Effect of Exogenous Ketosis During Ultra-endurance Exercise

Phase 2

• Conditions: Exercise; Ultra-endurance Running; Skeletal Muscle; Cognitive Function; Ketosis
• Interventions: Dietary Supplement: Ketone ester; Dietary Supplement: Placebo

• Registration Number: NCT05407753
• Lead Sponsor: KU Leuven

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-20
• Primary Completion: 2021-10-24
• Study First Submitted: 2022-05-26
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-02
• Last Update Submitted: 2022-06-02
• Study First Posted: 2022-06-07
• Last Update Posted: 2022-06-07
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• Males between 18 and 55 years old
• Recreational or competitive runner having performed an ultramarathon (>42km) during the last 2 years
• Good health status confirmed by a medical screening
• Body Mass Index (BMI) between 18 and 25

Exclusion Criteria

• Any kind of injury/pathology that is a contra-indication to perform ultra-endurance exercise
• Intake of any medication or nutritional supplement that is known to affect exercise performance
• Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study.
• Blood donation within 3 months prior to the start of the study
• Smoking
• More than 3 alcoholic beverages per day
• Current participation in another research trial
• Any other argument to believe that the subject is unlikely to successfully complete the full study protocol
• Adherence to a high-fat, low-carbohydrate ketogenic diet (less than 20% of energy intake derived from carbohydrates)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketone ester	Ketone ester	Subjects receive the ketone ester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (25g before ultrarun, 12.5g every 30 min during race, 25g immediately after race, 25g before sleep, 3 x 25g on day after race.
Con	Placebo	Subjects receive a non-caloric, taste matched placebo (water and sucrose octaacetate).

Primary Outcome Measures

Name	Time	Method
Countermovent jump	Before race - immediately after race - 48 hours after start of race	Change in countermovement jump height
Skeletal muscle inflammatory cell infiltration	Before race - 48 hours after start of race	Change in infiltration of inflammatory cells in skeletal muscle
Reaction time	Before race - immediately after race	Change in reaction time during a reaction time task
Exercise performance	Immediately after race	Time needed to complete the ultrarun

Secondary Outcome Measures

Name	Time	Method
Catecholamines in blood	Before race - immediately after race - 48 hours after start of race	Change in catecholamine concentration in plasma

Trial Locations

Locations (1)

Exercise Physiology Research Group; 🇧🇪 Leuven, Vlaams-Brabant, Belgium