UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020188 |
|---|---|
| Receipt number | R000023315 |
| Scientific Title | Dose-dependent anti-obesity effect of the plant extract in subjects with abdominal obesity |
| Date of disclosure of the study information | 2015/12/15 |
| Last modified on | 2017/06/15 11:12:38 |
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Basic information
Public title
Dose-dependent anti-obesity effect of the plant extract in subjects with abdominal obesity
Acronym
Dose-dependent anti-obesity effect of the plant extract in subjects with abdominal obesity
Scientific Title
Dose-dependent anti-obesity effect of the plant extract in subjects with abdominal obesity
Scientific Title:Acronym
Dose-dependent anti-obesity effect of the plant extract in subjects with abdominal obesity
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the dose-dependent effect of the plant extract (four doses) on adiposity-related parameters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Visceral fat area at baseline, 8 and 12 weeks.
Key secondary outcomes
Body weight, body fat percentage, and waist circumference at baseline, 8 and 12 weeks.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects receive 3.2 g/day of placebo powder for 12 weeks, by dissolving the powder in 350 mL of hot water and replacing their daily tea drink with it.
Interventions/Control_2
Subjects receive 4.2 g/day of study treatment powder (containing 300 mg of the plant extract) for 12 weeks, by dissolving the powder in 350 mL of hot water and replacing their daily tea drink with it.
Interventions/Control_3
Subjects receive 5.7 g/day of study treatment powder (containing 413 mg of the plant extract) for 12 weeks, by dissolving the powder in 350 mL of hot water and replacing their daily tea drink with it.
Interventions/Control_4
Subjects receive 6.2 g/day of study treatment powder (containing 551 mg of the plant extract) for 12 weeks, by dissolving the powder in 350 mL of hot water and replacing their daily tea drink with it.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Visceral fat area not lower than 100 cm2
Key exclusion criteria
1) Smoker
2) Heavy user of alcohol (more than two drinks a day)
3) Taking medicines or receiving health guidance for hypertension, diabetes, and/or hyperlipidemia
4) Taking drugs or functional food that may affect the trial
5) Participation in any clinical trial within 90 days of the commencement of the trial
6) In pregnancy or nursing a child
7) Cardiac, renal, and/or hepatic dysfunction
8) History of severe disease and/or major surgery
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumiko Higashikawa |
Organization
Hiroshima University, Institute of Biomedical & Health Sciences
Division name
Project Research Center for Clinical Trial and Preventive Medicine
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL
082-257-1533
fumiko@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumiko Higashikawa |
Organization
Hiroshima University, Institute of Biomedical & Health Sciences
Division name
Project Research Center for Clinical Trial and Preventive Medicine
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL
082-257-1533
Homepage URL
fumiko@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 15 | 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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | 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
| 2015 | Year | 12 | Month | 14 | Day |
Last modified on
| 2017 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023315
