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Randomized, controlled, double-blind, single-center, double-blind 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 a sustained release beta alanine on physiological physical performance efficacy 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 1 day. They will have to take four intakes every hour and a quarter, on the same day.
The study subjects will have to make 2 visits to the laboratory. In the first one, they will have to perform a 10-minute time trial, without consumption. In the second visit, they will perform the same performance test but with acute consumption of the product. Their physical and physiological performance will be evaluated.
The two tests will be separated by 7 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beta Alanine high dose | Experimental | Consumption for 1 day. |
|
| Beta Alanine low dose | Experimental | Consumption for 1 day. |
|
| Control group | Placebo Comparator | Consumption for 1 day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beta Alanine high dose | Dietary Supplement | 4 intakes of 5 g of beta alanine every 1 hour and 15 minutes. |
|
| 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. Day one and seven days later with acute consumption of product. |
| Distance covered | Physical performance is measured by direct variables evaluated by the power roller. | It will be measured on two different occasions. Day one and seven days later with acute consumption of product. |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | Rate of perceived exertion, assessed by the 10-point modified Borg Scale. | Change of baseline rate of perceived exertion at seven 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 1 hour and 15 minutes. |
|
| Control group | Dietary Supplement | 4 intakes of 2.5 g of wheat semolina every 1 hour and 15 minutes. |
|
| It will be measured on two different occasions. on day 1 (before consumption) and seven 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 seven days later. |
| Lactate | Lactate levels will be measured using the Lactate Pro | It will be measured on two different occasions. Day one and seven 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 seven days later. |
| D004812 |
| Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |