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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036031
Receipt No. R000040934
Scientific Title A Dose Finding Study on the Effect of Food Containing Plant Extract on Visceral Fat Area -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Date of disclosure of the study information 2019/03/01
Last modified on 2019/02/20

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Basic information
Public title A Dose Finding Study on the Effect of Food Containing Plant Extract on Visceral Fat Area
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym A Dose Finding Study on the Effect of Food Containing Plant Extract on Visceral Fat Area
Scientific Title A Dose Finding Study on the Effect of Food Containing Plant Extract on Visceral Fat Area
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym A Dose Finding Study on the Effect of Food Containing Plant Extract on Visceral Fat Area
Region
Japan

Condition
Condition No
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the effect of food containing plant extract on visceral fat area
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visceral fat area
Key secondary outcomes Subcutaneous fat area, Total fat area, Body weight(BMI), Waist circumference, Hip circumference, Waist circumference/ Hip circumference

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Food containing low-dose plant extract
Interventions/Control_2 Food containing medium-dose plant extract
Interventions/Control_3 Food containing high-dose plant extract
Interventions/Control_4 Food not containing plant extract
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
65 years-old >
Gender Male and Female
Key inclusion criteria (1)Healthy males and females aged 20 to 64 years-old.
(2)Subjects whose BMI are 23 or over and under 30.
(3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria (1) Subjects who use habitually medications.
(2) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting obesity, hyperglycemia, hyperlipidemia, lipid metabolism, and so on during test periods.
(3) Subjects who can't stop drinking from 2 days before each measurement.
(4) Subjects who contract or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease and/or metabolic disease).
(5) Subjects who have declared allergic reaction to ingredients of test foods.
(6) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
(7) Subjects who have been implanted metal in the abdominal area, as detected by computerized tomography.
(8) Subjects who have implantable medical devices (e.g., cardiac pacemaker and/or implantable defibrillator).
(9) Subjects who have claustrophobia.
(10) Subjects who are shiftworker and/or midnight-shift worker.
(11) Subjects who have been diagnosed as familial hyperlipidemia.
(12) Subjects who are planning to become pregnant after imformed consent for the current study, pregnant or lactating.
(13) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study.
(14) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoya Sekiguchi
Organization Urayasu Sekiguchi Clinic
Division name Director
Zip code
Address 5-17-27 Nekozane, Urayasu-shi, Chiba
TEL 047-306-3557
Email scfira@royal.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshika Komori
Organization KSO Corporation
Division name Sales department
Zip code
Address 1-9-7 Shibaura, Minato-ku, Tokyo
TEL 03-3452-7733
Homepage URL
Email yoshi@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization TOYO SHINYAKU Co., Ltd.
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

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 02 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
2019 Year 02 Month 27 Day
Last modified on
2019 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040934

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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