ProAlgaZyme Novel Algae Infusion: Applications in Metabolic Syndrome

Metabolic Syndrome X Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489333
• Other study ID #: H-0001-01
• Secondary ID: 087/2006
• Status: Completed
• Phase: N/A
• First received: June 19, 2007
• Last updated: June 19, 2007
• Start date: May 2006
• Est. completion date: September 2006

Study information

• Verified date: June 2007
• Source: Health Enhancement Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cameroon: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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]

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• ProAlgaZyme

Locations

Country	Name	City	State
Cameroon	Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I	Yaounde

Sponsors (2)

Lead Sponsor	Collaborator
Health Enhancement Products, Inc.	University of Yaounde

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hsCRP		10 weeks
Primary	Lipids (total cholesterol, triglycerides HDL-C, LDL-C)		10 weeks
Primary	Anthropometric measurements (weight/BMI, % body fat, blood pressure)		10 weeks
Primary	Fasting Blood Glucose		10 weeks
Secondary	Insulin		10 weeks
Secondary	Interleukin-6 (IL-6)		10 weeks
Secondary	TNF-alpha		10 weeks
Secondary	RBC Sedimentation Rate		10 weeks