Skip to main content
OpenTrials
Completed

NCT Number: NCT05464342

Integral Physiological Adaptations to Carbohydrate Periodization

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleepiness Behavior Behavior, Animal Daytime Sleepiness, Excessive Disorders of Excessive Somnolence Dyssomnias Fatigue Feeding Behavior Feeding Patterns Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Life and Health Sciences, Nicosia, Cyprus

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Evening LGI Carbohydrate Consumption Group

Behavioral

Participants will receive in the evening food with low glycemic index

Evening HGI Carbohydrate Consumption

Behavioral

Participants will receive in the evening food with high glycemic index

Evening NO-CHO Carbohydrate Consumption

Behavioral

Participants will receive in the evening a meal with no carbohydrates at all.

Primary outcomes

  1. Sleep Efficiency

    Time frame: 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.

  2. Quality of Sleep Score

    Time frame: 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.

  3. Daytime Sleepiness

    Time frame: 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.

Secondary outcomes

  1. Body Composition

    Time frame: Assessed at 0-month (pre) and at 1-month (post)

    Changes in Body composition. The changes in body composition will be assessed by the skinfold measurements and BIA

  2. Exercise Performance

    Time frame: Assessed at 0-month (pre) and at 1-month (post)

    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.

  3. Gut Microbiome

    Time frame: Assessed at 0-month (pre) and at 1-month (post)

    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.

  4. miRNA levels

    Time frame: Assessed at 0-month (pre) and at 1-month (post)

    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.

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Collaborators

  • University of Cyprus
  • University of Nicosia

Registry information

Acronym: IPACP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2022
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.