The Effect of Coleus Forskohlii Extract on the Risk Factors of Metabolic Syndrome

Phase 3

• Conditions: Obesity; Metabolic Syndrome
• Interventions: Dietary Supplement: Coleus forskohlii extract; Other: Placebo

• Registration Number: NCT02143349
• Lead Sponsor: Olive Lifesciences Pvt Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Status Verified: 2014-05
• Study First Submitted: 2014-05-17
• Study First Submitted QC: 2014-05-17
• Last Update Submitted: 2014-05-17
• Study First Posted: 2014-05-21
• Last Update Posted: 2014-05-21
• Primary Completion: 2015-05
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coleus forskohlii extract	Coleus forskohlii extract	Ingestion of 250 mg capsle (Coleus forskohlii extract) twice a day for 12 weeks
Placebo	Placebo	Ingestion of 250 mg capsule (placebo) twice a day for 12 weeks

Primary Outcome Measures

Name	Time	Method
changes in appetite will be assessed using visual analogue scale; blood hormone levels will also be measured using commercial kits.	Baseline and 12 weeks

Secondary Outcome Measures

Name	Time	Method
reduction in central obesity - waist circumference will be measured on fortnight basis	12 weeks

Trial Locations

Locations (1)

College of Health and Biomedicine Victoria University; 🇦🇺 St. Albans, Victoria, Australia