Effects Of Acute Supplementation Of Citrus Aurantium L. On The Recovery Of Autonomic And Cardiovascular Activity After A Sub-Maximum Aerobic Exercise Session In Healthy Individuals

Phase 3

• Conditions: To Evaluate the Effect of Supplementation of Citrus Aurantium in Active Individuals

• Registration Number: NCT04875143
• Lead Sponsor: University of Pernambuco

Brief Summary

INTRODUCTION: Non-pharmacological interventions for the treatment of cardiovascular and metabolic disorders have been investigated. In this context, Citrus aurantium L., popularly known as Bitter Orange, rich in synephrine (p-synephrine), a phenylethylaminic alkaloid that is present in the bitter orange peel, has been used as an adjunct in metabolic disorders. Given the effects, the components of Citrus aurantium L. diverge from other thermogens by being able to activate metabolism and lipolysis without interfering with the performance of the cardiovascular system, making this an advantage for its use in diets. In studies, it has been observed that the activation of β-3 receptors plays an important role in the regulation and activation of other receptors, modulating and, when they are stimulated in excess, and thus, it presents effects that in addition to not causing overload in the cardiovascular system. OBJECTIVE: To evaluate the effect of supplementation of Citrus aurantium L. in combination with submaximal aerobic exercise on autonomic and cardiovascular parameters of physically active. METHODOLOGY: This is a prospective, randomized, placebo-controlled, double-blind crossover trial. 40 physically active volunteers will participate in the study. They will be qualified for the voluntary study of the male gender, who are aged between 18 and 30 years old and have a Body Mass Index (BMI) between 18.5 kg / m² and 29.9 kg / m². Do not use any medication that may interfere with cardiac autonomic modulation and do not have skeletal muscle damage. They will be considered as exclusion criteria for clinical patients, as well as those who have already used anabolic steroids or who have cardiorespiratory, neurological disorders and other known impairments that prevent the subject from performing the procedures. EXPECTED RESULTS: Speculated that the protective effects of flavonoids and their antioxidant properties found in Citrus aurantium L., optimize autonomic recovery after aerobic exercise. In addition, HRV can be used to ascertain its SNA activation effects and validate the safety of the applicability of this supplement for overweight populations, considering that it is used for this purpose.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Status Verified: 2021-04
• Study First Submitted: 2021-04-30
• Study First Submitted QC: 2021-04-30
• Last Update Submitted: 2021-04-30
• Study First Posted: 2021-05-06
• Last Update Posted: 2021-05-06
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Male volunteers, aged between 18 and 30 years and with a Body Mass Index (BMI) between 18.5 kg / m² and 29.9 kg / m² will be considered eligible for the study.

Exclusion Criteria

• Smoking patients will be considered as exclusion criteria. As well as individuals with cardiorespiratory, neurological disorders and other known impairments that prevent the subject from performing the procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Heart rate variability	through study completion, an average of 1 year	Heart rate variability (HRV) is a non-invasive method that analyzes the autonomic regulation of heart rate in humans. It is a conventionally accepted term to describe oscillations in the intervals between consecutive heartbeats (RR intervals), which are related to the influences of the ANS on the sinus node. It is a non-invasive technique, whose analysis can be performed using linear methods, in the domain of time and frequency, and non-linear, in the domain of chaos

Secondary Outcome Measures

Name	Time	Method
Blood pressure	through study completion, an average of 1 year	Check the blood pressure of subjects with and without the ingestion of Citrus aurantium L. before and in the recovery period after physical exercise;

Trial Locations

Locations (1)

Cicero Jonas Rodrigues Benjamim; 🇧🇷 Juazeiro do Norte, Ceará, Brazil