Efficacy of Acute Intake of Ketones on Performance in Professional Road Cyclists (KETA)

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

Study Overview

• Status: Completed
• Conditions: Ketosis; Ketoses, Metabolic
• Intervention / Treatment: Dietary supplement: Ketone monoester; Dietary supplement: Control product consumption

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 Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Placebo Comparator: Control product; 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.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Actual): February 5, 2022
• Study Completion (Actual): March 28, 2022

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: March 19, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis; Ketosis
• Other Study ID Numbers: UCAMCFE-00022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No