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Effect of Ketone Ester Supplementation on Sleep and Recovery in Hypoxia

Primary Purpose

Ketosis, Hypoxia, Sleep

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Placebo
Ketone ester
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ketosis focused on measuring Exercise, Ketones, Living-high Training-low

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Written informed consent must be obtained prior to any experimental procedures Males between 18 and 35 years old Recreational or competitive cyclists performing regular cycling training sessions with an average training volume of more than 6 hours per week Good health status confirmed by a medical screening Body Mass Index (BMI) between 18 and 25 Normal sleep pattern as assessed by the Pittsburgh Sleep Quality Index Moderate sleep chronotype (extreme morning and evening chronotypes will be excluded), assessed by the Horne and Östberg questionnaire Exclusion Criteria: Any kind of injury/pathology that is a contra-indication for hypoxic exposure and/or to perform high-intensity exercise, evaluated by a sport medical screening Intake of any medication or nutritional supplement that is known to affect exercise, performance or sleep. Intake will be assessed during recruitment and the sport medical screening. 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 the last 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 Pre-existing, diagnosed psychiatric conditions or diagnosed anxiety Excessive daytime sleepiness as assessed by the Epworth scale Depression or anxiety as assessed by the Beck Depression Inventory and Beck Anxiety Inventory. Only a score in the range of 'normal ups and downs' (score 1-10) for depression or 'minimal anxiety' (score 0-7) for anxiety are tolerated. History of addiction or excessive caffeine/alcohol consumption assessed by a questionnaire 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 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Normoxia - placebo

Hypoxia - placebo

Hypoxia - ketones

Arm Description

Both training and sleep in normoxia, supplemented with placebo

Training in normoxia and sleep in hypoxia, supplemented with placebo

Training in normoxia and sleep in hypoxia, supplemented with ketones

Outcomes

Primary Outcome Measures

Duration of different sleep stages
Measured using polysomnography
Exercise performance
Measured as the average power output (W) during a 30 minutes time trial
Change in nocturnal oxygen saturation
Measured using pulse oximetry
Absolute amount of nocturnal urinary catecholamine excretion
Measured using ELISA of collected nocturnal urine

Secondary Outcome Measures

Full Information

First Posted
August 29, 2023
Last Updated
September 27, 2023
Sponsor
KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT06060093
Brief Title
Effect of Ketone Ester Supplementation on Sleep and Recovery in Hypoxia
Official Title
Effect of Ketone Ester Supplementation on Sleep and Recovery in Hypoxia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study specifically aims to elucidate the effects of IEK on sleep and recuperation in hypoxia, after training in normoxia. These conditions are in line with the widely applied live-high train-low strategy. Moreover, blood and tissue oxygenation status, as well as cerebral blood flow and cognitive function will be assessed.
Detailed Description
During training stages in order to prepare for an important event, sleep and recuperation are almost equally important as the appropriate training strategy. This training strategy often consists of living-high (sleeping at -stimulated- altitude) and training low (training at sea level). A decreased oxygen availability, also known as hypoxia, however often disrupts sleep quality and thus compromises the overall training efficiency. Ketones are recently found to improve sleep quality, thus potentially playing a pivotal role in altitude training. Therefore, the investigators want to evaluate the effects of ketones on sleep in hypoxia, after training in normoxia. Moreover, the effect on a performance test, during a simulated 30 min time trial on the next morning, will be investigated. During this protocol, cerebral blood flow will be assessed, as well as ventilation, blood and tissue oxygen status, heart rate variability, and cognitive function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketosis, Hypoxia, Sleep
Keywords
Exercise, Ketones, Living-high Training-low

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
1 session with both training and sleep in normoxia, supplemented with placebo (NPL) 1 session with training in normoxia, sleep in hypoxia, supplemented with placebo (HPL) 1 session with training in normoxia, sleep in hypoxia, supplemented with ketones (HKE)
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normoxia - placebo
Arm Type
Placebo Comparator
Arm Description
Both training and sleep in normoxia, supplemented with placebo
Arm Title
Hypoxia - placebo
Arm Type
Experimental
Arm Description
Training in normoxia and sleep in hypoxia, supplemented with placebo
Arm Title
Hypoxia - ketones
Arm Type
Experimental
Arm Description
Training in normoxia and sleep in hypoxia, supplemented with ketones
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Water, 5% collagen(w/w), octoacetate (1 mM)
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone ester
Intervention Description
A total of 75g ketone ester supplementation will be administered in 3 bouts of 25g in order to establish intermittent exogenous ketosis: twice immediately after training, and one 30 minutes before sleep. The ketone ester used is (R)-3-hydroxybutyl (R)-3-hydroxybutyrate
Primary Outcome Measure Information:
Title
Duration of different sleep stages
Description
Measured using polysomnography
Time Frame
Throughout the entire duration of the night, up to 9 hours after individual bedtime
Title
Exercise performance
Description
Measured as the average power output (W) during a 30 minutes time trial
Time Frame
30 minutes on the second morning of the protocol
Title
Change in nocturnal oxygen saturation
Description
Measured using pulse oximetry
Time Frame
Throughout the entire duration of the night, up to 9 hours after individual bedtime
Title
Absolute amount of nocturnal urinary catecholamine excretion
Description
Measured using ELISA of collected nocturnal urine
Time Frame
Subjects empty bladder before sleep and urine will be collected throughout the entire duration of the night, up to 9 hours after individual bedtime and in the morning immediately after waking up

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Written informed consent must be obtained prior to any experimental procedures Males between 18 and 35 years old Recreational or competitive cyclists performing regular cycling training sessions with an average training volume of more than 6 hours per week Good health status confirmed by a medical screening Body Mass Index (BMI) between 18 and 25 Normal sleep pattern as assessed by the Pittsburgh Sleep Quality Index Moderate sleep chronotype (extreme morning and evening chronotypes will be excluded), assessed by the Horne and Östberg questionnaire Exclusion Criteria: Any kind of injury/pathology that is a contra-indication for hypoxic exposure and/or to perform high-intensity exercise, evaluated by a sport medical screening Intake of any medication or nutritional supplement that is known to affect exercise, performance or sleep. Intake will be assessed during recruitment and the sport medical screening. 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 the last 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 Pre-existing, diagnosed psychiatric conditions or diagnosed anxiety Excessive daytime sleepiness as assessed by the Epworth scale Depression or anxiety as assessed by the Beck Depression Inventory and Beck Anxiety Inventory. Only a score in the range of 'normal ups and downs' (score 1-10) for depression or 'minimal anxiety' (score 0-7) for anxiety are tolerated. History of addiction or excessive caffeine/alcohol consumption assessed by a questionnaire 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
No

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Effect of Ketone Ester Supplementation on Sleep and Recovery in Hypoxia

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