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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
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Exercise

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

First Posted
May 26, 2022
Last Updated
June 2, 2022
Sponsor
KU Leuven
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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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