UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033917
Receipt number R000038682
Scientific Title A Study for the effect of Bifidobacterium-containing food intake on cognitive function for healthy elderly subject
Date of disclosure of the study information 2018/08/28
Last modified on 2019/11/04 12:55:53

* 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

A Study for the effect of Bifidobacterium-containing food intake on cognitive function for healthy elderly subject

Acronym

A Study for the effect of Bifidobacterium-containing food intake on cognitive function

Scientific Title

A Study for the effect of Bifidobacterium-containing food intake on cognitive function for healthy elderly subject

Scientific Title:Acronym

A Study for the effect of Bifidobacterium-containing food intake on cognitive function

Region

Japan


Condition

Condition

None (Healthy adult)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect on cognitive function of Bifidobacterium-containing food intake for 12 consecutive weeks

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cognitrax (memory) at 12 week ingestion

Key secondary outcomes

Cognitrax (others) and BDNF at 12 week ingestion


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

Ingestion of Bifidobacterium-containing food for 12 consecutive weeks

Interventions/Control_2

Ingestion of placebo for 12 consecutive 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

50 years-old <=

Age-upper limit

69 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Healthy male and female aged from 50 to 69
2)Subjects with self-awareness of forgetfulness
3)Subjects with inferior scores of cognitive function tests

Key exclusion criteria

1)Subjects who are difficult to discriminate color
2)Subjects with bad eyesight, or are diagnosed with amblyopia or blindness
3)Subjects with bad hearing, or are diagnosed with hearing loss or permanent hearing loss
4)Subjects with history of cranial nerve disease
5)Subjects who are under treatment of cognitive functions, or are prescribed with medicine for them
6)Subjects who are suspected dementia
7)Subjects who have depressive symptoms, or who have been diagnosed as depressive disorder
8)Subjects who are under hormone treatment or who have been diagnosed as menopausal symptoms 9) Subjects who have a pain or disease that troubles with keystrokes
10)Subjects who have some irregular schedules during the study, due to night work or something
11)Subjects who drink much alcohol
12)Subjects who smoke, or quit smoking within one year before pre-inspection
13)Subjects who have done the same cognitive function test within one yea4
14)Subjects who continuously take medicine, health foods related to cognitive functions and/or rich in lactic acid bacteria
15)Subjects who was given or donated 200 ml or 400 ml whole blood within three months before pre-inspection
16)Subjects who participated in other study within one month before pre-inspection, or are going to participate in other study during the study
17)Subjects who have a disease which needs regular medication, or have a history of the disease
18)Subjects who are judged as unsuitable for the study by investigator because of clinical test, anthropometric test and physical examination in pre-inspection
19)Subjects who have possibilities for emerging allergy onset related to the study
20)Subjects who are pregnant or lactating, or plan to become pregnant or lactate during the study
21)Subjects who are judged as unsuitable for the study because of lifestyle questionnaire
22)Subjects who are judged as unsuitable for the study by investigator for other reasons

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Soichi
Middle name
Last name Tanabe

Organization

NISSIN FOODS HOLDINGS CO., LTD.
R&D Platform NISSIN Global Innovation Center

Division name

Health Science Research Office

Zip code

192-0001

Address

2100, Tobukimachi, Hachioji, Tokyo

TEL

042-696-7685

Email

Soichi.tanabe@nissin.com


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Nakagawa

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code

150-0021

Address

Seibu Shinkin Bank Ebisu Bldg., 1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL


Email

t.nakagawa@ttc-tokyo.co.jp


Sponsor or person

Institute

TTC Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

NISSIN FOODS HOLDINGS CO., 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

Aisei Hospital Ueno Clinic Research Ethics Committee

Address

2-18-6, Higashiueno, Taitou-ku, Tokyo

Tel

03-6455-0880

Email

t.saito@ttc-smo.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

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

60

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 23 Day

Date of IRB

2018 Year 08 Month 23 Day

Anticipated trial start date

2018 Year 08 Month 29 Day

Last follow-up date

2019 Year 01 Month 26 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 08 Month 27 Day

Last modified on

2019 Year 11 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038682


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name