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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

Tracking Information
First Submitted Date  ICMJE July 4, 2022
First Posted Date  ICMJE July 19, 2022
Last Update Posted Date July 19, 2022
Actual Study Start Date  ICMJE July 5, 2022
Estimated Primary Completion Date November 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2022)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2022)
  • 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
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Integral Physiological Adaptations to Carbohydrate Periodization
Official Title  ICMJE Integral Physiological Adaptations to Carbohydrate Periodization
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Sleepiness
  • Fatigue
  • Feeding Patterns
  • Daytime Sleepiness, Excessive
Intervention  ICMJE
  • Behavioral: Evening LGI Carbohydrate Consumption Group
    Participants will receive in the evening food with low glycemic index
  • Behavioral: Evening HGI Carbohydrate Consumption
    Participants will receive in the evening food with high glycemic index
  • Behavioral: Evening NO-CHO Carbohydrate Consumption
    Participants will receive in the evening a meal with no carbohydrates at all.
Study Arms  ICMJE
  • Experimental: Evening LGI Carbohydrate Consumption
    Dietary Intervention: Consumption of Low Glyceamic Index (LGI) carbohydrates intake post-workout/evening.
    Intervention: Behavioral: Evening LGI Carbohydrate Consumption Group
  • Experimental: Evening HGI Carbohydrate Consumption
    Dietary Intervention: Consumption of High Glyceamic Index (HGI) carbohydrates intake post-workout/evening.
    Intervention: Behavioral: Evening HGI Carbohydrate Consumption
  • Experimental: Evening NO-CHO Carbohydrate Consumption
    Dietary Intervention: No consumption of carbohydrates intake post-workout/evening.
    Intervention: Behavioral: Evening NO-CHO Carbohydrate Consumption
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 14, 2022)		 45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date November 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Angelos Vlahoyiannis, MSc +357-96001354 vlahoyiannis.a@unic.ac.cy
Contact: Christoforos Giannaki, PhD giannaki.c@unic.ac.cy
Listed Location Countries  ICMJE Cyprus,   Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05464342
Other Study ID Numbers  ICMJE EEBK/EΠ/2018/10
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Giorgos K. Sakkas, University of Thessaly
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Thessaly
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of Nicosia
  • University of Cyprus
Investigators  ICMJE
Study Chair: Georgios Sakkas, PhD University of Thessaly
PRS Account University of Thessaly
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP