<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/NCT02202863</url>
  </required_header>
  <id_info>
    <org_study_id>13-029</org_study_id>
    <secondary_id>FONDEF AF10 I1014</secondary_id>
    <nct_id>NCT02202863</nct_id>
  </id_info>
  <brief_title>Effects of Wine Grape Pomace Flour Used as a Dietary Supplement on Metabolic Syndrome Components</brief_title>
  <official_title>Study on the Effects of Wine Grape Pomace Flour, Used as a Dietary Supplement to Increase the Intake of Dietary Fiber and Antioxidants in Human, on Components of Metabolic Syndrome, Plasma Antioxidants, Oxidative Stress Markers and Inflammatory Markers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pontificia Universidad Catolica de Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pontificia Universidad Catolica de Chile</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Lifestyle modifications, including healthy food intake, exercise, and suppression of tobacco&#xD;
      smoking, constitute the most powerful tool to fight chronic diseases. Antioxidants and fiber,&#xD;
      two components of Mediterranean diets, are key functional elements for healthy eating and&#xD;
      nutrition. We prepared flour from wine grape pomace (WGPF), a rich source of antioxidant and&#xD;
      fiber, to be used as an ingredient for functional foods and as a dietary supplement to&#xD;
      increase the intake of dietary fiber and bioactive compounds. WGPF was obtained from red&#xD;
      grapes (Cabernet Sauvignon variety, Chile). The byproduct of pressing crushed grapes after&#xD;
      alcoholic fermentation was dried, grounded and stored. The purpose of this study is to&#xD;
      determine the effects of red wine grape pomace flour intake on glycaemia, plasma lipid&#xD;
      profile, plasma antioxidants (vitamin C and E), oxidative stress and inflammatory markers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A 16-week longitudinal intervention study. Males, 30-65 years of age, with at least one&#xD;
      component of metabolic syndrome, were randomly assigned to either the intervention group or&#xD;
      the control group. At lunch, the intervention group was given 20 g of WGPF per day, which&#xD;
      contained 10 g of dietary fiber and an antioxidant capacity of 7,258 ORAC (oxygen radical&#xD;
      absorbance capacity) units. Both groups were asked to maintain their regular eating habits&#xD;
      and lifestyles. Clinical evaluation, anthropometric measurements and biochemical blood&#xD;
      analyses were done at the beginning and the end of the study.&#xD;
&#xD;
      The intervention was carried out at a heavy mining machinery company in Santiago, Chile. All&#xD;
      employees were informed about the study and invited to participate. Initially, 47 male&#xD;
      workers free of exclusion criteria agreed to participate. The number of participants in each&#xD;
      group was chosen based on the variation coefficients in the evolution of total cholesterol in&#xD;
      the intervention and in the control group, observed in a previous work (Jiménez, J.P., et&#xD;
      al., Effects of grape antioxidant dietary fiber in cardiovascular disease risk factors.&#xD;
      Nutrition, 2008. 24(7-8): 646-53).&#xD;
&#xD;
      Statistical analysis: Continuous variables will be shown as mean and standard deviation,&#xD;
      while categorical variables as the number of cases and percentage. The student t-test for&#xD;
      independent samples and the chi-square test will be used to analyze differences of means and&#xD;
      proportions between the two groups, respectively. The student t-test for paired samples and&#xD;
      McNemar's test will be used to analyze differences of means and proportions within each&#xD;
      group. When appropriate, the Wilcoxon signed rank-sum test will be used to compare paired&#xD;
      medians. All p values will be two-tailed and a value &lt;0.05 will be considered to be&#xD;
      statistically significant. Data processing and statistical analyses will be done with the SAS&#xD;
      statistical software package version 9.1 for Windows.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Metabolic Syndrome</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>The presence of metabolic syndrome components was defined using the criteria proposed by the Adult Treatment Panel III of the US National Cholesterol Education Program: (i) abdominal obesity as waist circumference &gt;102 cm for men; (ii) low levels (&lt;40 mg/dL for men) of serum high density lipoprotein cholesterol; (iii) hypertriglyceridemia as 150 mg/dL or more; (iv) elevated blood pressure as 130/85 mm Hg or higher; and (v) impaired glucose homeostasis as fasting plasma glucose levels of 100 mg/dL or higher</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postprandial insulin</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>An oral glucose tolerance test (OGTT) was performed after overnight fasting. Subjects ingested a solution containing 75 g of dextrose, and venous blood samples were obtained at 0 and 120 min to determine plasma glucose and insulin levels. Insulin was measured by electrochemiluminescence immunoassay (ECLIA; Roche Diagnostics®).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Antioxidants</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Antioxidants measurements: Total Plasma Antioxidant Capacity (TRAP), Total Plasma Antioxidant Reactivity (TAR), Vitamin C and Vitamin E.</description>
