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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033973
Receipt No. R000038745
Scientific Title Effect of intake of heat-killed lactic acid bacteria on the physical function.
Date of disclosure of the study information 2019/04/05
Last modified on 2019/04/05

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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 Grip strength, knee extension strength, gait speed
One-leg standing duration with vision, One-leg standing duration with no vision
Key secondary outcomes BMI, body fat percentage, muscle mass, body fat mass, limb muscle mass

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 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 26.0kg or gait speed is less than 0.8 m/s.
2.Female subjects whose grip strength values are less than 18.0kg or gait speed is less than 0.8m/s.
3.Persons who cannot give up the intake of possible supplements which may affect the status of fat, blood pressure and plasma lipids
4.Persons who cannot terminate the consumption of foods containing large number of lactic acid bacteria during the trial
Target sample size 130

Research contact person
Name of lead principal investigator
1st name masanori
Middle name
Last name akanuma
Organization Akanuma Surgery Clinic
Division name Department
Zip code 005-0842
Address 14-1, Isiyama2-jo 6, , Minami-ku Sapporo-shi, Hokkaido
TEL 011-200-9431
Email y-kohzai@kyowa-t.com

Public contact
Name of contact person
1st name Yoshimichi
Middle name
Last name kozai
Organization Kyowa Trial Co., Ltd.
Division name Clinical Trials Division
Zip code 064-0923
Address 1-40, minami 2-jo nisi 11-tyoume, , tyuuou-ku Sapporo-shi, Hokkaido
TEL 011-200-9431
Homepage URL https://www.kyowa-t.com/
Email y-kohzai@kyowa-t.com

Sponsor
Institute Akanuma Surgery Clinic
Institute
Department

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 akanuma surgery clinic ethics review board
Address 14-1, Isiyama2-jo 6, , Minami-ku Sapporo-shi, Hokkaido
Tel 011-200-9431
Email y-kohzai@kyowa

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 赤沼外科医院

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 05 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
2018 Year 08 Month 08 Day
Date of IRB
2018 Year 07 Month 03 Day
Anticipated trial start date
2018 Year 09 Month 18 Day
Last follow-up date
2018 Year 12 Month 15 Day
Date of closure to data entry
2018 Year 12 Month 19 Day
Date trial data considered complete
2018 Year 12 Month 20 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 31 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038745

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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