Integral Physiological Adaptations to Carbohydrate Periodization

NCT ID: NCT05464342

Last Updated: 2023-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-05

Study Completion Date

2023-05-31

Brief Summary

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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

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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.

Conditions

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Sleepiness Fatigue Feeding Patterns Daytime Sleepiness, Excessive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Evening LGI Carbohydrate Consumption

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

Group Type EXPERIMENTAL

Evening LGI Carbohydrate Consumption Group

Intervention Type BEHAVIORAL

Participants will receive in the evening food with low glycemic index

Evening HGI Carbohydrate Consumption

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

Group Type EXPERIMENTAL

Evening HGI Carbohydrate Consumption

Intervention Type BEHAVIORAL

Participants will receive in the evening food with high glycemic index

Evening NO-CHO Carbohydrate Consumption

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

Group Type EXPERIMENTAL

Evening NO-CHO Carbohydrate Consumption

Intervention Type BEHAVIORAL

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

Interventions

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Evening LGI Carbohydrate Consumption Group

Participants will receive in the evening food with low glycemic index

Intervention Type BEHAVIORAL

Evening HGI Carbohydrate Consumption

Participants will receive in the evening food with high glycemic index

Intervention Type BEHAVIORAL

Evening NO-CHO Carbohydrate Consumption

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nicosia

OTHER

Sponsor Role collaborator

University of Cyprus

OTHER

Sponsor Role collaborator

University of Thessaly

OTHER

Sponsor Role lead

Responsible Party

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Giorgos K. Sakkas

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georgios Sakkas, PhD

Role: STUDY_CHAIR

University of Thessaly

Locations

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Department of Life and Health Sciences

Nicosia, , Cyprus

Site Status

Lifestlye Medicine Laboratory, TEFAA, University of Thessaly

Trikala, Thessaly, Greece

Site Status

Countries

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Cyprus Greece

References

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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.

Reference Type DERIVED
PMID: 39585451 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38367595 (View on PubMed)

Other Identifiers

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EEBK/EΠ/2018/10

Identifier Type: -

Identifier Source: org_study_id

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