UMIN-CTR Clinical Trial

Basic information
Public title	Test on the influence of food intake on muscle degradation inhibitory effect during exercise
Acronym	Test on the influence of food intake on muscle degradation during exercise
Scientific Title	Test on the influence of food intake on muscle degradation inhibitory effect during exercise
Scientific Title:Acronym	Test on the influence of food intake on muscle degradation during exercise
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Explore the influence of food intake on muscle degradation inhibitory effect during exercise.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood urea nitrogen at the beginning of and after exercise
Key secondary outcomes	General blood biochemical test (total protein, albumin, total cholesterol, blood neutral fat (TG), HDL-cholesterol, LDL-cholesterol, AST(GOT), ALT(GPT), ALP, gamma-GTP, CPK, total bilirubin, uric acid, urea nitrogen, creatinine, sodium, potassium, chlorine, calcium, phosphorus, LDH, HbA1c), Saliva test (urea nitrogen), physical examination (body weight, blood pressure, pulse rate, BMI, body fat percentage), questionnaire on lifestyle habit and on fatigue at the beginning of and after exercise, and maximal oxygen uptake

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Ingest total 234 g of banana before exercise
Interventions/Control_2	none
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	40 years-old >
Gender	Male and Female
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 20 years old or more and under 40 years old 3. Persons who have confidence to possess physical fitness to withstand exercise stress test
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. 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 agreement 4. Persons who are judged inappropriate for the exam by the principal investigator 5. Persons who are breastfeeding, pregnant, scheduled or hoping to be pregnant during the exam period 6. Persons who are prohibited from exercising by the doctor
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takamasa Masuda
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development
Zip code
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	03-6809-2722
Email	masudat@hc-sys.jp

Public contact
Name of contact person	1st name Middle name Last name Takamasa Masuda
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development
Zip code
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
Address
Tel
Email

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	2018 Year 09 Month 10 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	2018 Year 09 Month 07 Day
Date of IRB	2018 Year 09 Month 07 Day
Anticipated trial start date	2018 Year 09 Month 10 Day
Last follow-up date	2019 Year 11 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 09 Month 10 Day
Last modified on	2019 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038841

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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