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

NCT06596083 | Recruiting DMC

• 1 other identifier: S67562
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia; Exogenous Ketosis

Keywords

Altitude training camp; Exercise; Live high, train low; EPO

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (2)

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

Experimental group

EXPERIMENTAL

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

Interventions

Placebo supplement DIETARY_SUPPLEMENT

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

Placebo Comparator

Ketone ester supplement DIETARY_SUPPLEMENT

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Physically fit and regularly involved in physical activity (2-5h per week)
• Good health status confirmed by a medical screening
• Non-smoking

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Hypoxia; Motor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Chiel Poffé

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wout Lauriks

CONTACT

+32474360778; wout.lauriks@kuleuven.be

Chiel Poffé

CONTACT

chiel.poffe@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: postdoctoral researcher

Model Details: 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).

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 19, 2024
• Study Start: September 10, 2024
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

BE (1)