UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030461 |
|---|---|
| Receipt number | R000034777 |
| Scientific Title | A study for the effect of intake of test foods on cognitive functions |
| Date of disclosure of the study information | 2019/06/29 |
| Last modified on | 2021/06/22 13:17:52 |
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Basic information
Public title
A study for the effect of intake of test foods on cognitive functions
Acronym
A study for the effect of intake of test foods on cognitive functions
Scientific Title
A study for the effect of intake of test foods on cognitive functions
Scientific Title:Acronym
A study for the effect of intake of test foods on cognitive functions
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A study for the effect of intake of test foods on cognitive functions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tests for cognitive functions
Key secondary outcomes
Measurements of cerebral blood flow
Questionnaires
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of test food,6 tablets a day, 12 weeks
Interventions/Control_2
Intake of placebo 6 tablets a day, 12 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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Healthy men and women aged from 50 to 75
2)Subjects with self-awareness of cognitive decline such as forgetfulness or carelessness
3)Subjects whose primary language is Japanese
Key exclusion criteria
1)Subjects who have difficulties in performing cognitive tests due to the low visual acuity or the low hearing acuity.
2)Subjects who are suspected of dementia.
3)Subjects who have anamnesis of cranial nerve disease
4)Subjects who have depressive symptoms, or who have been to diagnosed as depressive disorders
5) Subjects who are being treated with hormone, or who have been diagnosed as menopausal symptoms
6)Subjects who sometimes have irregular lifestyles during the study
7)Heavy drinkers
8)Smokers or subjects who started smoking cessation within 12 months
9)Subjects who have taken the similar cognitive function tests within 12 months
10)Subjects who are being treated for cognitive functions, or who are prescribed drugs associated with cognitive functions
11)Subjects who regularly take drugs or health foods which may affect cognitive functions more than once a week
12)Subjects who regularly take foods similar to test foods more than once a week
13)Subjects who have diseases requiring regular administration, or who have severe diseases
14)Subjects who may have physical deconditioning due to test foods
15) Subjects who are, or are planning to be pregnant or breastfeeding during study
16)Subjects who and whose family work in a company developing functional foods
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kuniaki Obara |
Organization
Kirin company, Limited
Division name
Research and Development division, Research Laborarories for Health Science and Food Technologies
Zip code
Address
1-13-5, Fukuura Kanazawa-ku, Yokohama, Japan
TEL
080-1930-9932
k-obara@kirin.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ko MASUDA |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
Address
3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL
03-5408-1555
Homepage URL
k_masuda@mail.souken-r.com
Sponsor or person
Institute
SOUKEN Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Kirin company, Limited
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
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
| 2019 | Year | 06 | Month | 29 | 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
Main results already published
Date of protocol fixation
| 2017 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 19 | Day |
Last modified on
| 2021 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034777
