UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031001 |
|---|---|
| Receipt number | R000035396 |
| Scientific Title | The effect of milk beverage intake on brain activity |
| Date of disclosure of the study information | 2018/01/25 |
| Last modified on | 2020/01/27 14:50:05 |
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Basic information
Public title
The effect of milk beverage intake on brain activity
Acronym
The effect of milk beverage intake on brain activity
Scientific Title
The effect of milk beverage intake on brain activity
Scientific Title:Acronym
The effect of milk beverage intake on brain activity
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of milk beverage with placebo beverage on brain activity during cognitive task in healthy subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes in oxygenated hemoglobin concentration during cognitive task
Key secondary outcomes
The changes in deoxygenated and total hemoglobin concentration during cognitive task and the scores of the Uchida-Kraepelin test
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of milk beverage(176kcal)-> Washout more than 2days-> Single ingestion of placebo beverage(176kcal)
Interventions/Control_2
Single ingestion of placebo beverage(176kcal)-> Washout more than 2days-> Single ingestion of milk beverage(176kcal)
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Subjects who have given written informed consent
2)Employees of Meiji Co., Ltd.
3)Healthy subjects aged 20 to 40 years old
4)Subjects who are right-handed
Key exclusion criteria
1)Subjects with wheat, milk, chicken, pork, beef, soybeans, apples or gelatin allergies
2)Subjects who are using devices which are affected by magnetic fields(e.g. cochlear implants and pacemakers).
3)Subjects who have had serious head injuries or central nervous system diseases.
4)Subjects who have been regularly taking drugs, quasi drugs, health foods or supplements that may affect this study within 3 months prior to the start of this study
5)Subjects who have participated in other clinical studies within 1 month prior to the start of this study
6)Subjects who are judged as ineligible by the medical doctor or lead principal investigator for other reasons
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Okaya Eiji |
Organization
Meiji Co., Ltd.
Division name
Food science & Technology Research Laboratories, R&D Division
Zip code
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, JAPAN
TEL
042-632-5849
eiji.okaya@meiji.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yamaguchi Makoto |
Organization
Meiji Co., Ltd.
Division name
Food science & Technology Research Laboratories, R&D Division
Zip code
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, JAPAN
TEL
042-632-5849
Homepage URL
makoto.yamaguchi@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
株式会社 明治 研究本部/ R&D Division, Meiji Co., Ltd.
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 25 | 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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 20 | 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 | 01 | Month | 25 | Day |
Last modified on
| 2020 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035396
