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Integral Physiological Adaptations to Carbohydrate Periodization (IPACP)

Primary Purpose

Sleepiness, Fatigue, Feeding Patterns

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Evening LGI Carbohydrate Consumption Group
Evening HGI Carbohydrate Consumption
Evening NO-CHO Carbohydrate Consumption
Sponsored by
University of Thessaly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sleepiness focused on measuring sleep, Carbohydrate periodization, Dietary Intervention, Sports Nutrition, Chrononutrition, Chronobiology, Gut Microbiome, miRNA

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Life and Health Sciences
  • Lifestlye Medicine Laboratory, TEFAA, University of Thessaly

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Evening LGI Carbohydrate Consumption

Evening HGI Carbohydrate Consumption

Evening NO-CHO Carbohydrate Consumption

Arm Description

Dietary Intervention: Consumption of Low Glyceamic Index (LGI) carbohydrates intake post-workout/evening.

Dietary Intervention: Consumption of High Glyceamic Index (HGI) carbohydrates intake post-workout/evening.

Dietary Intervention: No consumption of carbohydrates intake post-workout/evening.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
July 4, 2022
Last Updated
June 2, 2023
Sponsor
University of Thessaly
Collaborators
University of Nicosia, University of Cyprus
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1. Study Identification

Unique Protocol Identification Number
NCT05464342
Brief Title
Integral Physiological Adaptations to Carbohydrate Periodization
Acronym
IPACP
Official Title
Integral Physiological Adaptations to Carbohydrate Periodization
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Thessaly
Collaborators
University of Nicosia, University of Cyprus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleepiness, Fatigue, Feeding Patterns, Daytime Sleepiness, Excessive
Keywords
sleep, Carbohydrate periodization, Dietary Intervention, Sports Nutrition, Chrononutrition, Chronobiology, Gut Microbiome, miRNA

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized controlled trial. The study is composed of three groups, differentiating on evening carbohydrate quantity and quality (glycaemic index) intake. The trial period will last for 1 month for all groups. Intervention includes lifestyle changes, targeting exercise, and diet. The design is parallel.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evening LGI Carbohydrate Consumption
Arm Type
Experimental
Arm Description
Dietary Intervention: Consumption of Low Glyceamic Index (LGI) carbohydrates intake post-workout/evening.
Arm Title
Evening HGI Carbohydrate Consumption
Arm Type
Experimental
Arm Description
Dietary Intervention: Consumption of High Glyceamic Index (HGI) carbohydrates intake post-workout/evening.
Arm Title
Evening NO-CHO Carbohydrate Consumption
Arm Type
Experimental
Arm Description
Dietary Intervention: No consumption of carbohydrates intake post-workout/evening.
Intervention Type
Behavioral
Intervention Name(s)
Evening LGI Carbohydrate Consumption Group
Intervention Description
Participants will receive in the evening food with low glycemic index
Intervention Type
Behavioral
Intervention Name(s)
Evening HGI Carbohydrate Consumption
Intervention Description
Participants will receive in the evening food with high glycemic index
Intervention Type
Behavioral
Intervention Name(s)
Evening NO-CHO Carbohydrate Consumption
Intervention Description
Participants will receive in the evening a meal with no carbohydrates at all.
Primary Outcome Measure Information:
Title
Sleep Efficiency
Description
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)
Title
Quality of Sleep Score
Description
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)
Title
Daytime Sleepiness
Description
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)
Secondary Outcome Measure Information:
Title
Body Composition
Description
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)
Title
Exercise Performance
Description
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)
Title
Gut Microbiome
Description
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)
Title
miRNA levels
Description
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)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgios Sakkas, PhD
Organizational Affiliation
University of Thessaly
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Life and Health Sciences
City
Nicosia
ZIP/Postal Code
CY2417
Country
Cyprus
Facility Name
Lifestlye Medicine Laboratory, TEFAA, University of Thessaly
City
Trikala
State/Province
Thessaly
ZIP/Postal Code
42100
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

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Integral Physiological Adaptations to Carbohydrate Periodization

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