UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060791 |
|---|---|
| Receipt number | R000069553 |
| Scientific Title | A study on the effects of nutritional supplementation in athletes: A Partially Randomized Crossover Trial |
| Date of disclosure of the study information | 2026/03/04 |
| Last modified on | 2026/03/01 23:00:37 |
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Basic information
Public title
A study on the effects of nutritional supplementation in athletes
Acronym
ENSA Study
Scientific Title
A study on the effects of nutritional supplementation in athletes: A Partially Randomized Crossover Trial
Scientific Title:Acronym
ENSA Study
Region
| Japan |
Condition
Condition
None (Healthy adults)
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 pre-exercise nutritional supplements with different glycemic indices on exercise performance and glycemic responses in male collegiate athletes, using a partially randomized crossover trial design.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in exercise performance following pre-exercise nutritional supplements with different glycemic indices (vertical jump height, 20-m sprint time, pro-agility shuttle time, and three-point shooting success rate).
The pre- to post-practice differences under each condition will be evaluated.
Key secondary outcomes
1. Changes in blood glucose levels (Continuous glucose monitoring using FreeStyle Libre 2, from pre-intake to the end of practice)
2. Rating of perceived exertion (RPE)
3. Changes in heart rate
4. Gastrointestinal symptoms (e.g., satiety and gastric discomfort)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Low-GI group
Pre-exercise intake of low-glycemic index (GI) food containing 1.5 g of available carbohydrates per kg of body weight, 2 hours before practice. The amount is individually adjusted according to body weight. In this crossover study, each participant sequentially experiences the high-GI and no-intake conditions. Performance tests are conducted after intake, both before and after practice. Blood glucose is continuously measured from pre-intake to the end of post-practice performance tests using FreeStyle Libre 2.
Interventions/Control_2
High-GI group
Pre-exercise intake of high-glycemic index (GI) food containing 1.5 g of available carbohydrates per kg of body weight, 2 hours before practice. The amount is individually adjusted according to body weight. In this crossover study, each participant sequentially experiences the low-GI and no-intake conditions. Performance tests are conducted after intake, both before and after practice. Blood glucose is continuously measured from pre-intake to the end of post-practice performance tests using FreeStyle Libre 2.
Interventions/Control_3
No-intake group (Control group)
No pre-exercise nutritional intake 2 hours before practice. In this crossover study, each participant sequentially experiences the low-GI and high-GI conditions. Performance tests are conducted before and after practice. Blood glucose is continuously measured from 2 hours pre-practice to the end of post-practice performance tests using FreeStyle Libre 2.
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
Healthy male college basketball players aged 18 to 25 who practice at least four times per week. Participants are recommended by the team coach, but a study staff member with no conflict of interest will provide full explanation. Participation is voluntary, and refusal to participate will not result in any disadvantage.
Key exclusion criteria
Participants will be excluded if they have an injury impairing exercise function during the study period, a history of abnormal glucose metabolism on past health examinations, a food allergy to rice or barley, or cardiovascular disease. Female athletes will also be excluded because variations in blood glucose associated with the menstrual cycle may affect measurement accuracy during the study period.
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Yukihiko |
| Middle name | |
| Last name | Ushiyama |
Organization
Niigata University
Division name
Faculty of Engineering/ Faculty of Education
Zip code
950-2102
Address
8050 Ikarashininocho, Nishi-ku, Niigatashi, Niigata
TEL
025-262-6395
ushiyama@ed.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyo |
| Middle name | |
| Last name | Usami |
Organization
Niigata University, Niigata University of Management
Division name
Graduate School of Science and Technology/ Faculty of Management and Information Science
Zip code
959-1321
Address
2909 2 Kibogaoka, Kamoshi, Niigata
TEL
0256-53-3000
Homepage URL
t-usami@duck.niigataum.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Management
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Niigata University
Address
757 ichibancho, Asahimachidori, Chuo-ku, Niigatashi
Tel
025-227-2005
joho@med.niigata-u.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
新潟大学（新潟県），新潟経営大学（新潟県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 04 | 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 | 01 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | 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 | 03 | Month | 01 | Day |
Last modified on
| 2026 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069553
