UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048292 |
|---|---|
| Receipt number | R000055032 |
| Scientific Title | Study on taste improvement, nutritional status improvement and frailty prevention effect of elderly people by Zn (zinc) supplementation |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2024/01/05 14:52:47 |
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Basic information
Public title
Study of taste improvement, nutritional status improvement and frailty prevention effect of elderly people by zinc supplementation
Acronym
Study of taste improvement, nutritional status improvement and frailty prevention effect of elderly people by zinc supplementation
Scientific Title
Study on taste improvement, nutritional status improvement and frailty prevention effect of elderly people by Zn (zinc) supplementation
Scientific Title:Acronym
Study on taste improvement, nutritional status improvement and frailty prevention effect of elderly people by Zn (zinc) supplementation
Region
| Japan |
Condition
Condition
Early-stage elderly with decreased taste
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Taste and nutrition improvement effect by zinc supplementation for the elderly in the early stages of taste, prevention of frail and/or sarcopenia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of the taste
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Supply of Zn (zinc) supplements to the elderly (65-70 years old) with decreased taste
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Early-stage elderly (65-75years old) with poor taste who are not in the frailty of 65-70 years old and who are not taking Zn (zinc) supplements
Key exclusion criteria
1. Elderly people who have fallen into frailty or sarcopenia
2. Persons who have had surgery on the upper digestive organs such as the head and neck, esophagus, and stomach, or who have a history of anticancer drugs or radiation therapy.
3. Those who have already taken Zn (zinc) supplements
4. Persons with dementia or those who have difficulty in determining whether or not they have consented to participate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Koyama |
Organization
Niigata University
Division name
Graduate School of Health Sciences
Zip code
951-8518
Address
2-746 Asahimachi, Tyuo-ku, Niigata
TEL
0252272361
yukmy@clg.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Koyama |
Organization
Niigata University
Division name
Graduate School of Health Sciences
Zip code
951-8518
Address
2-746 Asahimachi, Tyuo-ku, Niigata
TEL
0252272361
Homepage URL
yukmy@clg.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Niigata University
Address
1-754 Asahimachi, Tyuo-ku, Niigata
Tel
025-227-2625
ethics@adm.niigata-u.ac.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
| 2022 | Year | 08 | Month | 01 | 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
56
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2022 | Year | 07 | Month | 05 | Day |
Last modified on
| 2024 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055032
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
