UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052460 |
|---|---|
| Receipt number | R000059469 |
| Scientific Title | Effects of test food on lower limb function |
| Date of disclosure of the study information | 2024/10/30 |
| Last modified on | 2024/09/27 09:01:32 |
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Basic information
Public title
Effects of test food on lower limb function
Acronym
Effects of test food on lower limb function
Scientific Title
Effects of test food on lower limb function
Scientific Title:Acronym
Effects of test food on lower limb function
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effects of test food on lower limb function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indicators for lower limb function
Key secondary outcomes
Nutrient intake status
questionnaire
Body composition
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test food(for 16 weeks)
Interventions/Control_2
Ingestion of placebo food(for 16 weeks)
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
Individuals who are able to participate in the measurement in good physical and mental condition with written consent.
Key exclusion criteria
Individuals who cannot give their consent to participate in the research.
Individuals with illness, pain, or history of surgery in a specific area of the body
Individuals with contraindications to MRI, such as metal in the body, tattoo, claustrophobia, etc.
Individuals who regularly perform resistance training in the 6 months prior to the start of the intervention
Individuals who regularly eat certain foods during the 6 months prior to the start of the intervention.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naokazu |
| Middle name | |
| Last name | Miyamoto |
Organization
Juntendo University
Division name
Faculty of Health and Sports Science
Zip code
270-1695
Address
1-1, Hirakagakuendai, Inzai-shi, Chiba
TEL
0467-98-1001
n-miyamoto@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Naokazu |
| Middle name | |
| Last name | Miyamoto |
Organization
Juntendo University
Division name
Faculty of Health and Sports Science
Zip code
270-1695
Address
1-1, Hirakagakuendai, Inzai-shi, Chiba
TEL
0467-98-1001
Homepage URL
n-miyamoto@juntendo.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
self-funding
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
MORINAGA & CO., LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee in Juntendo University Graduate School of Health and Sports Science
Address
1-1 Hirakagakuendai, Inzai, Chiba
Tel
0467-98-1001
sc-rinri@juntendo.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 | 10 | Month | 30 | 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
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 11 | Day |
Last modified on
| 2024 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059469
