Effect of Ketone Ester Supplementation on Sleep and Recovery in Hypoxia

• Sponsor: KU Leuven (Other)
• Overall Status: Completed
• CT.gov ID: NCT06060093
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Arms: 3
• Actual Duration (Months): 1.3
• Patients Per Site Per Month: 10.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ketosis; Hypoxia; Sleep	Dietary Supplement: Placebo; Dietary Supplement: Ketone ester	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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)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: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Effect of Ketone Ester Supplementation on Sleep and Recovery in Hypoxia
• Actual Study Start Date: Feb 20, 2023
• Actual Primary Completion Date: Mar 31, 2023
• Actual Study Completion Date: Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Normoxia - placebo Both training and sleep in normoxia, supplemented with placebo	Dietary Supplement: Placebo; Water, 5% collagen(w/w), octoacetate (1 mM)
Experimental: Hypoxia - placebo Training in normoxia and sleep in hypoxia, supplemented with placebo	Dietary Supplement: Placebo; Water, 5% collagen(w/w), octoacetate (1 mM)
Experimental: Hypoxia - ketones Training in normoxia and sleep in hypoxia, supplemented with ketones	Dietary Supplement: Ketone ester; 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

Outcome Measures

Primary Outcome Measures

1. Duration of different sleep stages [Throughout the entire duration of the night, up to 9 hours after individual bedtime]

   Measured using polysomnography

2. Exercise performance [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Written informed consent must be obtained prior to any experimental procedures

2. Males between 18 and 35 years old

3. Recreational or competitive cyclists performing regular cycling training sessions with an average training volume of more than 6 hours per week

4. Good health status confirmed by a medical screening

5. Body Mass Index (BMI) between 18 and 25

6. Normal sleep pattern as assessed by the Pittsburgh Sleep Quality Index

7. Moderate sleep chronotype (extreme morning and evening chronotypes will be excluded), assessed by the Horne and Östberg questionnaire

Exclusion Criteria:

1. 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

2. 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.

3. Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study.

4. Recent residence or training under hypoxia; more than 7 days exposure to altitude > 1500m during the last 3 months preceding the study.

5. Night-shifts or travel across time zones in the month preceding the study

6. Blood donation within 3 months prior to the start of the study

7. Smoking

8. More than 3 alcoholic beverages per day

9. Pre-existing, diagnosed psychiatric conditions or diagnosed anxiety

10. Excessive daytime sleepiness as assessed by the Epworth scale

11. 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.

12. History of addiction or excessive caffeine/alcohol consumption assessed by a questionnaire

13. Any other argument to believe that the subject is unlikely to successfully complete the full study protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KU Leuven	Leuven	Vlaams-Brabant	Belgium	3000

Sponsors and Collaborators

• KU Leuven

Investigators

• Principal Investigator: Chiel Poffé, Dr., KU Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chiel Poffé, Principal Investigator, KU Leuven
• ClinicalTrials.gov Identifier: NCT06060093
• Other Study ID Numbers: S67089
• First Posted: Sep 29, 2023
• Last Update Posted: Sep 29, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chiel Poffé, Principal Investigator, KU Leuven: Exercise; Ketones; Living-high Training-low
• Additional relevant MeSH terms: Hypoxia

Study Results

No Results Posted as of Sep 29, 2023