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