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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048292
Receipt No. 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 2022/07/05

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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
70 years-old >=
Gender Male and Female
Key inclusion criteria Early-stage elderly (65-70 years 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
Email 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
Email yukmy@clg.niigata-u.ac.jp

Sponsor
Institute Niigata University Graduate School of Health Sciences
Institute
Department

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
Email 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
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
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
2022 Year 07 Month 05 Day


Link to view the page
URL(English) 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
Registered date File name


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