UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051845 |
|---|---|
| Receipt number | R000059160 |
| Scientific Title | Effects of the test food on improving fatigue and muscle soreness |
| Date of disclosure of the study information | 2023/08/08 |
| Last modified on | 2023/08/07 12:34:44 |
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Basic information
Public title
Effects of the test food on improving fatigue and muscle soreness
Acronym
Effects of the test food on improving fatigue and muscle soreness
Scientific Title
Effects of the test food on improving fatigue and muscle soreness
Scientific Title:Acronym
Effects of the test food on improving fatigue and muscle soreness
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of test food on fatigue and muscle soreness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective degree of muscle soreness
Key secondary outcomes
Subjective degree of fatigue, muscle damage markers, inflammatory markers, stress markers, safety evaluation
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
Oral intake of the test food (1 week)
Interventions/Control_2
Oral intake of the test food (1 week)
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy individuals who have an aerobic exercise habit
Key exclusion criteria
Individuals who have a medical history
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tohru |
| Middle name | |
| Last name | Takemasa |
Organization
University of Tsukuba
Division name
Institute of Health and Sport Sciences
Zip code
305-8574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
0298532762
takemasa.tohru.gm@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Tohru |
| Middle name | |
| Last name | Takemasa |
Organization
University of Tsukuba
Division name
Institute of Health and Sport Sciences
Zip code
305-8574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-2762
Homepage URL
takemasa.tohru.gm@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
NIPPN CORPORATION
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
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel
029-853-2571
hitorinri@un.tsukuba.ac.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
筑波大学体育系
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 08 | 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
26
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
| 2022 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 07 | Day |
Last modified on
| 2023 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059160
