Acute Effect of Exogenous Ketosis on Sleep Architecture Following Strenuous Exercise

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sleep
• Intervention / Treatment: Dietary supplement: Ketone ester; Behavioral: Exercise; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Exercise Physiology Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise and ketone; Ketone ester is provided	Dietary supplement: Ketone ester; A dose of 25g of ketone ester after each training session and 30 minutes before sleeptime. The total dose is 75g of ketone ester.; Behavioral: Exercise; 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
Placebo Comparator: Exercise and placebo; Placebo is provided	Behavioral: Exercise; 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; Dietary supplement: Placebo; 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.
Placebo Comparator: Non-exercise and placebo; Placebo is provided	Dietary supplement: Placebo; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): August 15, 2022

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; Sleep; Ketone
• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis; Ketosis
• Other Study ID Numbers: S65394

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes