Acute Effect of Exogenous Ketosis on Sleep Architecture Following Strenuous Exercise

Phase 2

• Conditions: Sleep
• Interventions: Dietary Supplement: Ketone ester; Dietary Supplement: Placebo; Behavioral: Exercise

• Registration Number: NCT05439720
• Lead Sponsor: KU Leuven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-15
• Status Verified: 2022-06
• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-28
• Last Update Submitted: 2022-06-28
• Study First Posted: 2022-06-30
• Last Update Posted: 2022-06-30
• Primary Completion: 2022-07-01
• Study Completion: 2022-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Exercise and ketone	Ketone ester	Ketone ester is provided
Exercise and ketone	Exercise	Ketone ester is provided
Exercise and placebo	Placebo	Placebo is provided
Exercise and placebo	Exercise	Placebo is provided
Non-exercise and placebo	Placebo	Placebo is provided

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Exercise Physiology Group; 🇧🇪 Leuven, Belgium