UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032415 |
|---|---|
| Receipt number | R000036881 |
| Scientific Title | A Population-Based Prospective Study on the Roles of Shopping, Oral Function, Nutrition, and Genetics in Sarcopenia, Frailty and Healthy Life Expectancy in Mima City: The Mima-SONGS Study |
| Date of disclosure of the study information | 2018/04/28 |
| Last modified on | 2023/11/03 17:55:57 |
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Basic information
Public title
A Population-Based Prospective Study on the Roles of Shopping, Oral Function, Nutrition, and Genetics in Sarcopenia, Frailty and Healthy Life Expectancy in Mima City: The Mima-SONGS Study
Acronym
A Population-Based Prospective Study on the Roles of Shopping, Oral Function, Nutrition, and Genetics in Sarcopenia, Frailty and Healthy Life Expectancy in Mima City: The Mima-SONGS Study
Scientific Title
A Population-Based Prospective Study on the Roles of Shopping, Oral Function, Nutrition, and Genetics in Sarcopenia, Frailty and Healthy Life Expectancy in Mima City: The Mima-SONGS Study
Scientific Title:Acronym
A Population-Based Prospective Study on the Roles of Shopping, Oral Function, Nutrition, and Genetics in Sarcopenia, Frailty and Healthy Life Expectancy in Mima City: The Mima-SONGS Study
Region
| Japan |
Condition
Condition
Chronic diseases
Classification by specialty
| Geriatrics | Dental medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To study the roles of shopping, oral function, nutrition, and genetics in sarcopenia, frailty and healthy life expectancy in people living in a rural mountain village where fresh foods such as meat and fish are not readily available.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
End of healthy life expectancy
Key secondary outcomes
End of life at home, death, changes in indexes of nutrition and muscle.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Chronic diseases patients living in Koyadaira area in Mima City and visiting Mima City Koyadaira Municipal Clinic regularly
Key exclusion criteria
Patients decided not to be participated in this study by the lead principal investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Fujiwara |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Preventive Medicine, Clinical Research Institute
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, Japan
TEL
+81-75-641-9161
syfujiwara@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Fujiwara |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Preventive Medicine, Clinical Research Institute
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, Japan
TEL
+81-75-641-9161
Homepage URL
syfujiwara@jichi.ac.jp
Sponsor or person
Institute
Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science, and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyoto Medical Center
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, Japan
Tel
+81-75-641-9161
syomuhan@kyotolan.hosp.go.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
美馬市国民健康保険木屋平診療所（徳島県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 28 | 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
111
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
| 2018 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Items below are measured: height, body weight, food diversity, complete blood cell counts, serum chemistry, and urine analysis at points of baseline and every 3 months throughout a 2-year period; muscle mass, physical function, frequency of food consumption, shopping practices concerning food, oral function, physical activity, mental function, and cognitive function at points of baseline and follow-ups at 1 year and 2 years; head computerized tomography at points of baseline and follow-up at 2 years; genetic polymorphism at baseline.
Management information
Registered date
| 2018 | Year | 04 | Month | 27 | Day |
Last modified on
| 2023 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036881
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
