NCT06020313

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

1 month

First QC Date

June 26, 2023

Last Update Submit

August 27, 2023

Conditions

PolyphenolsCardiovascular DiseasesAutonomic Nervous System

Keywords

ResveratrolCardiovascular DiseasesAutonomic Nervous System

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Experimental Resveratrol

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

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).

Experimental ResveratrolPlacebo

Eligibility Criteria

Age20 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Individuals with overweight and obesity grade I

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taisy Cinthia Ferro Cavalcante

Petrolina, Pernambuco, 56328-900, Brazil

RECRUITING

Related Publications (8)

  • 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.

    PMID: 29075019BACKGROUND

  • 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.

    PMID: 27836300BACKGROUND

  • 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.

    PMID: 30426122BACKGROUND

  • 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.

    PMID: 22648627BACKGROUND

  • 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.

    PMID: 30741437BACKGROUND

  • 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.

    PMID: 29059644BACKGROUND

  • 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.

    PMID: 25281824RESULT

  • 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.

    PMID: 21385509RESULT

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Taisy Ferro Cavalcante, Dr

    University of Pernambuco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Taisy Ferro Cavalcante, Dr

CONTACT

+5581999735348taisy.cavalcante@upe.br

Taisy Ferro Cavalcante, Dr

CONTACT

+5581997180436taisyferro@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

June 26, 2023

First Posted

August 31, 2023

Study Start

August 1, 2023

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

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.

Locations

BR(1)