  </other_outcome>
  <other_outcome>
    <measure>Oxidative stress</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Oxitative stress markers: Malondialdehyde (MDA), Protein Carbonyl and the Methionine Sulfoxide in plasma.</description>
  </other_outcome>
  <other_outcome>
    <measure>Inflammation</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Inflammatory markers: Tumor Necrosis Factor -Alfa, IL-6, Monocyte Chemotactic Protein -1, in plasma</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Metabolic Syndrome X</condition>
  <condition>Oxidative Stress</condition>
  <arm_group>
    <arm_group_label>Red Wine Grape Pomace Flour (WGPF)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects were asked to maintain their regular eating habits and lifestyles for 16 weeks, except for the daily intake of 20 g of WGPF. WGPF was consumed in bread, biscuits or as flour mixed with water during lunch. Bread and biscuits with 20% WGPF were prepared especially in a bakery. WGPF intake was supervised every day at lunch. Participants were asked to consume the flour supplement with their regular meals on weekends.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects were asked to maintain their regular eating habits and lifestyles for 16 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Red wine grape pomace flour (WGPF)</intervention_name>
    <description>Pomace, a byproduct from wine production, was obtained from red wine grapes, Cabernet Sauvignon, vintage 2011, Maipo Valley, Chile, after alcoholic fermentation. The wine grape pomace was dried and grounded to obtain the flour. Intervention group ate 20 g per day of this flour, which contained 10 g of dietary fiber and an antioxidant capacity of 7,258 ORAC units.</description>
    <arm_group_label>Red Wine Grape Pomace Flour (WGPF)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject who regularly consumed an omnivorous diet.&#xD;
&#xD;
          -  Subjects that had at least one of the five components of metabolic syndrome.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects that were under treatment for diabetes mellitus, hypertension (&gt; 160/100) or&#xD;
             dyslipidemia (hypertriglyceridemia&gt; 500 mg / dl, hypercholesterolemia&gt; 350 mg / dl)&#xD;
&#xD;
          -  Subjects who consume drugs affecting lipid profile, blood pressure, metabolism of&#xD;
             carbohydrates or the antioxidant capacity of plasma.&#xD;
&#xD;
          -  Subjects with obesity, BMI &gt; 30&#xD;
&#xD;
          -  Subjects who have had a cardiovascular event.&#xD;
&#xD;
          -  Subjects with bariatric surgery&#xD;
&#xD;
          -  Subjects with untreated thyroid disease, renal disease (serum creatinine&gt; 1.5 mg /&#xD;
             dl), active liver disease, or other rheumatic disease that could alter the&#xD;
             measurements.&#xD;
&#xD;
          -  Subjects with chronic inflammatory diseases.&#xD;
&#xD;
          -  Subjects that use of supplements containing antioxidants.&#xD;
&#xD;
          -  Smoking more than 5 cigarettes per day&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ines Urquiaga, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centro de Nutricion y Enfermedades Cronicas, Pontificia Universidad Catolica de Chile</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro de Nutricion Molecular y Enfermedades Cronicas, Pontificia Universidad Catolica de Chile</name>
      <address>
        <city>Santiago</city>
        <state>Centro</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>July 25, 2014</last_update_submitted>
  <last_update_submitted_qc>July 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dietary intervention</keyword>
  <keyword>Wine grape pomace flour</keyword>
  <keyword>Metabolic Syndrome</keyword>
  <keyword>Oxidative stress</keyword>
  <keyword>Antioxidants</keyword>
  <keyword>Fiber</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02202863
org study id: 13-029
secondary id: FONDEF AF10 I1014
nct id: NCT02202863
lead sponsor: 
has dmc: No
Lifestyle modifications, including healthy food intake, exercise, and suppression of tobacco
      smoking, constitute the most powerful tool to fight chronic diseases. Antioxidants and fiber,
      two components of Mediterranean diets, are key functional elements for healthy eating and
      nutrition. We prepared flour from wine grape pomace (WGPF), a rich source of antioxidant and
      fiber, to be used as an ingredient for functional foods and as a dietary supplement to
      increase the intake of dietary fiber and bioactive compounds. WGPF was obtained from red
      grapes (Cabernet Sauvignon variety, Chile). The byproduct of pressing crushed grapes after
      alcoholic fermentation was dried, grounded and stored. The purpose of this study is to
      determine the effects of red wine grape pomace flour intake on glycaemia, plasma lipid
      profile, plasma antioxidants (vitamin C and E), oxidative stress and inflammatory markers.
