UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028873 |
|---|---|
| Receipt number | R000032976 |
| Scientific Title | Effect of intake of heat-killed lactic acid bacteria on the physical function. |
| Date of disclosure of the study information | 2018/08/28 |
| Last modified on | 2021/03/02 10:11:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of intake of heat-killed lactic acid bacteria on the physical function.
Acronym
Effect of intake of heat-killed LAB on the physical function.
Scientific Title
Effect of intake of heat-killed lactic acid bacteria on the physical function.
Scientific Title:Acronym
Effect of intake of heat-killed LAB on the physical function.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of intake of heat-killed LAB on the physical function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Gait speed
Key secondary outcomes
Grip strength, knee extension strength,
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of heat-killed LAB (1*10^12/200mg/day)for 12 weeks
Interventions/Control_2
Ingestion of 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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A health parson without an illness
Key exclusion criteria
1.Male subjects whose grip strength values are less than 29.0 kg or gait speed is less than 0.8 m/s.
2.Female subjects whose grip strength values are less than 17.0 kg or gait speed is less than 0.8 m/s.
3.Persons who take drugs for adiposity, hypertension and dyslipidemia
4.Persons who cannot give up the intake of possible supplements which may affect the status of fat, blood pressure and plasma lipids
5.Persons who cannot terminate the consumption of foods containing large number of lactic acid bacteria during the trial
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Hosino |
Organization
Jikoukai medical corporation
Division name
medical examination section
Zip code
0030011
Address
10-30, Chuo 1-jo 7, Siroisi-ku Sapporo-shi, Hokkaido
TEL
011-611-2711
kouzai@hmc.moo.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Sakata |
Organization
Asahi group holdings, LTD.
Division name
Core technology laboratories
Zip code
003-0011
Address
1-21, Midori 1Chome, moriya-shi, Ibaraki
TEL
0297-46-9339
Homepage URL
shinji.sakata@asahigroup-holdings.com
Sponsor or person
Institute
Jikoukai medical corporation
Institute
Department
Personal name
Funding Source
Organization
Asahi group holdings, 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
Asahi group holdings, LTD.
Address
1-21, Midori 1Chome, moriya-shi, Ibaraki
Tel
0297-46-9339
shinji.sakata@asahigroup-holdings.com
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
医療法人社団 慈昂会 白石内科クリニック(北海道）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 28 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000032976
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000032976
Number of participants that the trial has enrolled
116
Results
A significant difference was observed in the primary outcome
Results date posted
| 2021 | Year | 03 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy Japanese elderly
Participant flow
143participants completed and 116 subjects were incorporated into the analyses.
Adverse events
non
Outcome measures
ability of walking
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 07 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 16 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 16 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 29 | Day |
Last modified on
| 2021 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032976
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
