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/NCT05981053</url>
    </required_header>
    <id_info>
      <org_study_id>#26122021</org_study_id>
      <nct_id>NCT05981053</nct_id>
    </id_info>
    <brief_title>Biological Effects in Consumers of Resveratrol-enriched Wine</brief_title>
    <official_title>Biological Effects in Consumers of Resveratrol-enriched Wine</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>PINER Pastor Manfredi Winery</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Buenos Aires</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>PINER Pastor Manfredi Winery</source>
    <oversight_info>
      <has_dmc>No</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 objective of this clinical trial is to compare the health conditions of the participating&#xD;
        population before and after an intervention with Resveratrol enriched wine.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          1. • The consumption of wine enriched with resveratrol could slow down or reverse the&#xD;
             biological age ?&#xD;
  &#xD;
          2. • The consumption of wine enriched with resveratrol could improve body composition fat&#xD;
             mass / muscle mass ? The participants will be evaluated at the beginning and at the end&#xD;
             of the clinical trial and will adopt only one change in their habits, that is, change&#xD;
             the usual wine they consume with their meals for a wine enriched with resveratrol, in a&#xD;
             moderate measure, 250 cc for men and 125 cc/day for women. The design of the study will&#xD;
             be that each volunteer is their own control, pre and post intervention.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study objectives The objective of the study is to determine the possible relationship between&#xD;
        the consumption of pure Malbec wine 100% enriched with pure resveratrol (150 mg/L of wine)&#xD;
        ingested during meals, with biomarkers (oxidative stress, DNA damage, antioxidant defenses&#xD;
        and chronic systemic inflammation in blood and urine), generated in the body by the damage&#xD;
        produced by the oxidative stress of metabolism, age and chronic pathologies.&#xD;
  &#xD;
        Procedures to follow&#xD;
  &#xD;
          1. First visit A doctor will take details of your medical history, perform a complete&#xD;
             physical examination, and explain the reasons for the study. If you meet the criteria&#xD;
             and are eligible to be included in the study, you will only be told not to take dietary&#xD;
             supplements or antioxidants and you will be seen again in the office two weeks later. At&#xD;
             that time, you will be asked to carry out a blood laboratory analysis. These will be the&#xD;
             Baseline Controls.&#xD;
  &#xD;
          2. Visits 30, 60, 90 days:&#xD;
  &#xD;
             Each period between consultations is 30 days, during which time the participant follows&#xD;
             a free diet. At the end of each month, you will go for a medical consultation and be&#xD;
             given the resveratrol-enriched wine. In the 4th consultation (90 days) the procedure of&#xD;
             the first consultation will be repeated. That is, Consultation + Fasting blood&#xD;
             extraction.&#xD;
  &#xD;
             Observations of eventual adverse events will be recorded; the information will be&#xD;
             recorded in the CRF (Clinical Research Form).&#xD;
  &#xD;
             All the instruments used will be used only for you (disposable material), to avoid all&#xD;
             types of contagion or infection.&#xD;
  &#xD;
          3. Biochemical Analysis Determination of analysis to perform on the samples obtained from&#xD;
             venous blood, initial and final at 90 days.&#xD;
  &#xD;
             samples. Venous blood will be obtained with heparin at both moments according to the&#xD;
             protocol, with a 12-h fast. Start and end at 90 days.&#xD;
  &#xD;
             Determinations. Analysis of oxidative damage, analysis of enzymatic antioxidant&#xD;
             defenses, inflammatory response in polymorphonuclear cells (PMN), red blood cells,&#xD;
             plasma, and general biochemical analysis will be performed.&#xD;
  &#xD;
             Biochemical-Clinical Studies&#xD;
  &#xD;
               1. Ferritin&#xD;
  &#xD;
               2. Complete blood count w/Platelet count&#xD;
  &#xD;
               3. Mean cell volume&#xD;
  &#xD;
               4. RDW - Red Distribution Width&#xD;
  &#xD;
               5. Ultrasensitive PCR&#xD;
  &#xD;
               6. Glycemia&#xD;
  &#xD;
               7. Creatinine&#xD;
  &#xD;
               8. albumin&#xD;
  &#xD;
               9. Alkaline Phosphatase&#xD;
  &#xD;
          4. Body composition analysis The determination of the InBody analysis will be carried out&#xD;
             at the beginning and at the end of the study.&#xD;
  &#xD;
        Statistical analysis: The statistical analysis was performed using the Student t-test for&#xD;
        paired samples (Prism 7.0, GraphPad, San Diego, CA, USA). The Student t-test was selected to&#xD;
        evaluate a single biomarker at a time in eight series of paired data (D0 vs. D90 for&#xD;
        chronological and DNAm PhenoAge, muscle mass and fat mass) for each patient before and after&#xD;
        the intervention. Results with p &lt; 0.05 were considered significant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 15, 2022</start_date>
    <completion_date type="Actual">June 30, 2023</completion_date>
    <primary_completion_date type="Actual">April 28, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Epigenetic age</measure>
      <time_frame>3 months</time_frame>
      <description>DNAm Phenoage</description>
    </primary_outcome>
    <primary_outcome>
      <measure>InBody muscle mass</measure>
      <time_frame>3 months</time_frame>
      <description>Body composition</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body composition</measure>
      <time_frame>3 months</time_frame>
      <description>InBody fat mass</description>
    </primary_outcome>
    <enrollment type="Actual">30</enrollment>
    <condition>Aging</condition>
    <condition>Healthy Aging</condition>
    <condition>Sarcopenia</condition>
    <condition>Obesity</condition>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Wine enriched with Resveratrol</intervention_name>
      <description>Wine enriched with Resveratrol</description>
      <other_name>https://vinospiner.com.ar/</other_name>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Biochemical-Clinical Studies&#xD;
  &#xD;
          1. Ferritin&#xD;
  &#xD;
          2. Complete blood count w/Platelet count&#xD;
  &#xD;
          3. Mean cell volume&#xD;
  &#xD;
          4. RDW - Red Distribution Width&#xD;
  &#xD;
          5. ultrasensitive PCR&#xD;
  &#xD;
          6. Glycemia&#xD;
  &#xD;
          7. Creatinine&#xD;
  &#xD;
          8. albumin&#xD;
  &#xD;
          9. Alkaline Phosphatase&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy volunteers and with risk factors of cardiovascular diseases&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 1.1 Minimum 40 years 1.2 Maximum 80 years&#xD;
  &#xD;
            2. Gender 2.1 Male 2.2 Female&#xD;
  &#xD;
            3. Habits 3.1 Regular wine consumers&#xD;
  &#xD;
          Exclusion criteria&#xD;
  &#xD;
            1. Age 1.1 under 40 years 1.2 over 80 years&#xD;
  &#xD;
            2. Modifications in treatments during the clinical trial 2.1 Pharmacological 2.2&#xD;
               Non-Pharmacological.&#xD;
  &#xD;
            3. Pregnant women.&#xD;
  &#xD;
            4. Women in planned pregnancy during the study period.&#xD;
  &#xD;
            5. Women in the lactation period.&#xD;
  &#xD;
            6. Patients who have been hospitalized for an infectious disease.&#xD;
  &#xD;
            7. Patients suffering from autoimmune pathologies.&#xD;
  &#xD;
            8. Patients who have cancer.&#xD;
  &#xD;
            9. Patients with gastrointestinal pathologies.&#xD;
  &#xD;
           10. Patients who have a history of liver disease.&#xD;
  &#xD;
           11. Patients who have a history of kidney disease.&#xD;
  &#xD;
           12. Patients who have hematological disease.&#xD;
  &#xD;
           13. Patients who present disorders of the disease of psychiatric origin.&#xD;
  &#xD;
           14. Patients who have epilepsy.&#xD;
  &#xD;
           15. Patients with allergies to the active principles of: 15.1 Wine 15.2 Resveratrol.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Raul Francisco Pastor</name>
        <address>
          <city>Buenos Aires</city>
          <state>Buenos Aires City</state>
          <zip>1408</zip>
          <country>Argentina</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Argentina</country>
    </location_countries>
    <reference>
      <citation>Levine ME, Lu AT, Quach A, Chen BH, Assimes TL, Bandinelli S, Hou L, Baccarelli AA, Stewart JD, Li Y, Whitsel EA, Wilson JG, Reiner AP, Aviv A, Lohman K, Liu Y, Ferrucci L, Horvath S. An epigenetic biomarker of aging for lifespan and healthspan. Aging (Albany NY). 2018 Apr 18;10(4):573-591. doi: 10.18632/aging.101414.</citation>
      <PMID>29676998</PMID>
    </reference>
    <reference>
      <citation>Pastor RF, Restani P, Di Lorenzo C, Orgiu F, Teissedre PL, Stockley C, Ruf JC, Quini CI, Garcia Tejedor N, Gargantini R, Aruani C, Prieto S, Murgo M, Videla R, Penissi A, Iermoli RH. Resveratrol, human health and winemaking perspectives. Crit Rev Food Sci Nutr. 2019;59(8):1237-1255. doi: 10.1080/10408398.2017.1400517. Epub 2017 Dec 5.</citation>
      <PMID>29206058</PMID>
    </reference>
    <reference>
      <citation>Pastor RF, Repetto MG, Lairion F, Lazarowski A, Merelli A, Manfredi Carabetti Z, Pastor I, Pastor E, Iermoli LV, Bavasso CA, Iermoli RH. Supplementation with Resveratrol, Piperine and Alpha-Tocopherol Decreases Chronic Inflammation in a Cluster of Older Adults with Metabolic Syndrome. Nutrients. 2020 Oct 15;12(10):3149. doi: 10.3390/nu12103149.</citation>
      <PMID>33076345</PMID>
    </reference>
    <reference>
      <citation>Fitzgerald KN, Hodges R, Hanes D, Stack E, Cheishvili D, Szyf M, Henkel J, Twedt MW, Giannopoulou D, Herdell J, Logan S, Bradley R. Potential reversal of epigenetic age using a diet and lifestyle intervention: a pilot randomized clinical trial. Aging (Albany NY). 2021 Apr 12;13(7):9419-9432. doi: 10.18632/aging.202913. Epub 2021 Apr 12. Erratum In: Aging (Albany NY). 2022 Jul 27;14(14):5959.</citation>
      <PMID>33844651</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Food Science &amp; Technology</keyword>
    <keyword>Epigenetic age</keyword>
    <keyword>Biological aging</keyword>
    <keyword>Body composition</keyword>
    <keyword>Muscle mass</keyword>
    <keyword>Fat mass</keyword>
    <keyword>Wine enriched</keyword>
    <keyword>Resveratrol</keyword>
    <keyword>Wine and health</keyword>
    <keyword>Antiaging wine</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sarcopenia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Resveratrol</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05981053
  org study id: #26122021
  nct id: NCT05981053
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this clinical trial is to compare the health conditions of the participating
        population before and after an intervention with Resveratrol enriched wine.
  
        The main questions it aims to answer are:
  
          1. • The consumption of wine enriched with resveratrol could slow down or reverse the
             biological age ?
  
          2. • The consumption of wine enriched with resveratrol could improve body composition fat
             mass / muscle mass ? The participants will be evaluated at the beginning and at the end
             of the clinical trial and will adopt only one change in their habits, that is, change
             the usual wine they consume with their meals for a wine enriched with resveratrol, in a
             moderate measure, 250 cc for men and 125 cc/day for women. The design of the study will
             be that each volunteer is their own control, pre and post intervention.
  Study objectives The objective of the study is to determine the possible relationship between
        the consumption of pure Malbec wine 100% enriched with pure resveratrol (150 mg/L of wine)
        ingested during meals, with biomarkers (oxidative stress, DNA damage, antioxidant defenses
        and chronic systemic inflammation in blood and urine), generated in the body by the damage
        produced by the oxidative stress of metabolism, age and chronic pathologies.
  
        Procedures to follow
  
          1. First visit A doctor will take details of your medical history, perform a complete
             physical examination, and explain the reasons for the study. If you meet the criteria
             and are eligible to be included in the study, you will only be told not to take dietary
             supplements or antioxidants and you will be seen again in the office two weeks later. At
             that time, you will be asked to carry out a blood laboratory analysis. These will be the
             Baseline Controls.
  
          2. Visits 30, 60, 90 days:
  
             Each period between consultations is 30 days, during which time the participant follows
             a free diet. At the end of each month, you will go for a medical consultation and be
             given the resveratrol-enriched wine. In the 4th consultation (90 days) the procedure of
             the first consultation will be repeated. That is, Consultation + Fasting blood
             extraction.
  
             Observations of eventual adverse events will be recorded; the information will be
             recorded in the CRF (Clinical Research Form).
  
             All the instruments used will be used only for you (disposable material), to avoid all
             types of contagion or infection.
  
