The Effect of Acute Ketone Monoester Supplementation on Glucose Oxidation During Exercise
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CHO+KETONE, CHO+PLACEBO.
- Who it may be relevant to
- Registry conditions: Exercise Metabolism. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Acute Ketone Monoester Supplementation on Glucose Oxidation During Exercise Performed With High Rates of Carbohydrate Ingestion in Trained Cyclists
Overview
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.
Interventions
- Dietary supplement CHO+KETONE
Sports drink containing glucose and ketone mono-esters - Dietary supplement CHO+PLACEBO
Sports drink containing glucose and placebo
Primary outcome measures
- Exogenous carbohydrate oxidation rate [Time frame: Acute:during 3 hours of exercise]
Secondary outcome measures (7)
- Endogenous carbohydrate disappearance rate [Time frame: Acute:during 3 hours of exercise]
- Exogenous carbohydrate disappearance rate [Time frame: Acute:during 3 hours of exercise]
- Total carbohydrate disappearance rate [Time frame: Acute:during 3 hours of exercise]
- Exogenous carbohydrate appearance rate [Time frame: Acute:during 3 hours of exercise]
- Endogenous carbohydrate appearance rate [Time frame: Acute:during 3 hours of exercise]
- Total carbohydrate appearance rate [Time frame: Acute:during 3 hours of exercise]
- Plasma glucose enrichments during exercise [Time frame: Acute:during 3 hours of exercise]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
Netherlands · 1 center
- Maastricht University Medical Center+ — Maastricht
Identifiers
NCT: NCT06746805 · METC 23-001