- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06846840
Ketone Esters and Metabolism During Recovery from Endurance Exercise
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bath, United Kingdom, BA2 7AY
- University of Bath
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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