Clinical trial NCT00489333: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome X
Keywords: ProAlgaZyme
Metabolic syndrome
Inflammation
Cardiovascular
hsCRP
Lipids
Algae
Lead sponsor: Health Enhancement Products, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Yaounde
First posted: 2007-06-21
Enrollment: 52
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[Time frame: 10 weeks\]

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.

Primary outcomes:
measure: hsCRP
timeFrame: 10 weeks
measure: Lipids (total cholesterol, triglycerides HDL-C, LDL-C)
timeFrame: 10 weeks
measure: Anthropometric measurements (weight/BMI, % body fat, blood pressure)
timeFrame: 10 weeks
measure: Fasting Blood Glucose
timeFrame: 10 weeks
Secondary outcomes:
measure: Insulin
timeFrame: 10 weeks
measure: Interleukin-6 (IL-6)
timeFrame: 10 weeks
measure: TNF-alpha
timeFrame: 10 weeks
measure: RBC Sedimentation Rate
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Yaounde
country: Cameroon
facility: Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I
Study officials:
affiliation: Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I, Yaounde, Cameroon
name: Julius Oben, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.