UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050650 |
|---|---|
| Receipt number | R000057709 |
| Scientific Title | Effects of peptide-containing food intake on locomotive syndrome |
| Date of disclosure of the study information | 2023/03/24 |
| Last modified on | 2024/04/01 15:15:42 |
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Basic information
Public title
Effects of peptide-containing food intake on locomotive syndrome
Acronym
Nutritional food and locomotive syndrome
Scientific Title
Effects of peptide-containing food intake on locomotive syndrome
Scientific Title:Acronym
Nutritional food and locomotive syndrome
Region
| Japan |
Condition
Condition
Locomotive syndrome
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Locomotive syndrome is defined as "a condition in which mobility functions (standing, walking, running, sitting, etc.) are impaired due to disorders of the locomotor system," and is caused by aging, lack of exercise, decreased activity, and over/undernutrition. In this study, we will investigate the effects of peptide-containing foods on locomotive syndrome in the elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lower extremity muscle strength at 4, 8, and 12 weeks after intake
Key secondary outcomes
Stand-up test, two-step test, and 25-question Geriatric Locomotive Function Scale at 4, 8, and 12 weeks after intake
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of nutritional food twice a day for 3 months
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who have obtained the consent of the individual in writing
Key exclusion criteria
People judged by doctors as inappropriate for this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Tanaka |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Sports Medical Science
Zip code
5650871
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6210-8442
tanahiro-osk@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Tanaka |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Sports Medical Science
Zip code
5650871
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6210-8442
Homepage URL
tanahiro-osk@umin.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Saraya. Co. Ltd
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
Osaka University Clinical Research Review Committee
Address
2-2, Yamadaoka, Suita, Osaka, Japan
Tel
06-6210-8296
handai-nintei@hp-crc.med.osaka-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
| 2023 | Year | 03 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 03 | Month | 22 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057709
| 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 |
