Autonomic and Cardiovascular Recovery After the Acute Use of Resveratrol in Overweight and Obesity Individuals (Resveratrol)
August 27, 2023 updated by: Taisy Cinthia Ferro Cavalcante
Evaluation of the Metabolic Profile and Autonomic and Cardiovascular Recovery in Response to the Acute Use of Resveratrol in Individuals With Overweight and Obesity
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- 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 Contact
- Name: Taisy Ferro Cavalcante, Dr
- Phone Number: +5581999735348
- Email: taisy.cavalcante@upe.br
Study Contact Backup
- Name: Taisy Ferro Cavalcante, Dr
- Phone Number: +5581997180436
- Email: taisyferro@gmail.com
Study Locations
-
-
Pernambuco
-
Petrolina, Pernambuco, Brazil, 56328-900
- Recruiting
- Taisy Cinthia Ferro Cavalcante
-
Contact:
- Taisy Ferro Cavalcante, Dr
- Phone Number: +5581999735348
- Email: taisy.cavalcante@upe.br
-
Contact:
- Taisy Ferro Cavalcante, Dr
- Phone Number: +5581997180436
- Email: taisyferro@gmail.com
-
-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Resveratrol
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.
|
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).
|
|
Placebo Comparator: Placebo
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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Autonomic and cardiovascular recovery
Time Frame: Five months of collecting and analyzing data.
|
Analysis of linear and non-linear indices of heart rate variability
|
Five months of collecting and analyzing data.
|
|
biochemical parameters
Time Frame: Two weeks
|
complete blood count, blood glucose, triglycerides, total cholesterol
|
Two weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Taisy Ferro Cavalcante, Dr, University of Pernambuco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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 (Estimated)
August 1, 2023
Primary Completion (Estimated)
September 1, 2023
Study Completion (Estimated)
October 1, 2023
Study Registration Dates
First Submitted
June 26, 2023
First Submitted That Met QC Criteria
August 27, 2023
First Posted (Actual)
August 31, 2023
Study Record Updates
Last Update Posted (Actual)
August 31, 2023
Last Update Submitted That Met QC Criteria
August 27, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5.051.852
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD 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.
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.