UMIN-CTR Clinical Trial

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
Email	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
Email	masudat@hc-sys.jp

Sponsor
Institute	Healthcare Systems Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043154