Clinical trial NCT05294939: Efficacy of Acute Intake of Ketones on Performance in Professional Road Cyclists
Official title: Randomized Clinical Trial to Analyze the Efficacy of Acute Intake of a Ketone Supplement on Performance in Professional Cross-country Road Cyclists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ketoses, Metabolic
Ketosis
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 29
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Physical performance
timeFrame: Change in performance after product consumption and training at a competitive level
Secondary outcomes:
measure: Heart Rate
timeFrame: 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.
measure: Microcapillary blood
timeFrame: 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.
measure: Lactate
timeFrame: 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.
measure: Ketone
timeFrame: 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.
measure: Blood glucose
timeFrame: 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.
measure: Blood glucose
timeFrame: 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.
measure: Heart rate variability
timeFrame: 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.
measure: Stomach test
timeFrame: 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.
measure: Fatigue
timeFrame: 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.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References: