UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046179
Receipt number R000052650
Scientific Title Examination of cognitive function improving effect by ingestion of lactic acid bacteria for 12 weeks
Date of disclosure of the study information 2021/11/26
Last modified on 2021/11/20 11:48:28

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Basic information

Public title

12-week intake test of food containing lactic acid bacteria

Acronym

Lactic acid bacteria food intake test

Scientific Title

Examination of cognitive function improving effect by ingestion of lactic acid bacteria for 12 weeks

Scientific Title:Acronym

Cognitive function improvement test of lactic acid bacteria

Region

Japan


Condition

Condition

Healthy elders

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Cognitive function improvement

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cognitive function improvement

Key secondary outcomes

Psychological function improvement


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Lactic bacteria containing food

Interventions/Control_2

Placebo food

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy person

Key exclusion criteria

Dementia patient

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Tatsuhiro
Middle name
Last name Hisatsune

Organization

The University of Tokyo

Division name

GSFS

Zip code

277

Address

5-1-5 Kashiwanoha, Kashiwa, Chiba

TEL

0471363632

Email

hisatsune@edu.k.u-tokyo.ac.jp


Public contact

Name of contact person

1st name Tatsuhiro
Middle name
Last name Hisatsune

Organization

The University of Tokyo

Division name

GSFS

Zip code

277-8562

Address

5-1-5 Kashiwanoha, Kashiwa, Chiba

TEL

0471363632

Homepage URL


Email

hisatsune@edu.k.u-tokyo.ac.jp


Sponsor or person

Institute

The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

The University of Tokyo

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

GSFS, The University of Tokyo

Address

5-1-5 Kashiwanoha, Kashiwa, Chiba

Tel

04-7136-3632

Email

hisatsune@edu.k.u-tokyo.ac.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

2021 Year 11 Month 26 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

2021 Year 11 Month 19 Day

Date of IRB


Anticipated trial start date

2021 Year 11 Month 27 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 11 Month 25 Day

Last modified on

2021 Year 11 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052650


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name