UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028022 |
|---|---|
| Receipt number | R000032087 |
| Scientific Title | Inhibitory effects of dietary soy and whey proteins on muscle atrophy |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2025/03/19 15:26:49 |
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Basic information
Public title
Inhibitory effects of dietary soy and whey proteins on muscle atrophy
Acronym
Inhibitory effects of dietary soy and whey proteins on muscle atrophy
Scientific Title
Inhibitory effects of dietary soy and whey proteins on muscle atrophy
Scientific Title:Acronym
Inhibitory effects of dietary soy and whey proteins on muscle atrophy
Region
| Japan |
Condition
Condition
muscle atrophy
Classification by specialty
| Geriatrics | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is designed to elucidate the inhibitory effects of soy and whey proteins on muscle atrophy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
We will give whey protein (8 g/day) or whey + soy proteins (8 g/day) to bed-ridden patients with PS 2 or 3 for 28 days. We will measure the volume and strength of quadriceps muscles.
Key secondary outcomes
We will also measure urinary amounts of 8OHDG and 3-methylhistidine.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Whey protein or
8 gram per day, 28 days, with lunch
Interventions/Control_2
Soy protein + whey protein
8 gram per day, 28 days, with lunch
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
| 20 | years-old | < |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients in hospital or Patients with day service
Patients with Performance Score 2 or 3
Key exclusion criteria
Patients with muscle diseases, chronic kidney diseases, diabetes, steroid treatment, allergy against soy or whey protein
Patients getting supplement of soy-derived foods
Pregnant women
Patients with pace maker
Patients with claustrophobia
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nikawa |
Organization
Tokushima University Graduate School
Division name
Institute of Biomedical Sciences
Zip code
7708503
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
Tokushima University Graduate School
Division name
Institute of Biomedical Sciences
Zip code
7708054
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9248
Homepage URL
nikawa@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Nutritional Physiology, Institute of Biomedical Sciences, Tokushima University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Fuji Foundation for Protein Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Trial Center for Developmental Therapeutics
Address
3-18-15 Kuramoto-cho, Tokushima
Tel
088-633-9294
awachiken@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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
20
Results
Terminated
Results date posted
| 2025 | Year | 03 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Terminated
Participant flow
Terminated
Adverse events
Terminated
Outcome measures
Terminated
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2017 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 30 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032087
