Integral Physiological Adaptations to Carbohydrate Periodization (IPACP)

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.

Study Overview

• Status: Completed
• Conditions: Fatigue; Sleepiness; Feeding Patterns; Daytime Sleepiness, Excessive
• Intervention / Treatment: Behavioral: Evening LGI Carbohydrate Consumption Group; Behavioral: Evening HGI Carbohydrate Consumption; Behavioral: Evening NO-CHO Carbohydrate Consumption

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cyprus
  • Nicosia, Cyprus, CY2417
    • Department of Life and Health Sciences
• Greece
  • Thessaly
    • Trikala, Thessaly, Greece, 42100
      • Lifestlye Medicine Laboratory, TEFAA, University of Thessaly

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evening LGI Carbohydrate Consumption; Dietary Intervention: Consumption of Low Glyceamic Index (LGI) carbohydrates intake post-workout/evening.	Behavioral: Evening LGI Carbohydrate Consumption Group; Participants will receive in the evening food with low glycemic index
Experimental: Evening HGI Carbohydrate Consumption; Dietary Intervention: Consumption of High Glyceamic Index (HGI) carbohydrates intake post-workout/evening.	Behavioral: Evening HGI Carbohydrate Consumption; Participants will receive in the evening food with high glycemic index
Experimental: Evening NO-CHO Carbohydrate Consumption; Dietary Intervention: No consumption of carbohydrates intake post-workout/evening.	Behavioral: Evening NO-CHO Carbohydrate Consumption; Participants will receive in the evening a meal with no carbohydrates at all.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: University of Thessaly
• Collaborators: University of Nicosia; University of Cyprus
• Investigators: Study Chair: Georgios Sakkas, PhD, University of Thessaly

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: sleep; miRNA; Dietary Intervention; Gut Microbiome; Chronobiology; Chrononutrition; Sports Nutrition; Carbohydrate periodization
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disorders of Excessive Somnolence; Sleepiness
• Other Study ID Numbers: EEBK/EΠ/2018/10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No