Acute Effect of Exogenous Ketosis on Sleep Architecture Following Strenuous Exercise

NCT05439720 | Unknown Phase 2 FDA Drug

• 1 other identifier: S65394
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Keywords

Ketone; Exercise; Sleep

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (3)

Exercise and ketone

EXPERIMENTAL

Ketone ester is provided

Dietary Supplement: Ketone ester; Behavioral: Exercise

Exercise and placebo

PLACEBO COMPARATOR

Placebo is provided

Dietary Supplement: Placebo; Behavioral: Exercise

Non-exercise and placebo

PLACEBO COMPARATOR

Placebo is provided

Dietary Supplement: Placebo

Interventions

Ketone ester DIETARY_SUPPLEMENT

A dose of 25g of ketone ester after each training session and 30 minutes before sleeptime. The total dose is 75g of ketone ester.

Exercise and ketone

Placebo DIETARY_SUPPLEMENT

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.

Exercise and placebo; Non-exercise and placebo

Exercise BEHAVIORAL

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

Exercise and ketone; Exercise and placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

Exercise Physiology Group

Leuven, 3000, Belgium

Location

Related Publications (1)

• Robberechts R, Albouy G, Hespel P, Poffe C. Exogenous Ketosis Improves Sleep Efficiency and Counteracts the Decline in REM Sleep after Strenuous Exercise. Med Sci Sports Exerc. 2023 Nov 1;55(11):2064-2074. doi: 10.1249/MSS.0000000000003231. Epub 2023 Jun 1.

  PMID: 37259248 DERIVED

MeSH Terms

Conditions

Ketosis; Motor Activity

Interventions

formic acid 4-(3-oxobutyl)phenyl ester; Exercise

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 30, 2022
• Study Start: May 15, 2022
• Primary Completion: July 1, 2022
• Study Completion: August 15, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

BE (1)