UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035601 |
|---|---|
| Receipt number | 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 | 2021/01/22 11:42:52 |
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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
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
k.isobe@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC 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
| 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
Main results already published
Date of protocol fixation
| 2019 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2019 | Year | 07 | 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
| 2019 | Year | 01 | Month | 21 | Day |
Last modified on
| 2021 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040564
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
