Integral Physiological Adaptations to Carbohydrate Periodization

Fatigue Clinical Trial

— IPACP  

Official title:

Integral Physiological Adaptations to Carbohydrate Periodization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05464342
• Other study ID #: EEBK/E?/2018/10
• Status: Completed
• Phase: N/A
• Start date: July 5, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2023
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 31, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Disorders of Excessive Somnolence
• Fatigue
• Feeding Patterns
• Sleepiness

Intervention

Behavioral:
• Evening LGI Carbohydrate Consumption Group
Participants will receive in the evening food with low glycemic index
• Evening HGI Carbohydrate Consumption
Participants will receive in the evening food with high glycemic index
• Evening NO-CHO Carbohydrate Consumption
Participants will receive in the evening a meal with no carbohydrates at all.

Locations

Country	Name	City	State
Cyprus	Department of Life and Health Sciences	Nicosia
Greece	Lifestlye Medicine Laboratory, TEFAA, University of Thessaly	Trikala	Thessaly

Sponsors (3)

Lead Sponsor	Collaborator
University of Thessaly	University of Cyprus, University of Nicosia

Countries where clinical trial is conducted

Cyprus,  Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessed at 0-month (pre) and at 1-month (post)
Primary	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.	Assessed at 0-month (pre) and at 1-month (post)
Primary	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.	Assessed at 0-month (pre) and at 1-month (post)
Secondary	Body Composition	Changes in Body composition. The changes in body composition will be assessed by the skinfold measurements and BIA	Assessed at 0-month (pre) and at 1-month (post)
Secondary	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.	Assessed at 0-month (pre) and at 1-month (post)
Secondary	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.	Assessed at 0-month (pre) and at 1-month (post)
Secondary	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.	Assessed at 0-month (pre) and at 1-month (post)