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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Exercise; Cognitive Function; Ketosis; Skeletal Muscle; Ultra-endurance Running
• Intervention / Treatment: Dietary supplement: Ketone ester; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3001
      • Exercise Physiology Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 Comparator: Con; Subjects receive a non-caloric, taste matched placebo (water and sucrose octaacetate).	Dietary supplement: Placebo; Subjects receive a non-caloric taste-matched placebo (water with sucrose octaacetate)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catecholamines in blood	Change in catecholamine concentration in plasma	Before race - immediately after race - 48 hours after start of race

Collaborators and Investigators

• Sponsor: KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Actual): October 24, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: June 2, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis; Ketosis
• Other Study ID Numbers: S65311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No