Clinical trial NCT06596083: The Effects of Ketone Ester Supplementation During a 5 Week Live High, Train Low Altitude Training Camp
Official title: The Effects of Ketone Ester Supplementation During a 5 Week Live High, Train Low Altitude Training Camp
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypoxia
Exogenous Ketosis
Keywords: Altitude training camp
Exercise
Live high, train low
EPO
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will go through the entire 5 week training camp and 1 week follow up while taking either ketone ester supplements (KE) or an isocaloric placebo (CON).
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Total hemoglobin mass
timeFrame: Day 0, Day 35, Day 42
measure: Skeletal muscle capillarization
timeFrame: Day 0, Day 35, Day 42
measure: Cycling exercise performance
timeFrame: Day 0, Day 35, Day 42
Secondary outcomes:
measure: Maximal oxygen uptake (VO2max)
timeFrame: Day 0, Day 35, Day 42
measure: Change in peripheral blood flow
timeFrame: Day 0, Day 35, Day 42
measure: Serum EPO concentrations
timeFrame: Day 0, day1, week1, week2, week3, week4, week5, day35, day42
measure: Sleep Architecture
timeFrame: Day 0, day1, week 3, day35, day42
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven
name: Chiel Poffé
role: PRINCIPAL_INVESTIGATOR
References: