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A double-blind, placebo-controlled, randomised, with two arms (product and placebo) unicentric clinical trial to analyse the efficacy on physical performance parameters of a product designed for sport during a lapse of two weeks (7 days).
After recruitment, subject will be randomised and allocated to one group of the 2 study arms: treatment group or control group (placebo).
A simple randomisation will be performed using software by a random number generator, and assigned to participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Product: β-Alanine Supplementation strategy: 5 g, four times a day with main meals, for 7 days after the initial evaluation and until the end of the study. |
|
| Placebo group | Placebo Comparator | Product: wheat semolina Supplementation strategy: 5 g, four times a day with main meals, for 7 days after the initial evaluation and until the end of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| β-alanine | Dietary Supplement | 7 days of consumption |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | Rate of perceived exertion | Change of baseline rate of perceived exertion at seven days |
| Measure | Description | Time Frame |
|---|---|---|
| Performance outcomes | Physical performance is measured by direct variables: mean power output (MPO) and peak power output by ergometer (Cyclus 2) together with cadence. | It will be measured on two different occasions. Day one and seven days later. |
| Paresthesia test |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39226288 | Derived | Perez-Pinero S, Ramos-Campo DJ, Lopez-Roman FJ, Ortolano R, Torregrosa-Garcia A, Luque-Rubia AJ, Ibanez-Soroa N, Andreu-Caravaca L, Avila-Gandia V. Effect of high-dose beta-Alanine supplementation on uphill cycling performance in World Tour cyclists: A randomised controlled trial. PLoS One. 2024 Sep 3;19(9):e0309404. doi: 10.1371/journal.pone.0309404. eCollection 2024. |
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| ID | Term |
|---|---|
| D005433 | Flour |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| wheat semolina |
| Dietary Supplement |
7 days of consumption |
|
Visual analogue scale (1-10) |
| It will be measured on three different occasions. Twice on day 1 (before and after consumption) and seven days after. |
| Microcapillary blood | This test provides biochemical variables (ABL90FLEX). | It will be measured on two different occasions. Day one and seven days later. |