An interventional study of Evening LGI Carbohydrate Consumption Group and Evening HGI Carbohydrate Consumption in Sleepiness, Fatigue and Feeding Patterns, sponsored by University of Thessaly. Completed at 2 sites in 2 countries. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-05.
Sponsored by University of Thessaly · Not applicable, Interventional, and Prevention
The purpose of this study is to examine the effect of long-term carbohydrate periodization protocols on sleep architecture, sleep quality, daytime sleepiness, physical performance, body composition, gut microbiome, and miRNA in healthy trained individuals.
Athletic populations have been particularly susceptible to sleep inadequacies, experience several sleep issues, and fall below the age-specific sleep recommendations. However, it is well demonstrated that exercise does not impair sleep by itself, and furthermore, acute post-exercise nutrition could elevate the exercise-induced sleep-optimizing effect, with further benefits for the next physical performance. In line with these findings, in a metanalysis of clinical trials, it was shown that pre-bed carbohydrate availability resulted in significant alterations in sleep architecture. It is of utmost importance to highlight that throughout this metanalysis, it was revealed that no long-term nutrition intervention for sleep optimization has been studied yet. These data raise the question of whether a long-term carbohydrate periodization protocol could optimize sleep and alter gut function in a way that athletic performance will be also enhanced. This would allow elucidating further potential interrelations and biological pathways underlying these adaptations.
92 studies on the registry are indexed under Sleepiness; 20 are open to participants now.
This study's enrollment of 45 is below the median of 62 across 62 interventional studies indexed under Sleepiness.
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Exclusion Criteria:
Dietary Intervention: Consumption of Low Glyceamic Index (LGI) carbohydrates intake post-workout/evening.
Behavioral: Evening LGI Carbohydrate Consumption Group
Dietary Intervention: Consumption of High Glyceamic Index (HGI) carbohydrates intake post-workout/evening.
Behavioral: Evening HGI Carbohydrate Consumption
Dietary Intervention: No consumption of carbohydrates intake post-workout/evening.
Behavioral: Evening NO-CHO Carbohydrate Consumption
Participants will receive in the evening food with low glycemic index
Participants will receive in the evening food with high glycemic index
Participants will receive in the evening a meal with no carbohydrates at all.
Sleep Efficiency
Changes sleep efficiency assessed by the gold-standard method of polysomnography. Sleep efficiency is the percentage of time spent asleep while in bed. It is calculated by dividing the amount of time spent asleep (in minutes) by the total amount of time in bed (in minutes). A normal sleep efficiency is considered to be 85% or higher.
Time frame: Assessed at 0-month (pre) and at 1-month (post)
Quality of Sleep Score
Changes in Quality of Sleep will be assessed by the Pittsburgh Sleep Quality Index. The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as the global score) indicating worse sleep quality.
Time frame: Assessed at 0-month (pre) and at 1-month (post)
Daytime Sleepiness
Changes in Daytime sleepiness will be assessed by Epworth Sleepiness Scale (ESS). The Epworth Sleepiness Scale (ESS) measures the general level of daytime sleepiness. It is a subjective scale that asks the respondent to rate his or her propensity to doze or fall asleep during 8 common daily activities to determine the level of daytime sleepiness. The score varies between 0-24 with 0-5 Lower Normal Daytime Sleepiness, 6-10 Higher Normal Daytime Sleepiness, 11-12 Mild Excessive Daytime Sleepiness, 13-15 Moderate Excessive Daytime Sleepiness, 16-24 Severe Excessive Daytime Sleepiness.
Time frame: Assessed at 0-month (pre) and at 1-month (post)
Body Composition
Changes in Body composition. The changes in body composition will be assessed by the skinfold measurements and BIA
Time frame: Assessed at 0-month (pre) and at 1-month (post)
Exercise Performance
Changes in Exercise Performance will be assessed by a VO2max test. A VO2 max test is a maximal exercise test performed on a treadmill or bike while connected to a machine capable of analyzing your expired air. Your test provides data on how much oxygen you use as you exercise and determines the maximal oxygen you can consume during exercise.
Time frame: Assessed at 0-month (pre) and at 1-month (post)
Gut Microbiome
Changes in Gut Microbiome. Participants' gut microbiome will be studied by analyzing stool samples DNA will be extracted, and the presence of selected gut bacterial populations will be examined qualitatively and quantitatively using specific primers and quantitative Real-Time PCR.
Time frame: Assessed at 0-month (pre) and at 1-month (post)
miRNA levels
Changes in miRNA levels. miRNA levels that are associated with hypertrophy or cardiovascular function will be analyzed by blood sample collection at baseline and at one month.
Time frame: Assessed at 0-month (pre) and at 1-month (post)
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2022 to primary completion in Apr 2023, 8 months.
Of 22 interventional studies with no phase under Sleepiness, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 32. This study's 8 months is below that.
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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