UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate effect of test food on whole body endurance improvement and fatigue inhibition.
Acronym	A study to evaluate effect of test food on whole body endurance improvement and fatigue inhibition.
Scientific Title	A study to evaluate effect of test food on whole body endurance improvement and fatigue inhibition.
Scientific Title:Acronym	A study to evaluate effect of test food on whole body endurance improvement and fatigue inhibition.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm effects caused by test food whole body endurance and fatigue feeling after exercise.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	*Maximum oxygen uptake *Visual analog scale questionnaire on fatigue feeling
Key secondary outcomes	*Rate of perceived exertion *Exercise performance *PWC@75%HRmax *Heart beat number on exercise *Blood biochemical parameters *IL-6 *Growth hormone *Glucagon *Free fatty acid *Microbiota of gut *Blood metabolome analysis *Muscle mass *Body fat mass *SF-8 questionnaire *Incidence rate of adverse events and side effects

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 four tablets of test food per one day for nine weeks.
Interventions/Control_2	Intake four tablets of test food per one day for nine 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	20 years-old <=
Age-upper limit	49 years-old >=
Gender	Male
Key inclusion criteria	1)Males aged 20-49 years at a time of obtaining informed consent. 2)Subjects who have exercise habits (over 30 minutes at once) once or twice a week. 3)Subjects who can continue with the exercise habits. 4)Subjects who don't take prohibited foods whthin one week before informed consent and can keep it during test period. 5)Subjects who show understanding of the clinical study procedures and agreement with participating this study by written informed consent.
Key exclusion criteria	1) Smokers except subjects who has not been smoking more than one year. 2) From the background questionnaire at preliminary test, subjects who defecate less than and equal to 5 times in a week, who have weakness in their digestive organ, and/or who easily have diarrhea. 3) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ). 4) Subjects who have excessive alcohol intake. 5) Subjects who have extremely irregular dietary habits, have midnight work or irregular shift work. 6) Subjects who have allergy to medicines or foods. 7) Subjects who are participating the other clinical test, were participating it within the past 4 weeks, or are going to participate it. 8) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. 9) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study. 10) Subjects who are going to be collected over 1200mL blood and/or blood components which is collected whithin the last 12 month and at this study 11) Subjects judged as unsuitable for the study by the principal or attending investigator.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Suguru Middle name Last name Fujiwara
Organization	CPCC Company Limited
Division name	Division of Clinical Research
Zip code	101-0047
Address	4F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Masanori Middle name Last name Numa
Organization	CPCC Company Limited
Division name	Planning & Sales Department
Zip code	101-0047
Address	4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	ASAHI QUALITY & INNOVATIONS, 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 Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.co.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 07 Month 12 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	90
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 06 Month 24 Day
Date of IRB	2019 Year 06 Month 21 Day
Anticipated trial start date	2019 Year 07 Month 12 Day
Last follow-up date	2019 Year 12 Month 22 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 07 Month 04 Day
Last modified on	2020 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042489