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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04579770
Enrollment
14
Registered
2020-10-08
Start date
2020-11-04
Completion date
2020-12-15
Last updated
2021-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise, Hypoxia

Keywords

exercise, hypoxia, ketone

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.

Interventions

OTHERSodium bicarbonate

Sodium bicarbonate - widely accessible food ingredient will be provided.

OTHERPlacebo

Placebo

DIETARY_SUPPLEMENTKetone ester

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

Sponsors

KU Leuven
CollaboratorOTHER
Jozef Stefan Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Cycling performance - Simulated 15-min long time trial5 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 conditionsPerformance (average power output) during the 15 min long time trial on an ergometer
Change in Cycling performance - Simulated Sprint5 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 conditionsTime to exhaustion at 175% of the intensity of the second lactate threshold
Change in Blood acid-base balance (pH and [HCO3-]) during cycling5 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 conditionsBlood acid-base balance assement

Secondary

MeasureTime frameDescription
Change in Respiratory parameters (VE, V̇O2 and V̇CO2) during exercise5 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 conditionsGas exchange measurement
Change in Blood ketone concentrations during exercise5 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 conditionsBlood ketone assesment
Change in muscle oxygenation during exercise5 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 conditionsNear infrared spectroscopy measuremet
Change in arterial oxygen saturation during exercise5 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 conditionsPulse oxymetry measurement
Change in Blood glucose concentrations during exercise5 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 conditionsBlood glucose assesment
Change in Blood lactate concentrations during exercise5 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 conditionsBlood lactate assesment

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026