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

Ketosis Clinical Trial

— KETA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05294939
• Other study ID #: UCAMCFE-00022
• Status: Completed
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: March 28, 2022

Study information

• Verified date: November 2021
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 28, 2022
• Est. primary completion date: February 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ketoses, Metabolic
• Ketosis

Intervention

Dietary Supplement:
• 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.
• Control product consumption
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.

Locations

Country	Name	City	State
Spain	Catholic University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical performance	Measured using a power roller. Variables such as maximum power and average power	Change in performance after product consumption and training at a competitive level
Secondary	Heart Rate	Measured by a chest strap	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.
Secondary	Microcapillary blood	This test provides biochemical variables (ABL90FLEX) with 70 ml of capillary 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.
Secondary	Lactate	Lactate levels will be measured using the Lactate Pro	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.
Secondary	Ketone	Will be measured by the FreeStyle Optium	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.
Secondary	Blood glucose	Will be measured by the FreeStyle Optium	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.
Secondary	Blood glucose	It will be measured continuously by Supersapiens.	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.
Secondary	Heart rate variability	It will be measured for 5 minutes upon awakening.	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.
Secondary	Stomach test	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).	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.
Secondary	Fatigue	Rate of perceived exertion	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.