UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051007 |
|---|---|
| Receipt number | R000058146 |
| Scientific Title | Investigation of the effect of test food on improving the condition of athletes |
| Date of disclosure of the study information | 2023/05/11 |
| Last modified on | 2023/09/08 09:52:43 |
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Basic information
Public title
Investigation of the effect of test food on improving the condition of athletes
Acronym
Investigation of the effect of test food on improving the condition of athletes
Scientific Title
Investigation of the effect of test food on improving the condition of athletes
Scientific Title:Acronym
Investigation of the effect of test food on improving the condition of athletes
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of test food intake on body condition indices that worsen with training
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation by questionnaire on physical condition
Key secondary outcomes
Blood test (biochemistry, inflammation, etc.)
Saliva test (stress indicators)
Fecal test (microbiota analysis)
Autonomic nervous system index
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food for 8 weeks
Interventions/Control_2
Intake of placebo food for 8 weeks
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
1. Healthy adult
2. Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the present study and being able to sign a written informed consent
Key exclusion criteria
1. Subjects with food allergies
2. Subjects who have lactose intolerance
3. Subjects who take regularly OTC drugs, quasi-drugs, supplements, or health foods which have the possibility to affect the results of the present study
4. Subjects who is participating in other clinical trials
5. Subject who has external injury or medical disease
6. Subjects deemed unsuitable for the present study by the investigator
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Yoshimitsu |
| Middle name | |
| Last name | Kohmura |
Organization
Juntendo University
Division name
Faculty of Health and Sports Science
Zip code
2701605
Address
1-1 Hiraka-gakuendai, Inzai, Chiba
TEL
0476-98-1001
ykoumura@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yoshimitsu |
| Middle name | |
| Last name | Kohmura |
Organization
Juntendo University
Division name
Faculty of Health and Sports Science
Zip code
2701605
Address
1-1 Hiraka-gakuendai, Inzai, Chiba
TEL
0476-98-1001
Homepage URL
ykoumura@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Research Ethics Committee of the Faculty of Health and Sports Science, Juntendo University
Address
1-1 Hiraka-gakuendai, Inzai-shi, Chiba
Tel
0476-98-1032
sc-gradkyomu@juntendo.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
| 2023 | Year | 05 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2023 | Year | 05 | Month | 08 | Day |
Last modified on
| 2023 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058146
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
