UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058305 |
|---|---|
| Receipt number | R000066654 |
| Scientific Title | Effects of Carbohydrate Supplementation Before and During Exercise on Blood Glucose Dynamics and Pitching Performance in Baseball Pitchers: A Crossover Trial |
| Date of disclosure of the study information | 2025/06/27 |
| Last modified on | 2025/06/27 19:24:56 |
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Basic information
Public title
Effects of Pre- and During-Exercise Carbohydrate Supplementation on Blood Glucose Levels and Pitching Performance in Baseball Pitchers
Acronym
Carbo-Pitch Study
Scientific Title
Effects of Carbohydrate Supplementation Before and During Exercise on Blood Glucose Dynamics and Pitching Performance in Baseball Pitchers: A Crossover Trial
Scientific Title:Acronym
Carbo-Pitch Study
Region
| Japan |
Condition
Condition
Not applicable (healthy individuals)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects of carbohydrate supplementation before and during exercise on blood glucose dynamics and pitching performance in baseball pitchers.
Specifically, it examines whether carbohydrate intake alters blood glucose levels, ball velocity, and pitching accuracy, in order to evaluate the efficacy of nutritional strategies during prolonged pitching activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood glucose dynamics during pitching trials (change in blood glucose levels measured at the end of every even-numbered inning from the start of carbohydrate intake to the end of exercise)
Key secondary outcomes
1.Ball velocity and spin rate (measured for all pitches using a sensor-equipped ball)
2.Pitching accuracy (evaluated using high-speed camera data and 95% confidence ellipse analysis)
3.Heart rate variability during pitching (monitored with Polar H10 device)
4.Blood lactate concentration (measured via capillary blood sampling at six time points, aligned with blood glucose measurements)
5.Perceived exertion (evaluated using RPE at rest, post-warm-up, post-performance test, and after each inning)
6.Mental fatigue, concentration, motivation, and gastrointestinal discomfort (evaluated using VAS after each inning)
7.Grip strength (measured before and after pitching trials)
8.Jump performance via CMJ (jump height and peak ground reaction force measured before and after pitching)
9.Cognitive function (evaluated using Stroop Color-Word Task before and after pitching trials)
10.Blinding effectiveness (assessed by verbal identification of beverage condition after trials)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
To evaluate the acute effects of carbohydrate intake on performance, a liquid form is used for its rapid digestion and suitability during exercise. Participants ingest a 6.2% carbohydrate beverage (Pocari Sweat, Otsuka Pharmaceutical): 350 mL before pitching and 160 mL during each of six inning breaks, for a total intake of 1,310 mL and approximately 78 g of carbohydrate, equivalent to 60 g/hour. This intake aligns with international consensus recommendations for carbohydrate supplementation in sports nutrition.
Interventions/Control_2
Participants ingest a non-carbohydrate, zero-calorie sports drink (Aquarius Zero, Coca-Cola) in the same volume and timing as in the carbohydrate condition (350 mL before and 160 mL during each inning break). Its flavor and appearance are similar to the carbohydrate beverage, ensuring effective blinding.
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
･Male student athletes (aged 18-25 years) belonging to the Ritsumeikan University varsity hardball baseball team
･At least 3 years of experience as a baseball pitcher in hardball baseball
･Engaged in continuous performance-enhancing training, including resistance and aerobic exercise, for approximately 2 hours per day and at least 5 days per week
･No history of musculoskeletal injuries in the past 3 months or medical conditions such as neurological disorders, vascular disease, visual abnormalities, diabetes, or glucose metabolism disorders, and deemed capable of repeated pitching trials
Key exclusion criteria
･History of smoking within the past year
･Fasting blood glucose level >= 110 mg/dL (indicative of metabolic disease)
･Color vision deficiency or other visual problems that hinder the execution of cognitive tasks
･Allergies to any ingredients in the test beverages
･Determined to be unable to safely perform repeated pitching trials
･Deemed unsuitable for participation by the medical supervisor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Hashimoto |
Organization
Univ. Ritsumeikan
Division name
Faculty of Sport and Health Science
Zip code
525-8577
Address
1-1-1 Nojihigashi, Kusatsu-shi, Shiga
TEL
0775994134
thashimo@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | Haruru |
| Middle name | |
| Last name | Watabe |
Organization
Univ. Ritsumeikan
Division name
Graduate School of Sport and Health Science
Zip code
525-8577
Address
1-1-1 Nojihigashi, Kusatsu-shi, Shiga
TEL
08020300327
Homepage URL
gr0688hv@ed.ritsumei.ac.jp
Sponsor or person
Institute
Univ. Ritsumeikan
Institute
Department
Personal name
Funding Source
Organization
Univ. Ritsumeikan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
the Japan Society for the Promotion of Science
IRB Contact (For public release)
Organization
Office of the Research Ethics Committee for Medical Studies Involving Human Subjects, Ritsumeikan University
Address
1-1-1 Nojihigashi, Kusatsu-shi, Shiga
Tel
077-599-4175
b-rinri@st.ritsumei.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
立命館大学（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 27 | 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 | 03 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2027 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | 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 | 06 | Month | 27 | Day |
Last modified on
| 2025 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066654
