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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000030461
Receipt No. 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

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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
Email 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
Email k_masuda@mail.souken-r.com

Sponsor
Institute SOUKEN Co., Ltd
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034777

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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