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Trial registered on ANZCTR


Registration number
ACTRN12606000485538
Ethics application status
Approved
Date submitted
22/11/2006
Date registered
23/11/2006
Date last updated
11/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial to evaluate the effectiveness of Ganoderma lucidum for treatment of hyperglycemia in persons with metabolic syndrome
Scientific title
A randomised controlled trial to evaluate the effectiveness of Ganoderma lucidum for treatment of hyperglycemia in persons with metabolic syndrome
Secondary ID [1] 282313 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic syndrome 1462 0
Condition category
Condition code
Metabolic and Endocrine 1558 1558 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 1459 0
Treatment: Drugs
Comparator / control treatment
Control Arm 3. Control intervention of placebo of matched excipient ingredients as oral capsules taken for 16 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 2152 0
Fasting plasma glucose
Timepoint [1] 2152 0
Measured at baseline, 8 weeks, 16 weeks and follow-up at 24 weeks
Primary outcome [2] 2153 0
HbA1C (glycosylated haemoglobin)
Timepoint [2] 2153 0
Measured at baseline, 8 weeks, 16 weeks and follow-up at 24 weeks
Secondary outcome [1] 3736 0
Blood pressure
Timepoint [1] 3736 0
Measured at baseline, 8 weeks, 16 weeks and follow-up at 24 weeks
Secondary outcome [2] 3737 0
Blood triglycerides
Timepoint [2] 3737 0
Measured at baseline, 8 weeks, 16 weeks and follow-up at 24 weeks
Secondary outcome [3] 3738 0
Blood high density lipoproteins
Timepoint [3] 3738 0
Measured at baseline, 8 weeks, 16 weeks and follow-up at 24 weeks
Secondary outcome [4] 3739 0
Obesity
Timepoint [4] 3739 0
Measured at baseline, 8 weeks, 16 weeks and follow-up at 24 weeks
Secondary outcome [5] 3740 0
Health related Quality of Life (SF-36)
Timepoint [5] 3740 0
Measured at baseline, 8 weeks, 16 weeks and follow-up at 24 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
In this study the subjects, therapists, assessors and data analysts will all be blinded. The randomisation schedule will be released by the external randomisation officer after data analysis and preliminary write up is complete.
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 1699 0
University
Name [1] 1699 0
University of Western Sydney, Centre for Complementary Medicine Research
Address [1] 1699 0
Centre for Complementary Medicine Research, Blg 5, Campbelltown Campus, University of Western Sydney, Locked Bag 1797, Penrith, NSW 2751, Australia
Country [1] 1699 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Allife Pty Ltd
Address
12 Giffard Street, Silverwater NSW 2128 Australia
Country
Australia
Secondary sponsor category [1] 1499 0
Other
Name [1] 1499 0
Cardiac Health Institute
Address [1] 1499 0
173 Shaftsbury Road, Eastwood, 2122, NSW, Australia
Country [1] 1499 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3151 0
UWS Human Research Ethics Committee
Ethics committee address [1] 3151 0
Ethics committee country [1] 3151 0
Australia
Date submitted for ethics approval [1] 3151 0
Approval date [1] 3151 0
Ethics approval number [1] 3151 0
05/118
Ethics committee name [2] 3152 0
Biosafety Committee
Ethics committee address [2] 3152 0
Ethics committee country [2] 3152 0
Australia
Date submitted for ethics approval [2] 3152 0
Approval date [2] 3152 0
Ethics approval number [2] 3152 0
BRSC 05/18
Ethics committee name [3] 3153 0
Director of Cardiac Health Institute
Ethics committee address [3] 3153 0
Ethics committee country [3] 3153 0
Australia
Date submitted for ethics approval [3] 3153 0
Approval date [3] 3153 0
Ethics approval number [3] 3153 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27393 0
Ms Nerida Klupp
Address 27393 0
Centre for Complementary Medicine Research, Blg 5, Campbelltown Campus, University of Western Sydney, Locked Bag 1797, Penrith, NSW 2751, Australia
Country 27393 0
Australia
Phone 27393 0
+61 2 46203759
Fax 27393 0
Email 27393 0
n.klupp@uws.edu.au
Contact person for public queries
Name 10648 0
Ms Nerida Klupp
Address 10648 0
Room 5.02, Blg 24
Campbelltown Campus
University of Western Sydney
Locked Bag 1797
Penrith South DC
NSW 1797
Country 10648 0
Australia
Phone 10648 0
02 4620 3759
Fax 10648 0
02 4620 3792
Email 10648 0
n.klupp@uws.edu.au
Contact person for scientific queries
Name 1576 0
Ms Nerida Klupp
Address 1576 0
Room 5.02, Blg 24
Campbelltown Campus
University of Western Sydney
Locked Bag 1797
Penrith South DC
NSW 1797
Country 1576 0
Australia
Phone 1576 0
02 4620 3759
Fax 1576 0
02 4620 3792
Email 1576 0
n.klupp@uws.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary