The Effects of Exogenous Ketosis on Ultra-endurance Recovery and Performance

NCT ID: NCT06965491

Last Updated: 2025-05-11

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

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-10-30

Brief Summary

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The study aims to investigate the effects of post-exercise and pre-sleep ketosis via oral ketone ester supplementation on physical and mental recovery during a multi-day cycling stage race.

Detailed Description

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Ultra-endurance events are becoming increasing popular. Participation in the multi-day events adds a lot of physical and mental strain on the body, while the athletes are still required to perform. Without appropriate recovery the athletes are at increased risk of overreaching, injury, or illness.

Therefore, the purpose of the study is to create a better understanding of the exercise fatigue experienced during ultra-endurance performance and the role intermittent exogenous ketosis (IEK) plays in reducing the amount of fatigue to maintain performance during multi-day racing and lower the risk of injury and illness.

Participants will first compete in a 8-day simulated stage race performed on taxc trainers and then we will conduct a field study during the Absa Cape Epic a 8-day mountain bike stage race. Immediately following each stage and 30-mins before bed the participants will consume either a ketone ester and taste-match placebo drink. During the race the following variables will be measured; hydration status, weight change, activity readiness, and nutrition intake. Cognitive function will be assessed on day 2, 4 and 8 of racing. One day before and one day after the race the participants will report to the lab to assess basal metabolic rate, stress via questionnaires, appetite, cognitive function, muscle biopsies, venous blood samples, mechanical efficiency and 30-min Time Trial.

Conditions

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Exogenous Ketosis Endurance Cycling Performance Fatigue; Muscle, Heart Fatigue, Mental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Riders will be paired matched and randomly assigned to either the ketone ester supplementation (KE) group or the control group (CON) which will receive an isocaloric taste-matched placebo
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Participants and investigators are blinded from the experimental condition (KE or CON). Supplements are provided in non transparent tubes and the control supplement is identical in taste and viscosity to the ketone supplement.

Study Groups

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Control group

Intervention: 8-day multistage mountain bike race/simulation Dietary intervention: placebo supplement (oral supplement containing: 16.4 grams of medium chained triglycerides, 1mM of sucrose octaacetate and water)

Group Type PLACEBO_COMPARATOR

Placebo Supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo supplement:

Oral supplement containing: 16.4 grams of medium chained triglycerides, 1mM or sucrose octaacetate and water

Experimental group

Intervention: 8-day multistage mountain bike race/simulation Dietary intervention: ketone ester supplement (25 grams of pure R-(3)-hydroxybutyl-(R)-3-hydroxybutyrate ketone monoester drink)

Group Type EXPERIMENTAL

Ketone ester supplement

Intervention Type DIETARY_SUPPLEMENT

Ketone ester supplement Oral supplement containing: 25 grams of pure (R)-3-hydroxybutyl-(R)-3-hydroxybutyrate ketone monoester drink

Interventions

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Placebo Supplement

Placebo supplement:

Oral supplement containing: 16.4 grams of medium chained triglycerides, 1mM or sucrose octaacetate and water

Intervention Type DIETARY_SUPPLEMENT

Ketone ester supplement

Ketone ester supplement Oral supplement containing: 25 grams of pure (R)-3-hydroxybutyl-(R)-3-hydroxybutyrate ketone monoester drink

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* have been cycling consistently for at least 1 year before entry into the study
* have been cycling for a minimum of 7 hours per week for the 6 months leading up to the study
* additional for the field study: valid entry to the 2025 edition of the Absa Cape Epic
* non-smoker

Exclusion Criteria

* Do not follow a ketogenic diet or low-carbohydrate diet
* Have any metabolic or auto-immune disease that will influence their metabolism
* Take medication or supplements that is known to affect ketone supplement metabolism
* suffering from a recurring injury or illness from which they have not fully recovered that is a contr-indication to perform high-intensity exercise
* Unable to finish each stage
* Women: if they are pregnant or breastfeeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Stellenbosch

OTHER

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Chiel Poffé

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chiel Poffé

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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KU Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Louise Engelbrecht

Role: CONTACT

+27794919072

Chiel Poffé

Role: CONTACT

Facility Contacts

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Monique Ramaekers

Role: primary

+32 16 32 90 92

Other Identifiers

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S68178

Identifier Type: -

Identifier Source: org_study_id

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