UMIN-CTR Clinical Trial

Basic information
Public title	Survey of senior citizens after injectioning monitor foods
Acronym	Survey of senior citizens after injectioning monitor foods
Scientific Title	Survey of senior citizens after injectioning monitor foods
Scientific Title:Acronym	Survey of senior citizens after injectioning monitor foods
Region	Japan

Condition
Condition	Senior citizens
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore the usability of the monitor foods when it is consumed by the senior citizens, and to obtain reference information for product brand development.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The usability of the monitor foods
Key secondary outcomes	Acceptance and evaluation of the monitor foods Daily diary (physical condition, intake of the monitor foods, etc.) Participant background (age, medical history, allergies, stress etc.)

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	30 days intake of monitor food
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	65 years-old <=
Age-upper limit	79 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Subjects who have obtained written consent for participation in the survey. 2)Men and women between 65 and 79. 3)Subjects who have a family doctor whom they can consult in case of illness or injury, and who are in daily contact with their family doctor.
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)Subjects who have high stress level 4)Subjects who are estimated inappropriate to this survey by principal investigator.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yasutaka Middle name Last name Ikeda
Organization	Otsuka Pharmaceutical Co., Ltd.
Division name	AIR Project
Zip code	108-8241
Address	Shinagawa Grand Central Tower, 2-16-4, Konan, Minato-ku, Tokyo
TEL	03-6717-1499
Email	Ikeda.Yasutaka@otsuka.jp

Public contact
Name of contact person	1st name Rikichika Middle name Last name Kawata
Organization	Otsuka Pharmaceutical Co., Ltd.
Division name	AIR Project
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	2021 Year 08 Month 16 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	Preinitiation
Date of protocol fixation	2021 Year 08 Month 02 Day
Date of IRB	2021 Year 08 Month 02 Day
Anticipated trial start date	2021 Year 09 Month 01 Day
Last follow-up date	2021 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 08 Month 10 Day
Last modified on	2021 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051532