Acute Effect of Exogenous Ketosis on Sleep Architecture Following Strenuous Exercise
Primary Purpose
Sleep
Status
Active
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Ketone ester
Placebo
Exercise
Sponsored by
About this trial
This is an interventional basic science trial for Sleep focused on measuring Ketone, Exercise, Sleep
Eligibility Criteria
Inclusion Criteria:
- Males between 18 and 35 years old
- Recreational or competitive cyclists performing regularly 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 (PSQI)
- Moderate sleep chronotype, assessed by the Horne and Östberg questionnaire
Exclusion Criteria:
- Excessive daytime sleepiness as assessed by the Epworth scale
- Depression or anxiety as assessed by the Beck Depression Inventory and Beck Anxiety Inventory
- Night-shifts or travel across time zones in the month preceding the study
- Any kind of injury/pathology that is a contra-indication to perform high-intensity exercise
- Intake of any medication or nutritional supplement that is known to affect exercise performance or sleep
- Smoking
- Involvement in elite athletic training at a semi-professional or professional level
- Current participation in another research trial
- Any other argument to believe that the subject is unlikely to successfully complete the full study protocol
Sites / Locations
- Exercise Physiology Group
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
Exercise and ketone
Exercise and placebo
Non-exercise and placebo
Arm Description
Ketone ester is provided
Placebo is provided
Placebo is provided
Outcomes
Primary Outcome Measures
Total sleep time
Change in total sleep time between conditions as evaluated with polysomnography
Urinary nocturnal adrenaline excretion
Change in urinary nocturnal adrenaline excretion between conditions
Urinary nocturnal noradrenaline excretion
Change in urinary nocturnal adrenaline excretion between conditions
Secondary Outcome Measures
Total rapid-eye-movement sleep
Change in total rapid-eye-movement sleep between conditions as evaluated with polysomnography
Total non-rapid-eye-movement sleep
Change in total non-rapid-eye-movement sleep between conditions as evaluated with polysomnography
Total slow-wave sleep
Change in total slow-wave sleep between conditions as evaluated with polysomnography
Plasma adrenaline concentration
Change in plasma adrenaline concentration between conditions
Plasma noradrenaline concentration
Change in plasma noradrenaline concentration between conditions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05439720
Brief Title
Acute Effect of Exogenous Ketosis on Sleep Architecture Following Strenuous Exercise
Official Title
Acute Effect of Exogenous Ketosis on Sleep Architecture Following Morning and Evening Strenuous Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 15, 2022 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
August 15, 2022 (Anticipated)
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
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to investigate the effect of oral ketone ester administration on sleep architecture. To investigate this, the investigators use a randomised, placebo-controlled, cross-over research design. The study comprises three experimental sessions, each separated by a one-week washout period. Two of the three experimental sessions consist of a 120 minutes cycling endurance training session (ET) two hours after breakfast and an evening high-intensity-interval training (HIIT) ending one hour before bedtime. After each training session, and 30 minutes before sleeptime, subjects receive a ketone ester or a control drink . To investigate the effects of strenuous exercise on sleep alone, an additional experimental session without exercise is added.
Before bedtime, a venous blood sample is taken to evaluate hormones playing an important role in sleep regulation. During the experimental sessions, the subjects sleep in a sleep facility to evaluate quality of sleep. Time spent in different sleep phases is measured via polysomnography (PSG). Urine output throughout the day and night will be collected for measurement of urinary excretion of adrenaline and noradrenaline as an index of intrinsic sympathetic activity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep
Keywords
Ketone, Exercise, Sleep
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise and ketone
Arm Type
Experimental
Arm Description
Ketone ester is provided
Arm Title
Exercise and placebo
Arm Type
Placebo Comparator
Arm Description
Placebo is provided
Arm Title
Non-exercise and placebo
Arm Type
Placebo Comparator
Arm Description
Placebo is provided
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone ester
Intervention Description
A dose of 25g of ketone ester after each training session and 30 minutes before sleeptime. The total dose is 75g of ketone ester.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Collagen peptan (3g) mixed with 1 mM bitter sucrose octaacetate and 20ml of pure water. A dose of 25g of placebo drink is provided after each training session and 30 minutes before sleeptime. The total dose is 75g of placebo drink.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
A 120 minutes cycling endurance training session (ET) two hours after breakfast and an evening high-intensity-interval training (HIIT) ending one hour before bedtime
Primary Outcome Measure Information:
Title
Total sleep time
Description
Change in total sleep time between conditions as evaluated with polysomnography
Time Frame
Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Title
Urinary nocturnal adrenaline excretion
Description
Change in urinary nocturnal adrenaline excretion between conditions
Time Frame
Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Title
Urinary nocturnal noradrenaline excretion
Description
Change in urinary nocturnal adrenaline excretion between conditions
Time Frame
Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Secondary Outcome Measure Information:
Title
Total rapid-eye-movement sleep
Description
Change in total rapid-eye-movement sleep between conditions as evaluated with polysomnography
Time Frame
Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Title
Total non-rapid-eye-movement sleep
Description
Change in total non-rapid-eye-movement sleep between conditions as evaluated with polysomnography
Time Frame
Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Title
Total slow-wave sleep
Description
Change in total slow-wave sleep between conditions as evaluated with polysomnography
Time Frame
Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Title
Plasma adrenaline concentration
Description
Change in plasma adrenaline concentration between conditions
Time Frame
Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Title
Plasma noradrenaline concentration
Description
Change in plasma noradrenaline concentration between conditions
Time Frame
Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
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:
Males between 18 and 35 years old
Recreational or competitive cyclists performing regularly 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 (PSQI)
Moderate sleep chronotype, assessed by the Horne and Östberg questionnaire
Exclusion Criteria:
Excessive daytime sleepiness as assessed by the Epworth scale
Depression or anxiety as assessed by the Beck Depression Inventory and Beck Anxiety Inventory
Night-shifts or travel across time zones in the month preceding the study
Any kind of injury/pathology that is a contra-indication to perform high-intensity exercise
Intake of any medication or nutritional supplement that is known to affect exercise performance or sleep
Smoking
Involvement in elite athletic training at a semi-professional or professional level
Current participation in another research trial
Any other argument to believe that the subject is unlikely to successfully complete the full study protocol
Facility Information:
Facility Name
Exercise Physiology Group
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Acute Effect of Exogenous Ketosis on Sleep Architecture Following Strenuous Exercise
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