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Single-center, double-blind, placebo-controlled clinical trial with two arms (product and placebo) to analyze the safety of beta-alanine consumption in active people.
After recruitment, subjects will be randomized and assigned to one of the two arms of the study: beta-alanine group or control group (placebo).
Subjects must be active people, and will take a dose of 15 g per day of the product for 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product - Beta Alanine | Experimental | The product will be consumed every day for 4 weeks. Four intakes of 3g each, separated by three hours each, will be carried out. |
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| Control group - Placebo | Placebo Comparator | The product will be consumed every day for 4 weeks. Four intakes of 3g each, separated by three hours each, will be carried out. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beta-alanine | Dietary Supplement | The product will be consumed every day for 4 weeks. Four intakes of 3g each, separated by three hours each, will be carried out. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | Change in hepatic safety after 8 weeks of consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Paresthesia test | Visual analogue scale (1-10) | Change after 8 weeks of consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fco Javier López Román | Catholic University of Murcia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Murcia | Murcia | 30107 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37766731 | Derived | Maestre-Hernandez AB, Perez-Pinero S, Lopez-Roman FJ, Andreu-Caravaca L, Luque-Rubia AJ, Ramos-Campo DJ, Diaz-Silvestre MJ, Avila-Gandia V. Effect of a sustained-release formulation of beta-alanine on laboratory parameters and paresthesia in recreational trained men: a randomized double-blind placebo-controlled study. Front Nutr. 2023 Sep 12;10:1213105. doi: 10.3389/fnut.2023.1213105. eCollection 2023. |
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| ID | Term |
|---|---|
| D015091 | beta-Alanine |
| ID | Term |
|---|---|
| D000409 | Alanine |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Control product consumption | Other | Product with identical characteristics to the experimental product. The product will be consumed every day for 4 weeks. Four intakes of 3g each, separated by three hours each, will be carried out. |
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