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

O

Olive Lifesciences

Status and phase

Unknown
Phase 3

Conditions

Obesity
Metabolic Syndrome

Treatments

Other: Placebo
Dietary Supplement: Coleus forskohlii extract

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT02143349
ACTRN12614000305628

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

50 participants in 2 patient groups, including a placebo group

Coleus forskohlii extract
Experimental group
Description:
Ingestion of 250 mg capsle (Coleus forskohlii extract) twice a day for 12 weeks
Treatment:
Dietary Supplement: Coleus forskohlii extract
Placebo
Placebo Comparator group
Description:
Ingestion of 250 mg capsule (placebo) twice a day for 12 weeks
Treatment:
Other: Placebo

Trial contacts and locations

1

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Central trial contact

Dr HN Shivaprasad; Dr. Xiao Su

Data sourced from clinicaltrials.gov

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