Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069524
Status:
COMPLETED
Last Update Posted:
2007-09-26
First Post:
2003-09-29
Brief Title:
Antihyperlipidemic Effects of Oyster Mushrooms
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Antihyperlipidemic Effects of Oyster Mushrooms
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary goal of this study is to evaluate the short-term safety and potential efficacy of oyster mushrooms Pleurotus ostreatus for treatment of hyperlipidemia in HIV-infected patients who are taking Kaletra a protease inhibitor PI that is commonly used in highly active antiretroviral therapy HAART
Detailed Description:
This is a single-arm open-label 8-week proof of concept pilot study in 20 subjects to determine if there are detectable lipid-lowering effects of oyster mushrooms in patients with HIV and hyperlipidemia who are taking Kaletra a ritonavir-containing HAART regimen The study will also assess whether the concurrent administration of oyster mushrooms and such regimens is safe and investigate the mechanism of action whereby oyster mushrooms may exert their antihyperlipidemic effect
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