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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000035796 |
Receipt No. | R000040778 |
Official scientific title of the study | Acute benefits of milk protein drink on cognition |
Date of disclosure of the study information | 2019/02/07 |
Last modified on | 2019/02/07 |
Basic information | ||
Official scientific title of the study | Acute benefits of milk protein drink on cognition | |
Title of the study (Brief title) | Acute benefits of milk protein drink on cognition | |
Region |
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Condition | |||
Condition | Helthy adults | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | We investigate the benefits of milk protein on cognition.
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Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Calculation test |
Key secondary outcomes | Raven test
Japanese Reading Ability Test Stroop test memory updating digit symbol test digit symbol coding STAI: State-Trait Anxiety Inventory WHO-Five well-being index General Health Questionnaire 12 CES-D: center for epidemiologic studies depression scale sleep questionnaire brief-type self-administered diet history questionnaire physical activity scale Ten Item Personality Inventory Effort ful control scale Profile of Mood States 2 Two-dimensional Mood Scale-Short Term VAS rating for taste and sweetness blood sugar |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
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 | YES |
Concealment | No need to know |
Intervention | ||
No. of arms | 3 | |
Purpose of intervention | Educational,Counseling,Training | |
Type of intervention |
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Interventions/Control_1 | Intaking 15g milk protein drink | |
Interventions/Control_2 | Intaking 10g milk protein drink | |
Interventions/Control_3 | Intaking no milk protein drink (control drink) | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Japanese Speaker
right-handed a person who can do dietary restrictions |
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Key exclusion criteria | We will exclude the subjects with a mental disorder, diabetes, cranial nerve disease, cardiac disease, pregnant, dialysis, pacemaker, and food allergy.
In addition, a person who is a heavy alcohol drinker and participated in another intervention study within 1 month. |
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Target sample size | 66 |
Research contact person | |
Name of lead principal investigator | Ryuta Kawashima |
Organization | Tohoku University |
Division name | Department of functional brain imaging |
Address | Sendai, seiryo4-1 |
TEL | 022-717-7988 |
fbi@idac.tohoku.ac.jp |
Public contact | |
Name of contact person | Rui Nouchi |
Organization | Tohoku Univeristy |
Division name | Department of cognitive health science |
Address | Sendai, seiryo4-1 |
TEL | 022-717-8952 |
Homepage URL | |
rui@tohoku.ac.jp |
Sponsor | |
Institute | Tohoku Universiry |
Institute | |
Department |
Funding Source | |
Organization | Meiji |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
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 |
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Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
URL releasing results | |
Results | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040778 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |