Clinical trial NCT06965491: The Effects of Exogenous Ketosis on Ultra-endurance Recovery and Performance
Official title: Exploring the Role of Intermittent Exogenous Ketosis on Physical and Mental Fatigue During Ultra-endurance Performance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exogenous Ketosis
Endurance Cycling Performance
Fatigue; Muscle, Heart
Fatigue, Mental
Keywords: ultra-endurance
cycling
physiological strain
mental fatigue
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: University of Stellenbosch
First posted: 2025-05-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Riders will be paired matched and randomly assigned to either the ketone ester supplementation (KE) group or the control group (CON) which will receive an isocaloric taste-matched placebo
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims to investigate the effects of post-exercise and pre-sleep ketosis via oral ketone ester supplementation on physical and mental recovery during a multi-day cycling stage race.

Detailed description: Ultra-endurance events are becoming increasing popular. Participation in the multi-day events adds a lot of physical and mental strain on the body, while the athletes are still required to perform. Without appropriate recovery the athletes are at increased risk of overreaching, injury, or illness.

Therefore, the purpose of the study is to create a better understanding of the exercise fatigue experienced during ultra-endurance performance and the role intermittent exogenous ketosis (IEK) plays in reducing the amount of fatigue to maintain performance during multi-day racing and lower the risk of injury and illness.

Participants will first compete in a 8-day simulated stage race performed on taxc trainers and then we will conduct a field study during the Absa Cape Epic a 8-day mountain bike stage race. Immediately following each stage and 30-mins before bed the participants will consume either a ketone ester and taste-match placebo drink. During the race the following variables will be measured; hydration status, weight change, activity readiness, and nutrition intake. Cognitive function will be assessed on day 2, 4 and 8 of racing. One day before and one day after the race the participants will report to the lab to assess basal metabolic rate, stress via questionnaires, appetite, cognitive function, muscle biopsies, venous blood samples, mechanical efficiency and 30-min Time Trial.

Eligibility criteria: Inclusion Criteria:

* have been cycling consistently for at least 1 year before entry into the study
* have been cycling for a minimum of 7 hours per week for the 6 months leading up to the study
* additional for the field study: valid entry to the 2025 edition of the Absa Cape Epic
* non-smoker

Exclusion Criteria:

* Do not follow a ketogenic diet or low-carbohydrate diet
* Have any metabolic or auto-immune disease that will influence their metabolism
* Take medication or supplements that is known to affect ketone supplement metabolism
* suffering from a recurring injury or illness from which they have not fully recovered that is a contr-indication to perform high-intensity exercise
* Unable to finish each stage
* Women: if they are pregnant or breastfeeding

Primary outcomes:
measure: Muscle soreness
timeFrame: During the intervention
measure: Physical stress
timeFrame: pre-intervention and 1 day after the intervention
measure: Hydration status
timeFrame: Baseline, During the intervention and 1 day after the intervention
measure: Cognitive function: reaction time
timeFrame: Pre-intervention, day 2, 4 and 8 of the intervention
measure: Cognitive function: rapid visual processing
timeFrame: Pre-intervention, day 2, 4 and 8 of the intervention
measure: Cognitive function: swm
timeFrame: Pre-intervention, day 2, 4 and 8 of the intervention
measure: Sleep Duration
timeFrame: 1 week prior to racing and during the race
measure: Sleep: REM
timeFrame: 1 week prior to racing and during the race
measure: Sleep: Non-REM
timeFrame: 1 week prior to racing and during the race
measure: Sleep: WASO
timeFrame: 1 week prior to racing and during the race
Secondary outcomes:
measure: Mechanical efficiency
timeFrame: pre-intervention and 1 day after the intervention
measure: Time trial performance
timeFrame: pre-intervention and 1 day after the intervention
measure: Appetite
timeFrame: pre-intervention, during the intervention, 1 day after the intervention
measure: Macronutrient intake
timeFrame: baseline, during the intervention
measure: Total energy intake
timeFrame: baseline, during the intervention
measure: Racing intensity
timeFrame: during each stage
measure: Body weight change
timeFrame: During the intervention
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven
name: Chiel Poffé
role: PRINCIPAL_INVESTIGATOR
References: