Skip to content

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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05407753
Enrollment
24
Registered
2022-06-07
Start date
2021-05-20
Completion date
2022-12-31
Last updated
2022-06-07

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

Conditions

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

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.

Interventions

DIETARY_SUPPLEMENTKetone 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_SUPPLEMENTPlacebo

Subjects receive a non-caloric taste-matched placebo (water with sucrose octaacetate)

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Reaction timeBefore race - immediately after raceChange in reaction time during a reaction time task
Countermovent jumpBefore race - immediately after race - 48 hours after start of raceChange in countermovement jump height
Exercise performanceImmediately after raceTime needed to complete the ultrarun
Skeletal muscle inflammatory cell infiltrationBefore race - 48 hours after start of raceChange in infiltration of inflammatory cells in skeletal muscle

Secondary

MeasureTime frameDescription
Catecholamines in bloodBefore race - immediately after race - 48 hours after start of raceChange in catecholamine concentration in plasma

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026