NCT05407753

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 7, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

May 26, 2022

Last Update Submit

June 2, 2022

Conditions

ExerciseUltra-endurance RunningKetosisSkeletal MuscleCognitive Function

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Catecholamines in blood

    Before race - immediately after race - 48 hours after start of race

Study Arms (2)

Ketone ester

EXPERIMENTAL

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

Con

PLACEBO COMPARATOR

Subjects receive a non-caloric, taste matched placebo (water and sucrose octaacetate).

Dietary Supplement: Placebo

Interventions

Ketone esterDIETARY_SUPPLEMENT

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.

Ketone ester
PlaceboDIETARY_SUPPLEMENT

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

Con

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Physiology Research Group

Leuven, Vlaams-Brabant, 3001, Belgium

Location

MeSH Terms

Conditions

Motor ActivityKetosis

Interventions

formic acid 4-(3-oxobutyl)phenyl ester

Condition Hierarchy (Ancestors)

BehaviorAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 26, 2022

First Posted

June 7, 2022

Study Start

May 20, 2021

Primary Completion

October 24, 2021

Study Completion

December 31, 2022

Last Updated

June 7, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)