UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate effects of test food on physical performance and fatigue during exercise
Acronym	A study to evaluate effects of test food on physical performance and fatigue during exercise
Scientific Title	A study to evaluate effects of test food on physical performance and fatigue during exercise
Scientific Title:Acronym	A study to evaluate effects of test food on physical performance and fatigue during exercise
Region	Japan

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

Objectives
Narrative objectives1	To evaluate effects of test food on physical exercise and fatigue.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Maximal oxygen consumption (VO2 max) Questionnaire on fatigue
Key secondary outcomes	Ventilation threshold Rating of perceived exertion Physical performance Blood biochemistry Muscle mass Body fat mass Intestinal microbiome

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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake 3 tablets of active food 1 daily for 9 weeks.
Interventions/Control_2	Intake 3 tablets of active food 2 daily for 9 weeks.
Interventions/Control_3	Intake 3 tablets of placebo food daily for 9 weeks.
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. 2)Subjects who have exercise habits once or twice a week. 3)Subjects who can continue with the exercise habits during test period. 4)Subjects who don't take prohibited foods such as dietary supplements for exercise and can keep it during test period. 5)Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent.
Key exclusion criteria	1)Subjects who have consciousness of being constipation or diarrhea. 2)Subjects who have previous and/or current medical history of serious disease in heart, liver, kidney, or digestive system. 3)Subjects who drink alcohol a lot. 4)Subjects who have extremely irregular dietary habits or life rhythm. 5)Subjects who have allergy to medicines or foods. 6)Subjects who are participating the other clinical test, were participating it within the past 4 weeks, or are going to participate it. 7)Subjects who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. 8)Subjects judged as unsuitable for the study by the principal or attending investigator.
Target sample size	36

Research contact person
Name of lead principal investigator	1st name Middle name Last name Suguru Fujiwara
Organization	CPCC Company Limited
Division name	Clinical Research Planning Department
Zip code
Address	4F Chushin 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 Middle name Last name Masanori Numa
Organization	CPCC Company Limited
Division name	Plan Sales Department
Zip code
Address	4F Chushin 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 Group Holdings, 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 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
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 08 Month 10 Day
Date of IRB
Anticipated trial start date	2018 Year 09 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 08 Month 14 Day
Last modified on	2019 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038489

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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