Randomized, controlled, double-blind, single-center, controlled clinical trial with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) to measure the efficacy of 28-day consumption of a sustained-release beta alanine on the physiological efficacy of physical performance in recreational cyclists.
Subjects meeting the selection criteria will be randomly assigned to each of the study groups (investigational product dose 1 or dose 2, or placebo, depending on the group to which they have been assigned). The product to be consumed is beta alanine. Participants will consume the product for 28 days. They will have to take 4 intakes every three hours, the first intake being two hours after waking up. The study subjects will have to make 2 visits to the laboratory. Physical performance and physiological changes will be evaluated with a 10-minute time trial. The first test will be performed without product consumption and the second after 28 days of consumption.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
75
4 intakes of 5 g of beta alanine every 3 hour.
4 intakes of 2.5 g of beta alanine every 3 hour.
4 intakes of 2.5 g of wheat semolina every 3 hour.
Catholic University of Murcia
Murcia, Spain
Power
Physical performance is measured by direct variables evaluated by the power roller (average power, maximum power, etc.).
Time frame: It will be measured on two different occasions. The first day and twenty-eight days later.
Distance covered
Physical performance is measured by direct variables evaluated by the power roller.
Time frame: It will be measured on two different occasions. The first day and twenty-eight days later.
Fatigue
Rate of perceived exertion
Time frame: Change of baseline rate of perceived exertion at twenty-eight days
Paresthesia test
Visual analogue scale (1-10)
Time frame: It will be measured on two different occasions. on day 1 (before consumption) and twenty-eight days after (after consumption).
Microcapillary blood
This test provides biochemical variables (ABL90FLEX) with 70 ml of capillary blood (Na, K, Glucose, Lactate, etc). It is used to evaluate the effort made by the cyclist.
Time frame: It will be measured on two different occasions. Day one and twenty-eight days later.
Lactate
Lactate levels will be measured using the Lactate Pro
Time frame: It will be measured on two different occasions. Day one and twenty-eight days later.
Heart Rate
The heart rate will be evaluated by means of a heart rate strap.
Time frame: It will be measured on two different occasions. Day one and twenty-eight days later.
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Body weight
It is a control variable. Measured by bioimpedance.
Time frame: The test will be measured at baseline and after 28 days of consumption.
Fat mass
It is a control variable. Measured by bioimpedance.
Time frame: The test will be measured at baseline and after 28 days of consumption.
Muscle mass
It is a control variable. Measured by bioimpedance.
Time frame: The test will be measured at baseline and after 28 days of consumption.
Liver safety variables
It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)
Time frame: It will be measured twice, once at baseline or at the end of the study after 28 days.