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Effect of Ketone Ester Supplementation on Hypoxic Tolerance

Primary Purpose

Ketosis, Hypoxia

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Ketone ester

Placebo

About this trial

This is an interventional basic science trial for Ketosis focused on measuring Acute Mountain Sickness, Sleep, Cognitive Decline

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

KU Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketone group

Placebo group

Arm Description

Ketone esters will be provided

Ketone placebo will be provided

Outcomes

Primary Outcome Measures

Change in incidence of acute mountain sickness symptoms

Scored by Lake Louise Scoring system

Change in oxygenation status of brain, blood, muscle

Measured by NIRS, pulse oximetry, blood samples

Change in cerebral blood flow

Measured using duplex ultrasound

Time in hypoxia

Total time that subjects were able to comply to the experimental protocol and supplementation protocol

Secondary Outcome Measures

Sleep quality

Measured using polysomnography

Full Information

NCT ID

NCT05588427

First Posted

October 14, 2022

Last Updated

August 30, 2023

Sponsor

KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT05588427

Brief Title

Effect of Ketone Ester Supplementation on Hypoxic Tolerance

Official Title

Effect of Ketone Ester Supplementation on Hypoxic Tolerance

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

November 15, 2022 (Actual)

Primary Completion Date

December 20, 2022 (Actual)

Study Completion Date

December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ketosis, Hypoxia

Keywords

Acute Mountain Sickness, Sleep, Cognitive Decline

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ketone group

Arm Type

Experimental

Arm Description

Ketone esters will be provided

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Ketone placebo will be provided

Intervention Type

Dietary Supplement

Intervention Name(s)

Ketone ester

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in incidence of acute mountain sickness symptoms

Description

Scored by Lake Louise Scoring system

Time Frame

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

Title

Change in oxygenation status of brain, blood, muscle

Description

Measured by NIRS, pulse oximetry, blood samples

Time Frame

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

Title

Change in cerebral blood flow

Description

Measured using duplex ultrasound

Time Frame

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

Title

Time in hypoxia

Description

Total time that subjects were able to comply to the experimental protocol and supplementation protocol

Time Frame

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 Outcome Measure Information:

Title

Sleep quality

Description

Measured using polysomnography

Time Frame

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chiel Poffé, Dr.

Organizational Affiliation

KU Leuven

Official's Role

Principal Investigator

Facility Information:

Facility Name

KU Leuven

City

Leuven

State/Province

Vlaams-Brabant

ZIP/Postal Code

3000

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

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Effect of Ketone Ester Supplementation on Hypoxic Tolerance

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