UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037850 |
|---|---|
| Receipt number | R000043154 |
| Scientific Title | Test on the influence of banana intake for 2 weeks on exercise performance and fatigue |
| Date of disclosure of the study information | 2019/08/29 |
| Last modified on | 2019/12/12 09:14:29 |
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Basic information
Public title
Test on the influence of banana intake for 2 weeks on exercise performance and fatigue
Acronym
Test on the influence of continuous banana intake on exercise performance
Scientific Title
Test on the influence of banana intake for 2 weeks on exercise performance and fatigue
Scientific Title:Acronym
Test on the influence of continuous banana intake on exercise performance
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Explore the effects of banana intake for 2 weeks on exercise performance and fatigue reduction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Record of 5000m run before and after intake
Key secondary outcomes
Saliva test (alfa-amylase, cortisol), and urine test (8-OHdG, indoxyl sulfate) before and after exercise.
Physical examination (body height, weight, BMI)
Subjective fatigue level (VAS questionnaire) before and after exercise, and when waking up and sleep
Questionnaire about physical condition before exercise
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
In addition to eating as usual during the first intake period, one banana is continuously consumed for two weeks at breakfast and dinner, and the usual eating habits are provided during the second intake period.
Interventions/Control_2
In the first intake period, usual eating habits are provided and in the second intake period, in addition to eating as usual, one banana is continuously consumed for two weeks at breakfast and dinner.
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 | months-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Healthy Japanese who are 18 years old or more
3. Students belonging to the Nippon Sport Science University athletic track club men's Ekiden team
Key exclusion criteria
1. Persons who have a chronic disease and is under medication, or has a serious disease history
2. Persons who are allergic to the test food
3. Those who cannot perform sufficient training due to injury at the start of the exam
4. Those who plan to have surgery during the exam period
5. Those who regularly use vitamins, nourishing tonics, traditional Chinese medicines, general cold medicines, and pharmaceuticals during the exam period
6. Persons who participated in other examination during the first month before the start of the exam, or those who plan to participate in other exams following this exam
7. Persons who are judged inappropriate for the exam by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Sugita |
Organization
Nippon Sport Science University
Division name
Faculty of physical education Department of physical education
Zip code
158-0081
Address
7-1-1 Fukazawa, Setagaya-ku, Tokyo
TEL
03-5708-1148
m-sugita@nittai.ac.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Masuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
masudat@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
SOLROS 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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel
03-6809-2722
kakehashi@hc-sys.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 | 29 | 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
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 29 | Day |
Last modified on
| 2019 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043154
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
