UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Measurement of blood concentration of vitamins in disabled elderly people and study of effects of intake of food containing BCAA (pilot study)
Title of the study (Brief title)	Measurement of blood concentration of vitamins in disabled elderly people and study of effects of intake of food containing BCAA (pilot study)
Region	Japan

Condition
Condition	Elderly people who live in senior citizens health facilities
Classification by specialty	Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the increase in blood concentration of vitamins by ingesting food containing BCAA.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood concentrations of VB1, VB2, VB6
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of the test food once daily for 4 weeks
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Persons who are judged to be rank A, B, C in the determination of bedridden degree 2)Persons who plan to live in a senior citizen health facility within 1 month 3)Persons who can eat daily and can ingest the test food continually 4)Persons who can provide informed consent
Key exclusion criteria	1)Persons with severe diabetes 2)Persons with severe hepatic dysfunction 3)Persons with severe renal dysfunction 4)Persons who take supplements before or during the observation period 5)Persons with congenital amino acid metabolism abnormality 6)Persons who are allergic to milk ingredients 7)Persons who are judged ineligible by the principal investigator
Target sample size	30

Research contact person
Name of lead principal investigator	Takashi Tsuchiya
Organization	Sendai City Medical Center Sendai Open Hospital
Division name	director
Address	5-22-1, Trugaya, Miyagino-ku, Sendai 98-0824, Japan
TEL	022-252-1111
Email	tsuchiya@openhp.or.jp

Public contact
Name of contact person	Takashi Tsuchiya
Organization	Sendai City Medical Center Sendai Open Hospital
Division name	director
Address	5-22-1, Trugaya, Miyagino-ku, Sendai 98-0824, Japan
TEL	022-252-1111
Homepage URL
Email	tsuchiya@openhp.or.jp

Sponsor
Institute	Moniwadai houreihome
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Factory
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 03 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 21 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2018 Year 02 Month 28 Day
Date of closure to data entry	2018 Year 04 Month 01 Day
Date trial data considered complete	2018 Year 05 Month 01 Day
Date analysis concluded	2018 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 06 Day
Last modified on	2018 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035540