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Trial registered on ANZCTR


Registration number
ACTRN12610000289011
Ethics application status
Approved
Date submitted
8/04/2010
Date registered
9/04/2010
Date last updated
9/04/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Caralluma fimbriata extract (Slimaluma) reduce the risk factors of metabolic syndrome in overweight and obese adults?
Scientific title
The effects of Caralluma fimbriata extract (Slimaluma) in combination with lifestyle intervention on the risk factors of metabolic syndrome in overweight and obese adults: a randomised controlled trial
Secondary ID [1] 1587 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of metabolic syndrome 257113 0
Condition category
Condition code
Diet and Nutrition 257264 257264 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 257268 257268 0 0
Metabolic disorders
Alternative and Complementary Medicine 257269 257269 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Caralluma fimbriata extract capsule 500mg oral administration, twice per day
before meals for three months.
Water soluble, Caralluma fimbriata extract containing 27.8% Pregnane Glycosides and 13.3% Saponin Glvcosides. Lifestyle intervention focuses on healthy dietary intake based on the Dietary guidelines for Australian adults for three months.
Intervention code [1] 256277 0
Prevention
Intervention code [2] 256280 0
Lifestyle
Comparator / control treatment
Placebo capsule containing maltodextrin, 500mg oral administration, twice per day before meals for three months.
Control group
Placebo

Outcomes
Primary outcome [1] 258185 0
Blood analysis in circulating levels of leptin, glucose, triglyceride, total cholesterol and high density lipoprotein (HDL).
Timepoint [1] 258185 0
pre- and post-intervention
Primary outcome [2] 258188 0
Anthropometric measurements including body weight and waist circumference.
Timepoint [2] 258188 0
pre- and post-intervention
Primary outcome [3] 258189 0
Basal metobolic rate (BMR) will be measured using the metabolic cart (closed circuit spirometry).
Timepoint [3] 258189 0
pre- and post-intervention
Secondary outcome [1] 263819 0
Blood analysis of adiponectin, Glucagon-like peptide-1 (GLP1), C-reactive protein (CRP) and homocystiene.
Timepoint [1] 263819 0
pre- and post-intervention

Eligibility
Key inclusion criteria
Males and females aged 30-60 years with a body mass index (BMI) greater than 25 or a waist circumference > 94cm for males and >80cm for females.
Minimum age
30 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Liver, kidney and heart disease, pregnancy, type 1 and type 2 diabetes with insulin medication, cigarette smoking and the use of any medication for weight loss.

Study design
Purpose of the study
Prevention
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)
computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2748 0
3029

Funding & Sponsors
Funding source category [1] 256781 0
University
Name [1] 256781 0
Victoria University
Country [1] 256781 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
McKechnie Street
St Albans,
PO BOX 14428
Melbourne, Victoria 8001
Country
Australia
Secondary sponsor category [1] 256058 0
None
Name [1] 256058 0
Address [1] 256058 0
Country [1] 256058 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258800 0
Victoira University Human Research Ethics Committee
Ethics committee address [1] 258800 0
Office for Research
Victoria University
PO Box 14428
Melbourne VIC 8001
Ethics committee country [1] 258800 0
Australia
Date submitted for ethics approval [1] 258800 0
Approval date [1] 258800 0
23/03/2010
Ethics approval number [1] 258800 0
HRETH10/22

Summary
Brief summary
A 3-month intervention using encapsulated Caralluma fimbriata extract in combination with lifestyle intervention to investigate whether or not Caralluma fimbriata extract suppresses the appetite and decreases the risk factors of metabolic syndrome
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31029 0
Address 31029 0
Country 31029 0
Phone 31029 0
Fax 31029 0
Email 31029 0
Contact person for public queries
Name 14276 0
Katie Astell
Address 14276 0
School of Biomedical & Health Sciences
Victoria University
McKechnie Street
St Albans
PO Box 14428,
Melbourne VIC 8001
Country 14276 0
Australia
Phone 14276 0
+61 413 974 652
Fax 14276 0
+61 3 9919 2465
Email 14276 0
[email protected]
Contact person for scientific queries
Name 5204 0
Xiao Su & Michael Mathai
Address 5204 0
School of Biomedical & Health Sciences
Victoria University
McKechnie Street
St Albans
PO Box 14428,
Melbourne VIC 8001
Country 5204 0
Australia
Phone 5204 0
+61 3 9919 2318; +61 3 9919 2211
Fax 5204 0
+61 3 9919 2465
Email 5204 0
[email protected]; [email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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