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

Obesity Clinical Trial

Official title:

Investigation of Appetite Suppressant Properties Associated With Coleus Forskohlii in Overweight and Obese Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02143349
• Other study ID #: ACTRN12614000305628
• Status: Recruiting
• Phase: Phase 3
• First received: May 17, 2014
• Last updated: May 17, 2014
• Start date: April 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2014
• Source: Olive Lifesciences Pvt Ltd
• Contact: Dr. Xiao Su
• Phone: +61399192318
• Email: xiao.su[@]vu.edu.au
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

Dietary Supplement:
• Coleus forskohlii extract
Ingestion of 250 mg Coleus forskohlii extract capsule twice a day for 12 weeks

Other:
• Placebo
Ingestion of 250 mg placebo capsule twice a day for 12 weeks

Locations

Country	Name	City	State
Australia	College of Health and Biomedicine Victoria University	St. Albans	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Olive Lifesciences Pvt Ltd	College of Health and Biomedicine, Victoria University

Country where clinical trial is conducted

Australia, 

References & Publications (2)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	alterations in blood lipids. This will be measured using commercial kits		12 weeks	No
Primary	changes in appetite will be assessed using visual analogue scale; blood hormone levels will also be measured using commercial kits.		Baseline and 12 weeks	No
Secondary	reduction in central obesity - waist circumference will be measured on fortnight basis		12 weeks	No

External Links

•   Coleus forskohlii extract