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

Not Applicable

Completed

• Conditions: Ketosis; Ketoses, Metabolic
• Interventions: Dietary Supplement: Control product consumption; Dietary Supplement: Ketone monoester

• Registration Number: NCT05294939
• Lead Sponsor: Universidad Católica San Antonio de Murcia

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.

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2022-01-10
• Study Start: 2022-01-31
• Primary Completion: 2022-02-05
• Study First Submitted QC: 2022-03-19
• Study First Posted: 2022-03-24
• Study Completion: 2022-03-28
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control product	Control product consumption	Consumption of placebo product (carbohydrates) masked with citric, divided in two intakes. The mixture will be prepared with bicarbonate. In addition, every hour they should consume 90g of carbohydrates.
Ketone monoester	Ketone monoester	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.

Primary Outcome Measures

Name	Time	Method
Physical performance	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 Outcome Measures

Name	Time	Method
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.	It will be measured continuously by Supersapiens.
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.	Measured by a chest strap
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.	Will be measured by the FreeStyle Optium
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.	It will be measured for 5 minutes upon awakening.
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.	Rate of perceived exertion
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.	This test provides biochemical variables (ABL90FLEX) with 70 ml of capillary blood.
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.	Lactate levels will be measured using the Lactate Pro
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.	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).

Trial Locations

Locations (1)

Catholic University of Murcia; 🇪🇸 Murcia, Spain