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Role of Intermittent Exogenous Ketosis in the Physiological and Muscular Adaptive Response to Endurance Training

Primary Purpose

Exercise Adaptations

Status
Active
Phase
Phase 2
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 Exercise Adaptations focused on measuring ketone bodies, Exercise adaptations, Sleep

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Physically fit and regularly involved in physical activity (2-5 exercise sessions of > 30min per week) Good health status confirmed by a medical screening VO2max higher than 50 ml.min-1.kg-1 Body Mass Index (BMI) between 18 and 25 Normal sleep pattern as assessed by the Pittsburgh Sleep Quality Index (PSQI, appendix 2) Exclusion Criteria: 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 Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of 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 or more than one glass if wine per day Involvement in elite athletic training at a semi-professional or professional level Any other argument to believe that the subject is unlikely to successfully complete the full study protocol

Sites / Locations

  • Exercise Physiology Research Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Experimental groep

Arm Description

Placebo is provided

Ketone ester is provided

Outcomes

Primary Outcome Measures

Change in mean power output during a 30min cycling time trial
Change in mean power output during a self-paced 30 min cycling time trial on a cyling ergometer
Change in capillarization of the musculus vastus lateralis
Change in capillarization (CFPE-index) of the musculus vastus lateralis
Change in sleep efficiency
Change in sleep efficiency measured by polysomnography
Change in REM sleep
Change in REM sleep measured by polysomnography

Secondary Outcome Measures

Change in the nocturnal urinary excretion of dopamine
Change in the nocturnal urinary excretion of dopamine
Change in the nocturnal urinary excretion of noradrenaline
Change in the nocturnal urinary excretion of noradrenaline
Change in the nocturnal urinary excretion of adrenaline
Change in the nocturnal urinary excretion of adrenaline
Change in maximal oxygen uptake
Change in maximal oxygen uptake measured during a maximal incremental exercise test on a cycling ergometer

Full Information

First Posted
June 27, 2023
Last Updated
June 27, 2023
Sponsor
KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT05932420
Brief Title
Role of Intermittent Exogenous Ketosis in the Physiological and Muscular Adaptive Response to Endurance Training
Official Title
Role of Intermittent Exogenous Ketosis in the Physiological and Muscular Adaptive Response to Endurance Training. A Study in Young, Male Volunteers.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
December 31, 2023 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In a recent study (Poffé et al., 2019), we demonstrated that increasing the concentration of ketone bodies in the blood through the ingestion of a ketone ester (KE) post-exercise and just before sleeping time during a 3-week overtraining period resulted in suppression of the physiological symptoms of overtraining. Consistent KE intake improved endurance performance, positively affected the autonomic regulation of the heart, suppressed the increase of nocturnal sympathetic activity, and increased spontaneous energy intake. In addition, KE intake had a positive effect on muscular adaptive response, as evidenced by the significantly increased muscular angiogenesis. Therefore, in this study, we aim to investigate whether the oral administration of ketones after exercise and just before bedtime also has a positive effect on the adaptive response during a well-dosed endurance training program. Since suppression of nocturnal sympathetic activity can positively influence sleep quality, we will also study the effect of KE and the training period on sleep quality. To investigate this, we will use a randomized, placebo-controlled parallel research design. Well-trained male cyclists will participate in a fully controlled intervention period of 8 weeks. During the intervention period, participants will follow a supervised cycling training program (5-7 training sessions per week) with a gradual buildup aimed at improving endurance capacity. Throughout the intervention period, participants will ingest 25g ketone ester or a corresponding placebo after each training session and 30 minutes before bedtime. Endurance performance will be evaluated before the start of the training period (pretest), after week 3 (midtest), after week 7 (posttest) of the training period, and at the end of the training intervention (posttest+taper). Additionally, blood samples will be taken at the pre-test and post-test to analyze markers of hormonal status and inflammation. Muscle biopsies will be taken from the vastus lateralis muscle of the right leg at pretest and posttest to analyze cross-sectional area, muscle fiber typing, angiogenesis, protein synthesis and degradation, mitochondrial function, and energy substrate concentrations. One month after the intervention period, an additional biopsy will be taken to study changes in gene expression (epigenetic modifications). Sleep will be evaluated via polysomnography (PSG) at the pretest, midtest and posttest. Finally, before and after the training period, resting and exercise echocardiography will be taken to investigate investigate structural and morphological changes of the heart.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Adaptations
Keywords
ketone bodies, Exercise adaptations, Sleep

