UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037498 |
|---|---|
| Receipt number | R000042745 |
| Scientific Title | Development of a new physical condition evaluation method based on oral science |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2021/11/09 20:57:02 |
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Basic information
Public title
Development of a new physical condition evaluation method based on oral science
Acronym
Development of a new physical condition evaluation method based on oral science
Scientific Title
Development of a new physical condition evaluation method based on oral science
Scientific Title:Acronym
Development of a new physical condition evaluation method based on oral science
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of a simple and non-invasive method of physical condition evaluation by intraoral sampling
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
During the period as if camp, competition etc
1 Physical parameters
Fatigue degree (subjective)
Oxidative stress
S-IgA, cortisol in sliva
body weight
Urine specific gravity
SpO2
2 intraoral parameters
Inflammation index
Drying
Bacteria
miRNA
temperature in mouth
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults who play sports on a daily basis
Key exclusion criteria
None
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Ueno |
Organization
Tokyo Medical and Dental University
Division name
Sports medicine and dentistry
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
0358035867
t.ueno.spmd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Churei |
Organization
Tokyo Medical and Dental University
Division name
Sports medicine and dentistry
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
0358035867
Homepage URL
chu.spmd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Department of Sports medicine and dentistry
Institute
Department
Personal name
Funding Source
Organization
Yamaha motor foundation for sports
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Triathlon Union
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-4724
info.bec@tmd.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | 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
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
Main results already published
Date of protocol fixation
| 2019 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
During the period as if camp, competition etc
1 Physical parameters
Fatigue degree (subjective)
Oxidative stress
S-IgA, cortisol in sliva
body weight
Urine specific gravity
SpO2
2 intraoral parameters
Inflammation index
Drying
Bacteria
miRNA
temperature in mouth
Management information
Registered date
| 2019 | Year | 07 | Month | 25 | Day |
Last modified on
| 2021 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042745
