Effect of Ketone Ester Supplementation on Hypoxic Tolerance

NCT05588427 | Completed DMC

• 1 other identifier: S66320
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Ketosis; Hypoxia

Keywords

Acute Mountain Sickness; Sleep; Cognitive Decline

Outcome Measures

Primary Outcomes (4)

• Change in incidence of acute mountain sickness symptoms

  Scored by Lake Louise Scoring system

  Hour 0 - Hour 4 - Hour 10 - Hour 24 - Hour 28

• 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

• Change in cerebral blood flow

  Measured using duplex ultrasound

  Hour 1 - Hour 4 - Hour 10 - Hour 24 - Hour 28

• 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 Outcomes (1)

• Sleep quality

  Throughout the entire duration of the night, up to 9 hours after individual bedtime

Study Arms (2)

Ketone group

EXPERIMENTAL

Ketone esters will be provided

Dietary Supplement: Ketone ester

Placebo group

PLACEBO COMPARATOR

Ketone placebo will be provided

Dietary Supplement: Placebo

Interventions

Ketone ester DIETARY_SUPPLEMENT

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

Ketone group

Placebo DIETARY_SUPPLEMENT

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

Placebo group

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Ketosis; Hypoxia; Altitude Sickness; Cognitive Dysfunction

Interventions

formic acid 4-(3-oxobutyl)phenyl ester

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Chiel Poffé, Dr.

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 1 session with ketone ester supplementation and 1 session with taste and viscosity matched placebo

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 20, 2022
• Study Start: November 15, 2022
• Primary Completion: December 20, 2022
• Study Completion: December 31, 2022
• Last Updated: September 5, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)