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Placebo is provided
Arm Title
Experimental groep
Arm Type
Experimental
Arm Description
Ketone ester is provided
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
16.4g pure medium triglyceride oil mixed with 1 mM of bitter sucrose octaacetate. A dose of 25g of the placebo drink is provided immediately after each training session and 30 minutes before sleeptime throughout the training period.
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 throughout the training period.
Primary Outcome Measure Information:
Title
Change in mean power output during a 30min cycling time trial
Description
Change in mean power output during a self-paced 30 min cycling time trial on a cyling ergometer
Time Frame
Pretest (before the start of the training intervention) - Midtest (after week 3 of the training intervention) - Posttest (after week 7 of the training intervention) - Posttest+taper (after week 8 of the training intervention)
Title
Change in capillarization of the musculus vastus lateralis
Description
Change in capillarization (CFPE-index) of the musculus vastus lateralis
Time Frame
Pretest (before the start of the training intervention) - Posttest (after week 7 of the training intervention)
Title
Change in sleep efficiency
Description
Change in sleep efficiency measured by polysomnography
Time Frame
Pretest (before the start of the training intervention) - Midtest (after week 3 of the training intervention) - Posttest (after week 7 of the training intervention)
Title
Change in REM sleep
Description
Change in REM sleep measured by polysomnography
Time Frame
Pretest (before the start of the training intervention) - Midtest (after week 3 of the training intervention) - Posttest (after week 7 of the training intervention)
Secondary Outcome Measure Information:
Title
Change in the nocturnal urinary excretion of dopamine
Description
Change in the nocturnal urinary excretion of dopamine
Time Frame
Pretest (before the start of the training intervention) - Midtest (after week 3 of the training intervention) - Posttest (after week 7 of the training intervention)
Title
Change in the nocturnal urinary excretion of noradrenaline
Description
Change in the nocturnal urinary excretion of noradrenaline
Time Frame
Pretest (before the start of the training intervention) - Midtest (after week 3 of the training intervention) - Posttest (after week 7 of the training intervention)
Title
Change in the nocturnal urinary excretion of adrenaline
Description
Change in the nocturnal urinary excretion of adrenaline
Time Frame
Pretest (before the start of the training intervention) - Midtest (after week 3 of the training intervention) - Posttest (after week 7 of the training intervention)
Title
Change in maximal oxygen uptake
Description
Change in maximal oxygen uptake measured during a maximal incremental exercise test on a cycling ergometer
Time Frame
Pretest (before the start of the training intervention) - Midtest (after week 3 of the training intervention) - Posttest (after week 7 of the training intervention)

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: Physically fit and regularly involved in physical activity (2-5 exercise sessions of > 30min per week) Good health status confirmed by a medical screening VO2max higher than 50 ml.min-1.kg-1 Body Mass Index (BMI) between 18 and 25 Normal sleep pattern as assessed by the Pittsburgh Sleep Quality Index (PSQI, appendix 2) Exclusion Criteria: 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 Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of 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 or more than one glass if wine per day Involvement in elite athletic training at a semi-professional or professional level Any other argument to believe that the subject is unlikely to successfully complete the full study protocol
Facility Information:
Facility Name
Exercise Physiology Research Group
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31039280
Citation
Poffe C, Ramaekers M, Van Thienen R, Hespel P. Ketone ester supplementation blunts overreaching symptoms during endurance training overload. J Physiol. 2019 Jun;597(12):3009-3027. doi: 10.1113/JP277831. Epub 2019 May 22.
Results Reference
background
PubMed Identifier
37259248
Citation
Robberechts R, Albouy G, Hespel P, Poffe C. Exogenous Ketosis Improves Sleep Efficiency and Counteracts the Decline in REM Sleep Following Strenuous Exercise. Med Sci Sports Exerc. 2023 Jun 1. doi: 10.1249/MSS.0000000000003231. Online ahead of print.
Results Reference
background

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Role of Intermittent Exogenous Ketosis in the Physiological and Muscular Adaptive Response to Endurance Training

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