Antihyperlipidemic Effects of Oyster Mushrooms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-05-31

Brief Summary

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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

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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.

Conditions

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HIV Infections Hyperlipidemia

Keywords

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Highly active antiretroviral therapy (HAART) Ritonavir Oyster mushrooms Non-HDL cholesterol Complementary Therapies Treatment Experienced

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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oyster mushroom

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Donald I Abrams, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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General Clinical Research Center, San Francisco General Hospital

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED

PMID: 21831304 (View on PubMed)

Other Identifiers

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R21AT001782-01

Identifier Type: NIH

Identifier Source: org_study_id

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