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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
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

Study type
Description of intervention(s) / exposure
Other interventions - 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

Other interventions: 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
Other interventions
Comparator / control treatment
Control group

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

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Olive Lifesciences Pvt Ltd
Other collaborator category [1] 0 0
Name [1] 0 0
College of Health and Biomedicine, Victoria University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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
Trial related presentations / publications
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

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
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see