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Effect of Ketone Ester Supplementation on Hypoxic Tolerance

Effect of Ketone Ester Supplementation on Hypoxic Tolerance

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05588427
Enrollment
16
Registered
2022-10-20
Start date
2022-11-15
Completion date
2022-12-31
Last updated
2023-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxia, Ketosis

Keywords

Acute Mountain Sickness, Sleep, Cognitive Decline

Brief 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.

Interventions

DIETARY_SUPPLEMENTKetone ester

A 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_SUPPLEMENTPlacebo

Water, 5% sucralose (w/w), octaacetate (1 mM)

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Intervention model description

1 session with ketone ester supplementation and 1 session with taste and viscosity matched placebo

Eligibility

Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Males or females between 18 and 35 years old * Body Mass Index (BMI) between 18 and 25 * Physically fit and regularly involved in physical activity (2-5 exercise sessions of \> 30min per week) * Good health status confirmed by a medical screening * Non smoking * Normal sleep pattern as assessed by the Pittsburgh Sleep Quality Index (PSQI, appendix 2)

Exclusion criteria

* Any kind of injury/pathology that is a contra-indication for hypoxic exposure and/or to perform high-intensity exercise * Intake of any medication or nutritional supplement that is known to affect exercise, performance or sleep * Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study. * Recent residence or training under hypoxia; more than 7 days exposure to altitude \> 1500m during a period of 3 months preceding the study. * Night-shifts or travel across time zones in the month preceding the study * Blood donation within 3 months prior to the start of the study * Smoking * More than 3 alcoholic beverages per day * Involvement in elite athletic training at a semi-professional or professional level * Any other argument to believe that the subject is unlikely to successfully complete the full study protocol

Design outcomes

Primary

MeasureTime frameDescription
Change in incidence of acute mountain sickness symptomsHour 0 - Hour 4 - Hour 10 - Hour 24 - Hour 28Scored by Lake Louise Scoring system
Change in oxygenation status of brain, blood, muscleHour 1 - Hour 4 - Hour 10 - Hour 24 - Hour 28Measured by NIRS, pulse oximetry, blood samples
Change in cerebral blood flowHour 1 - Hour 4 - Hour 10 - Hour 24 - Hour 28Measured using duplex ultrasound
Time in hypoxiaFrom start of hypoxic exposure until subjects are too sick to comply to (supplementation) protocol or until end of protocol, up to 29 hoursTotal time that subjects were able to comply to the experimental protocol and supplementation protocol

Secondary

MeasureTime frameDescription
Sleep qualityThroughout the entire duration of the night, up to 9 hours after individual bedtimeMeasured using polysomnography

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026