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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2014 by Olive Lifesciences Pvt Ltd.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02143349
First Posted: May 21, 2014
Last Update Posted: May 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
College of Health and Biomedicine, Victoria University
Information provided by (Responsible Party):
Olive Lifesciences Pvt Ltd
  Purpose
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.

Condition Intervention Phase
Metabolic Syndrome Obesity Dietary Supplement: Coleus forskohlii extract Other: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Investigation of Appetite Suppressant Properties Associated With Coleus Forskohlii in Overweight and Obese Individuals

Resource links provided by NLM:


Further study details as provided by Olive Lifesciences Pvt Ltd:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • reduction in central obesity - waist circumference will be measured on fortnight basis [ Time Frame: 12 weeks ]

Other Outcome Measures:
  • alterations in blood lipids. This will be measured using commercial kits [ Time Frame: 12 weeks ]

Estimated Enrollment: 50
Study Start Date: April 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143349


Contacts
Contact: Dr. Xiao Su +61399192318 xiao.su@vu.edu.au
Contact: Dr HN Shivaprasad 918971489704 shiv@olivelifesciences.com

Locations
Australia, Victoria
College of Health and Biomedicine Victoria University Recruiting
St. Albans, Victoria, Australia, 14428
Contact: Dr. Xiao Su    +61399192318    xiao.su@vu.edu.au   
Contact: A/Prof Michael Mathai    +61399192211    michael.mathai@vu.edu.au   
Principal Investigator: Dr. Xiao Su         
Sub-Investigator: A/Prof Michael Mathai         
Sponsors and Collaborators
Olive Lifesciences Pvt Ltd
College of Health and Biomedicine, Victoria University
  More Information

Additional Information:
Publications:
Responsible Party: Olive Lifesciences Pvt Ltd
ClinicalTrials.gov Identifier: NCT02143349     History of Changes
Other Study ID Numbers: ACTRN12614000305628
First Submitted: May 17, 2014
First Posted: May 21, 2014
Last Update Posted: May 21, 2014
Last Verified: May 2014

Keywords provided by Olive Lifesciences Pvt Ltd:
obesity
herbal remedies
metabolic disorders

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases