Tokyo, Feb. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060528) titled 'The effects of creatine supplementation on athletic and cognitive performance in collegiate student-athletes following a short-term sleep restriction' on Feb. 2.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Sendai University
Condition:
Condition - Healthy adults / University-affiliated student-athletes
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to explore the effects of short-term sleep restriction on athletic and cognitive performance in collegiate student-athletes and to examine whether creatine can mitigate the potential effects of sleep restriction
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Creatine supplementation (0.35g/kg/day for 5 days)+ 6 hours of sleep restriction for 5 days
Interventions/Control_2 - Placebo + 6 hours of sleep restriction for 5 days
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male
Key inclusion criteria - 1)Healthy male university student athletes
2)Individuals who are capable of making an independent decision regarding participation in the study
3)Non smokers
4)Individuals who have not used prescription sleep medications or over-the-counter sleep aids on a long-term basis (more than 1 year)
Key exclusion criteria - 1)Individuals with allergies to standard foods or the test food
2)Individuals with suspected or diagnosed severe gastrointestinal, hepatic, renal, cardiovascular, hematological, or endocrine disorders, or malignant neoplasms; those with a history of such diseases; those currently receiving medical treatment; or those with ongoing medical conditions
3)Individuals with sleep disorders such as insomnia who have previously received treatment
4)Individuals who, during the habituation period (5 days), complied with controlled bedtime/wake-time schedules and wore an activity tracker to record sleep, and who experienced sleep duration of less than 6 hours on three or more days
5)Individuals who consumed excessive amounts of alcohol during the habituation period (5 days)*
6)Individuals who regularly use, or plan to use during the study period, supplements, medications, or health foods containing creatine (including Foods for Specified Health Uses, Foods with Function Claims, or Nutrient Function Foods)
7)Individuals who are unable to abstain from alcohol consumption during the experimental period (Days 0~5)
8)Individuals who participated in another study within one month prior to the start of this study, or who plan to participate in another similar study after providing consent for this study
*Definition of excessive alcohol consumption:
Alcohol intake of one 'go' of sake or more, three or more times per week, equivalent to:
/One medium bottle of beer
/One double shot of whisky
/0.6 'go' of shochu
Target Size - 15
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 02 Day
Anticipated trial start date - 2026 Year 04 Month 03 Day
Last follow-up date - 2028 Year 04 Month 03 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069241
Disclaimer: Curated by HT Syndication.