ProAlgaZyme Novel Algae Infusion: Applications in Metabolic Syndrome

June 19, 2007 updated by: Health Enhancement Products, Inc.

The Effects of ProAlgaZyme Novel Algae Infusion vs. Placebo on Metabolic Syndrome and Markers of Cardiovascular Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cameroon
      • Yaounde, Cameroon
        • Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Insulin
Time Frame: 10 weeks
10 weeks
Interleukin-6 (IL-6)
Time Frame: 10 weeks
10 weeks
TNF-alpha
Time Frame: 10 weeks
10 weeks
RBC Sedimentation Rate
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Health Enhancement Products, Inc.

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

June 19, 2007

First Submitted That Met QC Criteria

June 19, 2007

First Posted (Estimate)

June 21, 2007

Study Record Updates

Last Update Posted (Estimate)

June 21, 2007

Last Update Submitted That Met QC Criteria

June 19, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-0001-01
  • 087/2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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