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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05588427
Other study ID # S66320
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2022
Est. completion date December 31, 2022

Study information

Verified date August 2023
Source KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 31, 2022
Est. primary completion date December 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Ketone 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
Placebo
Water, 5% sucralose (w/w), octaacetate (1 mM)

Locations

Country Name City State
Belgium KU Leuven Leuven Vlaams-Brabant

Sponsors (1)

Lead Sponsor Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in incidence of acute mountain sickness symptoms Scored by Lake Louise Scoring system Hour 0 - Hour 4 - Hour 10 - Hour 24 - Hour 28
Primary Change in oxygenation status of brain, blood, muscle Measured by NIRS, pulse oximetry, blood samples Hour 1 - Hour 4 - Hour 10 - Hour 24 - Hour 28
Primary Change in cerebral blood flow Measured using duplex ultrasound Hour 1 - Hour 4 - Hour 10 - Hour 24 - Hour 28
Primary Time in hypoxia Total time that subjects were able to comply to the experimental protocol and supplementation protocol From start of hypoxic exposure until subjects are too sick to comply to (supplementation) protocol or until end of protocol, up to 29 hours
Secondary Sleep quality Measured using polysomnography Throughout the entire duration of the night, up to 9 hours after individual bedtime
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