Back to resultsEffect of Oral Ketone and Sodium Bicarbonate Administration During Endurance Exercise in Hypoxia
Primary Purpose
Exercise, Hypoxia
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Ketone ester
Sodium bicarbonate
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Exercise focused on measuring exercise, hypoxia, ketone
Eligibility Criteria
Inclusion Criteria:
- Males between 18 and 35 years old
- Recreational or competitive cyclist performing regularly cycling training sessions of at least 4 hours, with an average training volume of more than 6 hours per week
- Good health status confirmed by a medical screening
- VO2max higher than 55 ml.min-1.kg-1
- Body Mass Index (BMI) between 18 and 25
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
- Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study.
- Blood donation within 3 months prior to the start of the study
- Smoking
- More than 3 alcoholic beverages per day, including a maximum of one glass of wine per day
- 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
- KU Leuven
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
Ketone ester
Ketone ester + bicarbonate
Bicarbonate
Arm Description
Only carbohydrates will be provided
Ketone ester with carbohydrates will be provided
Ketone ester with bicarbonate and carbohydrates will be provided
Bicarbonate and carbohydrates will be provided
Outcomes
Primary Outcome Measures
Change in Cycling performance - Simulated 15-min long time trial
Performance (average power output) during the 15 min long time trial on an ergometer
Change in Cycling performance - Simulated Sprint
Time to exhaustion at 175% of the intensity of the second lactate threshold
Change in Blood acid-base balance (pH and [HCO3-]) during cycling
Blood acid-base balance assement
Secondary Outcome Measures
Change in Blood ketone concentrations during exercise
Blood ketone assesment
Change in Blood glucose concentrations during exercise
Blood glucose assesment
Change in Blood lactate concentrations during exercise
Blood lactate assesment
Change in Respiratory parameters (VE, V̇O2 and V̇CO2) during exercise
Gas exchange measurement
Change in arterial oxygen saturation during exercise
Pulse oxymetry measurement
Change in muscle oxygenation during exercise
Near infrared spectroscopy measuremet
Full Information
NCT ID
NCT04579770
First Posted
September 24, 2020
Last Updated
February 8, 2021
Sponsor
Jozef Stefan Institute
Collaborators
KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT04579770
Brief Title
Effect of Oral Ketone and Sodium Bicarbonate Administration During Endurance Exercise in Hypoxia
Official Title
Effect of Oral Ketone and Sodium Bicarbonate Administration on Physiological and Metabolic Parameters During Endurance Exercise in Hypoxia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 4, 2020 (Actual)
Primary Completion Date
December 5, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jozef Stefan Institute
Collaborators
KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is investigating the effects of oral ketone and sodium bicarbonate administration on physiological and metabolic parameters during cycling endurance exercise in hypoxia. Ketone body supplementation is commonly used among elite endurance athletes that also compete in the hypoxia (at altitude). To-date effects of ketones have only been investigated in normoxia and the data in hypoxia is lacking. Hence, we want to investigate the effect of oral ketone ester intake with and without additional sodium bicarbonate (NaHCO3) ingestion on i) blood-acid base balance and ii) exercise performance during prolonged exercise under hypoxic conditions. Information obtained via this study should provide valuable information with regard to optimisation of exercise training and athletic performance, and more importantly, provide pioneering insight on the metabolic and physiological responses to ketosis under hypoxic conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise, Hypoxia
Keywords
exercise, hypoxia, ketone
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Only carbohydrates will be provided
Arm Title
Ketone ester
Arm Type
Experimental
Arm Description
Ketone ester with carbohydrates will be provided
Arm Title
Ketone ester + bicarbonate
Arm Type
Experimental
Arm Description
Ketone ester with bicarbonate and carbohydrates will be provided
Arm Title
Bicarbonate
Arm Type
Experimental
Arm Description
Bicarbonate and carbohydrates will be provided
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone ester
Intervention Description
75g ketone ester in the form of a drink [96% (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, Oxfordshire, UK)] will be provided.
Intervention Type
Other
Intervention Name(s)
Sodium bicarbonate
Intervention Description
Sodium bicarbonate - widely accessible food ingredient will be provided.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in Cycling performance - Simulated 15-min long time trial
Description
Performance (average power output) during the 15 min long time trial on an ergometer
Time Frame
5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Title
Change in Cycling performance - Simulated Sprint
Description
Time to exhaustion at 175% of the intensity of the second lactate threshold
Time Frame
5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Title
Change in Blood acid-base balance (pH and [HCO3-]) during cycling
Description
Blood acid-base balance assement
Time Frame
5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Secondary Outcome Measure Information:
Title
Change in Blood ketone concentrations during exercise
Description
Blood ketone assesment
Time Frame
5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Title
Change in Blood glucose concentrations during exercise
Description
Blood glucose assesment
Time Frame
5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Title
Change in Blood lactate concentrations during exercise
Description
Blood lactate assesment
Time Frame
5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Title
Change in Respiratory parameters (VE, V̇O2 and V̇CO2) during exercise
Description
Gas exchange measurement
Time Frame
5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Title
Change in arterial oxygen saturation during exercise
Description
Pulse oxymetry measurement
Time Frame
5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Title
Change in muscle oxygenation during exercise
Description
Near infrared spectroscopy measuremet
Time Frame
5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
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 cyclist performing regularly cycling training sessions of at least 4 hours, with an average training volume of more than 6 hours per week
Good health status confirmed by a medical screening
VO2max higher than 55 ml.min-1.kg-1
Body Mass Index (BMI) between 18 and 25
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
Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study.
Blood donation within 3 months prior to the start of the study
Smoking
More than 3 alcoholic beverages per day, including a maximum of one glass of wine per day
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
KU Leuven
City
Leuven
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Effect of Oral Ketone and Sodium Bicarbonate Administration During Endurance Exercise in Hypoxia
We'll reach out to this number within 24 hrs