Integral Physiological Adaptations to Carbohydrate Periodization

NCT05464342 | Completed

• 1 other identifier: EEBK/EΠ/2018/10
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 2

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.

Conditions

Sleepiness; Fatigue; Feeding Patterns; Daytime Sleepiness, Excessive

Keywords

sleep; Carbohydrate periodization; Dietary Intervention; Sports Nutrition; Chrononutrition; Chronobiology; Gut Microbiome; miRNA

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Body Composition

  Assessed at 0-month (pre) and at 1-month (post)

• Exercise Performance

  Assessed at 0-month (pre) and at 1-month (post)

• Gut Microbiome

  Assessed at 0-month (pre) and at 1-month (post)

• miRNA levels

  Assessed at 0-month (pre) and at 1-month (post)

Study Arms (3)

Evening LGI Carbohydrate Consumption

EXPERIMENTAL

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

Behavioral: Evening LGI Carbohydrate Consumption Group

Evening HGI Carbohydrate Consumption

EXPERIMENTAL

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

Behavioral: Evening HGI Carbohydrate Consumption

Evening NO-CHO Carbohydrate Consumption

EXPERIMENTAL

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

Behavioral: Evening NO-CHO Carbohydrate Consumption

Interventions

Evening LGI Carbohydrate Consumption Group BEHAVIORAL

Participants will receive in the evening food with low glycemic index

Evening LGI Carbohydrate Consumption

Evening HGI Carbohydrate Consumption BEHAVIORAL

Participants will receive in the evening food with high glycemic index

Evening HGI Carbohydrate Consumption

Evening NO-CHO Carbohydrate Consumption BEHAVIORAL

Participants will receive in the evening a meal with no carbohydrates at all.

Evening NO-CHO Carbohydrate Consumption

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Both sexes, Age between 18 and 50 yrs old, Regularly participating in sports activities.

You may not qualify if:

• Any kind of history of major diseases or medication, Excessive amounts of alcohol and caffeine consumption

Sponsors & Collaborators

• University of Thessaly: lead
• University of Nicosia: collaborator
• University of Cyprus: collaborator

Study Sites (2)

Department of Life and Health Sciences

Nicosia, CY2417, Cyprus

Location

Lifestlye Medicine Laboratory, TEFAA, University of Thessaly

Trikala, Thessaly, 42100, Greece

Location

Related Publications (2)

• Vlahoyiannis A, Andreou E, Aphamis G, Felekkis K, Pieri M, Sakkas GK, Giannaki CD. Evaluating the evening carbohydrate dilemma: the effect of within-the-day carbohydrate periodization on body composition and physical fitness. Eur J Nutr. 2024 Nov 25;64(1):23. doi: 10.1007/s00394-024-03540-6.

  PMID: 39585451 DERIVED

• Vlahoyiannis A, Andreou E, Bargiotas P, Aphamis G, Sakkas GK, Giannaki CD. The effect of chrono-nutritional manipulation of carbohydrate intake on sleep macrostructure: A randomized controlled trial. Clin Nutr. 2024 Mar;43(3):858-868. doi: 10.1016/j.clnu.2024.02.016. Epub 2024 Feb 15.

  PMID: 38367595 DERIVED

MeSH Terms

Conditions

Sleepiness; Fatigue; Feeding Behavior; Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Georgios Sakkas, PhD

  University of Thessaly

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 19, 2022
• Study Start: July 5, 2022
• Primary Completion: April 1, 2023
• Study Completion: May 31, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1); CY (1)