UMIN-CTR Clinical Trial

Basic information
Public title	Changes in body (size, blood etc.) due to intake of test article
Acronym	Trial of changes in body
Scientific Title	Changes in body (size, blood etc.) due to intake of test article : a randomized, double blind, placebo-controlled study
Scientific Title:Acronym	Trial of changes in body
Region	Japan

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

Objectives
Narrative objectives1	Intake test products for 8 weeks to assess body changes(size, blood etc.)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	physical measurement, blood test
Key secondary outcomes

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	Intake test sample A for 8weeks
Interventions/Control_2	Intake test sample B for 8weeks
Interventions/Control_3	Intake placebo A for 8weeks
Interventions/Control_4	Intake placebo B for 8weeks
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	subjects who want to gain weight
Key exclusion criteria	1.Subjects with BMI 30 or more 2.Subjects with milk allergies 3.Subjects with food allergies 4.Subjects who are pregnant or lactating 5.Subject who wants to avoid weight gain and body size increase. 6.Subject on a diet 7.Subjects who consume medicinal product which may influence the outcome of the study 8.Subjects who consume food which may influence the outcome of the study 9. Subjects who are judged as unsuitable for the study by the investigator for the other reason
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Masatomo Middle name Last name Najima
Organization	Japan Clinical Trial Association
Division name	N.A.
Zip code	1600022
Address	5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL	0364574666
Email	info@yakujihou.org

Public contact
Name of contact person	1st name Takeshi Middle name Last name Kaneko
Organization	Japan Clinical Trial Association
Division name	N.A.
Zip code	1600022
Address	5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL	0364574666
Homepage URL
Email	info@yakujihou.org

Sponsor
Institute	Japan Clinical Trial Association
Institute
Department

Funding Source
Organization	furusato wakando Inc.
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	Institutional Review Board of Pharmaceutical Law Wisdoms
Address	5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel	0364574911
Email	master@yakujihou.net

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 05 Month 25 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	72
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 04 Month 18 Day
Date of IRB	2019 Year 04 Month 18 Day
Anticipated trial start date	2019 Year 05 Month 25 Day
Last follow-up date	2019 Year 07 Month 27 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 05 Month 24 Day
Last modified on	2020 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041970