UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028873
Receipt No. 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 2019/03/01

* 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
Middle name
Last name Hideaki Hosino
Organization Jikoukai medical corporation
Division name medical examination section
Zip code
Address 10-30, Chuo 1-jo 7, Siroisi-ku Sapporo-shi, Hokkaido
TEL 011-611-2711
Email kouzai@hmc.moo.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinji Sakata
Organization Asahi group holdings, LTD.
Division name Core technology laboratories
Zip code
Address 1-21, Midori 1Chome, moriya-shi, Ibaraki
TEL 0297-46-9339
Homepage URL
Email shinji.sakata@asahigroup-holdings.com

Sponsor
Institute Jikoukai medical corporation
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
Address
Tel
Email

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
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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 26 Day
Date of IRB
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
2019 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.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


Contact us.