Ketone Esters and Metabolism During Recovery from Endurance Exercise

February 20, 2025 updated by: Javier Gonzalez, University of Bath

Effect of Ketone Esters Ingested During Recovery on Metabolism and Subsequent Exercise Capacity

Infusion of beta-hydroxybutyrate can suppress endogenous glucose production, which may result in increased net liver glycogen storage. If ketone esters exert similar effects, then the increase in liver glycogen storage may have implication for recovery from exercise and subsequent exercise performance.

The aim of this study is to assess the effects of ketone esters ingested during recovery from exercise, on metabolism and subsequent exercise capacity.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • VO2max ≥ 45mL.kg-1.min-1
  • Weekly aerobic training > 3hours.
  • 2years running experience.
  • BMI < 30kg/m2

Exclusion Criteria:

  • <18yrs or >60yrs of age
  • Habitual smoker within last 5 years.
  • History of uncontrollable metabolic or respiratory disease.
  • Currently taking medication, following a low carbohydrate or ketogenic diet, or consuming nutritional ketone supplements.
  • History of Irritable Bowel Syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: PLACEBO
Energy matched placebo containing medium-chain triglycerides and bitter taste
Medium chain triglycerides and bitter tastant (Bitrex)
Experimental: KETONE
Beta-hydroxybutyrate monoester
0.29 g per kilogram body mass per hour of ketone monoester (R)-3-hydroxybutyrate (R)-3-hydroxybutyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose concentrations
Time Frame: 240 minutes
Blood glucose concentrations during the recovery period (240 minutes)
240 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-oxidative fate of ingested sucrose
Time Frame: 240 minutes
Non-oxidative fate of ingested glucose measured by appearance of 13C on breath CO2 from high 13C sucrose ingested during recovery
240 minutes
Exercise capacity
Time Frame: 240 minutes
Time to exhaustion running at 70% of maximal aerobic capacity after the recovery period
240 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood beta-hydroxybutyrate concentrations
Time Frame: 240 minutes
Blood beta-hydroxybutyrate concentrations throughout the 240 minute recovery
240 minutes
Urinary urea
Time Frame: 240 minutes
Urea in urine, determined by urea concentration multiplied by total urine output during the 240 minutes of recovery
240 minutes
Blood lactate concentrations
Time Frame: 240 minutes
Blood lactate concentrations during 240 minutes of recovery
240 minutes
Plasma insulin concentrations
Time Frame: 240 minutes
Plasma insulin concentrations during 240 minutes of recovery
240 minutes
Blood pH
Time Frame: 240 minutes
Blood pH during 240 minutes of recovery
240 minutes
Blood bicarbonate
Time Frame: 240 minutes
Blood bicarbonate concentrations during 240 minutes of recovery
240 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Actual)

February 17, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 5202-6834

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Plan is to share individual deidentied data on a public repository such as Mendeleydata.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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