The Effects of Acute Ketone Monoester Supplementation on 20-Minute Time-Trial Performance in Trained Cyclists

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.

Study Overview

• Status: Completed
• Conditions: Exercise; Ketosis
• Intervention / Treatment: Dietary supplement: Ketone monoester; Other: Placebo

Detailed Description

This study will determine if the acute ingestion of a ketone supplement alters cycling time trial performance. Trained participants with competitive cycling experience will be recruited. Exercise will involve a 20-minute bout of cycling on a stationary ergometer with the goal of producing the highest power output possible. Participants will ingest either a ketone supplement or a taste-matched placebo drink prior to exercise using a randomized, double-blind crossover design. Diet prior to exercise will be standardized between trials for a given participant. Blood samples will be obtained to assess selected metabolic responses. This study will provide information regarding the effect of ketone supplementation on exercise responses.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S4K1
      • McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

- 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ketone; An acute bout of exercise performed after the ingestion of a commercial ketone monoester supplement.	Dietary supplement: Ketone monoester; A commercial liquid supplement ingested in a dose intended to provide ~0.35 g of ketone monoester per kg body mass of the participant
PLACEBO_COMPARATOR: Control; An acute bout of exercise performed after the ingestion of a taste-matched placebo supplement.	Other: Placebo; A liquid placebo that is volume- and taste-matched to the ketone monoester supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Power output	Mean power output produced while cycling	20-minute measurement during exercise

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Mean heart rate while cycling	20-minute measurement during exercise
Perceived exertion	Rating of perceived exertion while cycling	Single measurement immediately after exercise
Blood ketone	Blood ketone before exercise	Single measurement immediately prior to exercise
Blood glucose	Mean blood glucose while cycling	20-minute measurement during exercise

Collaborators and Investigators

• Sponsor: McMaster University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2022
• Primary Completion (ACTUAL): September 1, 2022
• Study Completion (ACTUAL): October 1, 2022

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (ACTUAL): February 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Performance
• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis; Ketosis
• Other Study ID Numbers: 13837

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No