed

28

Starts

2007-04-01

Expected to finish

2007-09-01

Last updated by the study team

2007-08-21

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MAPS Applied Research Center (MARC) — Edina, Minnesota, United States

Full record on ClinicalTrials.gov

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