UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036684
Receipt No. R000041778
Scientific Title Evaluation of the effect of dairy product on health status of elderly people
Date of disclosure of the study information 2019/05/08
Last modified on 2019/05/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of the effect of dairy product on health status of elderly people
Acronym Evaluation of the effect of dairy product on health status of elderly people
Scientific Title Evaluation of the effect of dairy product on health status of elderly people
Scientific Title:Acronym Evaluation of the effect of dairy product on health status of elderly people
Region
Japan

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

Objectives
Narrative objectives1 Elderly residing in nursing home are enrolled and participants are divided into two groups. The elderly in one group take a daily drink every day for 1 year and those in another does not. Effects of the daily drink on nutritional status of the elderly are evaluated through body weight and blood parameters during the intervention. Effects on defecation status, disease history and immune parameter are also evaluated. In addition, fecal microbiota are evaluated every 6 month during intervention and its relation with other evaluations are analyzed.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Nutritional status
Key secondary outcomes 1) Fecal microbiota
2) Bowel movement (fecal appearance, frequency)
3) Bacterial metabolite in feces
4) Fecal protein
5) Medication history
6) Morbidity of infectious diseases
7) Immune function

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 1-year intervention of dairy drink (one bottle per day)
Interventions/Control_2 Non-treatment
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Nursing home residents of Benesse Style Care Co., Ltd.
Key exclusion criteria 1) Milk allergy
2) Participation in other clinical trial
3) Unable to receive oral intake
4) Not suitable for the study
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Taisaku
Middle name
Last name Okumura
Organization Benesse Style Care Co., Ltd.
Division name Benesse Institute for Research on KAIGO (Continuing Care)
Zip code 163-0905
Address Shinjuku Monolith Building 2-3-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL 03-6836-1111
Email okumra-t@benesse-style-care.co.jp

Public contact
Name of contact person
1st name Ryoko
Middle name
Last name Fukuda
Organization Benesse Style Care Co., Ltd.
Division name Benesse Institute for Research on KAIGO (Continuing Care)
Zip code 163-0905
Address Shinjuku Monolith Building 2-3-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL 03-6836-1075
Homepage URL
Email fukuda-ryoko@benesse-style-care.co.jp

Sponsor
Institute Benesse Institute for Research on KAIGO (Continuing Care)
Institute
Department

Funding Source
Organization Benesse Institute for Research on KAIGO (Continuing Care)
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethics Committee of Benesse Institute for Research on KAIGO (Continuing Care)
Address Shinjuku Monolith Building 2-3-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
Tel 03-6836-1111
Email hi-nagata@benesse-style-care.co.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
2019 Year 05 Month 08 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
2019 Year 05 Month 03 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 09 Day
Last follow-up date
2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 08 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041778

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.