Integral Physiological Adaptations to Carbohydrate Periodization (IPACP)
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|ClinicalTrials.gov Identifier: NCT05464342|
Recruitment Status : Recruiting
First Posted : July 19, 2022
Last Update Posted : July 19, 2022
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|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.|
|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|
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.
- 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.
- 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.
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
|Contact: Angelos Vlahoyiannis, MScfirstname.lastname@example.org|
|Contact: Christoforos Giannaki, PhDemail@example.com|
|Department of Life and Health Sciences||Recruiting|
|Nicosia, Cyprus, CY2417|
|Contact: Angelos Vlahoyiannis, MSc +35796001354 firstname.lastname@example.org|
|Contact: Christoforos Giannaki, PhD email@example.com|
|Lifestlye Medicine Laboratory, TEFAA, University of Thessaly||Recruiting|
|Trikala, Thessaly, Greece, 42100|
|Contact: Giorgos K Sakkas, PhD +30-24310-47022 firstname.lastname@example.org|
|Study Chair:||Georgios Sakkas, PhD||University of Thessaly|