UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033748 |
|---|---|
| Receipt number | 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 11:03:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038489
