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

  • Australia
    • Victoria
      • St. Albans, Victoria, Australia, 14428
        • Recruiting
        • College of Health and Biomedicine Victoria University
        • Contact:
        • Contact:
        • 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
Dietary supplement: Coleus forskohlii extract
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
Other: Placebo
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

Olive Lifesciences Pvt Ltd

Collaborators

College of Health and Biomedicine, Victoria University

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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