Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00518960
Status:
UNKNOWN
Last Update Posted:
2007-08-21
First Post:
2007-08-17
Brief Title:
The Effects of ProAlgaZyme on HDL Cholesterol in Individuals With Metabolic Syndrome
Sponsor:
Health Enhancement Products Inc
Organization:
Health Enhancement Products Inc
Study Overview
Official Title:
The Effects of ProAlgaZyme Novel Algae Infusion on HDL Cholesterol and C-Reactive Protein in Individuals With Metabolic Syndrome
Status:
UNKNOWN
Status Verified Date:
2007-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effectiveness of ProAlgaZyme in increasing levels of HDL good cholesterol and decreasing total cholesterol and C-reactive protein in patients with Metabolic Syndrome
Detailed Description:
Cardiovascular disease CVD is the most common cause of mortality in the United States In 1988 Reaven et al published findings that indicate a majority of individuals who developed CVD had multiple concurrent risk factors including dyslipidemia hypertension and hyperglycemia Reaven et al defined this cluster of risk factors as Syndrome X and hypothesized that insulin resistance was the underlying factor in its development Over time metabolic syndrome has been used as a more meaningful term and additional risk factors have been associated with its diagnosis Grundy et al 2004 Metabolic syndrome is an increasingly prevalent problem in the United States and other westernized nations It is estimated that approximately 50 million Americans have metabolic syndrome The risk factors linked to metabolic syndrome include
Abdominal obesity
Atherogenic dyslipidemia high triglycerides low HDL cholesterol and high LDL cholesterol
Elevated blood pressure
Insulin resistance with or without glucose intolerance
Pro-thrombotic state eg high fibrinogen or plasminogen activator inhibitor-1 in the blood
Pro-inflammatory state eg elevated C-reactive protein CRPin the blood
The management goals for metabolic syndrome include reducing the risk for developing CVD and type 2 diabetes Therefore therapy is directed at reducing LDL cholesterol blood pressure and glucose as well as increasing HDL cholesterol levels Additional interventions to control blood pressure and lipids provide the next line of treatment for patients with metabolic syndrome
ProAlgaZyme a novel fermentation product of a freshwater algae ecosystem will be evaluated in this trial for its effects on circulating lipids According to the sponsor ProAlgaZyme is expected to increase the circulating levels of HDL cholesterol while lowering total cholesterol and CRP ProAlgaZyme was previously tested in a double blind placebo controlled pilot trial in 60 subjects with metabolic syndrome 30 subjects per arm conducted at the University of Yaoundé Cameroon Statistically significant p 005 or better improvements were seen in total cholesterol HDL-C and C-reactive protein when compared to placebo In Press - Lipids in Health and Disease
The present study will evaluate the effect of ProAlgaZyme versus placebo on blood lipids and hsCRP in subjects who meet the criteria for Metabolic Syndrome
Abdominal obesity
Atherogenic dyslipidemia high triglycerides low HDL cholesterol and high LDL cholesterol
Elevated blood pressure
Insulin resistance with or without glucose intolerance
Pro-thrombotic state eg high fibrinogen or plasminogen activator inhibitor-1 in the blood
Pro-inflammatory state eg elevated C-reactive protein CRPin the blood
The management goals for metabolic syndrome include reducing the risk for developing CVD and type 2 diabetes Therefore therapy is directed at reducing LDL cholesterol blood pressure and glucose as well as increasing HDL cholesterol levels Additional interventions to control blood pressure and lipids provide the next line of treatment for patients with metabolic syndrome
ProAlgaZyme a novel fermentation product of a freshwater algae ecosystem will be evaluated in this trial for its effects on circulating lipids According to the sponsor ProAlgaZyme is expected to increase the circulating levels of HDL cholesterol while lowering total cholesterol and CRP ProAlgaZyme was previously tested in a double blind placebo controlled pilot trial in 60 subjects with metabolic syndrome 30 subjects per arm conducted at the University of Yaoundé Cameroon Statistically significant p 005 or better improvements were seen in total cholesterol HDL-C and C-reactive protein when compared to placebo In Press - Lipids in Health and Disease
The present study will evaluate the effect of ProAlgaZyme versus placebo on blood lipids and hsCRP in subjects who meet the criteria for Metabolic Syndrome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MARC007-003 | None | None | None |