NCT06405477

Brief 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 on the recovery of cardiorespiratory parameters after exercise testing maximum need to be clarified.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

April 26, 2024

Last Update Submit

May 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Autonomic Nervous System

    Heart Rate Variability

    10 minutes previous to exercise and 20 minutes after exercise.

Secondary Outcomes (3)

  • Blood Pressure

    10 minutes previous to exercise and 20 minutes after exercise.

  • Heart Rate

    10 minutes previous to exercise and 20 minutes after exercise.

  • Oxygen Saturation

    10 minutes previous to exercise and 20 minutes after exercise.

Study Arms (2)

Sun

EXPERIMENTAL

We are blind and don't know which group is which.

Dietary Supplement: L-arginineDietary Supplement: Placebo

Moon

PLACEBO COMPARATOR

We are blind and don't know which group is which.

Dietary Supplement: L-arginineDietary Supplement: Placebo

Interventions

L-arginineDIETARY_SUPPLEMENT

Capsules of 3 grams of L-arginine per Dose

MoonSun
PlaceboDIETARY_SUPPLEMENT

Capsules of 3 grams of maize Starch per Dose

MoonSun

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNESP

Presidente Prudente, São Paulo, 19060-900, Brazil

RECRUITING

MeSH Terms

Interventions

Arginine

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Essential

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 26, 2024

First Posted

May 8, 2024

Study Start

February 15, 2024

Primary Completion

May 30, 2024

Study Completion

August 15, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations