Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114855
Status:
COMPLETED
Last Update Posted:
2011-07-06
First Post:
2005-06-17
Brief Title:
The Effect of Hypocol on Lipids in Subjects With Mild Hypercholesterolemia and Mildly Elevated Blood Glucose
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
A Single-Centre Randomised Double-Blind Placebo-Controlled Study to Measure the Effect of Hypocol on Lipids in Subjects With Mild Hypercholesterolemia and Mildly Elevated Blood Glucose
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
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 to what degree Hypocol Red Yeast Rice may lower low density lipoprotein LDL-cholesterol in a European population The effect of Red Yeast Rice on fasting blood glucose and inflammatory markers will also be investigated
Detailed Description:
Clinical end-point trials have demonstrated that lowering cholesterol levels with statins reduces the incidence of cardiovascular events and mortality Subgroup analyses of the large clinical studies the West of Scotland Coronary Prevention WOSCOP and Cholesterol and Recurrent Events CARE have suggested that the beneficial effects of statins may extend to mechanisms beyond cholesterol reduction A variety of mechanisms accounting for these effects have been suggested Among these the anti-inflammatory activity is particularly attractive because inflammation is considered an early step in the development of atherosclerosis Thus statin therapy has been shown to lower high-sensitivity C-reactive protein CRP a plasma marker of inflammation in hypercholesterolemic patients Furthermore statins may possess anti-inflammatory properties by their ability to reduce the number of inflammatory cells in atherosclerotic plaques Red Yeast Rice contains Lovastatin and lowers LDL-cholesterol However it is not known to what degree Red Yeast Rice may lower LDL-cholesterol in a European population Some reports have suggested an effect of Red Yeast Rice on fasting blood glucose by an unknown mechanism
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 |
|---|---|---|---|
| 200303963-3 SLV | None | None | None |
| S-04329 REK Sør | None | None | None |
| 11850 NSD | None | None | None |
| 05896 TSP ShDir | None | None | None |