UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000038745