UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036684 |
|---|---|
| Receipt number | 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 | 2023/05/23 13:35:40 |
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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
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
fukuda-ryoko@benesse-style-care.co.jp
Sponsor or person
Institute
Benesse Institute for Research on KAIGO (Continuing Care)
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 03 | Day |
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
| 2023 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041778
