UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060318 |
|---|---|
| Receipt number | R000068999 |
| Scientific Title | Influence of consecutive cocoa flavanol intake after eccentric exercise on muscle soreness and muscular performance |
| Date of disclosure of the study information | 2026/01/10 |
| Last modified on | 2026/01/10 13:57:29 |
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Basic information
Public title
Effect of cocoa flavanol intake on muscle strength and soreness after exercise
Acronym
Cocoa flavanol and muscle strength and soreness after exercise
Scientific Title
Influence of consecutive cocoa flavanol intake after eccentric exercise on muscle soreness and muscular performance
Scientific Title:Acronym
Cocoa flavanol and muscle strength and soreness after exercise
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the influence of consecutive cocoa flavanol intake after eccentric exercise on muscle soreness and muscular performance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle soreness and isometric torque at 24 and 48 h after exercise
Key secondary outcomes
Urinary concentration of oxidative stress marker 24 and 48 h after exercise
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Capsulated high-dose or low-dose cocoa flavanols are consumed at immediately and 22 h after exercise.
High-dose cocoa flavanol condition -> at least 2 week of wash out period -> low-dose cocoa flavanol condition
Interventions/Control_2
Capsulated high-dose or low-dose cocoa flavanols are consumed at immediately and 22 h after exercise.
Low-dose cocoa flavanol condition -> at least 2 week of wash out period -> high-dose cocoa flavanol condition
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
| 29 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy young males not involving training using their upper limbs
Key exclusion criteria
Participants who have smoking status within the past year; injuries at upper limbs; allergy to caffeine; or cardiovascular or mental diseases.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Hashimoto |
Organization
Ritsumeikan University
Division name
Faculty of Sport and Health Science
Zip code
525-8577
Address
1-1-1, Noji-Higashi, Kusatsu, Shiga
TEL
077-599-4134
thashimo@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Hashimoto |
Organization
Ritsumeikan University
Division name
Faculty of Sport and Health Science
Zip code
525-8577
Address
1-1-1, Noji-Higashi, Kusatsu, Shiga
TEL
077-599-4134
Homepage URL
thashimo@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
Takeshi Hashimoto
Funding Source
Organization
Japanese Ministry of Education, Culture, Sports, Science, and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee for Medical and Health Research Involving Human Subjects (natural Sciences), Ritsumeikan University
Address
1-1-1, Noji-Higashi, Kusatsu, Shiga
Tel
077-599-4175
b-rinri@st.ritsumei.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 10 | 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
16
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 06 | 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
| 2026 | Year | 01 | Month | 10 | Day |
Last modified on
| 2026 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068999