A 16-week longitudinal intervention study. Males, 30-65 years of age, with at least one
      component of metabolic syndrome, were randomly assigned to either the intervention group or
      the control group. At lunch, the intervention group was given 20 g of WGPF per day, which
      contained 10 g of dietary fiber and an antioxidant capacity of 7,258 ORAC (oxygen radical
      absorbance capacity) units. Both groups were asked to maintain their regular eating habits
      and lifestyles. Clinical evaluation, anthropometric measurements and biochemical blood
      analyses were done at the beginning and the end of the study.

      The intervention was carried out at a heavy mining machinery company in Santiago, Chile. All
      employees were informed about the study and invited to participate. Initially, 47 male
      workers free of exclusion criteria agreed to participate. The number of participants in each
      group was chosen based on the variation coefficients in the evolution of total cholesterol in
      the intervention and in the control group, observed in a previous work (Jiménez, J.P., et
      al., Effects of grape antioxidant dietary fiber in cardiovascular disease risk factors.
      Nutrition, 2008. 24(7-8): 646-53).

      Statistical analysis: Continuous variables will be shown as mean and standard deviation,
      while categorical variables as the number of cases and percentage. The student t-test for
      independent samples and the chi-square test will be used to analyze differences of means and
      proportions between the two groups, respectively. The student t-test for paired samples and
      McNemar's test will be used to analyze differences of means and proportions within each
      group. When appropriate, the Wilcoxon signed rank-sum test will be used to compare paired
      medians. All p values will be two-tailed and a value <0.05 will be considered to be
      statistically significant. Data processing and statistical analyses will be done with the SAS
      statistical software package version 9.1 for Windows.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Metabolic Syndrome
time frame: Baseline and 16 weeks
description: The presence of metabolic syndrome components was defined using the criteria proposed by the Adult Treatment Panel III of the US National Cholesterol Education Program: (i) abdominal obesity as waist circumference >102 cm for men; (ii) low levels (<40 mg/dL for men) of serum high density lipoprotein cholesterol; (iii) hypertriglyceridemia as 150 mg/dL or more; (iv) elevated blood pressure as 130/85 mm Hg or higher; and (v) impaired glucose homeostasis as fasting plasma glucose levels of 100 mg/dL or higher
measure: Postprandial insulin
time frame: Baseline and 16 weeks
description: An oral glucose tolerance test (OGTT) was performed after overnight fasting. Subjects ingested a solution containing 75 g of dextrose, and venous blood samples were obtained at 0 and 120 min to determine plasma glucose and insulin levels. Insulin was measured by electrochemiluminescence immunoassay (ECLIA; Roche Diagnostics®).
measure: Antioxidants
time frame: Baseline and 16 weeks
description: Antioxidants measurements: Total Plasma Antioxidant Capacity (TRAP), Total Plasma Antioxidant Reactivity (TAR), Vitamin C and Vitamin E.
measure: Oxidative stress
time frame: Baseline and 16 weeks
description: Oxitative stress markers: Malondialdehyde (MDA), Protein Carbonyl and the Methionine Sulfoxide in plasma.
measure: Inflammation
time frame: Baseline and 16 weeks
description: Inflammatory markers: Tumor Necrosis Factor -Alfa, IL-6, Monocyte Chemotactic Protein -1, in plasma
arm group label: Red Wine Grape Pomace Flour (WGPF)
arm group type: Experimental
description: Subjects were asked to maintain their regular eating habits and lifestyles for 16 weeks, except for the daily intake of 20 g of WGPF. WGPF was consumed in bread, biscuits or as flour mixed with water during lunch. Bread and biscuits with 20% WGPF were prepared especially in a bakery. WGPF intake was supervised every day at lunch. Participants were asked to consume the flour supplement with their regular meals on weekends.
arm group label: Control
arm group type: No Intervention
description: Subjects were asked to maintain their regular eating habits and lifestyles for 16 weeks.
intervention type: Dietary Supplement
intervention name: Red wine grape pomace flour (WGPF)
description: Pomace, a byproduct from wine production, was obtained from red wine grapes, Cabernet Sauvignon, vintage 2011, Maipo Valley, Chile, after alcoholic fermentation. The wine grape pomace was dried and grounded to obtain the flour. Intervention group ate 20 g per day of this flour, which contained 10 g of dietary fiber and an antioxidant capacity of 7,258 ORAC units.
arm group label: Red Wine Grape Pomace Flour (WGPF)
criteria: 
gender: Male
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ines Urquiaga, Ph.D
role: Principal Investigator
affiliation: Centro de Nutricion y Enfermedades Cronicas, Pontificia Universidad Catolica de Chile
facility: 
country: Chile
responsible party type: Sponsor
mesh term: Metabolic Syndrome
mesh term: Syndrome