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 |
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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 | 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
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
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
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
