UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055799 |
|---|---|
| Receipt number | R000063218 |
| Scientific Title | Evaluation of the improvement in physical function by high 11S globulin content soybeans in healthy middle-aged and elderly individuals with low physical activity levels |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2025/05/12 14:52:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the improvement in physical function by high 11S globulin content soybeans in healthy middle-aged and elderly individuals with low physical activity levels
Acronym
Evaluation of the improvement in physical function by high 11S globulin content soybeans in healthy middle-aged and elderly individuals with low physical activity levels
Scientific Title
Evaluation of the improvement in physical function by high 11S globulin content soybeans in healthy middle-aged and elderly individuals with low physical activity levels
Scientific Title:Acronym
Evaluation of the improvement in physical function by high 11S globulin content soybeans in healthy middle-aged and elderly individuals with low physical activity levels
Region
| Japan |
Condition
Condition
Healthy middle-aged and elderly Individuals
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and improvement in physical function of high 11S globulin soybeans in healthy middle-aged and elderly individuals with low physical activity levels.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lean body mass (Muscle mass)
Quadriceps Volume by MRI
Muscle Strength
Walking Time and Speed
Key secondary outcomes
Muscle Atrophy Marker
Oxidative Stress Marker
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Specifics of the intervention act (high 11S globulin content soybeans in blended diet 100g /day, administration period of 28 days)
Criteria for modification of the intervention; discontinuation of the intervention if any discomfort (allergic symptoms, etc.) occurs due to ingestion
Criteria for discontinuation or completion of the intervention (prophylaxis, testing, etc.); discontinuation if any intake-related discomfort (allergic symptoms, etc.) occurs
Interventions/Control_2
Specifics of the intervention act (milk protein in blended diet 100g /day, administration period of 28days)
Criteria for modification of the intervention; discontinuation of the intervention if any discomfort (allergic symptoms, etc.) occurs due to ingestion
Criteria for discontinuation or completion of the intervention (prophylaxis, testing, etc.); discontinuation if any intake-related discomfort (allergic symptoms, etc.) occurs
Interventions/Control_3
Specifics of the intervention act (placebo in blended diet 100g /day, administration period of 28days)
Criteria for modification of the intervention; discontinuation of the intervention if any discomfort (allergic symptoms, etc.) occurs due to ingestion
Criteria for discontinuation or completion of the intervention (prophylaxis, testing, etc.); discontinuation if any intake-related discomfort (allergic symptoms, etc.) occurs
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Over 45 years old
Female (If it is not possible to gather only female participants, males may also be included)
Individuals who have given their consent
Individuals with low physical activity level
Key exclusion criteria
Individuals with myogenetic diseases
Individuals with moderate or severe renal dysfunction (including those with diabetes)
Individuals with dietary protein restrictions
Individuals receiving medications that affect muscles, such as corticosteroids
Individuals with allergies (especially soy, milk and pollen allergies)
Individuals taking health supplements containing soy or protein
Individuals with pacemakers, claustrophobia, or other conditions that prevent MRI examinations
Individuals who refuse to participate in the study
Individuals deemed by the principal investigator to be unable to participate in the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nikawa |
Organization
The University of Tokushima Graduate School
Division name
Graduate School of Biomedical Sciences
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9248
nikawa@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Nikawa |
Organization
The University of Tokushima Graduate School
Division name
Graduate School of Biomedical Sciences
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9248
Homepage URL
nikawa@tokushima-u.ac.jp
Sponsor or person
Institute
The University of Tokushima
Institute
Department
Personal name
Nikawa Takeshi
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
2-50-1 Kuramoto-cho, Tokushima
Tel
0886339295
first-ec@tokushima-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
徳島大学
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 06 | 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
30
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
| 2024 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 23 | 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 | 10 | Month | 10 | Day |
Last modified on
| 2025 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063218
