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Clinical Trials/NCT06596083
NCT06596083RecruitingNot Applicable

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

KU Leuven2 sites in 1 country18 target enrollmentStarted: September 10, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
KU Leuven
Enrollment
18
Locations
2
Primary Endpoint
Total hemoglobin mass

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Masking Description

Participants and investigators are blinded from the experimental condition (KE or CON). Supplements are provided in non transparent tubes and the control supplement is identical in taste and viscosity to the ketone supplement.

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Total hemoglobin mass

Time Frame: Day 0, Day 35, Day 42

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

Skeletal muscle capillarization

Time Frame: Day 0, Day 35, Day 42

Changes in muscle capillarization are measured using immunohistochemical anlyses

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

  • Maximal oxygen uptake (VO2max)(Day 0, Day 35, Day 42)
  • Change in peripheral blood flow(Day 0, Day 35, Day 42)
  • Serum EPO concentrations(Day 0, day1, week1, week2, week3, week4, week5, day35, day42)
  • Sleep Architecture(Day 0, day1, week 3, day35, day42)

Investigators

Sponsor
KU Leuven
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chiel Poffé

postdoctoral researcher

KU Leuven

Study Sites (2)

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