Status:
UNKNOWN
Acute Effect of Exogenous Ketosis on Sleep Architecture Following Strenuous Exercise
Lead Sponsor:
KU Leuven
Conditions:
Sleep
Eligibility:
MALE
18-35 years
Phase:
PHASE2
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2022
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT05439720
Start Date
May 15 2022
End Date
August 15 2022
Last Update
June 30 2022
Active Locations (1)
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1
Exercise Physiology Group
Leuven, Belgium, 3000