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PolyphenolsResveratrolNCT06020313

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

A study testing Resveratrol Experimental in people with Polyphenols and Cardiovascular Diseases, run by Taisy Cinthia Ferro Cavalcante at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 59 yearsHealthy volunteers can take part
What is being tested?
Resveratrol Experimental
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteBrazil
Study dates
Aug 2023to Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Individuals with overweight and obesity grade I

Who cannot join

  • Cardiorespiratory disorders
  • Neurological disorders
  • skeletal muscle injury
  • Known impairments that prevent the subject from performing the procedures.

Trial locations and contacts

1 site in 1 country.

Taisy Ferro Cavalcante, Dr contact

+5581999735348

taisy.cavalcante@upe.br

Taisy Ferro Cavalcante, Dr contact

+5581997180436

taisyferro@gmail.com

Brazil1 site, 1 recruiting

  • Taisy Cinthia Ferro Cavalcante

    Petrolina, Pernambuco, 56328-900

    Taisy Ferro Cavalcante, Dr, +5581999735348, taisy.cavalcante@upe.br

    Taisy Ferro Cavalcante, Dr, +5581997180436, taisyferro@gmail.com

    Recruiting

Other trials in Brazil

About this study

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

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.

Read the 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.

Being tested
Resveratrol Experimental
Keywords
Resveratrol, Cardiovascular Diseases, Autonomic Nervous System
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resveratrol ExperimentalDietary supplement

    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).

Study groups in NCT06020313
Study groupRoleWhat they receive
Experimental ResveratrolExperimentalResveratrol 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.
Receives: Dietary Supplement: Resveratrol Experimental
PlaceboPlacebo comparatorAfter 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.
Receives: Dietary Supplement: Resveratrol Experimental

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Autonomic and cardiovascular recovery

    Analysis of linear and non-linear indices of heart rate variability

    Measured: Five months of collecting and analyzing data.

  2. biochemical parameters

    complete blood count, blood glucose, triglycerides, total cholesterol

    Measured: Two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2023
  2. Study startAug 2023 (estimated)
  3. Primary completionSep 2023 (estimated)
  4. Study completionOct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
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 blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06020313
Sponsor's protocol ID
5.051.852
Acronym
Resveratrol
Status last verified
Aug 2023
First submitted
26 Jun 2023
Last updated
31 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 29075019

  • 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.

    PubMed 27836300

  • 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.

    PubMed 30426122

  • 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.

    PubMed 22648627

  • 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.

    PubMed 30741437

  • 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.

    PubMed 29059644

  • 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.

    PubMed 25281824

  • 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.

    PubMed 21385509

Questions about this trial

What is this clinical trial studying?

A study testing Resveratrol Experimental in people with Polyphenols and Cardiovascular Diseases, run by Taisy Cinthia Ferro Cavalcante at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Taisy Ferro Cavalcante, Dr (+5581999735348, taisy.cavalcante@upe.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Autonomic and cardiovascular recovery (time frame: Five months of collecting and analyzing data.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06020313, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.

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