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 syndromeMetabolic 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
Name Time Method 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
Name Time Method 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]