UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063269 |
|---|---|
| Receipt number | R000072420 |
| Scientific Title | Effects of Maslinic Acid Intake on Performance, Fatigue, and Associated Decline in Immune Function During Short-Duration Exercise |
| Date of disclosure of the study information | 2026/10/19 |
| Last modified on | 2026/10/14 10:53:39 |
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Basic information
Public title
Effects of Maslinic Acid Intake on Performance, Fatigue, and Associated Decline in Immune Function During Short-Duration Exercise
Acronym
Effects of Maslinic Acid Intake on Performance During Short-Duration Exercise
Scientific Title
Effects of Maslinic Acid Intake on Performance, Fatigue, and Associated Decline in Immune Function During Short-Duration Exercise
Scientific Title:Acronym
Effects of Maslinic Acid Intake on Performance During Short-Duration Exercise
Region
| Japan |
Condition
Condition
immunity
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the effects of maslinic acid intake on performance, fatigue, and associated immune function during short-duration, high-intensity exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Regarding performance, we will examine whether MA intake affects peak power, mean power, and fatigue index in the Wingate test compared to the placebo group.
Key secondary outcomes
Regarding decreased immune function and fatigue, we will verify these using salivary markers. As a salivary marker, secretory immunoglobulin A (s-IgA) will be employed. It serves as the front line of mucosal immunity, and a decrease in its secretion rate is associated with an increased risk of upper respiratory tract infection (URTI) and an immunosuppressed state (the "open window" phenomenon) following strenuous exercise. We will verify whether MA intake suppresses the decline in s-IgA secretion rate or promotes its recovery after the Wingate test compared with the placebo group.
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Ingestion of placebo or maslinic acid (60 mg) on the day of the test
Interventions/Control_2
Conducting the Wingate test (30-second all-out pedaling)
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
Key inclusion criteria
Individuals with no relevant medical history: Medical history, injuries, surgeries, etc., within the past five years (excluding common colds, influenza, and COVID-19).
Key exclusion criteria
As the test food (maslinic acid) contains porcine gelatin and olive fruit extract, and the control food (placebo) contains porcine gelatin, individuals with allergies to these ingredients are excluded from the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Tokinoya |
Organization
Yokohama National University
Division name
College of Education
Zip code
240-8501
Address
79-2 Tokiwadai, Hodogaya-ku, Yokohama, Kanagawa
TEL
0453393277
tokinoya-katsuyuki-ys@ynu.ac.jp
Public contact
Name of contact person
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Tokinoya |
Organization
Yokohama National University
Division name
College of Education
Zip code
240-8501
Address
79-2 Tokiwadai, Hodogaya-ku, Yokohama, Kanagawa
TEL
0453393277
Homepage URL
tokinoya-katsuyuki-ys@ynu.ac.jp
Sponsor or person
Institute
Yokohama National University
Institute
Department
Personal name
Funding Source
Organization
Nippn Corporation (Research & Development)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama National University
Address
Yokohama National University
Tel
0453393075
kenkyu.somu@ynu.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 | 10 | Month | 19 | 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 | 10 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | 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 | 10 | Month | 14 | Day |
Last modified on
| 2026 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072420
