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

NCT04579770 | Completed

• 1 other identifier: J5-9350
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise; Hypoxia

Keywords

exercise; hypoxia; ketone

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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

• 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

• 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

• 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

• 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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Only carbohydrates will be provided

Other: Placebo

Ketone ester

EXPERIMENTAL

Ketone ester with carbohydrates will be provided

Dietary Supplement: Ketone ester

Ketone ester + bicarbonate

EXPERIMENTAL

Ketone ester with bicarbonate and carbohydrates will be provided

Dietary Supplement: Ketone ester; Other: Sodium bicarbonate

Bicarbonate

EXPERIMENTAL

Bicarbonate and carbohydrates will be provided

Other: Sodium bicarbonate

Interventions

Ketone ester DIETARY_SUPPLEMENT

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

Ketone ester; Ketone ester + bicarbonate

Sodium bicarbonate OTHER

Sodium bicarbonate - widely accessible food ingredient will be provided.

Bicarbonate; Ketone ester + bicarbonate

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jozef Stefan Institute: lead
• KU Leuven: collaborator

Study Sites (1)

KU Leuven

Leuven, Belgium

Location

MeSH Terms

Conditions

Motor Activity; Hypoxia; Ketosis

Interventions

formic acid 4-(3-oxobutyl)phenyl ester; Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Behavior; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 8, 2020
• Study Start: November 4, 2020
• Primary Completion: December 5, 2020
• Study Completion: December 15, 2020
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

BE (1)