UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043580 |
|---|---|
| Receipt number | R000049767 |
| Scientific Title | A prospective observational study on the assessment of nutritional status of nursing home users by using a nutritional assessment web form (MNA Plus) |
| Date of disclosure of the study information | 2021/03/18 |
| Last modified on | 2023/03/13 10:07:01 |
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Basic information
Public title
A prospective observational study on the assessment of nutritional status of nursing home users by using a nutritional assessment web form (MNA Plus)
Acronym
Assessment of nutritional status using the Nutrition Assessment Web Form (MNA Plus)
Scientific Title
A prospective observational study on the assessment of nutritional status of nursing home users by using a nutritional assessment web form (MNA Plus)
Scientific Title:Acronym
Assessment of nutritional status using the Nutrition Assessment Web Form (MNA Plus)
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Nutritional status will be assessed using Mini Nutritional Assessment (MNA) Plus for elderly people using nursing homes, and changes in weight will be investigated for those who are determined to be undernourished and in need of nutritional supplements.
Basic objectives2
Others
Basic objectives -Others
Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weight change at 3, 6, 9, and 12 months after the start of observation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Age 65 years or older at the time of consent.
(2) Patients who have been determined by MNA Plus to be in need of an energy boost at the time of eligibility determination and who are undernourished or at risk of undernourishment
(3) Those who fully understand the contents of the study and are able to give consent.
Key exclusion criteria
(1) Patients who are taking nutritional supplements at least once a week at the time of obtaining consent.
(2) Patients who have significant musculoskeletal disorders such as fracture at the time of consent.
(3) Patients who have difficulty in weighing themselves at nursing home.
(4) Patients with severe dementia
(5) Patients who have undergone a surgical operation 4 weeks prior to the start of observation, or who are scheduled to undergo a surgical operation during the observation period
6) Those who are judged by the principal investigator to be inappropriate for this study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yukikazu |
| Middle name | |
| Last name | Kamada |
Organization
Nestle Health Science Company, Nestle Japan Ltd
Division name
Marketing & Medical Affairs
Zip code
140-0002
Address
2-2-20 Higashi-Shinagawa, Shinagawa-ku, Tokyo
TEL
03-5769-6227
Yukikazu.Kamada@jp.nestle.com
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Takano |
Organization
Nestle Health Science Company, Nestle Japan Ltd
Division name
Marketing & Medical Affairs
Zip code
140-0002
Address
2-2-20 Higashi-Shinagawa, Shinagawa-ku, Tokyo
TEL
03-5769-6227
Homepage URL
Hiroki.Takano@jp.nestle.com
Sponsor or person
Institute
Solasto Corporation
Institute
Department
Personal name
Funding Source
Organization
Nestle Japan 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
Yamauchi Clinic IRB
Address
1-15-19, Jiyugaoka, Meguro Ku, Tokyo To, Japan
Tel
03-5575-5862
c-irb_ug@neues.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
| 2021 | Year | 03 | Month | 18 | 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
50
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
| 2021 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2021 | Year | 03 | Month | 10 | Day |
Last modified on
| 2023 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049767
