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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038041
Receipt No. 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

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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
Email 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
Email isozaki@antiaging-bank.com

Sponsor
Institute Anti-Aging Bank Co.,Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043366

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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