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The Effects of Exogenous Ketosis on Ultra-endurance Recovery and Performance

Exploring the Role of Intermittent Exogenous Ketosis on Physical and Mental Fatigue During Ultra-endurance Performance

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06965491
Enrollment
18
Registered
2025-05-11
Start date
2024-03-01
Completion date
2025-10-30
Last updated
2026-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endurance Cycling Performance, Exogenous Ketosis, Fatigue, Mental, Fatigue; Muscle, Heart

Keywords

ultra-endurance, cycling, physiological strain, mental fatigue

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.

Interventions

DIETARY_SUPPLEMENTPlacebo Supplement

Placebo supplement: Oral supplement containing: 16.4 grams of medium chained triglycerides, 1mM or sucrose octaacetate and water

DIETARY_SUPPLEMENTKetone ester supplement

Ketone ester supplement Oral supplement containing: 25 grams of pure (R)-3-hydroxybutyl-(R)-3-hydroxybutyrate ketone monoester drink

Sponsors

KU Leuven
Lead SponsorOTHER
University of Stellenbosch
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Masking description

Participants and investigators are blinded from the experimental condition (KE or CON). Supplements are provided in non transparent tubes and the control supplement is identical in taste and viscosity to the ketone supplement.

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cognitive function: rapid visual processingPre-intervention, day 2, 4 and 8 of the interventionCANTAB test battery rapid visual processing test was used to assess their susceptibility to false alarms
Muscle sorenessDuring the interventionVisual analog scale (0-10) How sore does you leg muscles feel? The VAS was used as a subjective measure of muscle soreness
Physical stresspre-intervention and 1 day after the interventionRESTQ-76 sport questionnaire was used to assess the stress-recovery balance
Hydration statusBaseline, During the intervention and 1 day after the interventionBefore every stage, the participants provided a urine sample in a cup. A urine-specific refractometer (Atago) was used to determine their hydration status
Cognitive function: reaction timePre-intervention, day 2, 4 and 8 of the interventionCANTAB test battery reaction time test was used to determine reaction time in milliseconds.
Cognitive function: swmPre-intervention, day 2, 4 and 8 of the interventionCANTAB spatial working memory test was used to access executive function; the main outcome measure used was the number of errors
Sleep Duration1 week prior to racing and during the raceFitbit inspire 3 was used to measure sleep duration (hours:minutes:seconds)
Sleep: REM1 week prior to racing and during the raceThe Fitbit Inspire 3 was used to measure the total duration of rapid eye motion (REM)sleep during each night for the duration of the study. The REM sleep phase will be analysed in minutes
Sleep: Non-REM1 week prior to racing and during the raceThe Fitbit Inspire 3 will be used to determine the NON-REM sleep phase for each night in minutes
Sleep: WASO1 week prior to racing and during the raceThe FITBIT inspire 3 will be used to measure wake after sleep onset in minutes for each night

Secondary

MeasureTime frameDescription
Mechanical efficiencypre-intervention and 1 day after the interventionMechanical efficiency will be determined during three constant load (100 watts, 150 watts, and 200 watts) cycling bouts of 5 minutes on a calibrated ergometer (Avantronic Cyclus II). Throughout the test, gas exchange will continuously be measured using calibrated metabolic analyzer with a face mask (Cortex, Metalyzer IIIb). VO2 and VCO2 data of the final minute of each workload will be used to calculate gross efficiency (%).
Time trial performancepre-intervention and 1 day after the interventionThe participants will perform a 30-minute time trial. The average power output (watts) achieved will be used as the outcome measure.
Appetitepre-intervention, during the intervention, 1 day after the interventionAppetite will be assessed with a Likert visual analog scale (0-10) using the following four questions: "How hungry do you feel?" "How full do you feel?" "How satisfied do you feel?" "How much do you think you could eat now?"
Macronutrient intakebaseline, during the interventionParticipants will complete a food diary using the Mijnetemeter application on their phone. Total fat, protein and carbohydrate intake will be determined in grams for each day.
Total energy intakebaseline, during the interventionParticipants will complete a food diary, using the Mijnetemeter application on their phones. total energy intake (kilojoules) will be calculated for each day.
Racing intensityduring each stagehear rate zones during racing
Body weight changeDuring the interventionBody mass was measured using a SECA, model 813 electrical scale, before and after each stage as a secondary method to assess hydration status. Body mass was measured to the nearest 0.1 kilogram

Countries

Belgium

Contacts

PRINCIPAL_INVESTIGATORChiel Poffé

KU Leuven

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026