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Completed

NCT Number: NCT05294939

Efficacy of Acute Intake of Ketones on Performance in Professional Road Cyclists

Randomized, controlled, double-blind, crossover clinical trial, depending on the product consumed, to analyze the efficacy on physical performance of a sports supplement consumed prior to and during competition or training.

Completed

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Key information

Conditions

Ketoses, Metabolic Acid-Base Imbalance Acidosis Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

About this study

Subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product or placebo, depending on the group to which they have been assigned). On the second day, participants will consume the product that subjects did not consume on the first day.

The product to be consumed will be ketone monoester. Participants will consume 800 mg/kg body weight, distributed in two intakes. The first one, half an hour before exercise and the same dose will be consumed one hour and a half after the first dose. The intakes will be accompanied by carbohydrates and bicarbonate.

The tests that the cyclists will perform are a time trial on a cycloergometer to measure performance, as well as a 30" sprint. Afterwards, the cyclists will do a 4 and a half hour training session at competition pace. After this training session, the participants will do the same time trial and the 30'' sprint.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male professional cyclists.
  • Start the study with previous rest.

Exclusion criteria

  • Participant suffering from chronic illness.
  • Suffering a long-term injury that prevents her from training in the month prior to the intervention.
  • Inability to understand the informed consent.
  • Having consumed ketone bodies chronically in the previous four weeks.
  • To have undergone cholecystectomy.

Treatment and study plan

Ketone monoester

Dietary Supplement

Consumption of 800mg/kg body weight of ketone monoester, divided in two intakes. The mixture will be prepared with bicarbonate. In addition, every hour they should consume 90g of carbohydrates.

Control product consumption

Dietary Supplement

Consumption of placebo product (carbohydrates) masked with citric, divided in two intakes. The mixture will be prepared with bicarbonate. In addition, 90g of carbohydrates should be consumed every hour.

Primary outcomes

  1. Physical performance

    Time frame: Change in performance after product consumption and training at a competitive level

    Measured using a power roller. Variables such as maximum power and average power

Secondary outcomes

  1. Heart Rate

    Time frame: It will be measured on four different occasions. Two on the first day (after one intake of product and after a second intake and training at competitive pace) and 4 days later, the same measurements but with the opposite product.

    Measured by a chest strap

  2. Microcapillary blood

    Time frame: It will be measured on four different occasions. Two on the first day (after one intake of product and after a second intake and training at competitive pace) and 4 days later, the same measurements but with the opposite product.

    This test provides biochemical variables (ABL90FLEX) with 70 ml of capillary blood.

  3. Lactate

    Time frame: It will be measured on four different occasions. Two on the first day (after one intake of product and after a second intake and training at competitive pace) and 4 days later, the same measurements but with the opposite product.

    Lactate levels will be measured using the Lactate Pro

  4. Ketone

    Time frame: It will be measured on four different occasions. Two on the first day (after one intake of product and after a second intake and training at competitive pace) and 4 days later, the same measurements but with the opposite product.

    Will be measured by the FreeStyle Optium

  5. Blood glucose

    Time frame: It will be measured on four different occasions. Two on the first day (after one intake of product and after a second intake and training at competitive pace) and 4 days later, the same measurements but with the opposite product.

    Will be measured by the FreeStyle Optium

  6. Blood glucose

    Time frame: It will be measured on a daily basis. Measurements will begin two days before the first performance test and end one day after the completion of the performance tests.

    It will be measured continuously by Supersapiens.

  7. Heart rate variability

    Time frame: It will be measured every morning. Measurements will be started two days before the first performance test and finished one day after the end of the performance tests.

    It will be measured for 5 minutes upon awakening.

  8. Stomach test

    Time frame: It will be measured on four different occasions. Two on the first day (after one intake of product and after a second intake and training at competitive pace) and 4 days later, the same measurements but with the opposite product.

    It will be measured by means of a visual analog scale from 0 to 10 to determine the annoyance produced by the product (0: none and 10: maximum annoyance).

  9. Fatigue

    Time frame: It will be measured on four different occasions. Two on the first day (after one intake of product and after a second intake and training at competitive pace) and 4 days later, the same measurements but with the opposite product.

    Rate of perceived exertion

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

Randomized Clinical Trial to Analyze the Efficacy of Acute Intake of a Ketone Supplement on Performance in Professional Cross-country Road Cyclists

Acronym: KETA

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 24, 2022
Registry last updated
Apr 13, 2022

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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