<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/NCT02197910</url>
  </required_header>
  <id_info>
    <org_study_id>BACCHUS_PASTATREND_2014</org_study_id>
    <nct_id>NCT02197910</nct_id>
  </id_info>
  <brief_title>Different Dosages of Bioactive Wheat Peptides and Blood Pressure Level and CVD Risk Biomarkers in Healthy Subjects</brief_title>
  <official_title>Association Between Consumption of Different Dosages of Bioactive Wheat Peptides and Blood Pressure (BP) Level and Other Biomarkers of Cardiovascular Disease Risk in Healthy Subjects With High-normal BP: a Double-blind, Cross-over, RCT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Commission</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Bologna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study we will assess the effects of bioactive peptide rich wheat products on blood&#xD;
      pressure and estimated cardiovascular disease risk. This will be a pilot, explorative,&#xD;
      cross-over, randomized double-blind 2 groups x 2-arms controlled, clinical trial. The&#xD;
      intervention will be based on commercially-packaged pasta, which will appear and taste the&#xD;
      same; (i) low dose bioactive peptides vs. (ii) high dose bioactive peptides. Inclusion&#xD;
      Criteria will be: Male and female non-diabetic adult volunteers at increased estimated CV&#xD;
      risk (ESC/EAS SCORE) with SBP 130-139 mmHg and/or DBP 85-90 mmHg); Age included between 40&#xD;
      and 70 years old; Primary prevention for CVD but otherwise in good general health and have&#xD;
      had no major illness in the previous 6-months; Volunteer providing their signed and dated&#xD;
      informed consent form. Exclusion Criteria will be: Severe medical illness/chronic&#xD;
      disease/gastrointestinal pathology (e.g. coeliac disease); Secondary prevention for CVD;&#xD;
      Treatment with drugs potentially affecting BP (including antihypertensive drugs) or other&#xD;
      related CV risk factors; Consumption of nutraceuticals, botanical extracts or other vitamin&#xD;
      supplements; Volunteer diagnosed as being hypertensive A total of 60 participants will be&#xD;
      recruited and following adherence to a standardized diet for a 4-week period, will be&#xD;
      randomly assigned to complete one of 2 treatment sequences by consuming a prescribed quantity&#xD;
      of pasta products for a 4-week period followed by a 4-week washout before random assignment&#xD;
      to the 2nd treatment.&#xD;
&#xD;
      The Primary Outcome will be the modification of office blood pressure (assessed by systolic&#xD;
      and diastolic BP, pulse and mean pressure (mean of 3 standing &amp; sitting measures) and 24-hour&#xD;
      blood pressure.&#xD;
&#xD;
      Additional outcomes include: Anthropometric parameters (Weight, WC, HC, WC/HC, ICO, BMI),&#xD;
      Glucose and Lipid profile (TC, LDL-C, HDL-C, TG, non-HDL cholesterol, risk ratios), Estimated&#xD;
      CVD risk changes (EAS/ESC SCORE Charts), Measures of vascular health (FMD, PWA, PWV, Aix),&#xD;
      Liver and renal functionality biomarkers, 24-h urine collection at baseline of treatment&#xD;
      phase 1 and endpoint of the final phase will be analysed to account for potential confounding&#xD;
      of urinary sodium excretion (intake) As required by the GCPs and GLPs, all the SOPs have&#xD;
      already been established and all the personnel to be involved in the study is continuously&#xD;
      trained in trials with similar outcomes&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">March 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Office blood pressure modification</measure>
    <time_frame>4 weeks</time_frame>
    <description>Systolic, diastolic, pulse, mean arterial pressure, pulse pressure index, mean of 3 consecutive measurement as for the European guidelines on blood pressure measurement suggestion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>24-hour blood pressure modification (ABPM)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Twenty-four hour ambulatory blood pressure monitoring (ABPM) will be performed using a non-invasive automatic monitor (Space Labs, model 90207). For ABPM, patients will be instructed to act and work as normal between 6:00 AM and 10:00 PM and rest or sleep between 10:00 PM and 6:00 AM. Readings were obtained automatically at 15-min intervals throughout a 24-h study period. Separate averages will be obtained for the 24-h, daytime (6:00 AM-10:00 PM) and night-time (10:00 PM-6:00 AM) values. The accuracy of the automatic blood pressure readings will be checked against manual readings taken using a standard mercury sphygmomanometer, twice for each ABPM. Blood pressure were was measured with the patient sitting, before the beginning of the ABPM, and after a 5-min rest period. The accuracy test will be repeated after the end of each 24-h ABPM.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cholesterolemia modification</measure>
    <time_frame>4 weeks</time_frame>
    <description>12-hour fasting Total, LDL, HDL and non HDL-Cholesterol, evaluated with standardized methods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flow-mediated vasodilation modification</measure>
    <time_frame>4 weeks</time_frame>
    <description>Evaluation of endothelial function by automatic measurement executed with the Vicorder Endopath instrument, already validated in previous publications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting glucose modification</measure>
    <time_frame>4 weeks</time_frame>
    <description>12-hour fasting plasma glucose evaluated with standardized methods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse Wave Velocity modification</measure>
    <time_frame>4 weeks</time_frame>
    <description>Evaluation of arterial stiffness measured as Pulse Wave Velocity and related parameters by the Vicorder instrument, already validated in previous publications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglyceridemia modification</measure>
    <time_frame>4 weeks</time_frame>
    <description>12-hour fasting triglyceridemia evaluated by standardized lab methos</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Anthropometric measurement changes</measure>
