UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049883 |
|---|---|
| Receipt number | R000056811 |
| Scientific Title | A study of the effects of protein intake on brain and mental function, randomized placebo-controlled double-blind crossover study |
| Date of disclosure of the study information | 2022/12/24 |
| Last modified on | 2023/06/26 13:01:13 |
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Basic information
Public title
A study of the effects of protein intake on brain and mental function
Acronym
A study of the effects of protein intake on brain and mental function
Scientific Title
A study of the effects of protein intake on brain and mental function, randomized placebo-controlled double-blind crossover study
Scientific Title:Acronym
A study of the effects of protein intake on brain and mental function
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the effects of protein intake on brain and mental function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mood
Cognitive performance (Stroop test)
Key secondary outcomes
Body temperature
VO2, VCO2, Heat production
Brain activity index
Blood components
Hair components
Nutritional intakes
Body Composition
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
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Protein drink, single dose
Interventions/Control_2
Placebo drink, single dose
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 and Female
Key inclusion criteria
More than 18 years and less than 30 years old
Key exclusion criteria
1) Subjects with visual abnormalities
2) Subjects with serious drug or food allergies
3) Subjects have serious medical history of diseases in the respiratory, circulatory, nervous and endocrine systems
4) Subjects who are under medical treatment
5) Subjects who are judged inappropriate for the study by the physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Soya |
Organization
University of Tsukuba
Division name
Laboratory of Exercise Biochemistry and Neuroendocrinology, Faculty of Health and Sport Sciences
Zip code
305-8574
Address
1-1-1, Tennoudai, Tsukubashi, Ibarakiken, Japan
TEL
029-853-2620
soya.hideaki.gt@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Soya |
Organization
University of Tsukuba
Division name
Laboratory of Exercise Biochemistry and Neuroendocrinology, Faculty of Health and Sport Sciences
Zip code
305-8574
Address
1-1-1, Tennoudai, Tsukubashi, Ibarakiken, Japan
TEL
029-853-2620
Homepage URL
soya.hideaki.gt@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Hideaki Soya
Funding Source
Organization
Morinaga Milk Industry 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
Institutional Review Board of Tsukuba University
Address
1-1-1, Tennoudai, Tsukubashi, Ibarakiken, Japan
Tel
029-853-2571
tg-kenkyurinri@un.tsukuba.ac.jp
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
筑波大学体育系運動生化学研究室（茨城県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 09 | 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
| 2022 | Year | 12 | Month | 23 | Day |
Last modified on
| 2023 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056811
| 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 |
