UMIN-CTR Clinical Trial

Basic information
Public title	Evaluate a diet program that ingests carbohydrates and controls calories
Acronym	Evaluate a diet program that ingests carbohydrates and controls calories
Scientific Title	Evaluate a diet program that ingests carbohydrates and controls calories
Scientific Title:Acronym	Evaluate a diet program that ingests carbohydrates and controls calories
Region	Japan

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

Objectives
Narrative objectives1	This study aims to provide meals for 8 weeks and snacks and evaluate slimming effect
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	body weight, body fat percentage, BMI, waist circumference, hip circumference
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Provide meals for 8 weeks and snacks and evaluate slimming effect
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Men and women over 20 years old 2.BMI 23 or more
Key exclusion criteria	1.Subjects receiving treatment for slimming purpose 2.Subjects during pregnancy, lactating 3.Subjects who participated in other clinical trials within one month, those planned to participate 4.Subjects who are judged as unsuitable for the study by the investigator for the other reason
Target sample size	18

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	SONOKO 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	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	2018 Year 07 Month 03 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	2018 Year 06 Month 07 Day
Date of IRB	2018 Year 06 Month 14 Day
Anticipated trial start date	2018 Year 07 Month 03 Day
Last follow-up date	2018 Year 09 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 07 Month 02 Day
Last modified on	2020 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037890