UMIN-CTR Clinical Trial

Basic information
Public title	A preliminary survey to determine the effect of different timing of intake of monitor products on the level of fulfillment in daily life.
Acronym	A preliminary survey to determine the effect of different timing of intake of monitor products on the level of fulfillment in daily life.
Scientific Title	A preliminary survey to determine the effect of different timing of intake of monitor products on the level of fulfillment in daily life.
Scientific Title:Acronym	A preliminary survey to determine the effect of different timing of intake of monitor products on the level of fulfillment in daily life.
Region	Japan

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

Objectives
Narrative objectives1	To obtain preliminary information for a study to determine the effect of different timing of intaking monitor products on the fulfillment of daily life.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Questionnaire on Sleep
Key secondary outcomes	Questionnaire on fulfillment in daily life Questionnaire for Complaints

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	14 days intake of monitor product after breakfast
Interventions/Control_2	14 days intake of monitor product after dinner
Interventions/Control_3	14 days intake of monitor product after breakfast and after dinner
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)Subjects who have obtained written consent for participation in the survey. 2)Healthy adult males and females (Those who have not had a medical checkup within the past year and do not have any items that require further examination. However, those who have been diagnosed as not requiring treatment as a result of a detailed examination may participate 3)Worker 4)Those who are able to intake the monitor product and answer the questionnaire according to the predetermined schedule..
Key exclusion criteria	1)Subjects who had a serious major organ / internal organ or who are currently undergoing treatment and who are estimated inappropriate to this study. 2)Subjects who have food allergies. 3)Pregnant and lactating women 4)Subjects who are estimated inappropriate to this survey by principal investigator.
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Koichiro Middle name Last name Hamada
Organization	Otsuka Pharmaceutical Co., Ltd.
Division name	Saga Nutraceuticals Research Institute
Zip code	842-0195
Address	5006-5 Yoshinogari-cho Kanzaki-gun, Saga,
TEL	0952-52-1522
Email	hamadako@otsuka.jp

Public contact
Name of contact person	1st name Rikichika Middle name Last name Kawata
Organization	Otsuka Pharmaceutical Co., Ltd.
Division name	Societal Health Relations Department
Zip code	108-8241
Address	Shinagawa Grand Central Tower, 2-16-4, Konan, Minato-ku, Tokyo
TEL	03-6717-1499
Homepage URL
Email	kawatar@otsuka.jp

Sponsor
Institute	Otsuka Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical 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	Otsuka Pharmaceutical Co., Ltd.
Address	Shinagawa Grand Central Tower, 2-16-4, Konan, Minato-ku, Tokyo
Tel	03-6717-1499
Email	shimizu_se@otsuka.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	2022 Year 03 Month 09 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	245
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	2022 Year 02 Month 17 Day
Date of IRB	2022 Year 02 Month 17 Day
Anticipated trial start date	2022 Year 02 Month 28 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry	2022 Year 07 Month 30 Day
Date trial data considered complete	2022 Year 07 Month 30 Day
Date analysis concluded	2022 Year 09 Month 28 Day

Other
Other related information

Management information
Registered date	2022 Year 03 Month 09 Day
Last modified on	2022 Year 10 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053753