ProAlgaZyme Novel Algae Infusion: Applications in 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: NCT00489333
Recruitment Status : Completed
First Posted : June 21, 2007
Last Update Posted : June 21, 2007
University of Yaounde
Information provided by:
Health Enhancement Products, Inc.

Brief Summary:
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.

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

Detailed 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]

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effects of ProAlgaZyme Novel Algae Infusion vs. Placebo on Metabolic Syndrome and Markers of Cardiovascular Health
Study Start Date : May 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. hsCRP [ Time Frame: 10 weeks ]
  2. Lipids (total cholesterol, triglycerides HDL-C, LDL-C) [ Time Frame: 10 weeks ]
  3. Anthropometric measurements (weight/BMI, % body fat, blood pressure) [ Time Frame: 10 weeks ]
  4. Fasting Blood Glucose [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Insulin [ Time Frame: 10 weeks ]
  2. Interleukin-6 (IL-6) [ Time Frame: 10 weeks ]
  3. TNF-alpha [ Time Frame: 10 weeks ]
  4. RBC Sedimentation Rate [ Time Frame: 10 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00489333

Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I
Yaounde, Cameroon
Sponsors and Collaborators
Health Enhancement Products, Inc.
University of Yaounde
Principal Investigator: Julius Oben, Ph.D. Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I, Yaounde, Cameroon

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00489333     History of Changes
Other Study ID Numbers: H-0001-01
First Posted: June 21, 2007    Key Record Dates
Last Update Posted: June 21, 2007
Last Verified: June 2007

Keywords provided by Health Enhancement Products, Inc.:
Metabolic syndrome

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