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ProAlgaZyme Novel Algae Infusion: Applications in Metabolic Syndrome

This study has been completed.
Sponsor:
Collaborator:
University of Yaounde
Information provided by:
Health Enhancement Products, Inc.
ClinicalTrials.gov Identifier:
NCT00489333
First received: June 19, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

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 Intervention
Metabolic Syndrome X
 Drug: ProAlgaZyme

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effects of ProAlgaZyme Novel Algae Infusion vs. Placebo on Metabolic Syndrome and Markers of Cardiovascular Health

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Health Enhancement Products, Inc.:

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

Secondary Outcome Measures:
  • Insulin [ Time Frame: 10 weeks ]
  • Interleukin-6 (IL-6) [ Time Frame: 10 weeks ]
  • TNF-alpha [ Time Frame: 10 weeks ]
  • RBC Sedimentation Rate [ Time Frame: 10 weeks ]

Enrollment: 52
Study Start Date: May 2006
Study Completion Date: September 2006
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]

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489333

Locations
Cameroon
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
Investigators
Principal Investigator: Julius Oben, Ph.D. Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I, Yaounde, Cameroon
  More Information

No publications provided by Health Enhancement Products, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00489333     History of Changes
Other Study ID Numbers: H-0001-01, 087/2006
Study First Received: June 19, 2007
Last Updated: June 19, 2007
Health Authority: Cameroon: Ministry of Public Health

Keywords provided by Health Enhancement Products, Inc.:
ProAlgaZyme
Metabolic syndrome
Inflammation
Cardiovascular
 hsCRP
Lipids
Algae

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

ClinicalTrials.gov processed this record on June 17, 2013