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NCT Number: NCT06596083

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location status: Recruiting

Location contact

Chiel Poffé

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo supplement

Dietary Supplement

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

Ketone Ester Supplement

Dietary Supplement

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

Primary outcomes

  1. Total hemoglobin mass

    Time frame: Day 0, Day 35, Day 42

    Using the optimized CO-re-breathing method, total hemoglobin mass will be estimated

  2. Skeletal muscle capillarization

    Time frame: Day 0, Day 35, Day 42

    Changes in muscle capillarization are measured using immunohistochemical anlyses

  3. Cycling exercise performance

    Time frame: Day 0, Day 35, Day 42

    maximal average power output during a 30 minute time trial, cycling efficiency test and repeated sprint test

Secondary outcomes

  1. Maximal oxygen uptake (VO2max)

    Time frame: Day 0, Day 35, Day 42

    Using ergospirometry VO2max will be measured during a graded exercise test

  2. Change in peripheral blood flow

    Time frame: Day 0, Day 35, Day 42

    Measured using duplex ultrasonography

  3. Serum EPO concentrations

    Time frame: Day 0, day1, week1, week2, week3, week4, week5, day35, day42

    Serum EPO concentrations will be measured using a commercially available ELISA kit

  4. Sleep Architecture

    Time frame: Day 0, day1, week 3, day35, day42

    Polysomnography will be used to measure sleep architecture

Study contacts

Contact information is provided by the study sponsor or research team.

Chiel Poffé

CONTACT

[email protected]

Wout Lauriks

CONTACT

[email protected]

+32474360778

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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