Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000305628
Ethics application status
Approved
Date submitted
7/03/2014
Date registered
21/03/2014
Date last updated
21/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Coleus forskohlii extract on the risk factors of metabolic syndrome
Scientific title
Investigation of appetite suppressant properties associated with Coleus forskohlii in overweight and obese individuals
Secondary ID [1] 284221 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic syndrome 291332 0
Obesity 291334 0
Condition category
Condition code
Diet and Nutrition 291693 291693 0 0
Obesity
Alternative and Complementary Medicine 291718 291718 0 0
Herbal remedies
Metabolic and Endocrine 291817 291817 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ingestion of 250mg Coleus forskohlii extract twice a day for 12 weeks. Adherence to intervention protocols will be monitored through fortnight consulatation - capsule calendar and food diary will be collected, anthropomentric measurement will be taken in the clinic.
Intervention code [1] 288922 0
Prevention
Intervention code [2] 288923 0
Treatment: Other
Comparator / control treatment
Ingestion of 250mg maltodextrin (placebo) twice a day for 12 weeks. Adherence to intervention protocols will be monitored through fortnight consulatation - capsule calendar and food diary will be collected, anthropomentric measurement will be taken in the clinic.
Control group
Placebo

Outcomes
Primary outcome [1] 291631 0
changes in appetite will be assessed using visual analogue scale; blood hormone levels will also be measured using commercial kits.
Timepoint [1] 291631 0
12 weeks
Secondary outcome [1] 307203 0
reduction in central obesity - waist circumference will be measured on fortnight basis.
Timepoint [1] 307203 0
12 weeks
Secondary outcome [2] 307204 0
alterations in blood lipids. This will be measured using commercial kits.
Timepoint [2] 307204 0
12 weeks

Eligibility
Key inclusion criteria
Overweight or obese (BMI >25), waist circumference of > 94 cm (male), waist circumference of >80 cm (female)
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cigarette smoker, hypertension, all types of heart, liver and kidney disease, pregnancy, lactating, Type 1 diabetes and weight loss medication.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation will be employed using computer software. Dynamic (adaptive) random allocation methods such as Minimisation will be used. Factors used for the stratification include age, gender, BMI, waist circumference, body weight and height.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Randomised, placebo controlled
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was determined by statistical power analysis (two tailed t-test at the 5% significance level for the power of 90%) of expected differences in the major measured variables which include total energy intake, fat intake and anthropometry.
ANOVA and t-test using SPSS or Excel software will be performed to analyse the data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2014
Actual
Date of last participant enrolment
Anticipated
31/08/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288846 0
University
Name [1] 288846 0
Victoria University
Country [1] 288846 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
McKechnie Street
St Albans
PO Box 14428
Melbourne
VIC, 8001
Country
Australia
Secondary sponsor category [1] 287538 0
Commercial sector/Industry
Name [1] 287538 0
Olive Life Science
Address [1] 287538 0
No 30, Pride Quadra, 4th floor
Hebbal, Bangalore 560024
Karnataka
Country [1] 287538 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290682 0
Victoria University Ethics Committee
Ethics committee address [1] 290682 0
Victoria University
Office for Research
Footscray Park Campus
Ballarat Road, Footscray
Victoria 3011
Ethics committee country [1] 290682 0
Australia
Date submitted for ethics approval [1] 290682 0
29/01/2014
Approval date [1] 290682 0
03/03/2014
Ethics approval number [1] 290682 0
HRE14-020

Summary
Brief summary
Coleus forskohlii extract contains the bioactive compound, forskolin. Preliminary studies have shown that forskolin can increase fat metabolism thus reduce fat accumulation in both animals and humans. It has been suggested that forskolin may also suppress appetite thus reduce energy intake and results in weight loss. This study will evaluate the appetite suppressent properties of Coleus forskohlii extract. In addition the effect on central obesity and risk factors of metabolic syndrome will also be investigated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46778 0
Dr Xiao Su
Address 46778 0
College of Health and Biomedicine
Victoria University
St Albans
PO Box 14428
Melbourne
VIC 8001
Country 46778 0
Australia
Phone 46778 0
+61 3 99192318
Fax 46778 0
+61 3 99192465
Email 46778 0
[email protected]
Contact person for public queries
Name 46779 0
Hayley Loftus
Address 46779 0
College of Health and Biomedicine
Victoria University
St Albans
PO Box 14428
Melbourne
VIC 8001
Country 46779 0
Australia
Phone 46779 0
+61 431580501
Fax 46779 0
+61 3 99192465
Email 46779 0
[email protected]
Contact person for scientific queries
Name 46780 0
Michael Mathai
Address 46780 0
College of Health and Biomedicine
Victoria University
St Albans
PO Box 14428
Melbourne
VIC 8001
Country 46780 0
Australia
Phone 46780 0
+61 3 99192211
Fax 46780 0
+61 3 99192465
Email 46780 0
[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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.