NCT05407753

Effect of Exogenous Ketosis During Ultra-endurance Exercise

Effect of Oral Ketone Administration on Cognitive Function, Musculoskeletal Damage and Hormonal and Metabolic Dysregulations Induced by Ultra-endurance Running

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: KU Leuven · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to investigate the effect of oral ketone administration during and immediately after an ultramarathon. Potential changes in cognitive function (reaction time, number of errors), running performance, jump height, skeletal muscle inflammatory infiltration and hormonal alterations will be the main focus. In this context, subjects (n=24) will perform a 100km ultrarunning trail, while receiving either ketone ester (KE, n =12) or placebo (CON, n=12). Experimental measurements will be performed immediately before and after the ultramarathon as well as 24h after the ultramarathon.

Conditions

• Exercise
• Ultra-endurance Running
• Ketosis
• Skeletal Muscle
• Cognitive Function

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ketone ester	Subjects receive the ketone ester at the following timepoints: 25g before ultrarun, 12.5g every 30 min during race, 25g immediately after race, 25g before sleep, 3 x 25g on day after race.
DIETARY_SUPPLEMENT	Placebo	Subjects receive a non-caloric taste-matched placebo (water with sucrose octaacetate)

Timeline

• Start date: 2021-05-20
• Primary completion: 2021-10-24
• Completion: 2022-12-31
• First posted: 2022-06-07
• Last updated: 2022-06-07

Locations

1 site across 1 country: Belgium