Effect of Ketone Ester Supplementation on Sleep and Recovery in Hypoxia

September 27, 2023 updated by: Chiel Poffé, KU Leuven
This study specifically aims to elucidate the effects of IEK on sleep and recuperation in hypoxia, after training in normoxia. These conditions are in line with the widely applied live-high train-low strategy. Moreover, blood and tissue oxygenation status, as well as cerebral blood flow and cognitive function will be assessed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

Detailed Description

During training stages in order to prepare for an important event, sleep and recuperation are almost equally important as the appropriate training strategy. This training strategy often consists of living-high (sleeping at -stimulated- altitude) and training low (training at sea level). A decreased oxygen availability, also known as hypoxia, however often disrupts sleep quality and thus compromises the overall training efficiency. Ketones are recently found to improve sleep quality, thus potentially playing a pivotal role in altitude training. Therefore, the investigators want to evaluate the effects of ketones on sleep in hypoxia, after training in normoxia. Moreover, the effect on a performance test, during a simulated 30 min time trial on the next morning, will be investigated. During this protocol, cerebral blood flow will be assessed, as well as ventilation, blood and tissue oxygen status, heart rate variability, and cognitive function.

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.
13

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.
  • Not Applicable

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
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • KU Leuven

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Written informed consent must be obtained prior to any experimental procedures
  2. Males between 18 and 35 years old
  3. Recreational or competitive cyclists performing regular cycling training sessions with an average training volume of more than 6 hours per week
  4. Good health status confirmed by a medical screening
  5. Body Mass Index (BMI) between 18 and 25
  6. Normal sleep pattern as assessed by the Pittsburgh Sleep Quality Index
  7. Moderate sleep chronotype (extreme morning and evening chronotypes will be excluded), assessed by the Horne and Östberg questionnaire

Exclusion Criteria:

  1. Any kind of injury/pathology that is a contra-indication for hypoxic exposure and/or to perform high-intensity exercise, evaluated by a sport medical screening
  2. Intake of any medication or nutritional supplement that is known to affect exercise, performance or sleep. Intake will be assessed during recruitment and the sport medical screening.
  3. Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study.
  4. Recent residence or training under hypoxia; more than 7 days exposure to altitude > 1500m during the last 3 months preceding the study.
  5. Night-shifts or travel across time zones in the month preceding the study
  6. Blood donation within 3 months prior to the start of the study
  7. Smoking
  8. More than 3 alcoholic beverages per day
  9. Pre-existing, diagnosed psychiatric conditions or diagnosed anxiety
  10. Excessive daytime sleepiness as assessed by the Epworth scale
  11. Depression or anxiety as assessed by the Beck Depression Inventory and Beck Anxiety Inventory. Only a score in the range of 'normal ups and downs' (score 1-10) for depression or 'minimal anxiety' (score 0-7) for anxiety are tolerated.
  12. History of addiction or excessive caffeine/alcohol consumption assessed by a questionnaire
  13. 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.
Placebo Comparator: Normoxia - placebo
Both training and sleep in normoxia, supplemented with placebo
Dietary supplement: Placebo
Water, 5% collagen(w/w), octoacetate (1 mM)
Experimental: Hypoxia - placebo
Training in normoxia and sleep in hypoxia, supplemented with placebo
Dietary supplement: Placebo
Water, 5% collagen(w/w), octoacetate (1 mM)
Experimental: Hypoxia - ketones
Training in normoxia and sleep in hypoxia, supplemented with ketones
Dietary supplement: Ketone ester
A total of 75g ketone ester supplementation will be administered in 3 bouts of 25g in order to establish intermittent exogenous ketosis: twice immediately after training, and one 30 minutes before sleep. The ketone ester used is (R)-3-hydroxybutyl (R)-3-hydroxybutyrate

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
Duration of different sleep stages
Time Frame: Throughout the entire duration of the night, up to 9 hours after individual bedtime
Measured using polysomnography
Throughout the entire duration of the night, up to 9 hours after individual bedtime
Exercise performance
Time Frame: 30 minutes on the second morning of the protocol
Measured as the average power output (W) during a 30 minutes time trial
30 minutes on the second morning of the protocol
Change in nocturnal oxygen saturation
Time Frame: Throughout the entire duration of the night, up to 9 hours after individual bedtime
Measured using pulse oximetry
Throughout the entire duration of the night, up to 9 hours after individual bedtime
Absolute amount of nocturnal urinary catecholamine excretion
Time Frame: Subjects empty bladder before sleep and urine will be collected throughout the entire duration of the night, up to 9 hours after individual bedtime and in the morning immediately after waking up
Measured using ELISA of collected nocturnal urine
Subjects empty bladder before sleep and urine will be collected throughout the entire duration of the night, up to 9 hours after individual bedtime and in the morning immediately after waking up

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chiel Poffé, Dr., 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.
February 20, 2023

Primary Completion (Actual)

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.
March 31, 2023

Study Completion (Actual)

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.
March 31, 2023

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).
August 29, 2023

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.
September 27, 2023

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.
September 29, 2023

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.
September 29, 2023

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.
September 27, 2023

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.
September 1, 2023

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.
  • S67089

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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