Clinical Trials Directory

Trials / Completed

CompletedNCT05588427

Effect of Ketone Ester Supplementation on Hypoxic Tolerance

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
16 (actual)
Sponsor
KU Leuven · Academic / Other
Sex
Male
Age
18 Years – 35 Years
Healthy volunteers
Accepted

Summary

This WP specifically aims to elucidate the effects of IEK on hypoxic tolerance and the development and severity of AMS symptoms, blood and tissue oxygenation status, as well as sleep quality during an episode of acute exposure to severe hypoxia.

Detailed description

Acute altitude exposure impairs exercise tolerance and performance, decreases the rate of maximal oxygen uptake (V̇O2max), cognitive function and sleep quality, and often also induces symptoms of acute mountain sickness (AMS). Previous studies have clearly indicated that ketone bodies exert a neuroprotective effect under hypoxic-ischemic conditions as well as improve hypoxic tolerance in rodents. In support of these earlier observations, recent pilot experiments in young volunteers in our laboratory provide proof of concept that IEK can attenuate oxygen desaturation during exercise in hypoxia. Therefore, given that impaired exercise tolerance in hypoxia is primarily due to impaired oxidative energy production in active tissues (brain and muscle), we hypothesize that IEK can increase blood and tissue (muscle and brain) oxygenation status in hypoxia and thereby enhance global hypoxic tolerance, as well as improve exercise tolerance and endurance exercise performance.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTKetone esterA total of 240g ketone ester supplementation will be provided in one of the 28h experimental sessions in order to establish intermittent exogenous ketosis. Sucralose (5% w/w) is added to the ketone ester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate
DIETARY_SUPPLEMENTPlaceboWater, 5% sucralose (w/w), octaacetate (1 mM)

Timeline

Start date
2022-11-15
Primary completion
2022-12-20
Completion
2022-12-31
First posted
2022-10-20
Last updated
2023-09-05

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT05588427. Inclusion in this directory is not an endorsement.