Product SafetyHIPOX-βNCT05334121
Safety Analysis of Chronic Intake of a β-alanine Supplement
A study testing Beta-alanine in people with Product Safety, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Product Safety
- What is being tested?
- Beta-alanine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 21 Mar 2022to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial to Analyze the Safety of Chronic Intake of a β-alanine Supplement in Active Individuals
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.
Read the 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.
- Conditions
- Product Safety
- Being tested
- Beta-alanine, Control product consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-alanineDietary 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.
Control product consumptionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Beta-alanine |
| 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. Receives: Other: Control product consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change in hepatic safety after 8 weeks of consumption
Secondary outcomes (1)
Paresthesia test
Visual analogue scale (1-10)
Measured: Change after 8 weeks of consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start21 Mar 2022
- Primary completion25 Apr 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Product SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
- Investigators
- Fco Javier López Román, Principal investigator, Catholic University of Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334121
- Sponsor's protocol ID
- UCAMCFE-00025
- Acronym
- HIPOX-β
- Status last verified
- Mar 2022
- First submitted
- 26 Mar 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37766731
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Analyze the Safety of Chronic Intake of a β-alanine Supplement in Active Individuals
- ClinicalTrials.gov ID
- NCT05334121
- Acronym / sponsor ID
- HIPOX-β / UCAMCFE-00025
- Conditions
- Product Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Product - Beta Alanine | Experimental | Dietary Supplement: Beta-alanineThe product will be consumed every day for 4 weeks. Four intakes of 3g each, separated by three hours each, will be carried out. |
| Control group - Placebo | Placebo comparator | Other: Control product consumptionThe product will be consumed every day for 4 weeks. Four intakes of 3g each, separated by three hours each, will be carried out. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-alanineThe product will be consumed every day for 4 weeks. Four intakes of 3g each, separated by three hours each, will be carried out. | Dietary supplement | Product - Beta Alanine |
| Control product consumptionProduct 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. | Other | Control group - Placebo |
Primary outcome
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)
1 secondary outcome
Paresthesia test
Time frame: Change after 8 weeks of consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Derived from this study: PubMed 37766731Maestre-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fco Javier López Román principal investigator
Catholic University of Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta-alanine in people with Product Safety, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver safety variables (time frame: Change in hepatic safety after 8 weeks of consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05334121, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.