UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048775 |
|---|---|
| Receipt number | R000055567 |
| Scientific Title | A study to investigate the effects of bifidobacteria on muscle strength and physical function: a randomized, double-blind, placebo controlled, parallel-group comparative study. |
| Date of disclosure of the study information | 2022/08/28 |
| Last modified on | 2024/02/27 19:16:06 |
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Basic information
Public title
A study to investigate the effects of bifidobacteria on muscle strength and physical function: a randomized, double-blind, placebo controlled, parallel-group comparative study.
Acronym
The effect of bifidobacteria for muscle strength in healthy adults.
Scientific Title
A study to investigate the effects of bifidobacteria on muscle strength and physical function: a randomized, double-blind, placebo controlled, parallel-group comparative study.
Scientific Title:Acronym
The effect of bifidobacteria for muscle strength in healthy adults.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effects of bifidobacteria intake on muscle strength and physical function in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Grip strength test
Key secondary outcomes
Chair-stand test, 6m walk test, Body composition, Physical activities, Locomotive syndrome risk test, Questionnaire for fatigue, Microbiota analysis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
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
Oral intake of test food for 12 weeks
Interventions/Control_2
Oral intake of placebo food 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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subject aged 20 or more but less than 80 years old.
2. Subject without motor dysfunction.
3. Subject who have the capacity to consent by documents.
Key exclusion criteria
1. Subject with serious allergy to specific medicine or food
2. Subject with irregular lifestyles
3. Heavy smoker and heavy drinker
4. Subject who is under medication for cardiac, hepatic, renal, pulmonary, hematological, gastrointestinal, endocrine and metabolic problems, or subject who have history of serious disease.
5. Subject who is ineligible due to physician's judgment.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Toshifumi |
| Middle name | |
| Last name | Ohkusa |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Microbiota Research
Zip code
113-0033
Address
3-3-1 Hongo, Ochanomizu KS Building 4F 405 Bunkyo-ku, Tokyo 113-0033, Japan
TEL
070-3600-0977
ohkusa@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Toshifumi |
| Middle name | |
| Last name | Ohkusa |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Microbiota Research
Zip code
113-0033
Address
3-3-1 Hongo, Ochanomizu KS Building 4F 405 Bunkyo-ku, Tokyo 113-0033, Japan
TEL
070-3600-0977
Homepage URL
ohkusa@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Department of Microbiota Research
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Graduate School of Medicine
Department of Microbiota Research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Juntendo University Graduate School of Sports and Health Science
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Conference of Clinical Research
Address
1-13-23 Minami-ikebukuro, Toshima-ku, Tokyo 171-0022
Tel
03-5953-2108
http://www.jccr.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
| 2022 | Year | 08 | 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
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
| 2022 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 10 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 27 | Day |
Last modified on
| 2024 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055567
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| Registered date | File name |
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