Effect of Exogenous Ketosis During Ultra-endurance Exercise
Primary Purpose
Exercise, Ultra-endurance Running, Ketosis
Status
Active
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Ketone ester
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Exercise
Eligibility Criteria
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)
Sites / Locations
- Exercise Physiology Research Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ketone ester
Con
Arm Description
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.
Subjects receive a non-caloric, taste matched placebo (water and sucrose octaacetate).
Outcomes
Primary Outcome Measures
Reaction time
Change in reaction time during a reaction time task
Countermovent jump
Change in countermovement jump height
Exercise performance
Time needed to complete the ultrarun
Skeletal muscle inflammatory cell infiltration
Change in infiltration of inflammatory cells in skeletal muscle
Secondary Outcome Measures
Catecholamines in blood
Change in catecholamine concentration in plasma
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05407753
Brief Title
Effect of Exogenous Ketosis During Ultra-endurance Exercise
Official Title
Effect of Oral Ketone Administration on Cognitive Function, Musculoskeletal Damage and Hormonal and Metabolic Dysregulations Induced by Ultra-endurance Running
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
October 24, 2021 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise, Ultra-endurance Running, Ketosis, Skeletal Muscle, Cognitive Function
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketone ester
Arm Type
Experimental
Arm Description
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.
Arm Title
Con
Arm Type
Placebo Comparator
Arm Description
Subjects receive a non-caloric, taste matched placebo (water and sucrose octaacetate).
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone ester
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Subjects receive a non-caloric taste-matched placebo (water with sucrose octaacetate)
Primary Outcome Measure Information:
Title
Reaction time
Description
Change in reaction time during a reaction time task
Time Frame
Before race - immediately after race
Title
Countermovent jump
Description
Change in countermovement jump height
Time Frame
Before race - immediately after race - 48 hours after start of race
Title
Exercise performance
Description
Time needed to complete the ultrarun
Time Frame
Immediately after race
Title
Skeletal muscle inflammatory cell infiltration
Description
Change in infiltration of inflammatory cells in skeletal muscle
Time Frame
Before race - 48 hours after start of race
Secondary Outcome Measure Information:
Title
Catecholamines in blood
Description
Change in catecholamine concentration in plasma
Time Frame
Before race - immediately after race - 48 hours after start of race
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Exercise Physiology Research Group
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3001
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Exogenous Ketosis During Ultra-endurance Exercise
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