Nutrition, HealthyNCT06405477
EFFECTS OF L-ARGININE SUPPLEMENTATION ON THE RECOVERY OF CARDIORESPIRATORY PARAMETERS AFTER SUBMAXIMAL EXERCISE TEST
A study testing L-arginine in people with Nutrition, Healthy, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
L-Arginine is an amino acid capable of stimulating the production of nitric oxide (NO) metabolites. NO is responsible for several important activities of the body, such as: helping to regulate vasodilation, blood flow, mitochondrial respiration, platelet function and increasing growth hormone levels, but the effects… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- L-arginine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Feb 2024to 15 Aug 2024
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, aged between 18 and 30 years, body mass index (BMI) between 18.5 and 29.9 kg/m2 and physically active according to the international physical activity questionnaire
Who cannot join
- Individuals who are sedentary and insufficiently active according to the IPAQ questionnaire, who present cardiorespiratory, neurological, renal, endocrine, metabolic, musculoskeletal disorders and other known or reported impairments that prevent the subject from performing the procedures, smokers, alcohol drinkers, users of medications that influence the autonomic nervous system and individuals with systolic pressure greater than 130 mmHg and diastolic pressure greater than 85 mmHg at rest
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
UNESP
Presidente Prudente, São Paulo, 19060-900
Gustavo Stuani, Secretary, (18) 3229-5416 ext. 55, posgrad.fct@unesp.br
Vitor E Valenti, Professor, (14) 3402-1324. ext. 55, vitor.valenti@unesp.br
About this study
L-Arginine is an amino acid capable of stimulating the production of nitric oxide (NO) metabolites. NO is responsible for several important activities of the body, such as: helping to regulate vasodilation, blood flow, mitochondrial respiration, platelet function and increasing growth hormone levels, but the effects on the recovery of cardiorespiratory parameters after exercise testing maximum need to be clarified.
Read the detailed description
The protocols will be carried out at the Stress Physiology Laboratory of the Faculty of Science and Technology, UNESP-Presidente Prudente. The execution time of the protocols will be between 5:00 pm and 9:00 pm, to standardize the circadian influence on the evaluated parameters, the environmental climate will be controlled with a temperature between 23ºC and 24 ºC and humidity between 60% and 70%. Volunteers will be instructed not to drink alcoholic or caffeine-based drinks for 12 hours before all protocols, to consume a light meal and 500 ml of water two hours before and to avoid vigorous physical exertion the day before. The experimental procedure will be divided into two stages, all carried out on a treadmill, with a minimum interval of 48 hours between them, in order to allow adequate recovery. Before the start of the first stage of the protocols, anthropometric measurements will be taken, body weight using a digital scale and height using a stadiometer.
Before the beginning of each stage, a Polar RS800CX heart rate monitor will be placed to record the heart rate (HR) and its variability, remaining until the end of each protocol. Afterwards, he will sit for 60 minutes of initial rest and HR, Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), oxygen saturation (SpO2) and Heart Rate Variability (HRV) will be measured. After these measurements, volunteers will go to the second phase:
Placebo protocol (PP): consisting of the prior consumption of 3g of placebo (starch) and subsequently resting for 60 minutes, sitting, then a submaximal exercise test on an ergometric treadmill or;
Arginine (PA) experimental protocol: in this stage, volunteers will perform activities similar to the PC, but they previously consumed 3g of L-arginine 60 minutes before the submaximal test and then;
Perform physical exercise on a treadmill with a 1% incline for the first 3 minutes to warm up at a speed of 5km/h, followed by load increments of 1km/h every 2 minutes until reaching 80% of the maximum HR estimated by age (208-( 0.7*age) with the same inclination. At the end of the activity, you will remain lying down in a calm environment where HR, SBP, DBP, Spo2 and HRV will be monitored for another 20 minutes in the 1st, 3rd, 5th, 7th, 10th and 20th. minute.
- Conditions
- Nutrition, Healthy
- Being tested
- L-arginine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-arginineDietary supplement
Capsules of 3 grams of L-arginine per Dose
PlaceboDietary supplement
Capsules of 3 grams of maize Starch per Dose
| Study group | Role | What they receive |
|---|---|---|
| Sun | Experimental | We are blind and don't know which group is which. Receives: Dietary Supplement: L-arginine; Dietary Supplement: Placebo |
| Moon | Placebo comparator | We are blind and don't know which group is which. Receives: Dietary Supplement: L-arginine; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic Nervous System
Heart Rate Variability
Measured: 10 minutes previous to exercise and 20 minutes after exercise.
Secondary outcomes (3)
Blood Pressure
Measured: 10 minutes previous to exercise and 20 minutes after exercise.
Heart Rate
Measured: 10 minutes previous to exercise and 20 minutes after exercise.
Oxygen Saturation
Measured: 10 minutes previous to exercise and 20 minutes after exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start15 Feb 2024
- Primary completion30 May 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
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 Nutrition, HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luana Almeida Gonzaga, Universidade Estadual Paulista Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405477
- Sponsor's protocol ID
- LargExBr
- Status last verified
- May 2024
- First submitted
- 26 Apr 2024
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Porto AA, Gonzaga LA, Gomes RL, Candeloro BM, Raimundo RD, Vanderlei LCM, Valenti VE. Acute effects of l-arginine intake on heart rate variability after a submaximal exercise test in healthy men: randomized clinical trial. Nitric Oxide. 2025 Aug;157:68-73. doi: 10.1016/j.niox.2025.05.003. Epub 2025 May 17.
