Clinical trial NCT06746805: The Effect of Acute Ketone Monoester Supplementation on Glucose Oxidation During Exercise
Official title: The Effect of Acute Ketone Monoester Supplementation on Glucose Oxidation During Exercise Performed with High Rates of Carbohydrate Ingestion in Trained Cyclists
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exercise Metabolism
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind, randomized, placebo-controlled, cross-over trial
Primary purpose: OTHER

Brief summary: The purpose of this study is to examine the effect of exogenous ketone body supplementation on carbohydrate metabolism during exercise. In a randomized, crossover, and double-blind study, 20 endurance trained adult males and females aged 18-50 years, will ingest carbohydrates with either a ketone monoester supplement before and throughout a 3-hour exercise session or carbohydrates with a flavour-matched ketone-free placebo. The main aim of this study is to compare the exogenous carbohydrate oxidation rates during exercise between the ketone monoester and placebo conditions.


Eligibility criteria: Inclusion Criteria:

* 18-50 years of age
* Trained cyclist/triathlete (VO2peak \> 55 ml/kg/min for males and \>48 ml/mg/min for females)
* Healthy as per medical history and investigator's/physician's judgement
* Having given written informed consent

Exclusion Criteria:

* Use of medication that could impact study outcomes and/or interfere with the expected mechanism of action of ketone supplements (e.g. Chronic use of gastric acid suppressing medication, statins, corticosteroids)
* Smoking
* Diagnosed acute or chronic medical conditions that, in the opinion of the investigator, could impact study outcomes (e.g. Diabetes mellitus)
* Diagnosed musculoskeletal disorders
* Adhering to a carbohydrate restrictive diet
* Participation in another study at the same time
* Blood donation in the 2 months before the first experimental trial
* Plasma donation in the 2 weeks before the first experimental trial
* Males: VO2peak \<55 ml/min/kg body mass
* Females: VO2peak \<48 ml/min/kg body mass
* Females: pregnancy

Primary outcomes:
measure: Exogenous carbohydrate oxidation rate
timeFrame: Acute:during 3 hours of exercise
Secondary outcomes:
measure: Endogenous carbohydrate disappearance rate
timeFrame: Acute:during 3 hours of exercise
measure: Exogenous carbohydrate disappearance rate
timeFrame: Acute:during 3 hours of exercise
measure: Total carbohydrate disappearance rate
timeFrame: Acute:during 3 hours of exercise
measure: Exogenous carbohydrate appearance rate
timeFrame: Acute:during 3 hours of exercise
measure: Endogenous carbohydrate appearance rate
timeFrame: Acute:during 3 hours of exercise
measure: Total carbohydrate appearance rate
timeFrame: Acute:during 3 hours of exercise
measure: Plasma glucose enrichments during exercise
timeFrame: Acute:during 3 hours of exercise
Other outcomes:
measure: Total carbohydrate oxidation
timeFrame: Acute:during 3 hours of exercise
measure: Blood parameters
timeFrame: Acute:during 3 hours of exercise
measure: Exercise economy during cycling
timeFrame: Acute:during 3 hours of exercise
measure: Exercise heart rate
timeFrame: Acute:during 3 hours of exercise
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center+
state: Limburg
Study officials:
References: