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Antihyperlipidemic Effects of Oyster Mushrooms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00069524
Recruitment Status : Completed
First Posted : October 1, 2003
Last Update Posted : September 26, 2007
Office of Dietary Supplements (ODS)
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

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).

Condition or disease Intervention/treatment Phase
HIV Infections Hyperlipidemia Drug: oyster mushroom Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antihyperlipidemic Effects of Oyster Mushrooms
Study Start Date : June 2004
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00069524

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United States, California
General Clinical Research Center, San Francisco General Hospital
San Francisco, California, United States
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
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Principal Investigator: Donald I Abrams, MD University of California, San Francisco
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00069524    
Other Study ID Numbers: R21AT001782-01 ( U.S. NIH Grant/Contract )
First Posted: October 1, 2003    Key Record Dates
Last Update Posted: September 26, 2007
Last Verified: September 2007
Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Highly active antiretroviral therapy (HAART)
Oyster mushrooms
Non-HDL cholesterol
Complementary Therapies
Treatment Experienced
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases