We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Integral Physiological Adaptations to Carbohydrate Periodization (IPACP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05464342
Recruitment Status : Recruiting
First Posted : July 19, 2022
Last Update Posted : July 19, 2022
Sponsor:
Collaborators:
University of Nicosia
University of Cyprus
Information provided by (Responsible Party):
Giorgos K. Sakkas, University of Thessaly

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.

Condition or disease Intervention/treatment Phase
Sleepiness Fatigue Feeding Patterns Daytime Sleepiness, Excessive Behavioral: Evening LGI Carbohydrate Consumption Group Behavioral: Evening HGI Carbohydrate Consumption Behavioral: Evening NO-CHO Carbohydrate Consumption Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (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.
Primary Purpose: Prevention
Official Title: Integral Physiological Adaptations to Carbohydrate Periodization
Actual Study Start Date : July 5, 2022
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : December 31, 2022

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05464342


Contacts
Layout table for location contacts
Contact: Angelos Vlahoyiannis, MSc +357-96001354 vlahoyiannis.a@unic.ac.cy
Contact: Christoforos Giannaki, PhD giannaki.c@unic.ac.cy

Locations
Layout table for location information
Cyprus
Department of Life and Health Sciences Recruiting
Nicosia, Cyprus, CY2417
Contact: Angelos Vlahoyiannis, MSc    +35796001354    vlahoyiannis.a@unic.ac.cy   
Contact: Christoforos Giannaki, PhD       giannaki.c@unic.ac.cy   
Greece
Lifestlye Medicine Laboratory, TEFAA, University of Thessaly Recruiting
Trikala, Thessaly, Greece, 42100
Contact: Giorgos K Sakkas, PhD    +30-24310-47022    gsakkas@med.uth.gr   
Sponsors and Collaborators
University of Thessaly
University of Nicosia
University of Cyprus
Investigators
Layout table for investigator information
Study Chair: Georgios Sakkas, PhD University of Thessaly
Layout table for additonal information
Responsible Party: Giorgos K. Sakkas, Associate Professor, University of Thessaly
ClinicalTrials.gov Identifier: NCT05464342    
Other Study ID Numbers: EEBK/EΠ/2018/10
First Posted: July 19, 2022    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Giorgos K. Sakkas, University of Thessaly:
sleep
Carbohydrate periodization
Dietary Intervention
Sports Nutrition
Chrononutrition
Chronobiology
Gut Microbiome
miRNA
Additional relevant MeSH terms:
Layout table for MeSH terms
Disorders of Excessive Somnolence
Sleepiness
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders