UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051514 |
|---|---|
| Receipt number | R000058731 |
| Scientific Title | Research on the usefulness of "healthy diet" considering functional food ingredients for the prevention of frailty and dementia |
| Date of disclosure of the study information | 2023/07/04 |
| Last modified on | 2023/07/03 18:36:45 |
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Basic information
Public title
Research on the usefulness of "healthy diet" for preventing frailty
Acronym
Research on the usefulness of "healthy diet" for preventing frailty
Scientific Title
Research on the usefulness of "healthy diet" considering functional food ingredients for the prevention of frailty and dementia
Scientific Title:Acronym
Research on the usefulness of "healthy diet" for preventing frailty
Region
| Japan |
Condition
Condition
healthy elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our study aimed to evaluate the effectiveness of a combined health promotion program that incorporates exercise along with a menu enriched with protein and vitamin D. The goal was to determine how this program contributes to the prevention of frailty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
muscle strength
Key secondary outcomes
Blood Vitamin D Levels
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects will exercise and consume a nutritious diet for 10 days.
Interventions/Control_2
Subjects will only exercise for 10 days.
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
| 69 | years-old | >= |
Gender
Male
Key inclusion criteria
Subjects will be those who have been fully informed of the purpose and content of this research, have the capacity to consent, fully understand, volunteer of their own free will, and agree in writing to participate in this research.
Key exclusion criteria
1. Those who are currently receiving medication for kidney or heart disease
2. Those who have neurological diseases (stroke, Parkinson's disease, etc.)
3. Those who have bone disease (knee joint, hip joint, etc.)
4. Those who have muscular diseases (muscular dystrophy, etc.)
5. Those who have inflammatory diseases
6. Those who have allergies to foods provided during the study period.
7. Persons who are deemed inappropriate as subjects by the principal investigator and the study investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hidekazu |
| Middle name | |
| Last name | Arai |
Organization
The University of Shizuoka
Division name
Laboratory of Clinical Nutrition and Management, School of Food and Nutritional Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL
054-264-5511
arai@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Hidekazu |
| Middle name | |
| Last name | Arai |
Organization
The University of Shizuoka
Division name
Laboratory of Clinical Nutrition and Management, School of Food and Nutritional Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL
054-264-5511
Homepage URL
arai@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
The University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
This work was supported by the Food and Healthcare Open Innovation Project of Shizuoka Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of the University of Shizuoka
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
Tel
054-264-5103
tyous10@u-shizuoka-ken.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
| 2023 | Year | 07 | Month | 04 | 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
| 2021 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 28 | 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 | 07 | Month | 03 | Day |
Last modified on
| 2023 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058731
| Research Plan | |
|---|---|
| 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 |
