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

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04579770
• Other study ID #: J5-9350
• Status: Completed
• Phase: N/A
• Start date: November 4, 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: February 2021
• Source: Jozef Stefan Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 15, 2020
• Est. primary completion date: December 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise
• Hypoxia

Intervention

Dietary Supplement:
• Ketone ester
75g ketone ester in the form of a drink [96% (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, Oxfordshire, UK)] will be provided.

Other:
• Sodium bicarbonate
Sodium bicarbonate - widely accessible food ingredient will be provided.
• Placebo
Placebo

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Jozef Stefan Institute	KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in Respiratory parameters (VE, V?O2 and V?CO2) 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
Secondary	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
Secondary	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