UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038041 |
|---|---|
| Receipt number | R000043366 |
| Scientific Title | A study to examine the effects of beef bowl intake on physical and mental fatigue |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2020/01/14 12:31:07 |
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Basic information
Public title
A study to examine the effects of beef bowl intake on physical and mental fatigue
Acronym
A study to examine the effects of beef bowl intake on physical and mental fatigue
Scientific Title
A study to examine the effects of beef bowl intake on physical and mental fatigue
Scientific Title:Acronym
A study to examine the effects of beef bowl intake on physical and mental fatigue
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of beef bowl intake on physical and mental fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Saliva test (S-IgA,cortisol),VAS (Visual Analogue Scale) before and after mental load and physical load
Key secondary outcomes
Fatigue measurement with equipment(VM500)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Visit1 beef bowl
Visit2 beef bowl
Visit3 other food
Visit4 other food
Interventions/Control_2
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
[1]Aged between 20 and 49
[2]Individuals who are healthy and do not treat any disease
[3]Individuals whose written informed consent has been obtained
[4]Individuals who can have an examination on a designated check day
[5]Individuals judged appropriate for the study by the principal
Key exclusion criteria
[1]Individuals using medical products
[2]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease,or blood disease
[3]Individuals with serious anemia
[4]Individuals who are sensitive to test products or Individual with fear who causes severe allergy in a food and medical supplies
[5]Individual who is pregnant or lactate
[6]Individuals who participated in other clinical studies in the past three months
[7]Individuals judged inappropriate for the study by the principal
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Yonei |
Organization
Faculty of Life and Medical Sciences,Doshisha University
Division name
Anti-Aging Medical Research Center
Zip code
610-0394
Address
1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL
0774-65-6394
yyonei@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Seigo |
| Middle name | |
| Last name | Isozaki |
Organization
Anti-Aging Bank Co.,Ltd.
Division name
Clinical test support team
Zip code
101-0054
Address
3-21,Kanda-nishikicho,Chiyoda-ku,Tokyo
TEL
03-5577-1010
Homepage URL
isozaki@antiaging-bank.com
Sponsor or person
Institute
Anti-Aging Bank Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
YOSHINOYA HOLDINGS 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
Society of Glycative Stress Research
Address
5F-11,Musashino Bldg,2-13-10 Shinjuku,Shinjuku-ku,Tokyo
Tel
03-6709-8842
rinri-glycativestress@antiaging-bank.com
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
同志社大学生命医科学部アンチエイジングリサーチセンター
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 01 | 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
12
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
| 2019 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | 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 | 09 | Month | 18 | Day |
Last modified on
| 2020 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043366
