Effect of Oral Ketone and Sodium Bicarbonate Administration During Endurance Exercise in Hypoxia

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Oral Ketone and Sodium Bicarbonate Administration on Physiological and Metabolic Parameters During Endurance Exercise in Hypoxia

Conditions
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Exercise, Hypoxia

Intervention / Treatment
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* Dietary Supplement: Ketone ester
* Other: Sodium bicarbonate
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Only carbohydrates will be provided | Other: Placebo<br>* Placebo<br>|
| Experimental: Ketone ester<br>Ketone ester with carbohydrates will be provided | Dietary Supplement: Ketone ester<br>* 75g ketone ester in the form of a drink [96% (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, Oxfordshire, UK)] will be provided.<br>|
| Experimental: Ketone ester + bicarbonate<br>Ketone ester with bicarbonate and carbohydrates will be provided | Dietary Supplement: Ketone ester<br>* 75g ketone ester in the form of a drink [96% (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, Oxfordshire, UK)] will be provided.<br>Other: Sodium bicarbonate<br>* Sodium bicarbonate - widely accessible food ingredient will be provided.<br>|
| Experimental: Bicarbonate<br>Bicarbonate and carbohydrates will be provided | Other: Sodium bicarbonate<br>* Sodium bicarbonate - widely accessible food ingredient will be provided.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cycling performance - Simulated 15-min long time trial | Performance (average power output) during the 15 min long time trial on an ergometer | 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 | 
| Change in Cycling performance - Simulated Sprint | Time to exhaustion at 175% of the intensity of the second lactate threshold | 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 | 
| Change in Blood acid-base balance (pH and [HCO3-]) during cycling | Blood acid-base balance assement | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood ketone concentrations during exercise | Blood ketone assesment | 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 | 
| Change in Blood glucose concentrations during exercise | Blood glucose assesment | 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 | 
| Change in Blood lactate concentrations during exercise | Blood lactate assesment | 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 | 
| Change in Respiratory parameters (VE, V̇O2 and V̇CO2) during exercise | Gas exchange measurement | 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 | 
| Change in arterial oxygen saturation during exercise | Pulse oxymetry measurement | 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 | 
| Change in muscle oxygenation during exercise | Near infrared spectroscopy measuremet | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, hypoxia, ketone