Autonomic and Cardiovascular Recovery After the Acute Use of Resveratrol in Overweight and Obesity Individuals

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to understand the importance of resveratrol supplementation as a possible adjuvant in improving the metabolic profile and cardiovascular autonomic recovery of individuals with overweight and grade I obesity, reducing the incidence of diseases associated with obesity and the costs in primary, secondary and tertiary care.

Detailed Description
-----------------
Food is a strong ally in improving the metabolic state in overweight, obesity and prevention of associated diseases, working on weight loss and ingestion of anti-inflammatory, anti-oxidant and cardioprotective substances, among these substances, we highlight the polyphenols. Resveratrol or 3,5,4-trihydroxystilbene is a polyphenol studied since 1976, a phytoalexin synthesized in the skin of the grape, which is increased when exposed to stresses such as ultraviolet radiation, enhancing the antioxidant and cardioprotective characteristics.This study aims to evaluate the cardiovascular autonomic recovery and the metabolic profile with the acute effect of resveratrol extract after submaximal aerobic exercises in individuals with overweight and grade I obesity.Heart rate variation (HRV) is considered the most trivial method for analyzing the behavior of autonomic efferents (parasympathetic and sympathetic) on the heart. HRV recovery after exercise has been widely used as a method of analyzing ANS adaptation (vagal recovery) under various conditions.Healthy, physically active individuals with good health characteristics have a rapid recovery of HRV after exercise, indicating good adaptability and a lower risk for cardiovascular diseases. Meanwhile, changes HRV patterns provide a sensitive and early indicator of health impairments. The monitoring of these data is necessary, as they act as markers of emerging risk for the development of complications associated with CNCDs and risks of future injuries. In this context, the present project will make it possible to verify the effect of the acute use of resveratrol on the metabolic profile and on the autonomic and cardiovascular recovery of individuals with overweight and obesity grade I.

Official Title
-----------------
Evaluation of the Metabolic Profile and Autonomic and Cardiovascular Recovery in Response to the Acute Use of Resveratrol in Individuals With Overweight and Obesity

Conditions
-----------------
Polyphenols, Cardiovascular Diseases, Autonomic Nervous System

Intervention / Treatment
-----------------
* Dietary Supplement: Resveratrol Experimental


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Individuals with overweight and obesity grade I Exclusion Criteria: Cardiorespiratory disorders Neurological disorders skeletal muscle injury Known impairments that prevent the subject from performing the procedures.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 59 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This research is a randomized, double-blind, crossover, placebo-controlled clinical trial. Volunteers of both sexes aged between 20 and 59 years, with overweight or obesity grade I. Therefore, on the first day of collection, volunteers will be allocated to one of the following treatment protocols: Protocol I) Placebo or Protocol II) Experimental (Resveratrol, 500 mg). After ingestion, the heart rate receiver Polar RS800CX (Polar Electro, Finland) will be positioned on the chest of the volunteers. The blood pressure of the participants will be measured before (Rest) and after the submaximal strength exercise, during the first recovery time (REC1- 00-05 minutes) in 5 intervals, using an aneroid sphygmomanometer and stethoscope. Participants will be previously informed about blood collection for the evaluation of the biochemical profile of the following serum analytes: glucose, triglycerides, total cholesterol and fractions, albumin, total proteins and uric acid.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Resveratrol<br>Resveratrol capsules (100mg) will be used from 7am to 7pm, de 3 em 3h. That is, at 7 am, 10 am, 1 pm, 4 pm and 7 pm for 7 days. | Dietary Supplement: Resveratrol Experimental<br>* The amount of 500mg per day will be offered for seven days distributed in doses of 100mg per schedule (7am, 10am, 1pm, 4pm and 7pm).<br>|
| Placebo Comparator: Placebo<br>After 48h washout, placebo capsules (100mg) will be used from 7am to 7pm, de 3 em 3h. That is, at 7 am, 10 am, 1 pm, 4 pm and 7 pm for 7 days. | Dietary Supplement: Resveratrol Experimental<br>* The amount of 500mg per day will be offered for seven days distributed in doses of 100mg per schedule (7am, 10am, 1pm, 4pm and 7pm).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autonomic and cardiovascular recovery | Analysis of linear and non-linear indices of heart rate variability | Five months of collecting and analyzing data. | 
| biochemical parameters | complete blood count, blood glucose, triglycerides, total cholesterol | Two weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resveratrol, Cardiovascular Diseases, Autonomic Nervous System