Status:
COMPLETED
Effect of Ketone Ester Supplementation on Sleep and Recovery in Hypoxia
Lead Sponsor:
KU Leuven
Conditions:
Ketosis
Hypoxia
Eligibility:
MALE
18-35 years
Phase:
NA
Brief Summary
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 ...
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 li...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT06060093
Start Date
February 20 2023
End Date
March 31 2023
Last Update
September 29 2023
Active Locations (1)
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1
KU Leuven
Leuven, Vlaams-Brabant, Belgium, 3000