The Effect of Coleus Forskohlii Extract on the Risk Factors of Metabolic Syndrome
Investigation of Appetite Suppressant Properties Associated With Coleus Forskohlii in Overweight and Obese Individuals
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2014
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 17, 2014
CompletedFirst Posted
Study publicly available on registry
May 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMay 21, 2014
May 1, 2014
1.1 years
May 17, 2014
May 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
changes in appetite will be assessed using visual analogue scale; blood hormone levels will also be measured using commercial kits.
Baseline and 12 weeks
Secondary Outcomes (1)
reduction in central obesity - waist circumference will be measured on fortnight basis
12 weeks
Other Outcomes (1)
alterations in blood lipids. This will be measured using commercial kits
12 weeks
Study Arms (2)
Coleus forskohlii extract
EXPERIMENTALIngestion of 250 mg capsle (Coleus forskohlii extract) twice a day for 12 weeks
Placebo
PLACEBO COMPARATORIngestion of 250 mg capsule (placebo) twice a day for 12 weeks
Interventions
Ingestion of 250 mg Coleus forskohlii extract capsule twice a day for 12 weeks
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Cigarette smoker, hypertension, all types of heart, liver and kidney disease, pregnancy, lactating, Type 1 diabetes and weight loss medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
College of Health and Biomedicine Victoria University
St Albans, Victoria, 14428, Australia
Related Publications (2)
obesity
BACKGROUNDShivaprasad 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.
PMID: 24497741BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2014
First Posted
May 21, 2014
Study Start
April 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
May 21, 2014
Record last verified: 2014-05