A randomised controlled trial to evaluate the effectiveness of Ganoderma lucidum for treatment of hyperglycemia in persons with metabolic syndrome

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000485538

Enrollment

168

Registered

2006-11-23

Start date

2007-01-25

Completion date

2008-05-16

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Metabolic syndrome is a cluster of cardiovascular risk factors such as diabetes, hypertension, obesity, and abnormal cholesterol and blood fat levels. At present there is no single pharmaceutical agent which can effectively treat metabolic syndrome, but rather, multiple medications are given for each risk factor. In China, two mushrooms- Ganoderma lucidum and Cordyceps sinensis, have been used for these conditions and animal, in-vitro and small human studies indicate positive effects against the multiple components of metabolic syndrome. This study will be the first randomised clinical trial of this intervention for the efficacy and treatment of metabolic syndrome.

Interventions

Comparison Arm 1. Ganoderma lucidum spore and extract (imported by Alllife Pty Ltd) 4.2g per day taken as oral capsules for 16 weeks Comparison Arm 2. Ganoderma lucidum (3g) with Cordyceps sinensis extract (1.2g) (imported by Alllife Pty Ltd) total 4.2g per day taken as oral capsules for 16 weeks

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Must have hyperglycemia (FPG- Fasting Plasma Glucose over 6.1 mmol/L) and meet National Cholesterol Education Program- Adult Treatment Panel III criteria for metabolic syndrome.

Exclusion criteria

Unstable health (recent or immediate future hospitalisation, surgery), recent history of hypoglycemic episodes, use insulin, history or organ transplant, liver or kidney disease, infection, pregnancy and allergy to mushrooms.

Outcome results