UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050593 |
|---|---|
| Receipt number | R000057624 |
| Scientific Title | Effects of gusatory stimulation on physical and mental functions during exercise |
| Date of disclosure of the study information | 2023/04/08 |
| Last modified on | 2023/10/11 14:24:00 |
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Basic information
Public title
Effects of gusatory stimulation on physical and mental functions during exercise
Acronym
Effects of gusatory stimulation on physical and mental functions during exercise
Scientific Title
Effects of gusatory stimulation on physical and mental functions during exercise
Scientific Title:Acronym
Effects of gusatory stimulation on physical and mental functions during exercise
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to expose the effects of gusatory stimulation on physical and mental function during exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
oxygen intake
minute ventulation
Heart Rate
autonomic nervous activity
Key secondary outcomes
fatigue
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
drink purified water (300ml) group
Interventions/Control_2
drink sweetened aqueous solutions (300ml with erythritol 14.1g)
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
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
International University of Health and Welfare odawara Campus students
Key exclusion criteria
1) Persons with a history of orthopedic disorders and internal disorders
2) too short sleeping time
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shoki |
| Middle name | |
| Last name | Yamaguchi |
Organization
International University of Health and Welfare
Division name
Odawara Faculty of Health Sciences Department of Physical Therapy
Zip code
250-8588
Address
1-2-25 Shiroyama, Odawara, Kanagawa
TEL
0465-21-6724
shoki.yamaguchi@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Shoki |
| Middle name | |
| Last name | Yamaguchi |
Organization
International University of Health and Welfare
Division name
Odawara Faculty of Health Sciences Department of Physical Therapy
Zip code
250-8588
Address
1-2-25 Shiroyama, Odawara, Kanagawa
TEL
0465-21-6724
Homepage URL
shoki.yamaguchi@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Shoki Yamaguchi
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Akasaka District Ethics Review Board
Address
4-1-26 Akasaka, Minato-ku, Tokyo
Tel
03-5574-3900
rinri-tky@iuhw.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
国際医療福祉大学小田原キャンパス
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 08 | 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
26
Results
There were no significant differences at max heart rate, max oxygen intake and Borg scale compared with control group and gusatory stimulation group in phsical assessment. In change in mental status which assessed by TDMS, significantly decreased in control group, but gusatory group hadn't significantly differeneces.
Results date posted
| 2023 | Year | 10 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy adult male enrolled at international university of health and welfare
Participant flow
Adverse events
There were no adverse events.
Outcome measures
oxygen intake, heart rate, borg scale, TDMS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 07 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 08 | Day |
Date analysis concluded
| 2023 | Year | 09 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 15 | Day |
Last modified on
| 2023 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057624
