UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044999 |
|---|---|
| Receipt number | R000051409 |
| Scientific Title | Study on the effect of continuous intake of high-protein soymilk on frailty of the elderly |
| Date of disclosure of the study information | 2021/07/29 |
| Last modified on | 2023/07/31 15:38:17 |
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Basic information
Public title
Study on the effect of continuous intake of high-protein soymilk on frailty of the elderly
Acronym
Study on the effect of continuous intake of high-protein soymilk on frailty of the elderly
Scientific Title
Study on the effect of continuous intake of high-protein soymilk on frailty of the elderly
Scientific Title:Acronym
Study on the effect of continuous intake of high-protein soymilk on frailty of the elderly
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of continuous intake of high-protein soymilk on frailty in the elderly for 12 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in walking speed between baseline and 12 weeks after ingestion.
Key secondary outcomes
-Amount of change in walking speed from baseline and 6weeks after ingestion.
For the following, we evaluate amount of change 6 and 12weeks after ingestion.
-Skeletal muscle mass
- The Japanese version of the Cardiovascular Health Study criteria -Blood test (albumin, triglyceride, total cholesterol, HDL-cholesterol, LDL-cholesterol, Brain-derived neurotrophic factor, total carnitine)
-Hasegawa dementia scale-revised
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of 200mL high protein contained soymilk daily for 12 weeks.
Interventions/Control_2
Intake of 200mL low protein contained soymilk daily for 12 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
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Healthy Japanese who are 65 to 85 years old
3. Persons who meet at least one revised J-CHS at the time of screening
Key exclusion criteria
1. Persons who are allergic to the test food
2. Persons who are usually taking amount of the test food.
3. Persons who regularly use medicines, specified insurance foods, health foods, etc. that may affect the study.
4. Persons who drink a lot of alcohol or smoke excessively.
5. Persons who have participated in other intervention study within the first month before the start of the test, or those who intend to participate in another intervention study after consenting to this study.
6. Persons who were judged as inappropriate for study participants by the principal investigator
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hirohito |
| Middle name | |
| Last name | Ishikawa |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
ishikawa@hc-sys.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Asahina |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
asahina.yuki@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
MARUSAN-AI 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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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 | 07 | Month | 29 | 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
104
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
| 2020 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 07 | Month | 29 | Day |
Last modified on
| 2023 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051409
