Effect of Ketone Ester Supplementation on Sleep and Recovery in Hypoxia

NCT06060093 | Completed DMC

• 1 other identifier: S67089
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Ketosis; Hypoxia; Sleep

Keywords

Exercise; Ketones; Living-high Training-low

Outcome Measures

Primary Outcomes (4)

• Duration of different sleep stages

  Measured using polysomnography

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

• Exercise performance

  Measured as the average power output (W) during a 30 minutes time trial

  30 minutes on the second morning of the protocol

• Change in nocturnal oxygen saturation

  Measured using pulse oximetry

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

• Absolute amount of nocturnal urinary catecholamine excretion

  Measured using ELISA of collected nocturnal urine

  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

Study Arms (3)

Normoxia - placebo

PLACEBO COMPARATOR

Both training and sleep in normoxia, supplemented with placebo

Dietary Supplement: Placebo

Hypoxia - placebo

EXPERIMENTAL

Training in normoxia and sleep in hypoxia, supplemented with placebo

Dietary Supplement: Placebo

Hypoxia - ketones

EXPERIMENTAL

Training in normoxia and sleep in hypoxia, supplemented with ketones

Dietary Supplement: Ketone ester

Interventions

Placebo DIETARY_SUPPLEMENT

Water, 5% collagen(w/w), octoacetate (1 mM)

Hypoxia - placebo; Normoxia - placebo

Ketone ester DIETARY_SUPPLEMENT

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

Hypoxia - ketones

Eligibility Criteria

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

You may qualify if:

• 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

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, 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (1)

• Stalmans M, Tominec D, Robberechts R, Lauriks W, Ramaekers M, Debevec T, Poffe C. A Single Night in Hypoxia Either with or without Ketone Ester Ingestion Reduces Sleep Quality without Impacting Next-Day Exercise Performance. Med Sci Sports Exerc. 2025 Apr 1;57(4):807-819. doi: 10.1249/MSS.0000000000003604. Epub 2024 Nov 18.

  PMID: 39809236 DERIVED

MeSH Terms

Conditions

Ketosis; Hypoxia; Motor Activity

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; Behavior

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 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)

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 29, 2023
• Study Start: February 20, 2023
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)