EFFECTS OF L-ARGININE SUPPLEMENTATION ON THE RECOVERY OF CARDIORESPIRATORY PARAMETERS AFTER SUBMAXIMAL EXERCISE TEST

May 6, 2024 updated by: Luana Almeida Gonzaga, Universidade Estadual Paulista Júlio de Mesquita Filho
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Presidente Prudente, SP, Brazil, 19060-900
        • Recruiting
        • Unesp
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sun
We are blind and don't know which group is which.
Dietary supplement: L-arginine
Capsules of 3 grams of L-arginine per Dose
Dietary supplement: Placebo
Capsules of 3 grams of maize Starch per Dose
Placebo Comparator: Moon
We are blind and don't know which group is which.
Dietary supplement: L-arginine
Capsules of 3 grams of L-arginine per Dose
Dietary supplement: Placebo
Capsules of 3 grams of maize Starch per Dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Autonomic Nervous System
Time Frame: 10 minutes previous to exercise and 20 minutes after exercise.
Heart Rate Variability
10 minutes previous to exercise and 20 minutes after exercise.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Blood Pressure
Time Frame: 10 minutes previous to exercise and 20 minutes after exercise.
10 minutes previous to exercise and 20 minutes after exercise.
Heart Rate
Time Frame: 10 minutes previous to exercise and 20 minutes after exercise.
10 minutes previous to exercise and 20 minutes after exercise.
Oxygen Saturation
Time Frame: 10 minutes previous to exercise and 20 minutes after exercise.
10 minutes previous to exercise and 20 minutes after exercise.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Estadual Paulista Júlio de Mesquita Filho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LargExBr

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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