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

NCT05294939 | Completed DMC

• 1 other identifier: UCAMCFE-00022
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Ketoses, Metabolic; Ketosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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.

• 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.

• 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.

• Blood glucose

  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 Arms (2)

Ketone monoester

EXPERIMENTAL

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

Control product

PLACEBO COMPARATOR

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

Interventions

Ketone monoester DIETARY_SUPPLEMENT

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.

Ketone monoester

Control product consumption DIETARY_SUPPLEMENT

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.

Control product

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male professional cyclists.
• Start the study with previous rest.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Ketosis

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: March 24, 2022
• Study Start: January 31, 2022
• Primary Completion: February 5, 2022
• Study Completion: March 28, 2022
• Last Updated: April 13, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)