Clinical trial NCT05464342: Integral Physiological Adaptations to Carbohydrate Periodization
Official title: Integral Physiological Adaptations to Carbohydrate Periodization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleepiness
Fatigue
Feeding Patterns
Daytime Sleepiness, Excessive
Keywords: sleep
Carbohydrate periodization
Dietary Intervention
Sports Nutrition
Chrononutrition
Chronobiology
Gut Microbiome
miRNA
Lead sponsor: University of Thessaly
Sponsor class: OTHER
Collaborators: name: University of Nicosia
name: University of Cyprus
First posted: 2022-07-19
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Sleep Efficiency
timeFrame: Assessed at 0-month (pre) and at 1-month (post)
measure: Quality of Sleep Score
timeFrame: Assessed at 0-month (pre) and at 1-month (post)
measure: Daytime Sleepiness
timeFrame: Assessed at 0-month (pre) and at 1-month (post)
Secondary outcomes:
measure: Body Composition
timeFrame: Assessed at 0-month (pre) and at 1-month (post)
measure: Exercise Performance
timeFrame: Assessed at 0-month (pre) and at 1-month (post)
measure: Gut Microbiome
timeFrame: Assessed at 0-month (pre) and at 1-month (post)
measure: miRNA levels
timeFrame: Assessed at 0-month (pre) and at 1-month (post)
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: Department of Life and Health Sciences
city: Trikala
country: Greece
facility: Lifestlye Medicine Laboratory, TEFAA, University of Thessaly
state: Thessaly
Study officials:
affiliation: University of Thessaly
name: Georgios Sakkas, PhD
role: STUDY_CHAIR
References: