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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02143349




Registration number
NCT02143349
Ethics application status
Date submitted
17/05/2014
Date registered
21/05/2014
Date last updated
21/05/2014

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] 0 0
ACTRN12614000305628
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 0 0
Obesity 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Coleus forskohlii extract
Other interventions - Placebo

Experimental: Coleus forskohlii extract - Ingestion of 250 mg capsle (Coleus forskohlii extract) twice a day for 12 weeks

Placebo comparator: Placebo - Ingestion of 250 mg capsule (placebo) twice a day for 12 weeks


Treatment: Other: Coleus forskohlii extract
Ingestion of 250 mg Coleus forskohlii extract capsule twice a day for 12 weeks

Other interventions: Placebo
Ingestion of 250 mg placebo capsule twice a day for 12 weeks
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

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

Eligibility
Key inclusion criteria
* Both Australian males and females, age 20-60 years, 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2015
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
College of Health and Biomedicine Victoria University - St. Albans
Recruitment postcode(s) [1] 0 0
14428 - St. Albans

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Olive Lifesciences Pvt Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
College of Health and Biomedicine, Victoria University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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 suppressant properties of Coleus forskohlii extract. In addition the effect on central obesity and risk factors of metabolic syndrome will also be investigated.
Trial website
https://clinicaltrials.gov/study/NCT02143349
Trial related presentations / publications
obesity
Shivaprasad HN, Gopalakrishna S, Mariyanna B, Thekkoot M, Reddy R, Tippeswamy BS. Effect of Coleus forskohlii extract on cafeteria diet-induced obesity in rats. Pharmacognosy Res. 2014 Jan;6(1):42-5. doi: 10.4103/0974-8490.122916.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dr. Xiao Su
Address 0 0
Country 0 0
Phone 0 0
+61399192318
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02143349