Effect of Exogenous Ketosis During Ultra-endurance Exercise

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05407753
• Other study ID #: S65311
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 20, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2022
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 31, 2022
• Est. primary completion date: October 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Function
• Exercise
• Ketosis
• Skeletal Muscle

Intervention

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

Locations

Country	Name	City	State
Belgium	Exercise Physiology Research Group	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaction time	Change in reaction time during a reaction time task	Before race - immediately after race
Primary	Countermovent jump	Change in countermovement jump height	Before race - immediately after race - 48 hours after start of race
Primary	Exercise performance	Time needed to complete the ultrarun	Immediately after race
Primary	Skeletal muscle inflammatory cell infiltration	Change in infiltration of inflammatory cells in skeletal muscle	Before race - 48 hours after start of race
Secondary	Catecholamines in blood	Change in catecholamine concentration in plasma	Before race - immediately after race - 48 hours after start of race