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

Primary Purpose

Polyphenols, Cardiovascular Diseases, Autonomic Nervous System

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Resveratrol Experimental
Sponsored by
Taisy Cinthia Ferro Cavalcante
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Polyphenols focused on measuring Resveratrol, Cardiovascular Diseases, Autonomic Nervous System

Eligibility Criteria

20 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Taisy Cinthia Ferro CavalcanteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Resveratrol

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Autonomic and cardiovascular recovery
Analysis of linear and non-linear indices of heart rate variability
biochemical parameters
complete blood count, blood glucose, triglycerides, total cholesterol

Secondary Outcome Measures

Full Information

First Posted
June 26, 2023
Last Updated
August 27, 2023
Sponsor
Taisy Cinthia Ferro Cavalcante
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1. Study Identification

Unique Protocol Identification Number
NCT06020313
Brief Title
Autonomic and Cardiovascular Recovery After the Acute Use of Resveratrol in Overweight and Obesity Individuals
Acronym
Resveratrol
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Taisy Cinthia Ferro Cavalcante

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyphenols, Cardiovascular Diseases, Autonomic Nervous System
Keywords
Resveratrol, Cardiovascular Diseases, Autonomic Nervous System

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantOutcomes Assessor
Masking Description
The researchers who will do the experiment will be blind. They will not know who is the experimental group and the control group. The distribution of groups will be carried out by a partner researcher who is part of our research group, but is not directly involved in the current research.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Resveratrol
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Resveratrol Experimental
Intervention Description
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).
Primary Outcome Measure Information:
Title
Autonomic and cardiovascular recovery
Description
Analysis of linear and non-linear indices of heart rate variability
Time Frame
Five months of collecting and analyzing data.
Title
biochemical parameters
Description
complete blood count, blood glucose, triglycerides, total cholesterol
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taisy Ferro Cavalcante, Dr
Phone
+5581999735348
Email
taisy.cavalcante@upe.br
First Name & Middle Initial & Last Name or Official Title & Degree
Taisy Ferro Cavalcante, Dr
Phone
+5581997180436
Email
taisyferro@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taisy Ferro Cavalcante, Dr
Organizational Affiliation
University of Pernambuco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taisy Cinthia Ferro Cavalcante
City
Petrolina
State/Province
Pernambuco
ZIP/Postal Code
56328-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taisy Ferro Cavalcante, Dr
Phone
+5581999735348
Email
taisy.cavalcante@upe.br
First Name & Middle Initial & Last Name & Degree
Taisy Ferro Cavalcante, Dr
Phone
+5581997180436
Email
taisyferro@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This project was approved by the Research Ethics Committee of the University of Pernambuco/CISAM (CEP/UPE-CISAM), opinion number: 5.051.852. The results will be published in scientific articles and the final report will be forwarded to the ethics committee. Volunteers will be duly informed about the procedures and objectives of this study. Before participating, they will sign the Free and Informed Consent Form, being able to withdraw from the study at any time.
Citations:
PubMed Identifier
29075019
Citation
Gonzaga LA, Vanderlei LCM, Gomes RL, Valenti VE. Caffeine affects autonomic control of heart rate and blood pressure recovery after aerobic exercise in young adults: a crossover study. Sci Rep. 2017 Oct 26;7(1):14091. doi: 10.1038/s41598-017-14540-4.
Results Reference
background
PubMed Identifier
27836300
Citation
Pecanha T, Bartels R, Brito LC, Paula-Ribeiro M, Oliveira RS, Goldberger JJ. Methods of assessment of the post-exercise cardiac autonomic recovery: A methodological review. Int J Cardiol. 2017 Jan 15;227:795-802. doi: 10.1016/j.ijcard.2016.10.057. Epub 2016 Oct 23.
Results Reference
background
PubMed Identifier
30426122
Citation
Tabrizi R , Tamtaji OR , Lankarani KB , Mirhosseini N , Akbari M , Dadgostar E , Peymani P , Asemi Z . The effects of resveratrol supplementation on biomarkers of inflammation and oxidative stress among patients with metabolic syndrome and related disorders: a systematic review and meta-analysis of randomized controlled trials. Food Funct. 2018 Dec 13;9(12):6116-6128. doi: 10.1039/c8fo01259h.
Results Reference
background
PubMed Identifier
22648627
Citation
Tome-Carneiro J, Gonzalvez M, Larrosa M, Garcia-Almagro FJ, Aviles-Plaza F, Parra S, Yanez-Gascon MJ, Ruiz-Ros JA, Garcia-Conesa MT, Tomas-Barberan FA, Espin JC. Consumption of a grape extract supplement containing resveratrol decreases oxidized LDL and ApoB in patients undergoing primary prevention of cardiovascular disease: a triple-blind, 6-month follow-up, placebo-controlled, randomized trial. Mol Nutr Food Res. 2012 May;56(5):810-21. doi: 10.1002/mnfr.201100673.
Results Reference
background
PubMed Identifier
30741437
Citation
Singh AP, Singh R, Verma SS, Rai V, Kaschula CH, Maiti P, Gupta SC. Health benefits of resveratrol: Evidence from clinical studies. Med Res Rev. 2019 Sep;39(5):1851-1891. doi: 10.1002/med.21565. Epub 2019 Feb 11.
Results Reference
background
PubMed Identifier
29059644
Citation
Chekalina NI. Resveratrol has a positive effect on parameters of central hemodynamics and myocardial ischemia in patients with stable coronary heart disease. Wiad Lek. 2017;70(2 pt 2):286-291.
Results Reference
background
PubMed Identifier
25281824
Citation
Bastianetto S, Menard C, Quirion R. Neuroprotective action of resveratrol. Biochim Biophys Acta. 2015 Jun;1852(6):1195-201. doi: 10.1016/j.bbadis.2014.09.011. Epub 2014 Oct 2.
Results Reference
result
PubMed Identifier
21385509
Citation
Brasnyo P, Molnar GA, Mohas M, Marko L, Laczy B, Cseh J, Mikolas E, Szijarto IA, Merei A, Halmai R, Meszaros LG, Sumegi B, Wittmann I. Resveratrol improves insulin sensitivity, reduces oxidative stress and activates the Akt pathway in type 2 diabetic patients. Br J Nutr. 2011 Aug;106(3):383-9. doi: 10.1017/S0007114511000316. Epub 2011 Mar 9.
Results Reference
result

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

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