Effect of Exogenous Ketosis During Ultra-endurance Exercise

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Dietary Supplement: Ketone ester
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketone ester<br>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<br>* 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.<br>|
| Placebo Comparator: Con<br>Subjects receive a non-caloric, taste matched placebo (water and sucrose octaacetate). | Dietary Supplement: Placebo<br>* Subjects receive a non-caloric taste-matched placebo (water with sucrose octaacetate)<br>|

What is the study measuring?
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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 |