UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053586 |
|---|---|
| Receipt number | R000061134 |
| Scientific Title | Changes in muscle oxygen saturation and salivary components due to fatigue accumulated during endurance exercise |
| Date of disclosure of the study information | 2025/10/31 |
| Last modified on | 2024/02/09 18:58:37 |
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Basic information
Public title
Changes in muscle oxygen saturation and salivary components due to fatigue accumulated during endurance exercise
Acronym
Changes in muscle oxygen saturation and salivary components due to fatigue accumulated during endurance exercise
Scientific Title
Changes in muscle oxygen saturation and salivary components due to fatigue accumulated during endurance exercise
Scientific Title:Acronym
Changes in muscle oxygen saturation and salivary components due to fatigue accumulated during endurance exercise
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantify the exercise-induced fatigue by measuring changes in biological components, muscle oxygen saturation and others during endurance exercise
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in muscle oxygen saturation under cuff pressure
Changes in saliva metabolome
Subjective evaluation (fatigue)
Key secondary outcomes
Changes in blood metabolome
Changes in urinary 8-OHdG
Changes in salivary IgA
Changes in muscle oxygen saturation during exercise
Changes in anaerobic metabolic threshold
Subjective evaluation
(rating of perceived exertion)
Changes in sleep quality
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Endurance exercise over 3 days
Interventions/Control_2
Endurance exercise over 3 days
Interventions/Control_3
Do not exercise
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
1) Athletes who specialize in endurance sports and continue to train for competition purposes 5-7 days per week.
2) Athletes whose workout routine includes an endurance exercise, averaged over the last three months, 1-3 days per week (at least 30 minutes per session, lasting at least 6 months).
Key exclusion criteria
1)Persons who are unable to refrain from taking health foods, quasi-drugs and over-the-counter medicines, including supplements that affect the circulatory system and metabolism taken orally, and from using topical analgesic anti-inflammatory drugs such as compresses during the period of this study. However, those who have been prescribed medicines or other drugs by a doctor or pharmacist for therapeutic purposes should ask the doctor or pharmacist for a decision on discontinuation.
2)Persons who are unable to refrain from alcohol consumption and smoking during the period of this study.
3)Those with a BMI of 25.0 kg/m^2 or more.
4)Persons with serious illnesses such as diabetes, liver disease, renal disease, cardiac disease, cardiovascular disease, etc., and persons with pre-existing such illnesses.
5)Persons with a disease undergoing treatment or with a pre-existing serious disease requiring medication.
6)Persons who are unable to refrain from exercise other than that permitted by the research during the period of this study.
7)Persons who have participated in other clinical studies within one month of obtaining consent to participate in this study, or who plan to participate in other clinical studies after obtaining consent to participate in this study.
8)Any other person who is deemed unsuitable as a subject by his/her family doctor.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kawabata |
Organization
EZAKI GLICO Co., Ltd.
Division name
R&D LABORATORY
Zip code
555-8502
Address
4-6-5, Utajima, Nishiyodogawa-ku, Osaka, 555-8502, Japan
TEL
+81-6-6477-8793
hiroshi.kawabata@glico.com
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Takahashi |
Organization
EUPHORIA Co., Ltd.
Division name
SPORTS DATA MANAGEMENT DIV.
Zip code
102-0085
Address
Iida Bldg. 2nd Floor, 5-5, Rokubancho, Chiyoda-ku, Tokyo, 102-0085, Japan
TEL
+81-50-1742-8657
Homepage URL
sdm@eu-phoria.jp
Sponsor or person
Institute
EZAKI GLICO Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
+81-(0)50-3390-9275
y_huzita@mail.souken-r.com
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
| 2025 | Year | 10 | Month | 31 | 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
| 2024 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 26 | 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 | 02 | Month | 09 | Day |
Last modified on
| 2024 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061134
