- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06060093
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
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
13
Phase
- 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
-
-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Written informed consent must be obtained prior to any experimental procedures
- Males between 18 and 35 years old
- Recreational or competitive cyclists performing regular 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
- Moderate sleep chronotype (extreme morning and evening chronotypes will be excluded), assessed by the Horne and Östberg questionnaire
Exclusion Criteria:
- 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
- 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.
- Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study.
- Recent residence or training under hypoxia; more than 7 days exposure to altitude > 1500m during the last 3 months preceding the study.
- Night-shifts or travel across time zones in the month preceding the study
- Blood donation within 3 months prior to the start of the study
- Smoking
- More than 3 alcoholic beverages per day
- Pre-existing, diagnosed psychiatric conditions or diagnosed anxiety
- Excessive daytime sleepiness as assessed by the Epworth scale
- 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.
- History of addiction or excessive caffeine/alcohol consumption assessed by a questionnaire
- 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 |
Intervention / Treatment |
---|---|
Placebo Comparator: Normoxia - placebo
Both training and sleep in normoxia, supplemented with placebo
|
Water, 5% collagen(w/w), octoacetate (1 mM)
|
Experimental: Hypoxia - placebo
Training in normoxia and sleep in hypoxia, supplemented with placebo
|
Water, 5% collagen(w/w), octoacetate (1 mM)
|
Experimental: Hypoxia - ketones
Training in normoxia and sleep in hypoxia, supplemented with ketones
|
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
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
Investigators
- 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)
February 20, 2023
Primary Completion (Actual)
March 31, 2023
Study Completion (Actual)
March 31, 2023
Study Registration Dates
First Submitted
August 29, 2023
First Submitted That Met QC Criteria
September 27, 2023
First Posted (Actual)
September 29, 2023
Study Record Updates
Last Update Posted (Actual)
September 29, 2023
Last Update Submitted That Met QC Criteria
September 27, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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