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Completed

NCT Number: NCT00489333

ProAlgaZyme Novel Algae Infusion: Applications in Metabolic Syndrome

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.

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Key information

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Yaoundé, Cameroon

About this study

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]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ProAlgaZyme

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Health Enhancement Products, Inc.

Industry

Collaborators

  • University of Yaounde

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2006
First posted
Jun 21, 2007
Registry last updated
Jun 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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