Ketoses, Metabolic, Ketosis
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTKetone 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_SUPPLEMENTControl 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.
Sponsors
Universidad Católica San Antonio de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical performance | Change in performance after product consumption and training at a competitive level | Measured using a power roller. Variables such as maximum power and average power |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | This test provides biochemical variables (ABL90FLEX) with 70 ml of capillary blood. |
| 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. | Lactate levels will be measured using the Lactate Pro |
| 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. | Will be measured by the FreeStyle Optium |
| 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. | Measured by a chest strap |
| Heart rate variability | 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. | It will be measured for 5 minutes upon awakening. |
| Stomach test | 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. | 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). |
| Fatigue | 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. | Rate of perceived exertion |
| 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. | Will be measured by the FreeStyle Optium |
Countries
Spain
Outcome results
None listed