Antihyperlipidemic Effects of Oyster Mushrooms

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00069524
First received: September 29, 2003
Last updated: September 25, 2007
Last verified: September 2007

September 29, 2003
September 25, 2007
June 2004
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Complete list of historical versions of study NCT00069524 on ClinicalTrials.gov Archive Site
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Antihyperlipidemic Effects of Oyster Mushrooms
Antihyperlipidemic Effects of Oyster Mushrooms

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).

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Hyperlipidemia
Drug: oyster mushroom
Not Provided
Abrams DI, Couey P, Shade SB, Kelly ME, Kamanu-Elias N, Stamets P. Antihyperlipidemic effects of Pleurotus ostreatus (oyster mushrooms) in HIV-infected individuals taking antiretroviral therapy. BMC Complement Altern Med. 2011 Aug 10;11:60. doi: 10.1186/1472-6882-11-60.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2006
Not Provided

Inclusion criteria:

  • Documented HIV infection (positive ELISA and Western Blot or measurable plasma HIV RNA).
  • Taking Kaletra (ritonavir/lopinavir), a ritonavir-containing antiretroviral therapy, for at least 12 weeks
  • Elevated non-HDL cholesterol >= 160 mg/dl as defined by the National Cholesterol Education Program guidelines (within 30 days of enrollment)
  • AST or ALT <2.5 times the upper limit of normal (ULN) within 30 days of study entry.

Exclusion criteria:

  • Currently receiving antihyperlipidemic treatment (e.g., statins, fibrates, bile sequestrants, niacin)
  • Pregnancy or breastfeeding
  • Documented history of myopathy or myalgias on HMG-CoA reductase inhibitors
  • Documented history of rhabdomyolysis
  • Documented diagnosis of diabetes mellitus
  • Any condition that, in the judgment of the investigator, precludes successful participation in the study.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00069524
R21 AT001782-01
Not Provided
Not Provided
National Center for Complementary and Alternative Medicine (NCCAM)
Office of Dietary Supplements (ODS)
Principal Investigator: Donald I Abrams, MD University of California, San Francisco
National Center for Complementary and Alternative Medicine (NCCAM)
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP