UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063051 |
|---|---|
| Receipt number | R000072183 |
| Scientific Title | Effects of Test Food Intake on Delayed-Onset Muscle Soreness and Blood Biomarkers of Muscle Damage Following Eccentric Exercise: A Double-Blind, Placebo-Controlled Crossover Study |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/29 16:00:30 |
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Basic information
Public title
Effects of Test Food Intake on Delayed-Onset Muscle Soreness and Blood Biomarkers of Muscle Damage Following Eccentric Exercise: A Double-Blind, Placebo-Controlled Crossover Study
Acronym
Effects of Test Food Intake on Delayed-Onset Muscle Soreness (DOMS) and Blood Biomarkers of Muscle Damage
Scientific Title
Effects of Test Food Intake on Delayed-Onset Muscle Soreness and Blood Biomarkers of Muscle Damage Following Eccentric Exercise: A Double-Blind, Placebo-Controlled Crossover Study
Scientific Title:Acronym
Effects of Test Food Intake on Delayed-Onset Muscle Soreness (DOMS) and Blood Biomarkers of Muscle Damage
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of the test food on reducing muscle damage induced by eccentric exercise will be evaluated using subjective assessments of delayed-onset muscle soreness (DOMS) and blood biomarkers, including creatine kinase (CK).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Assessment of Delayed-Onset Muscle Soreness (DOMS) Using a Visual Analog Scale (VAS)
Key secondary outcomes
Serum concentrations of creatine kinase (CK), lactate dehydrogenase (LDH), and myoglobin
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
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Full-dose of test food
Interventions/Control_2
Half-dose of test food
Interventions/Control_3
Placebo food
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
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy men and women aged 18-45 years
2) No use of other dietary supplements during the study period
3) No known allergies or chronic diseases
Key exclusion criteria
1) Individuals who have, or have a history of, serious cardiovascular, hepatic, renal, respiratory, endocrine, or metabolic disorders.
2) Individuals with a history of serious illness requiring continuous medication.
3) Individuals who may be at risk of developing an allergic reaction related to the study intervention.
4) Individuals who are pregnant, breastfeeding, or planning to become pregnant during the study period.
5) Individuals who are otherwise deemed unsuitable for participation in the study by the study investigators.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Mitsutaka |
| Middle name | |
| Last name | Kohno |
Organization
Kyushu Women's University
Division name
Faculty of Home Nutrition, Department of Nutrition
Zip code
8078586
Address
1-1 Jiyugaoka, Yahatanishi, Kitakyushu, Fukuoka, 807-8586, Japan
TEL
0936933125
m-kohno@kwuc.ac.jp
Public contact
Name of contact person
| 1st name | Mitsutaka |
| Middle name | |
| Last name | Kohno |
Organization
Kyushu Wimen's University
Division name
Faculty of Home Nutrition, Department of Nutrition
Zip code
8078586
Address
1-1 Jiyugaoka, Yahatanishi, Kitakyushu, Fukuoka, 807-8586, Japan
TEL
0936933125
Homepage URL
m-kohno@kwuc.ac.jp
Sponsor or person
Institute
Kyushu Women's University
Institute
Department
Personal name
Mitsutaka Kohno
Funding Source
Organization
Konan Chemical Manufacturing Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japav
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu Wimen's University
Address
1-1 Jiyugaoka, Yahatanishi, Kitakyushu, Fukuoka, 807-8586, Japan
Tel
0936933125
m-kohno@kwuc.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
九州女子大学
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
| 2026 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 12 | Month | 25 | Day |
Date analysis concluded
| 2027 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 25 | Day |
Last modified on
| 2026 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072183
