Product Safety
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTBeta-alanine
The product will be consumed every day for 4 weeks. Four intakes of 3g each, separated by three hours each, will be carried out.
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.
Sponsors
Universidad Católica San Antonio de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Men between 18 and 40 years of age. * Physically active people. They must train at least 3 sessions per week. * Have been training continuously for at least one year.
Exclusion criteria
* Participant suffering from chronic illness. * Serious or terminal illness. * Suffering from a lasting injury that prevents him/her from training in the month prior to the intervention. * Inability to understand the informed consent. * Previous experience in the consumption of beta alanine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver safety variables | Change in hepatic safety after 8 weeks of consumption | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Paresthesia test | Change after 8 weeks of consumption | Visual analogue scale (1-10) |
Countries
Spain
Outcome results
None listed