    <time_frame>4 weeks</time_frame>
    <description>Height, weight, body mass index, waist circumference, hip circumference, waist/hip ratio, visceral adiposity index, index of central obesity measured from trained personnel following SOPs</description>
  </other_outcome>
  <other_outcome>
    <measure>Liver parameters modification</measure>
    <time_frame>4 weeks</time_frame>
    <description>12-hour liver transaminases, gamma-glutamyl-transferase, Lipid Accumulation Product, and Hepatic Steatosis Index evaluated with standardized methods</description>
  </other_outcome>
  <other_outcome>
    <measure>Renal function parameter modification</measure>
    <time_frame>4 weeks</time_frame>
    <description>12-hour fasting serum uric acid, creatinine, and estimated glomerular filtration rate (CKD-EPI formula) evaluated with standardized methods</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Pre-hypertension</condition>
  <arm_group>
    <arm_group_label>High content of wheat bioactive peptides</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 gr pasta/day, containing around 15 mg bioactive peptides (High content of wheat bioactive peptides)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dose of wheat bioactive peptides</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>100 gr pasta/day, containing around 3 mg bioactive peptides</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence Low-&gt;High)</intervention_name>
    <arm_group_label>Low dose of wheat bioactive peptides</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence High-&gt;Low)</intervention_name>
    <arm_group_label>High content of wheat bioactive peptides</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary prevention for cardiovascular diseases&#xD;
&#xD;
          -  Systolic blood pressure 130-139 mmHg and/or Diastolic blood pressure 85-89 mmHg&#xD;
&#xD;
          -  Estimated cardiovascular risk &gt;5% (Italian Heart Project cards)&#xD;
&#xD;
          -  Ability of the volunteer to understand the study finalities and to adhere to the study&#xD;
             protocol&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secundary prevention for cardiovascular disease or high risk to develop cardiovascular&#xD;
             disease&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  High level of a single cardiovascular disease risk factor (i.e.: severe&#xD;
             hypertension/hypercholesterolemia)&#xD;
&#xD;
          -  Chronic renal or liver failure&#xD;
&#xD;
          -  Obesity (Body Mass Index&gt;30 kg/m2)&#xD;
&#xD;
          -  Coeliac disease or gluten intolerance&#xD;
&#xD;
          -  Assumption of antihypertensive drugs at antihypertensive dosage• Each medical or&#xD;
             surgery condition potentially making difficult or inconstant the volunteer adhesion to&#xD;
             the study protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudio Borghi, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Bologna</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Claudio Borghi, MD</last_name>
    <email>claudio.borghi@unibo.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Arrigo FG Cicero, MD, PhD</last_name>
    <email>arrigo.cicero@unibo.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>S. Orsola-Malpighi University Hospital</name>
      <address>
        <city>Bologna</city>
        <state>BO</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arrigo FG Cicero, MD, PhD</last_name>
      <phone>++39516362224</phone>
      <email>arrigo.cicero@unibo.it</email>
    </contact>
    <investigator>
      <last_name>Arrigo FG Cicero, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Claudio Borghi, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maddalena Veronesi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sergio D'Addato, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>July 19, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>August 27, 2015</last_update_submitted>
  <last_update_submitted_qc>August 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bologna</investigator_affiliation>
    <investigator_full_name>Claudio Borghi</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prehypertension</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>February 7, 2017</submitted>
    <returned>March 27, 2017</returned>
    <submitted>March 30, 2017</submitted>
    <returned>June 19, 2017</returned>
  </pending_results>
  <!-- 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/NCT02197910
org study id: BACCHUS_PASTATREND_2014
nct id: NCT02197910
lead sponsor: 
collaborator: 
has dmc: No
In this study we will assess the effects of bioactive peptide rich wheat products on blood
      pressure and estimated cardiovascular disease risk. This will be a pilot, explorative,
      cross-over, randomized double-blind 2 groups x 2-arms controlled, clinical trial. The
      intervention will be based on commercially-packaged pasta, which will appear and taste the
      same; (i) low dose bioactive peptides vs. (ii) high dose bioactive peptides. Inclusion
      Criteria will be: Male and female non-diabetic adult volunteers at increased estimated CV
      risk (ESC/EAS SCORE) with SBP 130-139 mmHg and/or DBP 85-90 mmHg); Age included between 40
      and 70 years old; Primary prevention for CVD but otherwise in good general health and have
      had no major illness in the previous 6-months; Volunteer providing their signed and dated
      informed consent form. Exclusion Criteria will be: Severe medical illness/chronic
      disease/gastrointestinal pathology (e.g. coeliac disease); Secondary prevention for CVD;
      Treatment with drugs potentially affecting BP (including antihypertensive drugs) or other
      related CV risk factors; Consumption of nutraceuticals, botanical extracts or other vitamin
      supplements; Volunteer diagnosed as being hypertensive A total of 60 participants will be
      recruited and following adherence to a standardized diet for a 4-week period, will be
      randomly assigned to complete one of 2 treatment sequences by consuming a prescribed quantity
      of pasta products for a 4-week period followed by a 4-week washout before random assignment
      to the 2nd treatment.

