UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052283 |
|---|---|
| Receipt number | R000059685 |
| Scientific Title | The effects of personalized nutritional support and dietary guidance on malnourished elderly adults in elderly care institutions: a randomized clinical trial |
| Date of disclosure of the study information | 2023/09/22 |
| Last modified on | 2023/09/22 21:18:24 |
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Basic information
Public title
The effects of personalized nutritional support and dietary guidance on malnourished elderly adults in elderly care
Acronym
personalized nutritional support and dietary guidance on elderly adults
Scientific Title
The effects of personalized nutritional support and dietary guidance on malnourished elderly adults in elderly care institutions: a randomized clinical trial
Scientific Title:Acronym
personalized nutritional support and dietary guidance on elderly adults
Region
| Asia(except Japan) |
Condition
Condition
Malnourished elderly
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to determine the effects of personalized nutritional support and dietary guidance on malnourished elderly adults
Safety, Efficacy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The differences in serum total protein, serum albumin, grip strength, waist circumference, Calf circumference.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Food
80 g:Fish, pork blood beancurd, pork liver,
100g:pasteurized fresh milk,
50g: raw vegetables, fruits,
coarse grain,
15g nuts, 5g red dates.
Interventions/Control_2
Health education
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
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion:>=60 years-old; BMI<23;
Key exclusion criteria
participants who had liquid diet
Target sample size
39
Research contact person
Name of lead principal investigator
| 1st name | Kaijun |
| Middle name | |
| Last name | Niu |
Organization
Tianjin Medical University
Division name
Nutrition and epidemiology institution
Zip code
300070
Address
22 Qixiangtai Road, Heping District, Tianjin, P. R.China.
TEL
+86(0)22-83336613
nkj0809@gmail.com
Public contact
Name of contact person
| 1st name | Li |
| Middle name | |
| Last name | Li |
Organization
Tianjin Medical University
Division name
Nutrition and epidemiology institution
Zip code
300070
Address
22 Qixiangtai Road, Heping District, Tianjin, P. R.China.
TEL
+86(0)22-83336613
Homepage URL
nkj0809@gmail.com
Sponsor or person
Institute
Tianjin Medical University, Nutrition and epidemiology institution
Institute
Department
Personal name
Funding Source
Organization
Tianjin Medical University
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tianjin Medical University
Address
22 Qixiangtai Road, Heping District, Tianjin, P. R.China.
Tel
+86(0)22-83336613
nkj0809@gmail.com
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
| 2023 | Year | 09 | Month | 22 | 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
39
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 | 06 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 22 | Day |
Last modified on
| 2023 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059685
