NCT05226962

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 time trial performance. Participants will perform two trials in a randomized order. Each trial will involve a 20-minute bout of cycling on a stationary ergometer. Participants will ingest either 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 responses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 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

January 27, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

February 15, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

7 months

First QC Date

January 27, 2022

Last Update Submit

November 4, 2022

Conditions

Keywords

Performance

Outcome Measures

Primary Outcomes (1)

  • Power output

    Mean power output produced while cycling

    20-minute measurement during exercise

Secondary Outcomes (4)

  • Heart rate

    20-minute measurement during exercise

  • Perceived exertion

    Single measurement immediately after exercise

  • Blood ketone

    Single measurement immediately prior to exercise

  • Blood glucose

    20-minute measurement during exercise

Study Arms (2)

Ketone

ACTIVE COMPARATOR

An acute bout of exercise performed after the ingestion of a commercial ketone monoester supplement.

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 supplement ingested in a dose intended to provide \~0.35 g of ketone monoester per kg body mass of the participant

Ketone
PlaceboOTHER

A liquid placebo that is volume- and 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:

  • Habitually ingesting \>50 g of dietary carbohydrate daily i.e. not following a ketogenic diet.
  • Regularly performing cycling exercise at least 3 days per week and for a total of ≥5 hours per week.
  • Having an estimated peak oxygen uptake of ≥55 ml/kg/min for males and ≥48 ml/kg/min for females based on the online fitness calculator available at: www.worldfitnesslevel.org.
  • Having competitive cycling experience.

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 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
Professor

Study Record Dates

First Submitted

January 27, 2022

First Posted

February 7, 2022

Study Start

February 15, 2022

Primary Completion

September 1, 2022

Study Completion

October 1, 2022

Last Updated

November 7, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations