xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06020313</url>
    </required_header>
    <id_info>
      <org_study_id>5.051.852</org_study_id>
      <nct_id>NCT06020313</nct_id>
    </id_info>
    <brief_title>Autonomic and Cardiovascular Recovery After the Acute Use of Resveratrol in Overweight and Obesity Individuals</brief_title>
    <acronym>Resveratrol</acronym>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Taisy Cinthia Ferro Cavalcante</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Pernambuco</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to understand the importance of resveratrol supplementation as a&#xD;
        possible adjuvant in improving the metabolic profile and cardiovascular autonomic recovery of&#xD;
        individuals with overweight and grade I obesity, reducing the incidence of diseases&#xD;
        associated with obesity and the costs in primary, secondary and tertiary care.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Food is a strong ally in improving the metabolic state in overweight, obesity and prevention&#xD;
        of associated diseases, working on weight loss and ingestion of anti-inflammatory,&#xD;
        anti-oxidant and cardioprotective substances, among these substances, we highlight the&#xD;
        polyphenols. Resveratrol or 3,5,4-trihydroxystilbene is a polyphenol studied since 1976, a&#xD;
        phytoalexin synthesized in the skin of the grape, which is increased when exposed to stresses&#xD;
        such as ultraviolet radiation, enhancing the antioxidant and cardioprotective&#xD;
        characteristics.This study aims to evaluate the cardiovascular autonomic recovery and the&#xD;
        metabolic profile with the acute effect of resveratrol extract after submaximal aerobic&#xD;
        exercises in individuals with overweight and grade I obesity.Heart rate variation (HRV) is&#xD;
        considered the most trivial method for analyzing the behavior of autonomic efferents&#xD;
        (parasympathetic and sympathetic) on the heart. HRV recovery after exercise has been widely&#xD;
        used as a method of analyzing ANS adaptation (vagal recovery) under various&#xD;
        conditions.Healthy, physically active individuals with good health characteristics have a&#xD;
        rapid recovery of HRV after exercise, indicating good adaptability and a lower risk for&#xD;
        cardiovascular diseases. Meanwhile, changes HRV patterns provide a sensitive and early&#xD;
        indicator of health impairments. The monitoring of these data is necessary, as they act as&#xD;
        markers of emerging risk for the development of complications associated with CNCDs and risks&#xD;
        of future injuries. In this context, the present project will make it possible to verify the&#xD;
        effect of the acute use of resveratrol on the metabolic profile and on the autonomic and&#xD;
        cardiovascular recovery of individuals with overweight and obesity grade I.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <intervention_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.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <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.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Autonomic and cardiovascular recovery</measure>
      <time_frame>Five months of collecting and analyzing data.</time_frame>
      <description>Analysis of linear and non-linear indices of heart rate variability</description>
    </primary_outcome>
    <primary_outcome>
      <measure>biochemical parameters</measure>
      <time_frame>Two weeks</time_frame>
      <description>complete blood count, blood glucose, triglycerides, total cholesterol</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Polyphenols</condition>
    <condition>Cardiovascular Diseases</condition>
    <condition>Autonomic Nervous System</condition>
    <arm_group>
      <arm_group_label>Experimental Resveratrol</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Resveratrol Experimental</intervention_name>
      <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).</description>
      <arm_group_label>Experimental Resveratrol</arm_group_label>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Individuals with overweight and obesity grade I&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cardiorespiratory disorders&#xD;
  &#xD;
            -  Neurological disorders&#xD;
  &#xD;
            -  skeletal muscle injury&#xD;
  &#xD;
            -  Known impairments that prevent the subject from performing the procedures.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>59 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Taisy Ferro Cavalcante, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Pernambuco</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Taisy Ferro Cavalcante, Dr</last_name>
      <phone>+5581999735348</phone>
      <email>taisy.cavalcante@upe.br</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Taisy Ferro Cavalcante, Dr</last_name>
      <phone>+5581997180436</phone>
      <email>taisyferro@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Taisy Cinthia Ferro Cavalcante</name>
        <address>
          <city>Petrolina</city>
          <state>Pernambuco</state>
          <zip>56328-900</zip>
          <country>Brazil</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Taisy Ferro Cavalcante, Dr</last_name>
        <phone>+5581999735348</phone>
        <email>taisy.cavalcante@upe.br</email>
      </contact>
      <contact_backup>
        <last_name>Taisy Ferro Cavalcante, Dr</last_name>
        <phone>+5581997180436</phone>
        <email>taisyferro@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <reference>
      <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.</citation>
      <PMID>29075019</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>27836300</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>30426122</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>22648627</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>30741437</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>29059644</PMID>
    </reference>
    <results_reference>
      <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.</citation>
      <PMID>25281824</PMID>
    </results_reference>
    <results_reference>
      <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.</citation>
      <PMID>21385509</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Pernambuco</investigator_affiliation>
      <investigator_full_name>Taisy Cinthia Ferro Cavalcante</investigator_full_name>
      <investigator_title>doctor</investigator_title>
    </responsible_party>
    <keyword>Resveratrol</keyword>
    <keyword>Cardiovascular Diseases</keyword>
    <keyword>Autonomic Nervous System</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiovascular Diseases</mesh_term>
      <mesh_term>Overweight</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Resveratrol</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>This project was approved by the Research Ethics Committee of the University of Pernambuco/CISAM (CEP/UPE-CISAM), opinion number: 5.051.852.&#xD;
  The results will be published in scientific articles and the final report will be forwarded to the ethics committee.&#xD;
  Volunteers will be duly informed about the procedures and objectives of this study.&#xD;
  Before participating, they will sign the Free and Informed Consent Form, being able to withdraw from the study at any time.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06020313
  org study id: 5.051.852
  nct id: NCT06020313
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention 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.
  primary purpose: Prevention
  masking: Double (Participant, Outcomes 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.
  measure: Autonomic and cardiovascular recovery
  time frame: Five months of collecting and analyzing data.
  description: Analysis of linear and non-linear indices of heart rate variability
  measure: biochemical parameters
  time frame: Two weeks
  description: complete blood count, blood glucose, triglycerides, total cholesterol
  arm group label: Experimental Resveratrol
  arm group type: Experimental
  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 group label: Placebo
  arm group type: Placebo Comparator
  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: Resveratrol Experimental
  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).
  arm group label: Experimental Resveratrol
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 59 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Taisy Ferro Cavalcante, Dr
  role: Principal Investigator
  affiliation: University of Pernambuco
  last name: Taisy Ferro Cavalcante, Dr
  phone: +5581999735348
  email: taisy.cavalcante@upe.br
  last name: Taisy Ferro Cavalcante, Dr
  phone: +5581997180436
  email: taisyferro@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Brazil
  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.
  PMID: 29075019
  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.
  PMID: 27836300
  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.
  PMID: 30426122
  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.
  PMID: 22648627
  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.
  PMID: 30741437
  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.
  PMID: 29059644
  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.
  PMID: 25281824
  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.
  PMID: 21385509
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Pernambuco
  investigator full name: Taisy Cinthia Ferro Cavalcante
  investigator title: doctor
  mesh term: Cardiovascular Diseases
  mesh term: Overweight
  mesh term: Resveratrol
  sharing ipd: No
  ipd 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.