The Effects of Ketone Ester Supplementation During a 5 Week Live High, Train Low Altitude Training Camp

NCT ID: NCT06596083

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2024-10-15

Brief Summary

This study aims to investigate the effects of post-exercise and pre-sleep exogenous ketosis via oral ketone ester supplementation during a 5 week simulated altitude training camp.

Detailed Description

Altitude training camps, where you train at sea level but live at altitude, have become a popular way for athletes to prepare for upcoming races or events. The main aim of such training camps is to benefit from the adaptations following prolonged hypoxic exposure (increased EPO concentrations leading to an increase in oxygen carrying capacity in the blood). Recently, ketone bodies have been shown to cause similar adaptations. Therefore, this study aims to investigate whether the combination of exogenous ketosis and an altitude training camp is more beneficial compared to an altitude training camp on its own.

Participants will follow a 5 week simulated altitude training camp where they spend 75 hours per week at altitude (2000-3000 meters), while taking ketone or placebo supplements after every training sessions and before going to sleep. During these 5 weeks, they will adhere to a prescribed training plan, consisting of 5 to 7 training sessions per week. Before, after and 1 week after the training camp, their exercise performance, EPO concentrations, hemoglobin mass and VO2max will be tested.

Conditions

Hypoxia; Exogenous Ketosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo Comparator

Training intervention: 5 weeks of live high, train low followed by an additional 1 week of reduced training (to simulate preparation for an upcoming event or race) Dietary intervention: placebo supplement

Group Type: PLACEBO_COMPARATOR

Placebo supplement

Intervention Type: DIETARY_SUPPLEMENT

oral supplement containing: 16.4 grams of medium chained triglycerides, 1mM or sucrose octaacetate and water

Experimental group

Training intervention: 5 weeks of live high, train low followed by an additional 1 week of reduced training (to simulate preparation for an upcoming event or race) Dietary intervention: Ketone ester supplement

Group Type: EXPERIMENTAL

Ketone ester supplement

Intervention Type: DIETARY_SUPPLEMENT

Oral supplement containing: 25 grams of pure (R)-3-hydroxybutyl-(R)-3-hydroxybutyrate ketone monoester drink

Interventions

Placebo supplement

oral supplement containing: 16.4 grams of medium chained triglycerides, 1mM or sucrose octaacetate and water

Intervention Type: DIETARY_SUPPLEMENT

Ketone ester supplement

Oral supplement containing: 25 grams of pure (R)-3-hydroxybutyl-(R)-3-hydroxybutyrate ketone monoester drink

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Physically fit and regularly involved in physical activity (2-5h per week)
• Good health status confirmed by a medical screening
• Non-smoking

Exclusion Criteria

• Any kind of injury/pathology that is a contra-indication to perform high-intensity exercise
• Any kind of injury/pathology that is a contra-indication for exposure to hypoxia
• Ongoing pregnancy or breastfeeding
• intake of any medication or nutritional supplement that is proven to affect exercise performance during the last month prior to the start of the study
• Involvement in elite athletic training at a semi-professional or professional level
• Exposure to altitudes higher than 1500 m during the 3 months prior to the start of the study
• Blood ferritin levels below 30 ng/mL
• Current participation in another research trial
• Any other argument to believe that the subject is unlikely to succesfully complete the full study protocol

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Chiel Poffé

postdoctoral researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chiel Poffé

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

KU Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Wout Lauriks

Role: CONTACT

wout.lauriks@kuleuven.be

+32474360778

Chiel Poffé

Role: CONTACT

chiel.poffe@kuleuven.be

Facility Contacts

Chiel Poffé

Role: primary

chiel.poffe@kuleuven.be

Other Identifiers

S67562

Identifier Type: -

Identifier Source: org_study_id