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Clinical Trials/NCT05294939
NCT05294939
Completed
N/A

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

Universidad Católica San Antonio de Murcia1 site in 1 country29 target enrollmentJanuary 31, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Ketoses, Metabolic
Sponsor
Universidad Católica San Antonio de Murcia
Enrollment
29
Locations
1
Primary Endpoint
Physical performance
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 31, 2022
End Date
March 28, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Sponsor
Universidad Católica San Antonio de Murcia
Responsible Party
Principal Investigator
Principal Investigator

Francisco Javier López Román

Principal Investigator

Universidad Católica San Antonio de Murcia

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Blood glucose(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.)
  • Heart Rate(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.)
  • Ketone(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.)
  • Heart rate variability(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.)
  • Fatigue(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.)
  • Microcapillary blood(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(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.)
  • Stomach test(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.)

Study Sites (1)

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