Acute Effect of Exogenous Ketosis on Sleep Architecture Following Strenuous Exercise

Study Overview
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Brief Summary
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The aim of this study is to investigate the effect of oral ketone ester administration on sleep architecture. To investigate this, the investigators use a randomised, placebo-controlled, cross-over research design. The study comprises three experimental sessions, each separated by a one-week washout period. Two of the three experimental sessions consist of a 120 minutes cycling endurance training session (ET) two hours after breakfast and an evening high-intensity-interval training (HIIT) ending one hour before bedtime. After each training session, and 30 minutes before sleeptime, subjects receive a ketone ester or a control drink . To investigate the effects of strenuous exercise on sleep alone, an additional experimental session without exercise is added. Before bedtime, a venous blood sample is taken to evaluate hormones playing an important role in sleep regulation. During the experimental sessions, the subjects sleep in a sleep facility to evaluate quality of sleep. Time spent in different sleep phases is measured via polysomnography (PSG). Urine output throughout the day and night will be collected for measurement of urinary excretion of adrenaline and noradrenaline as an index of intrinsic sympathetic activity.

Official Title
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Acute Effect of Exogenous Ketosis on Sleep Architecture Following Morning and Evening Strenuous Exercise

Conditions
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Sleep

Intervention / Treatment
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* Dietary Supplement: Ketone ester
* Dietary Supplement: Placebo
* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males between 18 and 35 years old Recreational or competitive cyclists performing regularly cycling training sessions with an average training volume of more than 6 hours per week Good health status confirmed by a medical screening Body Mass Index (BMI) between 18 and 25 Normal sleep pattern as assessed by the Pittsburgh Sleep Quality Index (PSQI) Moderate sleep chronotype, assessed by the Horne and Östberg questionnaire Exclusion Criteria: Excessive daytime sleepiness as assessed by the Epworth scale Depression or anxiety as assessed by the Beck Depression Inventory and Beck Anxiety Inventory Night-shifts or travel across time zones in the month preceding the study Any kind of injury/pathology that is a contra-indication to perform high-intensity exercise Intake of any medication or nutritional supplement that is known to affect exercise performance or sleep Smoking Involvement in elite athletic training at a semi-professional or professional level Current participation in another research trial Any other argument to believe that the subject is unlikely to successfully complete the full study protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise and ketone<br>Ketone ester is provided | Dietary Supplement: Ketone ester<br>* A dose of 25g of ketone ester after each training session and 30 minutes before sleeptime. The total dose is 75g of ketone ester.<br>Behavioral: Exercise<br>* A 120 minutes cycling endurance training session (ET) two hours after breakfast and an evening high-intensity-interval training (HIIT) ending one hour before bedtime<br>|
| Placebo Comparator: Exercise and placebo<br>Placebo is provided | Dietary Supplement: Placebo<br>* Collagen peptan (3g) mixed with 1 mM bitter sucrose octaacetate and 20ml of pure water. A dose of 25g of placebo drink is provided after each training session and 30 minutes before sleeptime. The total dose is 75g of placebo drink.<br>Behavioral: Exercise<br>* A 120 minutes cycling endurance training session (ET) two hours after breakfast and an evening high-intensity-interval training (HIIT) ending one hour before bedtime<br>|
| Placebo Comparator: Non-exercise and placebo<br>Placebo is provided | Dietary Supplement: Placebo<br>* Collagen peptan (3g) mixed with 1 mM bitter sucrose octaacetate and 20ml of pure water. A dose of 25g of placebo drink is provided after each training session and 30 minutes before sleeptime. The total dose is 75g of placebo drink.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total sleep time | Change in total sleep time between conditions as evaluated with polysomnography | Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks) | 
| Urinary nocturnal adrenaline excretion | Change in urinary nocturnal adrenaline excretion between conditions | Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks) | 
| Urinary nocturnal noradrenaline excretion | Change in urinary nocturnal adrenaline excretion between conditions | Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total rapid-eye-movement sleep | Change in total rapid-eye-movement sleep between conditions as evaluated with polysomnography | Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks) | 
| Total non-rapid-eye-movement sleep | Change in total non-rapid-eye-movement sleep between conditions as evaluated with polysomnography | Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks) | 
| Total slow-wave sleep | Change in total slow-wave sleep between conditions as evaluated with polysomnography | Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks) | 
| Plasma adrenaline concentration | Change in plasma adrenaline concentration between conditions | Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks) | 
| Plasma noradrenaline concentration | Change in plasma noradrenaline concentration between conditions | Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketone, Exercise, Sleep