UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059220 |
|---|---|
| Receipt number | R000067733 |
| Scientific Title | The effect of differences in carbohydrate-loading meal content on exercise performance: a crossover trial |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/29 10:25:50 |
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Basic information
Public title
The effect of differences in carbohydrate-loading meal content on exercise performance
Acronym
The effect of differences in carbohydrate-loading meal content on exercise performance
Scientific Title
The effect of differences in carbohydrate-loading meal content on exercise performance: a crossover trial
Scientific Title:Acronym
The effect of differences in carbohydrate-loading meal content on exercise performance
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of differences in carbohydrate-loading meal content on exercise performance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total distance covered in a test match
Key secondary outcomes
1. Height and body weight
2. Body composition
3. Body water content
4. Fluid intake
5. Subjective fatigue
6. Subjective gastrointestinal symptoms
7. Physical activity level
8. Running speed during the test match
9. Acceleration during the test match
10. Heart rate during the test match
11. Subjective exercise intensity during the test match
12. Sweat loss during the test match
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Standard diet: approximately 6 g/kg body weight/day of carbohydrate for 3 days.
Interventions/Control_2
High-carbohydrate diet (jelly): approximately 11 g/kg body weight/day of carbohydrate for 3 days, including 3 g/kg/day of carbohydrate from jelly.
Interventions/Control_3
High-carbohydrate diet (gummy): approximately 11 g/kg body weight /day of carbohydrate for 3 days, including 3 g/kg/day of carbohydrate from gummy candy.
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
| Not applicable |
Gender
Male
Key inclusion criteria
1. Individuals aged 18 years or older
2. Individuals who have been playing soccer continuously for at least 3 months
3. Individuals free from any diagnosed diseases and in good health
4. Individuals who are able to provide written informed consent
Key exclusion criteria
1. Individuals who have been advised by a physician to refrain from exercise due to injury or other reasons
2. Individuals who require dietary restrictions due to illness or other conditions
3. Individuals with an allergy to gelatin
4. Individuals currently participating in, or intending to participate in, other trials involving food intake or medication use
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Shiose |
Organization
University of Miyazaki
Division name
Faculty of Education
Zip code
889-2192
Address
1-1 Gakuen Kibanadai-nishi, Miyazaki, Japan
TEL
0985-75-7111
kshiose@cc.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Shiose |
Organization
University of Miyazaki
Division name
Faculty of Education
Zip code
889-2192
Address
1-1 Gakuen Kibanadai-nishi, Miyazaki, Japan
TEL
0985-75-7111
Homepage URL
kshiose@cc.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS), Grants-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
1. Faculty of Sports and Health Science, Fukuoka University
2. Bourbon Corporation
Name of secondary funder(s)
Bourbon Corporation
IRB Contact (For public release)
Organization
Research Ethics Committee, Faculty of Medicine, University of Miyazaki
Address
5200 Kihara, Kiyotake-cho, Miyazaki, Japan
Tel
0985-85-9010
igakubu_kenkyu@med.miyazaki-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
I-0088
Org. issuing International ID_1
Research Ethics Committee, Faculty of Medicine, University of Miyazaki
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 | 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
| 2025 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | 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 | 09 | Month | 29 | Day |
Last modified on
| 2025 | 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=R000067733
