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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031167
Receipt No. R000035540
Scientific Title Measurement of blood concentration of vitamins in disabled elderly people and study of effects of intake of food containing BCAA (pilot study)
Date of disclosure of the study information 2018/03/31
Last modified on 2018/08/08

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Basic information
Public title Measurement of blood concentration of vitamins in disabled elderly people and study of effects of intake of food containing BCAA (pilot study)
Acronym Measurement of blood concentration of vitamins in disabled elderly people and study of effects of intake of food containing BCAA (pilot study)
Scientific Title Measurement of blood concentration of vitamins in disabled elderly people and study of effects of intake of food containing BCAA (pilot study)
Scientific Title:Acronym 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
1st name
Middle name
Last name Takashi Tsuchiya
Organization Sendai City Medical Center Sendai Open Hospital
Division name director
Zip code
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
1st name
Middle name
Last name Takashi Tsuchiya
Organization Sendai City Medical Center Sendai Open Hospital
Division name director
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2017 Year 12 Month 21 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000035540

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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