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

NCT ID: NCT02143349

Last Updated: 2014-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metabolic Syndrome Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Coleus forskohlii extract

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

Group Type EXPERIMENTAL

Coleus forskohlii extract

Intervention Type DIETARY_SUPPLEMENT

Ingestion of 250 mg Coleus forskohlii extract capsule twice a day for 12 weeks

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Coleus forskohlii extract

Ingestion of 250 mg Coleus forskohlii extract capsule twice a day for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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College of Health and Biomedicine, Victoria University

UNKNOWN

Sponsor Role collaborator

Olive Lifesciences Pvt Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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College of Health and Biomedicine Victoria University

St Albans, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Dr. Xiao Su

Role: CONTACT

+61399192318

Dr HN Shivaprasad

Role: CONTACT

918971489704

Facility Contacts

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Dr. Xiao Su

Role: primary

+61399192318

A/Prof Michael Mathai

Role: backup

+61399192211

References

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obesity

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 24497741 (View on PubMed)

Other Identifiers

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ACTRN12614000305628

Identifier Type: -

Identifier Source: org_study_id

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