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

Not Applicable

Completed

• Conditions: Exercise; Hypoxia
• Interventions: Dietary Supplement: Ketone ester; Other: Placebo; Other: Sodium bicarbonate

• Registration Number: NCT04579770
• Lead Sponsor: Jozef Stefan Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-24
• Study First Submitted QC: 2020-10-01
• Study First Posted: 2020-10-08
• Study Start: 2020-11-04
• Primary Completion: 2020-12-05
• Study Completion: 2020-12-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ketone ester + bicarbonate	Sodium bicarbonate	Ketone ester with bicarbonate and carbohydrates will be provided
Bicarbonate	Sodium bicarbonate	Bicarbonate and carbohydrates will be provided
Ketone ester + bicarbonate	Ketone ester	Ketone ester with bicarbonate and carbohydrates will be provided
Placebo	Placebo	Only carbohydrates will be provided
Ketone ester	Ketone ester	Ketone ester with carbohydrates will be provided

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

KU Leuven; 🇧🇪 Leuven, Belgium