NCT06746805

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2024

Completed
10 months until next milestone

First Posted

Study publicly available on registry

December 24, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

September 24, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

March 11, 2024

Last Update Submit

September 19, 2025

Conditions

Exercise Metabolism

Outcome Measures

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

    Acute:during 3 hours of exercise

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Other Outcomes (4)

  • Total carbohydrate oxidation

    Acute:during 3 hours of exercise

  • Blood parameters

    Acute:during 3 hours of exercise

  • Exercise economy during cycling

    Acute:during 3 hours of exercise

  • +1 more other outcomes

Study Arms (2)

CHO+KETONE

EXPERIMENTAL

Interventional drink with glucose + ketone monoester

Dietary Supplement: CHO+KETONE

CHO+PLACEBO

PLACEBO COMPARATOR

Placebo drink with glucose + placebo

Dietary Supplement: CHO+PLACEBO

Interventions

CHO+KETONEDIETARY_SUPPLEMENT

Sports drink containing glucose and ketone mono-esters

CHO+KETONE
CHO+PLACEBODIETARY_SUPPLEMENT

Sports drink containing glucose and placebo

CHO+PLACEBO

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Limburg, 6229ER, Netherlands

RECRUITING

Central Study Contacts

Luc van Loon, PhD

CONTACT

0031 43 388 1743l.vanloon@maastrichtuniversity.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Color and flavor matched placebo
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Double-blind, randomized, placebo-controlled, cross-over trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2024

First Posted

December 24, 2024

Study Start

March 4, 2024

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

September 24, 2025

Record last verified: 2025-05

Locations

NL(1)