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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ketoses, Metabolic, Ketosis

Intervention / Treatment
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* Dietary Supplement: Ketone monoester
* Dietary Supplement: Control product consumption


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketone monoester<br>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<br>* 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.<br>|
| Placebo Comparator: Control product<br>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<br>* 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.<br>|

What is the study measuring?
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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. |