Catholic University of Murcia
Murcia, 30107, Spain
Completed
NCT Number: NCT05334121
Safety Analysis of Chronic Intake of a β-alanine Supplement
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.
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–40 year
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Beta-alanine
Dietary SupplementThe product will be consumed every day for 4 weeks. Four intakes of 3g each, separated by three hours each, will be carried out.
Control product consumption
OtherProduct 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.
Primary outcomes
-
Liver safety variables
Time frame: 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 outcomes
-
Paresthesia test
Time frame: Change after 8 weeks of consumption
Visual analogue scale (1-10)
Sponsors and collaborators
Lead sponsor
Universidad Católica San Antonio de Murcia
Other
Registry information
Official study title
Randomized Clinical Trial to Analyze the Safety of Chronic Intake of a β-alanine Supplement in Active Individuals
Acronym: HIPOX-β
Important dates
- Study start
- 2022
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Apr 19, 2022
- Registry last updated
- Jul 26, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.