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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020189
Receipt No. R000023318
Scientific Title 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

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Basic information
Public title Anti-obesity effect of the plant extract in subjects with abdominal obesity
Acronym Anti-obesity effect of the plant extract in subjects with abdominal obesity
Scientific Title Anti-obesity effect of the plant extract in subjects with abdominal obesity
Scientific Title:Acronym 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 investigate the effect of the plant extract on adiposity-related parameters in subjects with abdominal obesity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Visceral fat area at baseline, 8, 12 and 16 weeks.
Key secondary outcomes Body weight, body fat percentage, and waist circumference at baseline, 8, 12 and 16 weeks.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Subjects receive 350 mL/day of placebo drink for 12 weeks, by replacing their daily alcoholic drinks with it.
Interventions/Control_2 Subjects receive 350 mL/day of treatment drink (containing 540 mg of the plant extract) for 12 weeks, by replacing their daily alcoholic drinks with it.
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1) Regular user of alcohol (more than 5 days per week)
2) Visceral fat area not lower than 100 cm2
Key exclusion criteria 1) Taking medicines or receiving health guidance for hypertension, diabetes, and/or hyperlipidemia
2) Taking drugs or functional food that may affect the trial
3) Participation in any clinical trial within 90 days of the commencement of the trial
4) In pregnancy or nursing a child
5) Cardiac, renal, and/or hepatic dysfunction
6) 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
Email 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
Email fumiko@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023318

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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