UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054200 |
|---|---|
| Receipt number | R000061837 |
| Scientific Title | Questionnaire-based study for the effects of the testing food on daily health and physical performance in male long-distance runners. |
| Date of disclosure of the study information | 2024/04/22 |
| Last modified on | 2025/04/25 09:50:37 |
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Basic information
Public title
Questionnaire-based study for the effects of the testing food on daily health and physical performance in male long-distance runners.
Acronym
Questionnaire-based study for the effects of the testing food on daily health and physical performance in male long-distance runners.
Scientific Title
Questionnaire-based study for the effects of the testing food on daily health and physical performance in male long-distance runners.
Scientific Title:Acronym
Questionnaire-based study for the effects of the testing food on daily health and physical performance in male long-distance runners.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of the testing food on daily health and physical performance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in daily health and physical performance after the intake of the testing food in past years.
Key secondary outcomes
Changes in daily health and physical performance in the experience of continuous intake of the testing food before and after 4 weeks of free-choice intake.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Free-choice intake of the testing 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
(1) Subjects who have given their consent to participate in the research
(2) Subjects who have obtained consent for participation in the research from their surrogate.
(3) Male long-distance athletes who are members of university track and field teams during the study period
(4) Subjects who have taken the testing food in the past.
Key exclusion criteria
(1) Subjects who have a past or present medical history of serious diseases.
(2) Others who are determined ineligible by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Saito |
Organization
Otsuka Pharmaceutical Co.,Ltd.
Division name
Otsu Nutraceuticals Research Institute
Zip code
5200002
Address
3-31-13 Saigawa Otsu, Shiga
TEL
077-521-8835
Saito.Takao@otsuka.jp
Public contact
Name of contact person
| 1st name | Chika |
| Middle name | |
| Last name | Ibukuro |
Organization
Otsuka Pharmaceutical Co.,Ltd.
Division name
Otsu Nutraceuticals Research Institute
Zip code
520-0002
Address
3-31-13 Saigawa Otsu, Shiga
TEL
09041987134
Homepage URL
Natsume.Chika@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
OTS24C1
Org. issuing International ID_1
CPCC Company Limited
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 | 04 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
212
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
| 2024 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 08 | 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
| 2024 | Year | 04 | Month | 19 | Day |
Last modified on
| 2025 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061837
