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Completed

NCT Number: NCT06060093

Effect of Ketone Ester Supplementation on Sleep and Recovery in Hypoxia

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

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

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

Primary outcomes

  1. Duration of different sleep stages

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

    Measured using polysomnography

  2. Exercise performance

    Time frame: 30 minutes on the second morning of the protocol

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

  3. Change in nocturnal oxygen saturation

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

    Measured using pulse oximetry

  4. Absolute amount of nocturnal urinary catecholamine excretion

    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

    Measured using ELISA of collected nocturnal urine

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 29, 2023
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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