      The Primary Outcome will be the modification of office blood pressure (assessed by systolic
      and diastolic BP, pulse and mean pressure (mean of 3 standing & sitting measures) and 24-hour
      blood pressure.

      Additional outcomes include: Anthropometric parameters (Weight, WC, HC, WC/HC, ICO, BMI),
      Glucose and Lipid profile (TC, LDL-C, HDL-C, TG, non-HDL cholesterol, risk ratios), Estimated
      CVD risk changes (EAS/ESC SCORE Charts), Measures of vascular health (FMD, PWA, PWV, Aix),
      Liver and renal functionality biomarkers, 24-h urine collection at baseline of treatment
      phase 1 and endpoint of the final phase will be analysed to account for potential confounding
      of urinary sodium excretion (intake) As required by the GCPs and GLPs, all the SOPs have
      already been established and all the personnel to be involved in the study is continuously
      trained in trials with similar outcomes
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Office blood pressure modification
time frame: 4 weeks
description: Systolic, diastolic, pulse, mean arterial pressure, pulse pressure index, mean of 3 consecutive measurement as for the European guidelines on blood pressure measurement suggestion
measure: 24-hour blood pressure modification (ABPM)
time frame: 4 weeks
description: Twenty-four hour ambulatory blood pressure monitoring (ABPM) will be performed using a non-invasive automatic monitor (Space Labs, model 90207). For ABPM, patients will be instructed to act and work as normal between 6:00 AM and 10:00 PM and rest or sleep between 10:00 PM and 6:00 AM. Readings were obtained automatically at 15-min intervals throughout a 24-h study period. Separate averages will be obtained for the 24-h, daytime (6:00 AM-10:00 PM) and night-time (10:00 PM-6:00 AM) values. The accuracy of the automatic blood pressure readings will be checked against manual readings taken using a standard mercury sphygmomanometer, twice for each ABPM. Blood pressure were was measured with the patient sitting, before the beginning of the ABPM, and after a 5-min rest period. The accuracy test will be repeated after the end of each 24-h ABPM.
measure: Cholesterolemia modification
time frame: 4 weeks
description: 12-hour fasting Total, LDL, HDL and non HDL-Cholesterol, evaluated with standardized methods
measure: Flow-mediated vasodilation modification
time frame: 4 weeks
description: Evaluation of endothelial function by automatic measurement executed with the Vicorder Endopath instrument, already validated in previous publications
measure: Fasting glucose modification
time frame: 4 weeks
description: 12-hour fasting plasma glucose evaluated with standardized methods
measure: Pulse Wave Velocity modification
time frame: 4 weeks
description: Evaluation of arterial stiffness measured as Pulse Wave Velocity and related parameters by the Vicorder instrument, already validated in previous publications
measure: Triglyceridemia modification
time frame: 4 weeks
description: 12-hour fasting triglyceridemia evaluated by standardized lab methos
measure: Anthropometric measurement changes
time frame: 4 weeks
description: Height, weight, body mass index, waist circumference, hip circumference, waist/hip ratio, visceral adiposity index, index of central obesity measured from trained personnel following SOPs
measure: Liver parameters modification
time frame: 4 weeks
description: 12-hour liver transaminases, gamma-glutamyl-transferase, Lipid Accumulation Product, and Hepatic Steatosis Index evaluated with standardized methods
measure: Renal function parameter modification
time frame: 4 weeks
description: 12-hour fasting serum uric acid, creatinine, and estimated glomerular filtration rate (CKD-EPI formula) evaluated with standardized methods
arm group label: High content of wheat bioactive peptides
arm group type: Active Comparator
description: 100 gr pasta/day, containing around 15 mg bioactive peptides (High content of wheat bioactive peptides)
arm group label: Low dose of wheat bioactive peptides
arm group type: Placebo Comparator
description: 100 gr pasta/day, containing around 3 mg bioactive peptides
intervention type: Other
intervention name: Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence Low->High)
arm group label: Low dose of wheat bioactive peptides
intervention type: Other
intervention name: Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence High->Low)
arm group label: High content of wheat bioactive peptides
criteria: 
gender: All
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Claudio Borghi, MD
role: Study Director
affiliation: University of Bologna
last name: Claudio Borghi, MD
email: claudio.borghi@unibo.it
last name: Arrigo FG Cicero, MD, PhD
email: arrigo.cicero@unibo.it
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Bologna
investigator full name: Claudio Borghi
investigator title: Prof.
mesh term: Prehypertension
submitted: February 7, 2017
returned: March 27, 2017
submitted: March 30, 2017
returned: June 19, 2017