          3. Biochemical Analysis Determination of analysis to perform on the samples obtained from
             venous blood, initial and final at 90 days.
  
             samples. Venous blood will be obtained with heparin at both moments according to the
             protocol, with a 12-h fast. Start and end at 90 days.
  
             Determinations. Analysis of oxidative damage, analysis of enzymatic antioxidant
             defenses, inflammatory response in polymorphonuclear cells (PMN), red blood cells,
             plasma, and general biochemical analysis will be performed.
  
             Biochemical-Clinical Studies
  
               1. Ferritin
  
               2. Complete blood count w/Platelet count
  
               3. Mean cell volume
  
               4. RDW - Red Distribution Width
  
               5. Ultrasensitive PCR
  
               6. Glycemia
  
               7. Creatinine
  
               8. albumin
  
               9. Alkaline Phosphatase
  
          4. Body composition analysis The determination of the InBody analysis will be carried out
             at the beginning and at the end of the study.
  
        Statistical analysis: The statistical analysis was performed using the Student t-test for
        paired samples (Prism 7.0, GraphPad, San Diego, CA, USA). The Student t-test was selected to
        evaluate a single biomarker at a time in eight series of paired data (D0 vs. D90 for
        chronological and DNAm PhenoAge, muscle mass and fat mass) for each patient before and after
        the intervention. Results with p < 0.05 were considered significant.
  observational model: Case-Only
  time perspective: Prospective
  measure: Epigenetic age
  time frame: 3 months
  description: DNAm Phenoage
  measure: InBody muscle mass
  time frame: 3 months
  description: Body composition
  measure: Body composition
  time frame: 3 months
  description: InBody fat mass
  intervention type: Dietary Supplement
  intervention name: Wine enriched with Resveratrol
  description: Wine enriched with Resveratrol
  other name: https://vinospiner.com.ar/
  Biochemical-Clinical Studies
  
          1. Ferritin
  
          2. Complete blood count w/Platelet count
  
          3. Mean cell volume
  
          4. RDW - Red Distribution Width
  
          5. ultrasensitive PCR
  
          6. Glycemia
  
          7. Creatinine
  
          8. albumin
  
          9. Alkaline Phosphatase
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Argentina
  citation: Levine ME, Lu AT, Quach A, Chen BH, Assimes TL, Bandinelli S, Hou L, Baccarelli AA, Stewart JD, Li Y, Whitsel EA, Wilson JG, Reiner AP, Aviv A, Lohman K, Liu Y, Ferrucci L, Horvath S. An epigenetic biomarker of aging for lifespan and healthspan. Aging (Albany NY). 2018 Apr 18;10(4):573-591. doi: 10.18632/aging.101414.
  PMID: 29676998
  citation: Pastor RF, Restani P, Di Lorenzo C, Orgiu F, Teissedre PL, Stockley C, Ruf JC, Quini CI, Garcia Tejedor N, Gargantini R, Aruani C, Prieto S, Murgo M, Videla R, Penissi A, Iermoli RH. Resveratrol, human health and winemaking perspectives. Crit Rev Food Sci Nutr. 2019;59(8):1237-1255. doi: 10.1080/10408398.2017.1400517. Epub 2017 Dec 5.
  PMID: 29206058
  citation: Pastor RF, Repetto MG, Lairion F, Lazarowski A, Merelli A, Manfredi Carabetti Z, Pastor I, Pastor E, Iermoli LV, Bavasso CA, Iermoli RH. Supplementation with Resveratrol, Piperine and Alpha-Tocopherol Decreases Chronic Inflammation in a Cluster of Older Adults with Metabolic Syndrome. Nutrients. 2020 Oct 15;12(10):3149. doi: 10.3390/nu12103149.
  PMID: 33076345
  citation: Fitzgerald KN, Hodges R, Hanes D, Stack E, Cheishvili D, Szyf M, Henkel J, Twedt MW, Giannopoulou D, Herdell J, Logan S, Bradley R. Potential reversal of epigenetic age using a diet and lifestyle intervention: a pilot randomized clinical trial. Aging (Albany NY). 2021 Apr 12;13(7):9419-9432. doi: 10.18632/aging.202913. Epub 2021 Apr 12. Erratum In: Aging (Albany NY). 2022 Jul 27;14(14):5959.
  PMID: 33844651
  responsible party type: Sponsor
  mesh term: Sarcopenia
  mesh term: Resveratrol