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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033917
Receipt No. 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 2018/12/20

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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
Middle name
Last name Soichi Tanabe
Organization NISSIN FOODS HOLDINGS CO., LTD.
R&D Platform NISSIN Global Innovation Center
Division name Health Science Research Office
Zip code
Address 2100, Tobukimachi, Hachioji, Tokyo
TEL 042-696-7685
Email Soichi.tanabe@nissin.com

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Nakagawa
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Zip code
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
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

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 No longer recruiting
Date of protocol fixation
2018 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 29 Day
Last follow-up date
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
2018 Year 12 Month 20 Day


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


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