UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014122 |
|---|---|
| Receipt number | R000016422 |
| Scientific Title | Investigation of appetite suppressant properties associated with Coleus forskohlii in overweight and obese individuals |
| Date of disclosure of the study information | 2014/08/11 |
| Last modified on | 2014/08/11 15:54:54 |
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Basic information
Public title
Investigation of appetite suppressant properties associated with Coleus forskohlii in overweight and obese individuals
Acronym
The effect of Coleus forskohlii extract on the risk factors of metabolic syndrome
Scientific Title
Investigation of appetite suppressant properties associated with Coleus forskohlii in overweight and obese individuals
Scientific Title:Acronym
The effect of Coleus forskohlii extract on the risk factors of metabolic syndrome
Region
| Australia |
Condition
Condition
Metabolic syndrome
Obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the appetite suppressant properties of Coleus forskohlii extract after three months administration in overweight and obese individuals.
To assess the effect of Coleus forskohlii on central obesity and risk factors of metabolic syndrome in overweight and obese individuals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in appetite will be assessed using visual analogue scale.
changes in blood hormone levels will be analyzed using commercial kits.
Key secondary outcomes
Reduction in central obesity - waist circumference will be measured on fortnight basis.
Changes in blood lipids will be analysed using commercial kits.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Administration of Coleus forskohlii extract
Interventions/Control_2
Administration of Placebo control (microcrystalline cellulose)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Overweight or obese (BMI >25).
Waist circumference of >94 cm (male) and >80 cm (female).
Key exclusion criteria
Cigarette smoker.
Patient having any type of heart, liver and kidney diseases.
Pregnancy and lactating women.
Any medication for hypertension, type I diabetes and weight loss.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Dr. Xiao Su |
Organization
Victoria University
Division name
College of Health and Biomedicine
Zip code
Address
St. Albans, Victoria, Austalia 14428
TEL
+61399192211
xiao.su@vu.edu.au
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dr. Xiao Su |
Organization
Victoria University
Division name
College of Health and Biomedicine
Zip code
Address
St. Albans, Victoria, Australia 14428
TEL
+61399192211
Homepage URL
xiao.su@vu.edu.au
Sponsor or person
Institute
Victoria University
Institute
Department
Personal name
Funding Source
Organization
Victoria University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Australia
Other related organizations
Co-sponsor
Olive Lifesciences Pvt Ltd
Name of secondary funder(s)
Bio Actives Japan Corporation
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
ACTRN12614000305628
Org. issuing International ID_1
Australia New Zealand Clinical Trials Registry
Study ID_2
NCT02143349
Org. issuing International ID_2
ClinicalTrials.gov
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2014 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 30 | Day |
Last modified on
| 2014 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016422
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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