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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2022-03-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effects of Ketone Supplements With Carbohydrates on Cycling Performance Above Lactate Threshold

NCT07224282

Exogenous Ketosis

NOT_YET_RECRUITING EARLY_PHASE1

The Effects of Acute Ketone Monoester Supplementation on 20-Minute Time-Trial Performance in Trained Cyclists

NCT05226962

Exercise Ketosis

COMPLETED NA

The Effects of Exogenous Ketosis on Ultra-endurance Recovery and Performance

NCT06965491

Exogenous Ketosis Endurance Cycling Performance Fatigue; Muscle, Heart +1 more

RECRUITING NA

Ketone Administration During Inactivity and Retraining

NCT05398042

Exercise Healthy Male/Female Subjects

UNKNOWN PHASE2

The Effect of Acute Ketone Monoester Supplementation on Glucose Oxidation During Exercise

NCT06746805

Exercise Metabolism

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ketoses, Metabolic Ketosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Ketone monoester

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Control product consumption

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes