Acute Effect of Exogenous Ketosis on Sleep Architecture Following Strenuous Exercise

June 28, 2022 updated by: Peter Hespel, KU Leuven

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total sleep time
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total rapid-eye-movement sleep
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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