UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058800 |
|---|---|
| Receipt number | R000067232 |
| Scientific Title | Effects of plum extract food ingestion on muscle fatigue during exercise |
| Date of disclosure of the study information | 2025/08/26 |
| Last modified on | 2025/08/18 16:21:00 |
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Basic information
Public title
Effects of plum extract food ingestion on muscle fatigue during exercise
Acronym
Effects of plum extract food ingestion on muscle fatigue during exercise
Scientific Title
Effects of plum extract food ingestion on muscle fatigue during exercise
Scientific Title:Acronym
Effects of plum extract food ingestion on muscle fatigue during exercise
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of plum extract ingestion on muscle fatigue and blood circulation during endurance exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to exhaustion in handgrip exercise
Key secondary outcomes
Maximal workload or duration in cycling exercise, Oxygen saturation, EMG parameters, Subjective fatigue (VAS), Blood pressure
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Ingestion of plum extract beverage
Interventions/Control_2
Ingestion of placebo beverage
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Female students enrolled at the implementing research institution
Able to maintain consistent lifestyle conditions (e.g., exercise habits, dietary intake) during the study period
Can be directly recruited by the principal investigator or co-investigators
Have received a written and verbal explanation of the purpose and details of the study and can voluntarily provide written informed consent to participate
Included within the maximum of approximately 15 participants to ensure at least 10 valid data sets per condition
Key exclusion criteria
Individuals with a history or current presence of cardiovascular, respiratory, metabolic, or orthopedic disorders that may interfere with the safe performance of exercise tests
Individuals with food allergies, particularly to plum or ingredients in carbonated beverages
Individuals who plan to make significant changes to their habitual exercise routine or dietary habits during the study period
Individuals who habitually consume plum extract or similar products
Individuals deemed unsuitable for participation in the study by the principal investigator or co-investigators
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nagasawa |
Organization
Kio University
Division name
Department of Health and Nutrition, Faculty of Health Sciences
Zip code
635-0832
Address
4-2-2 Umeminaka, Koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL
0745-54-1601
t.nagasawa@kio.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Nagasawa |
Organization
Kio University
Division name
Department of Health and Nutrition, Faculty of Health Sciences
Zip code
635-0832
Address
4-2-2 Umeminaka, Koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL
0745-54-1601
Homepage URL
t.nagasawa@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2 Umeminaka, Koryo-cho, Kitakatsuragi-gun, Nara, Japan
Tel
0745-54-1601
t.nagasawa@kio.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
| 2025 | Year | 08 | Month | 26 | 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
| 2025 | Year | 08 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 08 | Month | 14 | Day |
Last modified on
| 2025 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067232
