UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023373 |
|---|---|
| Receipt number | R000026931 |
| Scientific Title | The effects of milk protein intake on cognitive performance in the morning |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2018/07/27 11:09:42 |
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Basic information
Public title
The effects of milk protein intake on cognitive performance in the morning
Acronym
The effects of milk protein intake on cognitive performance in the morning
Scientific Title
The effects of milk protein intake on cognitive performance in the morning
Scientific Title:Acronym
The effects of milk protein intake on cognitive performance in the morning
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 protein containing drink with placebo drink on cognitive performance in the morning in healthy subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The scores of the Uchida-Kraepelin test after single ingestion of milk protein containing drink or placebo drink
Key secondary outcomes
The scores of the Stroop test, subjective symptoms measured by VAS(visual analogue scale), body temperature, heart rate variability after single ingestion of milk protein containing drink or placebo drink
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of milk protein containing drink(176kcal)-> Washout more than 2days-> Single ingestion of placebo drink(176kcal)
Interventions/Control_2
Single ingestion of placebo drink(176kcal)-> Washout more than 2days-> Single ingestion of milk protein containing drink(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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
1)Subjects who have given written informed consent
2)Healthy males aged 18 to 30 years old
Key exclusion criteria
1)Subjects with milk or soy allergies
2)Subjects with serious or progressive illnesses
3)Subjects who have difficulty in
distinguishing between reds, blues, greens and yellows
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 doctor or lead principal investigator for other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Urashima Tadasu |
Organization
Obihiro University of Agriculture and Veterinary Medicine
Division name
Department of Animal and Food Hygiene
Zip code
Address
Nishi2sen 11banchi, Inada cho, Obihiro, Hokkaido
TEL
0155-49-5566
urashima@obihiro.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teruyuki Noma |
Organization
Meiji Co., Ltd
Division name
Functional Evaluation Drepartment1 Food Science Research Laboratories R&D Division
Zip code
Address
540 Naruda, Odawara, Kanagawa, Japan
TEL
0465-37-3654
Homepage URL
teruyuki.noma@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd
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
帯広畜産大学（北海道）/Obihiro University of Agriculture and Veterinary Medicine(Hokkaido)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.mdpi.com/2072-6643/10/5/574
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
| 2016 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 02 | 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
| 2016 | Year | 07 | Month | 28 | Day |
Last modified on
| 2018 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026931
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
