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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035601
Receipt No. R000040564
Scientific Title A study for the effect of intake of test food on cognitive functions
Date of disclosure of the study information 2020/07/30
Last modified on 2019/01/21

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Basic information
Public title A study for the effect of intake of test food on cognitive functions
Acronym A study for the effect of intake of test food on cognitive functions
Scientific Title A study for the effect of intake of test food on cognitive functions
Scientific Title:Acronym A study for the effect of intake of test food on cognitive functions
Region
Japan

Condition
Condition None (Healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of intake of test food 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 Autonomic nervous activity
Biochemical examination in saliva
Biochemical examination in blood
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 Supplementation of test food 3 capsules a day, 12 weeks
Interventions/Control_2 Supplementation of placebo 3 capsules 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
45 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria Subjects who fall under all of the following (1) to (6)
(1) Men and women aged from 45 to 69
(2) Subjects whose primary language is Japanese
(3) Subjects with self-awareness of decline of the brain or forgetfulness
(4) Subjects who often forget the name of people or objects
(5) Subjects who often carelessly make mistakes in daily life
(6) Subjects whose subjective cognitive function declines have been confirmed by questionnaires
Key exclusion criteria Subjects
(1)whose visual acuity is too low to perform test
(2)whose hearing acuity is too low to perform test
(3)whose score of the MMSE is 23 or less
(4)who have anamnesis of cranial nerve disease
(5)who have depressive symptoms, or have been diagnosed as depressive disorder
(6)who are being treated with hormone, or have been diagnosed as menopausal symptoms
(7)who have irregular lifestyles during the study
(8)who regularly take too much alcohol drink
(9)who regularly smoke or subjects who started smoking cessation within 1 year
(10)who have taken the similar cognitive tests within 1 year
(11)who are being treated for cognitive functions, or prescribed drugs associated with cognitive functions
(12)who suffer from sleep related diseases, or are conscious of it
(13)who are diagnosed with arrhythmias or xerostomia
(14)who have troubles in the mouth, those who develop at least once a week
(15)who regularly take drugs or health foods which may affect this study more than once a week
(16)who regularly take foods similar to test foods more than once a week
(17)who regularly take energy drinks more than once a week
(18)who have done blood transfusion or blood donation within 3 months
(19)who have participated in other clinical studies within 1 month, or are planning to participate in other clinical studies during this study
(20)who have diseases requiring regular administration, or have severe diseases
(21)who are judged as unsuitable for laboratory value, anthropometric measurements, or physical examination value
(22)who have allergy to test foods
(23)who are, or are planning to be pregnant or breastfeeding during study
(24)who are judged as unsuitable due to lifestyle questionnaire
(25)who and whose family work in a company developing functional foods
(26)who are judged as unsuitable by doctor for other reasons
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 Laboratories for Health Science and Food Technologies
Zip code
Address 1-13-5, Fukuura Kanazawa-ku, Yokohama, Japan
TEL 045-788-7200
Email k-obara@kirin.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Isobe Kotoha
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 k.isobe@ttc-tokyo.co.jp

Sponsor
Institute TTC 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
2020 Year 07 Month 30 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 Preinitiation
Date of protocol fixation
2019 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 23 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
2019 Year 01 Month 21 Day
Last modified on
2019 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040564

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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