ProAlgaZyme Novel Algae Infusion: Applications in Metabolic Syndrome
The Effects of ProAlgaZyme Novel Algae Infusion vs. Placebo on Metabolic Syndrome and Markers of Cardiovascular Health
2 other identifiers
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2006
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 19, 2007
CompletedFirst Posted
Study publicly available on registry
June 21, 2007
CompletedJune 21, 2007
June 1, 2007
June 19, 2007
June 19, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
hsCRP
10 weeks
Lipids (total cholesterol, triglycerides HDL-C, LDL-C)
10 weeks
Anthropometric measurements (weight/BMI, % body fat, blood pressure)
10 weeks
Fasting Blood Glucose
10 weeks
Secondary Outcomes (4)
Insulin
10 weeks
Interleukin-6 (IL-6)
10 weeks
TNF-alpha
10 weeks
RBC Sedimentation Rate
10 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Health Enhancement Products, Inc.lead
- University of Yaoundecollaborator
Study Sites (1)
Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I
Yaoundé, Cameroon
Related Publications (1)
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.
PMID: 17803818DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julius Oben, Ph.D.
Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I, Yaounde, Cameroon
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 19, 2007
First Posted
June 21, 2007
Study Start
May 1, 2006
Study Completion
September 1, 2006
Last Updated
June 21, 2007
Record last verified: 2007-06