UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037267 |
|---|---|
| Receipt number | R000042489 |
| Scientific Title | A study to evaluate effect of test food on whole body endurance improvement and fatigue inhibition. |
| Date of disclosure of the study information | 2019/07/12 |
| Last modified on | 2020/10/09 11:52:42 |
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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
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
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042489
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