UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056277 |
|---|---|
| Receipt number | R000064250 |
| Scientific Title | An evaluation trial of exercise performance following the intake of test food in corporate track and field athletes -Open trial- |
| Date of disclosure of the study information | 2024/11/30 |
| Last modified on | 2024/11/26 15:50:34 |
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Basic information
Public title
An evaluation trial of exercise performance following the intake of test food in corporate track and field athletes -Open trial-
Acronym
An evaluation trial of exercise performance following the intake of test food
Scientific Title
An evaluation trial of exercise performance following the intake of test food in corporate track and field athletes -Open trial-
Scientific Title:Acronym
An evaluation trial of exercise performance following the intake of test food
Region
| Japan |
Condition
Condition
Healthy Volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects on exercise performance after low-altitude and high-altitude training, and high-altitude adaptation following the continuous intake of test food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ventilatory threshold related indicators
Key secondary outcomes
oxygen uptake, oxygen utilization efficiency, ventilation volume, carbon dioxide output, respiratory exchange ratio, respiratory rate, heart rate, exercise duration, subjective exercise intensity, urinary excretion volume of test food components
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
exercise load, test 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
| Not applicable |
Gender
Female
Key inclusion criteria
1) Individuals who consented to participate in this trial through a written agreement.
2) Healthy female.
3) Individuals who able to maintain a diet, drink, intake of test food, urination, and maintaining rest according to the schedule instructed by the test person in charge.
Key exclusion criteria
1) Individuals whose blood test results are judged to be ineligible for this trial by lead principal investigator.
2) Individuals with gastrointestinal, cardiovascular, endocrine, or other disorders, or with a history of such disorders, who are judged by lead principal investigator to be ineligible for the trial.
3) As a rule, individuals who regularly use drugs for the treatment of diseases.
4) Individuals who are taking healthy foods that may affect this trial.
5) Individuals with allergies.
6) Individuals judged to be ineligible for this trial due to other reasons by lead principal investigator.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Yasutaka |
| Middle name | |
| Last name | Ikeda |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Nutraceuticals Research Institute
Zip code
520-0106
Address
1-11-1 Karasaki, Otsu, Shiga
TEL
+81-77-519-0111
Ikeda.Yasutaka@otsuka.jp
Public contact
Name of contact person
| 1st name | Yasutaka |
| Middle name | |
| Last name | Ikeda |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Nutraceuticals Research Institute
Zip code
520-0106
Address
1-11-1 Karasaki, Otsu, Shiga
TEL
+81-77-519-0111
Homepage URL
Ikeda.Yasutaka@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Otsuka Pharmaceutical Co., Ltd.
Address
Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
Tel
+81-3-6717-1499
shimizu_se@otsuka.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
| 2024 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Scheduled to be documented after publication.
Publication of results
Unpublished
Result
URL related to results and publications
Scheduled to be documented after publication.
Number of participants that the trial has enrolled
8
Results
Scheduled to be documented after publication.
Results date posted
| 2024 | Year | 11 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Scheduled to be documented after publication.
Participant flow
Scheduled to be documented after publication.
Adverse events
Scheduled to be documented after publication.
Outcome measures
Scheduled to be documented after publication.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 04 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 26 | Day |
Last modified on
| 2024 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064250
