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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033748
Receipt No. R000038489
Scientific Title A study to evaluate effects of test food on physical performance and fatigue during exercise
Date of disclosure of the study information 2018/09/12
Last modified on 2019/02/13

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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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