Effect of Exogenous Ketosis During Ultra-endurance Exercise

Catholic University (KU) of Leuven

Status and phase: Active, not recruiting; Phase 2

Conditions: Ultra-endurance Running; Cognitive Function; Ketosis; Skeletal Muscle; Exercise

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Ketone ester

Study type: Interventional

Funder types: Other

Identifiers

NCT05407753

S65311

Details and patient eligibility

About

The aim of this study is to investigate the effect of oral ketone administration during and immediately after an ultramarathon. Potential changes in cognitive function (reaction time, number of errors), running performance, jump height, skeletal muscle inflammatory infiltration and hormonal alterations will be the main focus. In this context, subjects (n=24) will perform a 100km ultrarunning trail, while receiving either ketone ester (KE, n =12) or placebo (CON, n=12). Experimental measurements will be performed immediately before and after the ultramarathon as well as 24h after the ultramarathon.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males between 18 and 55 years old
• Recreational or competitive runner having performed an ultramarathon (>42km) during the last 2 years
• Good health status confirmed by a medical screening
• Body Mass Index (BMI) between 18 and 25

Exclusion criteria

• Any kind of injury/pathology that is a contra-indication to perform ultra-endurance exercise
• Intake of any medication or nutritional supplement that is known to affect exercise performance
• Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study.
• Blood donation within 3 months prior to the start of the study
• Smoking
• More than 3 alcoholic beverages per day
• Current participation in another research trial
• Any other argument to believe that the subject is unlikely to successfully complete the full study protocol
• Adherence to a high-fat, low-carbohydrate ketogenic diet (less than 20% of energy intake derived from carbohydrates)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Ketone ester

Experimental group

Description:

Subjects receive the ketone ester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (25g before ultrarun, 12.5g every 30 min during race, 25g immediately after race, 25g before sleep, 3 x 25g on day after race.

Treatment:

Dietary Supplement: Ketone ester

Con

Placebo Comparator group

Description:

Subjects receive a non-caloric, taste matched placebo (water and sucrose octaacetate).

Treatment:

Dietary Supplement: Placebo