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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00518960
Recruitment Status : Unknown
Verified August 2007 by Health Enhancement Products, Inc..
Recruitment status was:  Active, not recruiting
First Posted : August 21, 2007
Last Update Posted : August 21, 2007
MAPS Applied Research Center
Information provided by:
Health Enhancement Products, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Hyperlipidemia Drug: ProAlgaZyme Not Applicable

Detailed Description:

Cardiovascular disease (CVD) is the most common cause of mortality in the United States. In 1988, Reaven, et al. published findings that indicate a majority of individuals who developed CVD had multiple concurrent risk factors including dyslipidemia, hypertension, and hyperglycemia. Reaven, et al., defined this cluster of risk factors as Syndrome X and hypothesized that insulin resistance was the underlying factor in its development. Over time, metabolic syndrome has been used as a more meaningful term and additional risk factors have been associated with its diagnosis (Grundy, et al. 2004). Metabolic syndrome is an increasingly prevalent problem in the United States and other westernized nations. It is estimated that approximately 50 million Americans have metabolic syndrome. The risk factors linked to metabolic syndrome include:

  • Abdominal obesity
  • Atherogenic dyslipidemia (high triglycerides, low HDL cholesterol and high LDL cholesterol)
  • Elevated blood pressure
  • Insulin resistance with or without glucose intolerance
  • Pro-thrombotic state (e.g., high fibrinogen or plasminogen activator inhibitor-1 in the blood)
  • Pro-inflammatory state [e.g. elevated C-reactive protein (CRP)in the blood]

The management goals for metabolic syndrome include reducing the risk for developing CVD and type 2 diabetes. Therefore, therapy is directed at reducing LDL cholesterol, blood pressure and glucose as well as increasing HDL cholesterol levels. Additional interventions to control blood pressure and lipids provide the next line of treatment for patients with metabolic syndrome.

ProAlgaZyme, a novel fermentation product of a freshwater algae ecosystem, will be evaluated in this trial for its effects on circulating lipids. According to the sponsor, ProAlgaZyme is expected to increase the circulating levels of HDL cholesterol while lowering total cholesterol and CRP. ProAlgaZyme was previously tested in a double blind, placebo controlled, pilot trial in 60 subjects with metabolic syndrome (30 subjects per arm), conducted at the University of Yaoundé, Cameroon. Statistically significant (p < 0.05 or better) improvements were seen in total cholesterol, HDL-C and C-reactive protein when compared to placebo. (In Press - Lipids in Health and Disease)

The present study will evaluate the effect of ProAlgaZyme versus placebo on blood lipids and hsCRP in subjects who meet the criteria for Metabolic Syndrome.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of ProAlgaZyme Novel Algae Infusion on HDL Cholesterol and C-Reactive Protein in Individuals With Metabolic Syndrome
Study Start Date : April 2007
Estimated Study Completion Date : September 2007

Primary Outcome Measures :
  1. HDL Cholesterol [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Lipid Panel (Total Chol., LDL-Chol., Triglycerides, Total Chol./HDL-Chol. ratio) [ Time Frame: 12 weeks ]
  2. C-Reactive Protein [ Time Frame: 12 weeks ]
  3. Blood Pressure [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00518960

United States, Minnesota
MAPS Applied Research Center (MARC)
Edina, Minnesota, United States, 55435
Sponsors and Collaborators
Health Enhancement Products, Inc.
MAPS Applied Research Center
Principal Investigator: Terence Pertile, Ph.D. MAPS Applied Research Center Identifier: NCT00518960     History of Changes
Other Study ID Numbers: H-0003-02
First Posted: August 21, 2007    Key Record Dates
Last Update Posted: August 21, 2007
Last Verified: August 2007

Keywords provided by Health Enhancement Products, Inc.:
High density lipoprotein; HDL
C-Reactive Protein; CRP
Metabolic Syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders