UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053440 |
|---|---|
| Receipt number | R000058646 |
| Scientific Title | Effect of dietary intervention on nutritional status among community-dwelling older people at higher risk of malnutrition: a randomized controlled trial |
| Date of disclosure of the study information | 2024/01/25 |
| Last modified on | 2024/01/25 15:20:00 |
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Basic information
Public title
Evaluation of the effectiveness of dietary interventions for improving malnutrition among community-dwelling older people
Acronym
Evaluation of the effectiveness of dietary interventions for improving malnutrition
Scientific Title
Effect of dietary intervention on nutritional status among community-dwelling older people at higher risk of malnutrition: a randomized controlled trial
Scientific Title:Acronym
Effects of dietary intervention on nutritional status: a randomized controlled trial
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of dietary interventions with food choices tailored to the subject's preferences on nutritional status among community-dwelling older people with mild to moderate malnutrition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle mass (change from the start of the intervention to 6 months)
Key secondary outcomes
1. Frailty score: The revised Japanese version of the cardiovascular health study criteria (revised J-CHS criteria)
2. Short Physical Performance Battery (SPPB) score
3. Geriatric Nutritional Risk Index (GNRI) score
4. Serum albumin
5. Total serum protein
6. Global Leadership Initiative on Malnutrition: Phenotypic Criteria
7. Body weight
8. Diet-related quality of life scale
9. Dietary intake
10. Appetite
11. Compliance with protocol implementation
12. Physical activity
13. Sleep status
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Outline: Once a week, a dietitian suggests food items suitable for the subject based on the results of an assessment of food preferences and dietary intake at the subject's home, and provides the approved food items free of charge.
Period: 6 months
Interventions/Control_2
Control group: Observation only (no intervention)
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
BMI <=20.0
Key exclusion criteria
- Persons who cannot make telephone calls on their own
- Persons who have difficulty in making decisions about research consent (substitute consent is not acceptable)
- Persons who is certified in the Japanese Long-term Care Insurance system.
- Persons who have been hospitalized for more than one week within one year
- Persons who are scheduled to be hospitalized or admitted within the next six months
- Persons who plan to move or travel for a week or more during the study period.
- Persons who are receiving nutritional guidance at any medical institution.
- Persons who are restricting energy or protein intake (e.g., have been instructed by a physician to limit energy or protein intake)
- Persons who have difficulty eating food by mouth (e.g., have difficulty in chewing and swallowing)
- Persons with food allergies (egg, milk, wheat, shrimp, crab, peanut, buckwheat, etc.)
- Persons who cannot refrigerate or heat provided foods at home.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kazumi |
| Middle name | |
| Last name | Tanaka |
Organization
Kanagawa University of Human Services
Division name
Faculty of Health and Social Services
Zip code
238-8522
Address
1-10-1 Heisei-cho, Yokosuka, Kanagawa, Japan
TEL
046-828-2500
tanaka-52x@kuhs.ac.jp
Public contact
Name of contact person
| 1st name | Kazumi |
| Middle name | |
| Last name | Tanaka |
Organization
Kanagawa University of Human Services
Division name
Faculty of Health and Social Services
Zip code
238-8522
Address
1-10-1 Heisei-cho, Yokosuka, Kanagawa, Japan
TEL
046-828-2500
Homepage URL
tanaka-52x@kuhs.ac.jp
Sponsor or person
Institute
Kanagawa University of Human Services
Institute
Department
Personal name
Funding Source
Organization
Toyota Motor Corporation
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
Research Ethics Review Committee, Kanagawa University of Human Services
Address
1-10-1 Heisei-cho, Yokosuka, Kanagawa, Japan
Tel
046-828-2907
jimu-rinri@kuhs.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
| 2024 | Year | 01 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 08 | 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
| 2024 | Year | 01 | Month | 25 | Day |
Last modified on
| 2024 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058646
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
