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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypoxia; Exercise
• Intervention / Treatment: Other: Placebo; Dietary supplement: Ketone ester; Other: Sodium bicarbonate

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Only carbohydrates will be provided	Other: Placebo; Placebo
Experimental: Ketone ester; Ketone ester with carbohydrates will be provided	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.
Experimental: Ketone ester + bicarbonate; Ketone ester with bicarbonate and carbohydrates will be provided	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.
Experimental: Bicarbonate; Bicarbonate and carbohydrates will be provided	Other: Sodium bicarbonate; Sodium bicarbonate - widely accessible food ingredient will be provided.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jozef Stefan Institute
• Collaborators: KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2020
• Primary Completion (Actual): December 5, 2020
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: exercise; hypoxia; ketone
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: J5-9350

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No