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Recruiting NCT06596083

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

No phase Interventional Hypoxia Exogenous Ketosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo supplement, Ketone ester supplement.
Who it may be relevant to
Registry conditions: Hypoxia, Exogenous Ketosis. Basic parameters: 18 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Dietary supplement Placebo supplement
    oral supplement containing: 16.4 grams of medium chained triglycerides, 1mM or sucrose octaacetate and water
  • Dietary supplement Ketone ester supplement
    Oral supplement containing: 25 grams of pure (R)-3-hydroxybutyl-(R)-3-hydroxybutyrate ketone monoester drink

Primary outcome measures

  • Total hemoglobin mass [Time frame: Day 0, Day 35, Day 42]
  • Skeletal muscle capillarization [Time frame: Day 0, Day 35, Day 42]
  • Cycling exercise performance [Time frame: Day 0, Day 35, Day 42]
Secondary outcome measures (4)
  • Maximal oxygen uptake (VO2max) [Time frame: Day 0, Day 35, Day 42]
  • Change in peripheral blood flow [Time frame: Day 0, Day 35, Day 42]
  • Serum EPO concentrations [Time frame: Day 0, day1, week1, week2, week3, week4, week5, day35, day42]
  • Sleep Architecture [Time frame: Day 0, day1, week 3, day35, day42]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

Belgium · 1 center
  • KU Leuven — Leuven

Identifiers

NCT: NCT06596083 · S67562

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