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Completed

NCT Number: NCT04579770

Effect of Oral Ketone and Sodium Bicarbonate Administration 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.

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Key information

Conditions

Exercise Acid-Base Imbalance Acidosis Behavior Hypoxia Ketosis Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven

Leuven, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sodium bicarbonate

Other

Sodium bicarbonate - widely accessible food ingredient will be provided.

Placebo

Other

Placebo

Primary outcomes

  1. Change in Cycling performance - Simulated 15-min long time trial

    Time frame: 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

  2. Change in Cycling performance - Simulated Sprint

    Time frame: 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

  3. Change in Blood acid-base balance (pH and [HCO3-]) during cycling

    Time frame: 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 outcomes

  1. Change in Blood ketone concentrations during exercise

    Time frame: 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

  2. Change in Blood glucose concentrations during exercise

    Time frame: 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

  3. Change in Blood lactate concentrations during exercise

    Time frame: 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

  4. Change in Respiratory parameters (VE, V̇O2 and V̇CO2) during exercise

    Time frame: 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

  5. Change in arterial oxygen saturation during exercise

    Time frame: 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

  6. Change in muscle oxygenation during exercise

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Jozef Stefan Institute

Other

Collaborators

  • KU Leuven

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 8, 2020
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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