UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy test of supplements containing plant extract for Japanese
Acronym	Efficacy test of supplements containing plant extract for Japanese
Scientific Title	Efficacy test of supplements containing plant extract for Japanese
Scientific Title:Acronym	Efficacy test of supplements containing plant extract for Japanese
Region	Japan

Condition
Condition	Healthy Japanese adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to verify the effects on body fat of test foods in adult men and women of BMI 25 and under 30 and abdominal visceral fat area (VFA) 80 cm^2.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body fat percentage and change Neutral fat and change
Key secondary outcomes	Weight and change BMI and change Waist circumference and change Hip circumference and amount of change

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of plant extract-containing food for 12 weeks
Interventions/Control_2	Intake of plant extract free food for 12 weeks
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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Persons aged 20 to 65 years of age at the time of obtaining informed consent 2) A healthy person who is not currently treating any disease 3) Persons with BMI of 25.0 kg / m2 or more and less than 30.0 kg / m2 at screening 4) Persons with a VFA of 80 cm2 or more using a CT scanner system 5) Those who can visit the designated medical institution on the scheduled examination date 6) A person who agreed in writing after fully understanding the purpose and content of this study
Key exclusion criteria	1) Those who have difficulty participating in the study due to liver, kidney, heart disease, respiratory disorder, endocrine disorder, metabolic disorder, neurological disorder, consciousness disorder, diabetes (according to the criteria established by the Japan Diabetes Association), and other diseases. 2) Person with a history of cardiovascular disease 3) Those who are taking glucose metabolism, lipid metabolism, blood pressure improvement drugs 4) Those who regularly use medicines and health foods / supplements (including foods for specified health, functional labeling foods and nutritionally functional foods) that may affect this study (but stop taking it at the time of obtaining consent) The person who can do it does not correspond) 5) Persons who have allergies related to the test food 6) Those who have experienced poor mood or physical condition by blood collection in the past 7) Those who donated more than 200 mL from the month before the start of the test to the start of the test 8) Those who are participating in other clinical trials or within 4 weeks after the trial 9) Alcoholic drinkers and excessive smokers 10) Eating habits are extremely irregular 11) Those who wish to become pregnant during the study period, pregnant women (including those who may be pregnant) or those who are lactating 12) Those who can not agree with the purpose of the description of this exam that is conducted in advance In addition, those who were judged inappropriate for this study by the study investigator
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Yoshiaki Middle name Last name Shiojima
Organization	RYUSENDO CO., LTD.
Division name	President and CEO
Zip code	171-0021
Address	1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
TEL	03-3985-8346
Email	y.shiojima@ryusendo.co.jp

Public contact
1st name of contact person	1st name Megumi Middle name Last name Takahashi
Organization	RYUSENDO CO., LTD.
Division name	Development Office
Zip code	171-0021
Address	1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
TEL	03-3985-8346
Homepage URL
Email	m.takahashi@ryusendo.co.jp

Sponsor
Institute	KYOWA TRIAL CO., LTD
Institute
Department

Funding Source
Organization	RYUSENDO 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	Akanuma Surgeon Board Ethics Review Committee
Address	Ishiyama 2-jo 6-chome 14-1, Minami-ku, Sapporo-shi, Hokkaido
Tel	011-591-1777
Email	s-ito@kyowa-t.com

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	赤沼外科医院（北海道）

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 08 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	0
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	Terminated
Date of protocol fixation	2019 Year 03 Month 25 Day
Date of IRB	2019 Year 03 Month 26 Day
Anticipated trial start date	2019 Year 05 Month 20 Day
Last follow-up date	2019 Year 08 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 04 Month 24 Day
Last modified on	2019 Year 05 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041627