UMIN-CTR Clinical Trial

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
Institute	TTC Co., Ltd
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038682