Acute Effect of Exogenous Ketosis on Sleep Architecture Following Strenuous Exercise

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05439720
• Other study ID #: S65394
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 15, 2022
• Est. completion date: August 15, 2022

Study information

• Verified date: June 2022
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11
• Est. completion date: August 15, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Ketosis
• Sleep

Intervention

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.
• 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.

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

Locations

Country	Name	City	State
Belgium	Exercise Physiology Group	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)