UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044966 |
|---|---|
| Receipt number | R000051373 |
| Scientific Title | The effect of soy peptide intake on sarcopenia and cognitive decline: A randomized controlled trial |
| Date of disclosure of the study information | 2021/08/05 |
| Last modified on | 2021/07/27 12:05:27 |
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Basic information
Public title
The effect of soy peptide intake on sarcopenia and cognitive decline: A randomized controlled trial
Acronym
The effect of soy peptide intake on physical and cognitive functions
Scientific Title
The effect of soy peptide intake on sarcopenia and cognitive decline: A randomized controlled trial
Scientific Title:Acronym
The effect of soy peptide intake on physical and cognitive functions
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of soy peptide on physical and cognitive functions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of correct answers on nueropsychological tests
skeletal muscle index
grip strength
Timed & Up Go Test
Key secondary outcomes
Blood parameter
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intervention group: soy peptide containing drink 190g, 3 months
Interventions/Control_2
Control group: non-intake of soy peptide containing drink
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Elderly adults who have participated in
cohort studies
2. Independent person in their activities
of daily living and do not utilize
Japan's long-term care service
Key exclusion criteria
1. Patient with dementia
2. Patient with severe cardiac, pulmonary,
neurological or musculoskeletal disorders
3. Patient with food, and/or specifically
soy allergy
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Itsushi |
| Middle name | |
| Last name | Takai |
Organization
Osaka University of Economics
Division name
Department of Human Sciences
Zip code
533-8533
Address
2-2-8, Osumi, Higashiyodogawa-ku, Osaka, 533-8533 Japan
TEL
06-6328-2431
takai@osaka-ue.ac.jp
Public contact
Name of contact person
| 1st name | Itsushi |
| Middle name | |
| Last name | Takai |
Organization
Osaka University of Economics
Division name
Department of Human Sciences
Zip code
533-8533
Address
2-2-8, Osumi, Higashiyodogawa-ku, Osaka, 533-8533 Japan
TEL
06-6328-2431
Homepage URL
takai@osaka-ue.ac.jp
Sponsor or person
Institute
Osaka University of Economics
Institute
Department
Personal name
Funding Source
Organization
Fuji Oil Co. Ltd.,
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Fuji Oil Co. Ltd.,
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Ethics Committee, Osaka University of Economics
Address
2-2-8, Osumi, Higashiyodogawa-ku, Osaka, 533-8533 Japan
Tel
06-6328-2431
kenkyuu@osaka-ue.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
| 2021 | Year | 08 | Month | 05 | 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
97
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
| 2018 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2021 | Year | 07 | Month | 27 | Day |
Last modified on
| 2021 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051373
