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ProAlgaZyme Novel Algae Infusion: Applications in Metabolic Syndrome

Primary Purpose

Metabolic Syndrome X

Status
Completed
Phase
Not Applicable
Locations
Cameroon
Study Type
Interventional
Intervention
ProAlgaZyme
Sponsored by
Health Enhancement Products, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome X focused on measuring ProAlgaZyme, Metabolic syndrome, Inflammation, Cardiovascular, hsCRP, Lipids, Algae

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Outcomes

Primary Outcome Measures

hsCRP
Lipids (total cholesterol, triglycerides HDL-C, LDL-C)
Anthropometric measurements (weight/BMI, % body fat, blood pressure)
Fasting Blood Glucose

Secondary Outcome Measures

Insulin
Interleukin-6 (IL-6)
TNF-alpha
RBC Sedimentation Rate

Full Information

First Posted
June 19, 2007
Last Updated
June 19, 2007
Sponsor
Health Enhancement Products, Inc.
Collaborators
University of Yaounde
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1. Study Identification

Unique Protocol Identification Number
NCT00489333
Brief Title
ProAlgaZyme Novel Algae Infusion: Applications in Metabolic Syndrome
Official Title
The Effects of ProAlgaZyme Novel Algae Infusion vs. Placebo on Metabolic Syndrome and Markers of Cardiovascular Health
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Health Enhancement Products, Inc.
Collaborators
University of Yaounde

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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]

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X
Keywords
ProAlgaZyme, Metabolic syndrome, Inflammation, Cardiovascular, hsCRP, Lipids, Algae

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ProAlgaZyme
Primary Outcome Measure Information:
Title
hsCRP
Time Frame
10 weeks
Title
Lipids (total cholesterol, triglycerides HDL-C, LDL-C)
Time Frame
10 weeks
Title
Anthropometric measurements (weight/BMI, % body fat, blood pressure)
Time Frame
10 weeks
Title
Fasting Blood Glucose
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Insulin
Time Frame
10 weeks
Title
Interleukin-6 (IL-6)
Time Frame
10 weeks
Title
TNF-alpha
Time Frame
10 weeks
Title
RBC Sedimentation Rate
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julius Oben, Ph.D.
Organizational Affiliation
Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I, Yaounde, Cameroon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I
City
Yaounde
Country
Cameroon

12. IPD Sharing Statement

Citations:
PubMed Identifier
17803818
Citation
Oben J, Enonchong E, Kuate D, Mbanya D, Thomas TC, Hildreth DJ, Ingolia TD, Tempesta MS. The effects of ProAlgaZyme novel algae infusion on metabolic syndrome and markers of cardiovascular health. Lipids Health Dis. 2007 Sep 5;6:20. doi: 10.1186/1476-511X-6-20.
Results Reference
derived

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ProAlgaZyme Novel Algae Infusion: Applications in Metabolic Syndrome

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