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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beta Alanine high dose | Experimental | Consumption for 28 days. |
|
| Beta Alanine low dose | Experimental | Consumption for 28 days. |
|
| Control group | Placebo Comparator | Consumption for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beta Alanine high dose | Dietary Supplement | 4 intakes of 5 g of beta alanine every 3 hour. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Power | Physical performance is measured by direct variables evaluated by the power roller (average power, maximum power, etc.). | 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. | It will be measured on two different occasions. The first day and twenty-eight days later. |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | Rate of perceived exertion | Change of baseline rate of perceived exertion at twenty-eight days |
| Paresthesia test | Visual analogue scale (1-10) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Murcia | Murcia | 30107 | Spain |
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| ID | Term |
|---|---|
| D015091 | beta-Alanine |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D000409 | Alanine |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D015340 | Epidemiologic Research Design |
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| Beta Alanine low dose | Dietary Supplement | 4 intakes of 2.5 g of beta alanine every 3 hour. |
|
| Control group | Other | 4 intakes of 2.5 g of wheat semolina every 3 hour. |
|
| 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. | 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 | 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. | It will be measured on two different occasions. Day one and twenty-eight days later. |
| Body weight | It is a control variable. Measured by bioimpedance. | The test will be measured at baseline and after 28 days of consumption. |
| Fat mass | It is a control variable. Measured by bioimpedance. | The test will be measured at baseline and after 28 days of consumption. |
| Muscle mass | It is a control variable. Measured by bioimpedance. | 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) | It will be measured twice, once at baseline or at the end of the study after 28 days. |
| D004812 |
| Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |