Tokyo, March 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060791) titled 'A study on the effects of nutritional supplementation in athletes' on March 4.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Niigata University
Condition:
Condition - None (Healthy adults)
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 18
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 Size - 27
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069553
Disclaimer: Curated by HT Syndication.