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

NCT ID: NCT04579770

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-04
• Study Completion Date: 2020-12-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Only carbohydrates will be provided

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Ketone ester

Ketone ester with carbohydrates will be provided

Group Type: EXPERIMENTAL

Ketone ester

Intervention Type: 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 + bicarbonate

Ketone ester with bicarbonate and carbohydrates will be provided

Group Type: EXPERIMENTAL

Ketone ester

Intervention Type: DIETARY_SUPPLEMENT

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

Sodium bicarbonate

Intervention Type: OTHER

Sodium bicarbonate - widely accessible food ingredient will be provided.

Bicarbonate

Bicarbonate and carbohydrates will be provided

Group Type: EXPERIMENTAL

Sodium bicarbonate

Intervention Type: OTHER

Sodium bicarbonate - widely accessible food ingredient will be provided.

Interventions

Ketone ester

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

Intervention Type: DIETARY_SUPPLEMENT

Sodium bicarbonate

Sodium bicarbonate - widely accessible food ingredient will be provided.

Intervention Type: OTHER

Placebo

Placebo

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

KU Leuven

OTHER

Sponsor Role: collaborator

Jozef Stefan Institute

OTHER

Sponsor Role: lead

Responsible Party

Tadej Debevec

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

KU Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

J5-9350

Identifier Type: -

Identifier Source: org_study_id