UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055775 |
|---|---|
| Receipt number | R000063745 |
| Scientific Title | Effect of oral intake of cocoa-derived polyphenols on muscle fatigue resistance and recovery in humans |
| Date of disclosure of the study information | 2024/10/08 |
| Last modified on | 2025/10/09 09:10:07 |
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Basic information
Public title
Effect of oral intake of cocoa-derived polyphenols on muscle fatigue resistance and recovery in humans
Acronym
Effect of oral intake of cocoa-derived polyphenols on muscle fatigue resistance and recovery in humans
Scientific Title
Effect of oral intake of cocoa-derived polyphenols on muscle fatigue resistance and recovery in humans
Scientific Title:Acronym
Effect of oral intake of cocoa-derived polyphenols on muscle fatigue resistance and recovery in humans
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of oral intake of cocoa-derived polyphenols on muscle fatigue resistance and recovery in humans.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Peak joint torque during maximal voluntary contraction, evoked torque, voluntary activation, muscle activity, salivary chromogranin A and amylase concentrations before and after muscle fatiguing task
- Time to complete the muscle fatigue task
Key secondary outcomes
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food
Cocoa flavanols: 500 mg
Theobromine: 180.8 mg
Ingestion: 1 time
Interventions/Control_2
Placebo
Theobromine: 180.8 mg
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
- No history of cardiac or cardiovascular disease.
- No neuromuscular or orthopedic diseases of the lower body at the time of the experiment, capable of walking independently and performing physical exercise measurements.
- Has not smoked for more than six months.
- The participant's lifestyle (timing and quantity of meals and sleep) should be relatively stable.
Key exclusion criteria
- Participants who have not had enough sleep on the night before the measurement day or who have not eaten on the day of the measurement, etc., which may affect the measurement results.
- Participants who have a regular exercise habit of at least twice a week
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Akagi |
Organization
Shibaura Institute of Technology
Division name
Systems engineering and Science
Zip code
337-8570
Address
307 Fukasaku, Minuma-ku, Saitama-shi, Saitama
TEL
+81-48-720-6020
rakagi12@shibaura-it.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Akagi |
Organization
Shibaura Institute of Technology
Division name
Systems engineering and Science
Zip code
337-8570
Address
307 Fukasaku, Minuma-ku, Saitama-shi, Saitama
TEL
+81-48-720-6020
Homepage URL
rakagi12@shibaura-it.ac.jp
Sponsor or person
Institute
Shibaura Institute of Technology
Institute
Department
Personal name
Ryota Akagi
Funding Source
Organization
Meiji Holdings Co., 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
the Ethics Committee of Shibaura Institute of Technology
Address
3-7-5 Toyosu, Koto-ku, Tokyo
Tel
+81-3-5859-7340
tgakuji@ow.shibaura-it.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
| 2024 | Year | 10 | 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
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
| 2024 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 08 | Day |
Last modified on
| 2025 | 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=R000063745
