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临床试验/NCT05464342
NCT05464342已完成不适用

Integral Physiological Adaptations to Carbohydrate Periodization

University of Thessaly4 个研究点 分布在 2 个国家目标入组 45 人开始时间: 2022年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
4
主要终点
Sleep Efficiency

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Parameters such as questionnaires' scores, polysomnography outcomes, indices of health, gut microbiome, miRNA and other data will be masked and coded for blind analysis by the main investigator.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Both sexes, Age between 18 and 50 yrs old, Regularly participating in sports activities.

排除标准

  • Any kind of history of major diseases or medication, Excessive amounts of alcohol and caffeine consumption

结局指标

主要结局

Sleep Efficiency

时间窗: Assessed at 0-month (pre) and at 1-month (post)

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.

Quality of Sleep Score

时间窗: Assessed at 0-month (pre) and at 1-month (post)

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.

Daytime Sleepiness

时间窗: Assessed at 0-month (pre) and at 1-month (post)

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.

次要结局

  • miRNA levels(Assessed at 0-month (pre) and at 1-month (post))
  • Body Composition(Assessed at 0-month (pre) and at 1-month (post))
  • Exercise Performance(Assessed at 0-month (pre) and at 1-month (post))
  • Gut Microbiome(Assessed at 0-month (pre) and at 1-month (post))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Giorgos K. Sakkas

Associate Professor

University of Thessaly

研究点 (4)

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