UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046285 |
|---|---|
| Receipt number | R000052817 |
| Scientific Title | Pre-frail New efforts to prevent the progression of frail by intervention of agarooligosaccharides in the elderly |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2021/12/05 23:38:07 |
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Basic information
Public title
Pre-frail New efforts to prevent the progression of frail by intervention of agarooligosaccharides in the elderly
Acronym
Trial that inhibits the progression of preflail
Scientific Title
Pre-frail New efforts to prevent the progression of frail by intervention of agarooligosaccharides in the elderly
Scientific Title:Acronym
Trial that inhibits the progression of preflail
Region
| Japan |
Condition
Condition
frail
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is a test study that functional foods do from frail to frail (weakness) in the elderly. It is a randomized controlled trial to reduce the walking speed and muscle weakness of a person and to make a frailty syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
10 meter walking test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
taking 60mg/day AOSs for 12 weeks
Interventions/Control_2
taking placebo 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
| Not applicable |
Gender
Male
Key inclusion criteria
Pre-flail
Key exclusion criteria
People with high blood pressure
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ryoji |
| Middle name | |
| Last name | Hirota |
Organization
Matsumoto university
Division name
Department of Nutrition
Zip code
3901295
Address
2095-1, Niimura, Matsumoto, Nagano
TEL
0263487200
ryoji.hirota@t.mastu.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Fujioka |
Organization
Matsumoo university
Division name
Department of Nutrition
Zip code
3901295
Address
2095-1, Niimura, Matsumoto, Nagano
TEL
0263487200
Homepage URL
ryoryo2003@yahoo.co.jp
Sponsor or person
Institute
Matsumoo university
Institute
Department
Personal name
Funding Source
Organization
Matsumoo university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Matsumoo university
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matsumoto.univ.
Address
2095-1, Niimura, Matsumoto, Nagano
Tel
0263487200
ryoji.hirota@t.matsu.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
松本大学
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 01 | 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
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 10 | 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 | 12 | Month | 05 | Day |
Last modified on
| 2021 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052817
