- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02143349
The Effect of Coleus Forskohlii Extract on the Risk Factors of Metabolic Syndrome
May 17, 2014 updated by: Olive Lifesciences Pvt Ltd
Investigation of Appetite Suppressant Properties Associated With Coleus Forskohlii in Overweight and Obese Individuals
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Victoria
-
St. Albans, Victoria, Australia, 14428
- Recruiting
- College of Health and Biomedicine Victoria University
-
Contact:
- Dr. Xiao Su
- Phone Number: +61399192318
- Email: xiao.su@vu.edu.au
-
Contact:
- A/Prof Michael Mathai
- Phone Number: +61399192211
- Email: michael.mathai@vu.edu.au
-
Principal Investigator:
- Dr. Xiao Su
-
Sub-Investigator:
- A/Prof Michael Mathai
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Coleus forskohlii extract
Ingestion of 250 mg capsle (Coleus forskohlii extract) twice a day for 12 weeks
|
Ingestion of 250 mg Coleus forskohlii extract capsule twice a day for 12 weeks
|
Placebo Comparator: Placebo
Ingestion of 250 mg capsule (placebo) twice a day for 12 weeks
|
Ingestion of 250 mg placebo capsule twice a day for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
reduction in central obesity - waist circumference will be measured on fortnight basis
Time Frame: 12 weeks
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
alterations in blood lipids. This will be measured using commercial kits
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Anticipated)
May 1, 2015
Study Completion (Anticipated)
May 1, 2015
Study Registration Dates
First Submitted
May 17, 2014
First Submitted That Met QC Criteria
May 17, 2014
First Posted (Estimate)
May 21, 2014
Study Record Updates
Last Update Posted (Estimate)
May 21, 2014
Last Update Submitted That Met QC Criteria
May 17, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACTRN12614000305628
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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