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

Primary Purpose

Metabolic Syndrome, Obesity

Status
Unknown status
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Coleus forskohlii extract
Placebo
Sponsored by
Olive Lifesciences Pvt Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring obesity, herbal remedies, metabolic disorders

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • College of Health and Biomedicine Victoria UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Coleus forskohlii extract

Placebo

Arm Description

Ingestion of 250 mg capsle (Coleus forskohlii extract) twice a day for 12 weeks

Ingestion of 250 mg capsule (placebo) twice a day for 12 weeks

Outcomes

Primary Outcome Measures

changes in appetite will be assessed using visual analogue scale; blood hormone levels will also be measured using commercial kits.

Secondary Outcome Measures

reduction in central obesity - waist circumference will be measured on fortnight basis

Full Information

First Posted
May 17, 2014
Last Updated
May 17, 2014
Sponsor
Olive Lifesciences Pvt Ltd
Collaborators
College of Health and Biomedicine, Victoria University
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1. Study Identification

Unique Protocol Identification Number
NCT02143349
Brief Title
The Effect of Coleus Forskohlii Extract on the Risk Factors of Metabolic Syndrome
Official Title
Investigation of Appetite Suppressant Properties Associated With Coleus Forskohlii in Overweight and Obese Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Olive Lifesciences Pvt Ltd
Collaborators
College of Health and Biomedicine, Victoria University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obesity
Keywords
obesity, herbal remedies, metabolic disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coleus forskohlii extract
Arm Type
Experimental
Arm Description
Ingestion of 250 mg capsle (Coleus forskohlii extract) twice a day for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Ingestion of 250 mg capsule (placebo) twice a day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Coleus forskohlii extract
Intervention Description
Ingestion of 250 mg Coleus forskohlii extract capsule twice a day for 12 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Ingestion of 250 mg placebo capsule twice a day for 12 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
reduction in central obesity - waist circumference will be measured on fortnight basis
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
alterations in blood lipids. This will be measured using commercial kits
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Xiao Su
Phone
+61399192318
Email
xiao.su@vu.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Dr HN Shivaprasad
Phone
918971489704
Email
shiv@olivelifesciences.com
Facility Information:
Facility Name
College of Health and Biomedicine Victoria University
City
St. Albans
State/Province
Victoria
ZIP/Postal Code
14428
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Xiao Su
Phone
+61399192318
Email
xiao.su@vu.edu.au
First Name & Middle Initial & Last Name & Degree
A/Prof Michael Mathai
Phone
+61399192211
Email
michael.mathai@vu.edu.au
First Name & Middle Initial & Last Name & Degree
Dr. Xiao Su
First Name & Middle Initial & Last Name & Degree
A/Prof Michael Mathai

12. IPD Sharing Statement

Citations:
Citation
obesity
Results Reference
background
PubMed Identifier
24497741
Citation
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.
Results Reference
background
Links:
URL
http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0066428895&QV1=COLEUS+FORSKOHLII+EXTRACTS
Description
Coleus forskohlii extract

Learn more about this trial

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

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