Hypoxia Clinical Trial
Official title:
Effect of Ketone Ester Supplementation on Hypoxic Tolerance
Verified date | August 2023 |
Source | KU Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | KU Leuven | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
KU Leuven |
Belgium,
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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