NCT05665855

Brief Summary

Diet can alter blood ketone levels and this in turn may affect exercise capacity. This study will determine if the acute ingestion of a ketone supplement alters cycling exercise efficiency. Participants will perform three trials in a randomized order. Each trial will involve an incremental exercise protocol on a stationary cycle ergometer to volitional fatigue. Participants will ingest either a high or low dose of a ketone supplement or a taste-matched placebo drink prior to exercise. Blood samples will be obtained to assess selected metabolic responses. This study will provide information regarding the effect of ketone supplementation on exercise efficiency.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 17, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

December 27, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

November 17, 2022

Last Update Submit

July 7, 2023

Conditions

ExerciseKetosis

Keywords

Efficiency

Outcome Measures

Primary Outcomes (1)

  • Exercise efficiency

    Power output expressed relative to pulmonary oxygen uptake to determine cycling economy in watt per litre of oxygen per minute

    Continuous measurement made over each of three, 5-minute consecutive stages of an incremental cycle exercise test at relative workloads corresponding to 75%, 100%, and 125% of individual ventilatory threshold intensity

Secondary Outcomes (3)

  • Heart rate

    Continuous measurement made over each of three, 5-minute consecutive stages of an incremental cycle exercise test at relative workloads corresponding to 75%, 100%, and 125% of individual ventilatory threshold intensity

  • Rating of perceived exertion

    Measurement made at the end of each of three, 5-minute consecutive stages of an incremental cycle exercise test at relative workloads corresponding to 75%, 100%, and 125% of individual ventilatory threshold intensity

  • Ketone body content in venous blood

    Measurement made immediately prior to exercise

Study Arms (3)

Ketone higher dose

EXPERIMENTAL

An acute bout of exercise performed after the ingestion of a commercial supplement intended to provide \~0.6 g of ketone monoester per kg body mass of the participant.

Dietary Supplement: Ketone monoester

Ketone lower dose

EXPERIMENTAL

An acute bout of exercise performed after the ingestion of a commercial supplement intended to provide \~0.3 g of ketone monoester per kg body mass of the participant.

Dietary Supplement: Ketone monoester

Control

PLACEBO COMPARATOR

An acute bout of exercise performed after the ingestion of a taste-matched placebo supplement.

Other: Placebo

Interventions

Ketone monoesterDIETARY_SUPPLEMENT

A commercial liquid ketone monoester supplement.

Ketone higher doseKetone lower dose
PlaceboOTHER

A liquid placebo that is taste-matched to the ketone monoester supplement.

Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be habitually consuming ≥50 g/d of carbohydrate (i.e., not following a ketogenic diet).
  • Be engaged in endurance-type exercise \>3h/wk.
  • Have an estimated VO2peak of ≥90% for age and sex as estimated by an online calculator found at www.worldfitnesslevel.org.

You may not qualify if:

  • Experiencing a condition that might preclude safe participation in physical activity and exercise, as determined by answering "Yes" to any question on Page 1 of the Canadian Society for Exercise Physiology Get Active Questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S4K1, Canada

Location

MeSH Terms

Conditions

Motor ActivityKetosis

Condition Hierarchy (Ancestors)

BehaviorAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Martin J Gibala, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 17, 2022

First Posted

December 27, 2022

Study Start

December 27, 2022

Primary Completion

May 31, 2023

Study Completion

June 30, 2023

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)