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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043580
Receipt No. 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 2021/04/14

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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
Email 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
Email Hiroki.Takano@jp.nestle.com

Sponsor
Institute Solasto Corporation
Institute
Department

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
Email 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
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 Enrolling by invitation
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
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing

Management information
Registered date
2021 Year 03 Month 10 Day
Last modified on
2021 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049767

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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