NCT06746805
Recruiting
Not Applicable
The Effect of Acute Ketone Monoester Supplementation on Glucose Oxidation During Exercise Performed With High Rates of Carbohydrate Ingestion in Trained Cyclists
Maastricht University Medical Center1 site in 1 country27 target enrollmentStarted: March 4, 2024Last updated:
ConditionsExercise Metabolism
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Exogenous carbohydrate oxidation rate
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Color and flavor matched placebo
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
- •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
Outcomes
Primary Outcomes
Exogenous carbohydrate oxidation rate
Time Frame: Acute:during 3 hours of exercise
Exogenous carbohydrate oxidation rate during exercise measured by 13C enrichment in breath. CHO+KETONE vs CHO+PLACEBO condition
Secondary Outcomes
- Endogenous carbohydrate disappearance rate(Acute:during 3 hours of exercise)
- Exogenous carbohydrate disappearance rate(Acute:during 3 hours of exercise)
- Total carbohydrate disappearance rate(Acute:during 3 hours of exercise)
- Exogenous carbohydrate appearance rate(Acute:during 3 hours of exercise)
- Endogenous carbohydrate appearance rate(Acute:during 3 hours of exercise)
- Total carbohydrate appearance rate(Acute:during 3 hours of exercise)
- Plasma glucose enrichments during exercise(Acute:during 3 hours of exercise)
Investigators
Study Sites (1)
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