NCT02143349UnknownPhase 3
Investigation of Appetite Suppressant Properties Associated With Coleus Forskohlii in Overweight and Obese Individuals
Olive Lifesciences Pvt Ltd2 sites in 1 country50 target enrollmentStarted: April 1, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- changes in appetite will be assessed using visual analogue scale; blood hormone levels will also be measured using commercial kits.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Exclusion Criteria
- •Cigarette smoker, hypertension, all types of heart, liver and kidney disease, pregnancy, lactating, Type 1 diabetes and weight loss medication.
Outcomes
Primary Outcomes
changes in appetite will be assessed using visual analogue scale; blood hormone levels will also be measured using commercial kits.
Time Frame: Baseline and 12 weeks
Secondary Outcomes
- reduction in central obesity - waist circumference will be measured on fortnight basis(12 weeks)
Investigators
Study Sites (2)
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