Metabolic SyndromePhase 3NCT02143349
The Effect of Coleus Forskohlii Extract on the Risk Factors of Metabolic Syndrome
A Phase 3 study testing Coleus forskohlii extract in people with Metabolic Syndrome and Obesity, run by Olive Lifesciences Pvt Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Metabolic Syndrome, Obesity
- What is being tested?
- Coleus forskohlii extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2014to May 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- Cigarette smoker, hypertension, all types of heart, liver and kidney disease, pregnancy, lactating, Type 1 diabetes and weight loss medication.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
College of Health and Biomedicine Victoria University
St Albans, Victoria, 14428
Dr. Xiao Su, +61399192318, xiao.su@vu.edu.au
A/Prof Michael Mathai, +61399192211, michael.mathai@vu.edu.au
About this study
Official title: Investigation of Appetite Suppressant Properties Associated With Coleus Forskohlii in Overweight and Obese Individuals
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.
- Conditions
- Metabolic Syndrome, Obesity
- Being tested
- Coleus forskohlii extract, Placebo
- Keywords
- obesity, herbal remedies, metabolic disorders
- Medical subject headings
- Metabolic Syndrome, Obesity, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coleus forskohlii extractDietary supplement
Ingestion of 250 mg Coleus forskohlii extract capsule twice a day for 12 weeks
PlaceboOther
Ingestion of 250 mg placebo capsule twice a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Coleus forskohlii extract | Experimental | Ingestion of 250 mg capsle (Coleus forskohlii extract) twice a day for 12 weeks Receives: Dietary Supplement: Coleus forskohlii extract |
| Placebo | Placebo comparator | Ingestion of 250 mg capsule (placebo) twice a day for 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in appetite will be assessed using visual analogue scale; blood hormone levels will also be measured using commercial kits.
Measured: Baseline and 12 weeks
Secondary outcomes (1)
reduction in central obesity - waist circumference will be measured on fortnight basis
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olive Lifesciences Pvt Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- College of Health and Biomedicine, Victoria University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143349
- Sponsor's protocol ID
- ACTRN12614000305628
- Status last verified
- May 2014
- First submitted
- 17 May 2014
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
obesity
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.
PubMed 24497741
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Appetite Suppressant Properties Associated With Coleus Forskohlii in Overweight and Obese Individuals
- ClinicalTrials.gov ID
- NCT02143349
- Acronym / sponsor ID
- ACTRN12614000305628
- Conditions
- Metabolic Syndrome, Obesity
- Keywords
- obesity, herbal remedies, metabolic disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Olive Lifesciences Pvt LtdIndustry (pharma, biotech, devices)
- Collaborators
- College of Health and Biomedicine, Victoria University
- Study start
- Apr 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 21 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coleus forskohlii extract | Experimental | Dietary Supplement: Coleus forskohlii extractIngestion of 250 mg capsle (Coleus forskohlii extract) twice a day for 12 weeks |
| Placebo | Placebo comparator | Other: PlaceboIngestion of 250 mg capsule (placebo) twice a day for 12 weeks |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- Cigarette smoker, hypertension, all types of heart, liver and kidney disease, pregnancy, lactating, Type 1 diabetes and weight loss medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coleus forskohlii extractIngestion of 250 mg Coleus forskohlii extract capsule twice a day for 12 weeks | Dietary supplement | Coleus forskohlii extract |
| PlaceboIngestion of 250 mg placebo capsule twice a day for 12 weeks | Other | Placebo |
Primary outcome
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
1 secondary outcome
reduction in central obesity - waist circumference will be measured on fortnight basis
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
- Backgroundobesity
- Background: PubMed 24497741Shivaprasad 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.
- Coleus forskohlii extractLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Coleus forskohlii extract in people with Metabolic Syndrome and Obesity, run by Olive Lifesciences Pvt Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Xiao Su (+61399192318, xiao.su@vu.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02143349, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2014.