The Effect of Acute Ketone Monoester Supplementation on Glucose Oxidation During Exercise

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorMaastricht University Medical Center

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • CHO+KETONE

    Dietary supplement

    Sports drink containing glucose and ketone mono-esters

  • CHO+PLACEBO

    Dietary supplement

    Sports drink containing glucose and placebo

Treatment groups

27 Participants
are divided into 2 treatment groups
Group A: CHO+KETONEExperimental treatment 1 intervention
Group B: CHO+PLACEBOPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Exogenous carbohydrate oxidation rate

Exogenous carbohydrate oxidation rate during exercise measured by 13C enrichment in breath. CHO+KETONE vs CHO+PLACEBO condition

Time frame
Acute:during 3 hours of exercise

Secondary outcomes

1

Endogenous carbohydrate disappearance rate

Endogenous carbohydrate disappearance rate during exercise measured by stable isotope tracer methodology. CHO+KETONE vs CHO+PLACEBO condition

Time frame
Acute:during 3 hours of exercise
2

Exogenous carbohydrate disappearance rate

Exogenous carbohydrate disappearance rate during exercise measured by stable isotope tracer methodology. CHO+KETONE vs CHO+PLACEBO condition

Time frame
Acute:during 3 hours of exercise
3

Total carbohydrate disappearance rate

Total carbohydrate disappearance rate during exercise measured by stable isotope tracer methodology. CHO+KETONE vs CHO+PLACEBO condition

Time frame
Acute:during 3 hours of exercise
4

Exogenous carbohydrate appearance rate

Exogenous carbohydrate appearance rate during exercise measured by stable isotope tracer methodology. CHO+KETONE vs CHO+PLACEBO condition

Time frame
Acute:during 3 hours of exercise

Other outcomes

1

Total carbohydrate oxidation

Total carbohydrate oxidation during exercise, measured indirectly by using traditional stoichiometric calculations of carbohydrate oxidation. CHO+KETONE vs CHO+PLACEBO condition

Time frame
Acute:during 3 hours of exercise
2

Blood parameters

Plasma glucose, insulin, glycerol, free fatty acids, and ketone body concentrations (including area under the curve) following drink ingestion. CHO+KETONE vs CHO+PLACEBO condition

Time frame
Acute:during 3 hours of exercise
3

Exercise economy during cycling

Exercise economy during the exercise trial. CHO+KETONE vs CHO+PLACEBO condition, will be determined based on the amount of work performed during cycling (workload), and the amount of energy expenditure as measured by indirect calorimetry.

Time frame
Acute:during 3 hours of exercise
4

Exercise heart rate

Heart rate during exercise. CHO+KETONE vs CHO+PLACEBO condition

Time frame
Acute:during 3 hours of exercise

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