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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypoxia; Exogenous Ketosis
• Intervention / Treatment: Dietary supplement: Placebo supplement; Dietary supplement: Ketone ester supplement

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.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chiel Poffé; Email: chiel.poffe@kuleuven.be
• Study Contact Backup: Name: Wout Lauriks; Phone Number: +32474360778; Email: wout.lauriks@kuleuven.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • KU Leuven
      • Contact: Chiel Poffé; Email: chiel.poffe@kuleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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	Dietary supplement: Placebo supplement; oral supplement containing: 16.4 grams of medium chained triglycerides, 1mM or sucrose octaacetate and water
Experimental: 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	Dietary supplement: Ketone ester supplement; Oral supplement containing: 25 grams of pure (R)-3-hydroxybutyl-(R)-3-hydroxybutyrate ketone monoester drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total hemoglobin mass	Using the optimized CO-re-breathing method, total hemoglobin mass will be estimated	Day 0, Day 35, Day 42
Skeletal muscle capillarization	Changes in muscle capillarization are measured using immunohistochemical anlyses	Day 0, Day 35, Day 42
Cycling exercise performance	maximal average power output during a 30 minute time trial, cycling efficiency test and repeated sprint test	Day 0, Day 35, Day 42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal oxygen uptake (VO2max)	Using ergospirometry VO2max will be measured during a graded exercise test	Day 0, Day 35, Day 42
Change in peripheral blood flow	Measured using duplex ultrasonography	Day 0, Day 35, Day 42
Serum EPO concentrations	Serum EPO concentrations will be measured using a commercially available ELISA kit	Day 0, day1, week1, week2, week3, week4, week5, day35, day42
Sleep Architecture	Polysomnography will be used to measure sleep architecture	Day 0, day1, week 3, day35, day42

Collaborators and Investigators

• Sponsor: KU Leuven
• Investigators: Principal Investigator: Chiel Poffé, KU Leuven

Study record dates

Study Major Dates

• Study Start (Estimated): September 10, 2024
• Primary Completion (Estimated): October 15, 2024
• Study Completion (Estimated): October 15, 2024

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: September 10, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 10, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; EPO; Altitude training camp; Live high, train low
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: S67562

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