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

Phase 1
Completed
Conditions
Metabolic syndrome
Metabolic and Endocrine - Normal metabolism and endocrine development and function
Registration Number
ACTRN12606000485538
Lead Sponsor
Allife Pty Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
168
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Fasting plasma glucose[Measured at baseline, 8 weeks, 16 weeks and follow-up at 24 weeks];HbA1C (glycosylated haemoglobin)[Measured at baseline, 8 weeks, 16 weeks and follow-up at 24 weeks]
Secondary Outcome Measures
NameTimeMethod
Health related Quality of Life (SF-36)[Measured at baseline, 8 weeks, 16 weeks and follow-up at 24 weeks];Blood pressure[Measured at baseline, 8 weeks, 16 weeks and follow-up at 24 weeks];Blood triglycerides[Measured at baseline, 8 weeks, 16 weeks and follow-up at 24 weeks];Blood high density lipoproteins[Measured at baseline, 8 weeks, 16 weeks and follow-up at 24 weeks];Obesity[Measured at baseline, 8 weeks, 16 weeks and follow-up at 24 weeks]
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