PubMed 40389021
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF L-ARGININE SUPPLEMENTATION ON THE RECOVERY OF CARDIORESPIRATORY PARAMETERS AFTER SUBMAXIMAL EXERCISE TEST
- ClinicalTrials.gov ID
- NCT06405477
- Acronym / sponsor ID
- LargExBr
- Conditions
- Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 8 May 2024 (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.
L-Arginine is an amino acid capable of stimulating the production of nitric oxide (NO) metabolites. NO is responsible for several important activities of the body, such as: helping to regulate vasodilation, blood flow, mitochondrial respiration, platelet function and increasing growth hormone levels, but the effects on the recovery of cardiorespiratory parameters after exercise testing maximum need to be clarified.
Detailed description
The protocols will be carried out at the Stress Physiology Laboratory of the Faculty of Science and Technology, UNESP-Presidente Prudente. The execution time of the protocols will be between 5:00 pm and 9:00 pm, to standardize the circadian influence on the evaluated parameters, the environmental climate will be controlled with a temperature between 23ºC and 24 ºC and humidity between 60% and 70%. Volunteers will be instructed not to drink alcoholic or caffeine-based drinks for 12 hours before all protocols, to consume a light meal and 500 ml of water two hours before and to avoid vigorous physical exertion the day before. The experimental procedure will be divided into two stages, all carried out on a treadmill, with a minimum interval of 48 hours between them, in order to allow adequate recovery. Before the start of the first stage of the protocols, anthropometric measurements will be taken, body weight using a digital scale and height using a stadiometer.
Before the beginning of each stage, a Polar RS800CX heart rate monitor will be placed to record the heart rate (HR) and its variability, remaining until the end of each protocol. Afterwards, he will sit for 60 minutes of initial rest and HR, Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), oxygen saturation (SpO2) and Heart Rate Variability (HRV) will be measured. After these measurements, volunteers will go to the second phase:
Placebo protocol (PP): consisting of the prior consumption of 3g of placebo (starch) and subsequently resting for 60 minutes, sitting, then a submaximal exercise test on an ergometric treadmill or;
Arginine (PA) experimental protocol: in this stage, volunteers will perform activities similar to the PC, but they previously consumed 3g of L-arginine 60 minutes before the submaximal test and then;
Perform physical exercise on a treadmill with a 1% incline for the first 3 minutes to warm up at a speed of 5km/h, followed by load increments of 1km/h every 2 minutes until reaching 80% of the maximum HR estimated by age (208-( 0.7*age) with the same inclination. At the end of the activity, you will remain lying down in a calm environment where HR, SBP, DBP, Spo2 and HRV will be monitored for another 20 minutes in the 1st, 3rd, 5th, 7th, 10th and 20th. minute.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sun | Experimental | Dietary Supplement: L-arginine, Dietary Supplement: PlaceboWe are blind and don't know which group is which. |
| Moon | Placebo comparator | Dietary Supplement: L-arginine, Dietary Supplement: PlaceboWe are blind and don't know which group is which. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male, aged between 18 and 30 years, body mass index (BMI) between 18.5 and 29.9 kg/m2 and physically active according to the international physical activity questionnaire
Key exclusion criteria (1 listed)
- Individuals who are sedentary and insufficiently active according to the IPAQ questionnaire, who present cardiorespiratory, neurological, renal, endocrine, metabolic, musculoskeletal disorders and other known or reported impairments that prevent the subject from performing the procedures, smokers, alcohol drinkers, users of medications that influence the autonomic nervous system and individuals with systolic pressure greater than 130 mmHg and diastolic pressure greater than 85 mmHg at rest
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 |
|---|---|---|
| L-arginineCapsules of 3 grams of L-arginine per Dose | Dietary supplement | Moon, Sun |
| PlaceboCapsules of 3 grams of maize Starch per Dose | Dietary supplement | Moon, Sun |
Primary outcome
Autonomic Nervous System
Time frame: 10 minutes previous to exercise and 20 minutes after exercise.
Heart Rate Variability
3 secondary outcomes
Blood Pressure
Time frame: 10 minutes previous to exercise and 20 minutes after exercise.
Heart Rate
Time frame: 10 minutes previous to exercise and 20 minutes after exercise.
Oxygen Saturation
Time frame: 10 minutes previous to exercise and 20 minutes after exercise.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 40389021Porto AA, Gonzaga LA, Gomes RL, Candeloro BM, Raimundo RD, Vanderlei LCM, Valenti VE. Acute effects of l-arginine intake on heart rate variability after a submaximal exercise test in healthy men: randomized clinical trial. Nitric Oxide. 2025 Aug;157:68-73. doi: 10.1016/j.niox.2025.05.003. Epub 2025 May 17.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-arginine in people with Nutrition, Healthy, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 May 2024. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autonomic Nervous System (time frame: 10 minutes previous to exercise and 20 minutes after exercise.). 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 NCT06405477, 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 8 May 2024.