UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045439 |
|---|---|
| Receipt number | R000051878 |
| Scientific Title | The effect of intensive care for diet and exercise for prevention of sarcopenia |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2024/03/13 11:53:31 |
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Basic information
Public title
The effect of intensive care for diet and exercise for prevention of sarcopenia
Acronym
Koshi Study 1
Scientific Title
The effect of intensive care for diet and exercise for prevention of sarcopenia
Scientific Title:Acronym
Koshi Study 1
Region
| Japan |
Condition
Condition
metabolic disease, sarcopenia
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Geriatrics |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prevention of sarcopenia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate lean body weight and fat mass by bioelectric impedance method in control group and high protein group.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
High protein intensive care every two months for two years
Interventions/Control_2
Standard intensive care every two months for two years
Interventions/Control_3
Standard care every six months for two years
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
HbA1c<6.5%, FB<126
SBP<140, DBP<90
40<HDL<96
LDL<160
TG<150
16<BMI<25
eGFR>60
65<Age<80
Key exclusion criteria
Person who
has cancer
has nutrition disorder
has severe disease
joins other clinical trial
can't understand this clinical study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Araki |
Organization
Kumamoto University
Division name
Center for metabolic regulation of healthy aging
Zip code
8608556
Address
Chuoku Honjyo1-1-1 , Kumamoto City, Kumamoto Prefecture Japan
TEL
0963737380
fukudakazuki@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Fukuda |
Organization
Kumamoto University
Division name
Center for metabolic regulation of healthy aging
Zip code
8608556
Address
Chuoku Honjyo1-1-1 , Kumamoto City, Kumamoto Prefecture Japan
TEL
0963737380
Homepage URL
fukudakazuki@kumamoto-u.ac.jp
Sponsor or person
Institute
Center for metabolic regulation of healthy aging Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Center for metabolic regulation of healthy aging Kumamoto University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for metabolic regulation of healthy aging Kumamoto University
Address
Chuoku Honjyo1-1-1 , Kumamoto City, Kumamoto Prefecture Japan
Tel
0963737380
fukudakazuki@kumamoto-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
| 2021 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
91
Results
Intervention was finished as scheduled.
Results date posted
| 2024 | Year | 03 | Month | 13 | Day |
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
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 10 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051878
