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SleepinessIPACPNCT05464342

Integral Physiological Adaptations to Carbohydrate Periodization

A study testing Evening LGI Carbohydrate Consumption Group, Evening HGI Carbohydrate Consumption and Evening NO-CHO Carbohydrate Consumption in people with Sleepiness and Fatigue, run by University of Thessaly at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Sleepiness, Fatigue, Feeding Patterns
What is being tested?
Evening LGI Carbohydrate Consumption Group, Evening HGI Carbohydrate Consumption and Evening NO-CHO Carbohydrate Consumption
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
2 sitesin 2 countries
Study dates
5 Jul 2022to 31 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Cyprus1 site

  • Department of Life and Health Sciences

    Nicosia, CY2417

Other trials in Cyprus

Greece1 site

  • Lifestlye Medicine Laboratory, TEFAA, University of Thessaly

    Trikala, Thessaly, 42100

Other trials in Greece

About this study

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.

Read the 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.

Being tested
Evening LGI Carbohydrate Consumption Group, Evening HGI Carbohydrate Consumption, Evening NO-CHO Carbohydrate Consumption
Keywords
sleep, Carbohydrate periodization, Dietary Intervention, Sports Nutrition, Chrononutrition, Chronobiology, Gut Microbiome, miRNA
Medical subject headings
Sleepiness, Fatigue, Feeding Behavior, Disorders of Excessive Somnolence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evening LGI Carbohydrate Consumption GroupBehavioural

    Participants will receive in the evening food with low glycemic index

  • Evening HGI Carbohydrate ConsumptionBehavioural

    Participants will receive in the evening food with high glycemic index

  • Evening NO-CHO Carbohydrate ConsumptionBehavioural

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

Study groups in NCT05464342
Study groupRoleWhat they receive
Evening LGI Carbohydrate ConsumptionExperimentalDietary Intervention: Consumption of Low Glyceamic Index (LGI) carbohydrates intake post-workout/evening.
Receives: Behavioral: Evening LGI Carbohydrate Consumption Group
Evening HGI Carbohydrate ConsumptionExperimentalDietary Intervention: Consumption of High Glyceamic Index (HGI) carbohydrates intake post-workout/evening.
Receives: Behavioral: Evening HGI Carbohydrate Consumption
Evening NO-CHO Carbohydrate ConsumptionExperimentalDietary Intervention: No consumption of carbohydrates intake post-workout/evening.
Receives: Behavioral: Evening NO-CHO Carbohydrate Consumption

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (4)

  1. Body Composition

    Changes in Body composition. The changes in body composition will be assessed by the skinfold measurements and BIA

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

  2. Exercise Performance

    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.

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

  3. Gut Microbiome

    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.

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

  4. miRNA levels

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2022
  2. Study start5 Jul 2022
  3. Primary completion1 Apr 2023
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05464342
Sponsor's protocol ID
EEBK/EΠ/2018/10
Acronym
IPACP
Status last verified
Jun 2023
First submitted
4 Jul 2022
Last updated
5 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39585451

  • 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.

    PubMed 38367595

Questions about this trial

What is this clinical trial studying?

A study testing Evening LGI Carbohydrate Consumption Group, Evening HGI Carbohydrate Consumption and Evening NO-CHO Carbohydrate Consumption in people with Sleepiness and Fatigue, run by University of Thessaly at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Cyprus, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep Efficiency (time frame: Assessed at 0-month (pre) and at 1-month (post)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05464342, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.

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