Effect of Exogenous Ketosis During Ultra-endurance Exercise

NCT ID: NCT05407753

Last Updated: 2022-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-20

Study Completion Date

2022-12-31

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.

Detailed Description

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Conditions

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Exercise Ultra-endurance Running Ketosis Skeletal Muscle Cognitive Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Ketone ester

Intervention Type DIETARY_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.

Con

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Peter Hespel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Exercise Physiology Research Group

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S65311

Identifier Type: -

Identifier Source: org_study_id

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