UMIN-CTR Clinical Trial

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 Naoya Middle name Last name Sekiguchi
Organization	Urayasu Sekiguchi Clinic
Division name	Director
Zip code	279-0004
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 Yoshika Middle name Last name Komori
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
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	Ethical Committee of Nihonbashi Cardiology Clinic
Address	Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel	03-5641-4133
Email	niho-jimucho@well-sleep.jp

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	Completed
Date of protocol fixation	2019 Year 02 Month 08 Day
Date of IRB	2019 Year 02 Month 08 Day
Anticipated trial start date	2019 Year 03 Month 02 Day
Last follow-up date	2019 Year 07 Month 31 Day
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	2021 Year 02 Month 18 Day

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