<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/NCT01682291</url>
  </required_header>
  <id_info>
    <org_study_id>450-B/2012/D</org_study_id>
    <nct_id>NCT01682291</nct_id>
  </id_info>
  <brief_title>Prehypertension and Dietary Supplements - The PYRAMIDS Study</brief_title>
  <acronym>PYRAMIDS</acronym>
  <official_title>Pre-hYpertension tReament With A coMbinatIon of Dietary Supplements and Life-style Modifications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Roma La Sapienza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Roma La Sapienza</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to compare the efficacy and tolerability of a&#xD;
      life-style modifications protocol versus a protocol including life-style modifications along&#xD;
      with a novel combination of dietary supplement in the management of subjects diagnosed as&#xD;
      having pre-hypertension.&#xD;
&#xD;
      The novel formulation includes: Allium sativum (Dosage: 1,000 mg/day), Crataegus monogyna&#xD;
      (Dosage: 500 mg/day), Orthosiphon (Dosage: 300 mg/day), Hibiscus sabdariffa (Dosage: 250&#xD;
      mg/day)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prehypertension. Prehypertension is an American classification for those subjects with a&#xD;
      normal-elevated blood pressure (BP) that does not reach the level considered to be&#xD;
      hypertension.&#xD;
&#xD;
      Because of the new data on lifetime risk of hypertension and the impressive increase in the&#xD;
      risk of cardiovascular complications associated with levels of BP previously considered to be&#xD;
      normal, the JNC 7 report has introduced a new classification that includes the term&#xD;
      &quot;prehypertension&quot; for those with BPs ranging from 120-139 mmHg systolic and/or 80-89 mmHg&#xD;
      diastolic.&#xD;
&#xD;
      This new designation is intended to identify those individuals in whom early intervention by&#xD;
      adoption of healthy lifestyles could reduce BP, decrease the rate of progression of BP to&#xD;
      hypertensive levels with age, or prevent hypertension entirely.&#xD;
&#xD;
      Data from the 1999 and 2000 National Health and Nutrition Examination Survey (NHANES III)&#xD;
      estimated that the prevalence of prehypertension among adults in the United States was&#xD;
      approximately 31%. The prevalence is higher among men than women (39 and 23 percent,&#xD;
      respectively).] People with prehypertension are at a higher risk for developing hypertension&#xD;
      and target organ damages (i.e. left ventricular hypertrophy), as compared to people with&#xD;
      normal blood pressure. Furthermore, similar to hypertension, prehypertension can increase the&#xD;
      risk for heart attacks, strokes, congestive heart failure, and renal failure. Researchers&#xD;
      have found that a prehypertensive person is 3 times more likely to have a heart attack and&#xD;
      1.7 times more likely to have heart disease than a person with normal blood pressure.&#xD;
&#xD;
      Management of Prehypertension.&#xD;
&#xD;
        -  Prehypertension is not a disease category. Rather, it identifies individuals at high&#xD;
           risk of developing hypertension, so that both patients and clinicians are alerted to&#xD;
           this risk and encouraged to intervene and prevent or delay the disease from developing.&#xD;
&#xD;
        -  Individuals who are prehypertensive are not candidates for drug therapy based on their&#xD;
           level of BP and should be firmly and unambiguously advised to practice lifestyle&#xD;
           modification in order to reduce their risk of developing hypertension.&#xD;
&#xD;
        -  Moreover, individuals with prehypertension, who also have diabetes or kidney disease,&#xD;
           should be considered candidates for appropriate drug therapy if a trial of lifestyle&#xD;
           modification fails to reduce their BP to 130/80 mmHg or less.&#xD;
&#xD;
      Lifestyle Modifications. The goal for individuals with prehypertension and no compelling&#xD;
      indications is to lower BP to normal levels with lifestyle changes, and prevent the&#xD;
      progressive rise in BP using the recommended lifestyle modifications.&#xD;
&#xD;
      Also, adoption of healthy lifestyles is an indispensable part of the management of those with&#xD;
      hypertension.&#xD;
&#xD;
      Lifestyle modifications include:&#xD;
&#xD;
        -  Weight loss of as little as 10 lbs (4.5 kg) reduces BP and/or prevents hypertension&#xD;
&#xD;
        -  Adoption of the Dietary Approaches to Stop Hypertension (DASH) eating plan94 which is a&#xD;
           diet rich in fruits, vegetables, and low fat dairy products&#xD;
&#xD;
        -  Dietary sodium should be reduced to no more than 100 mmol per day (2.4 g of sodium).&#xD;
&#xD;
        -  Regular aerobic physical activity such as brisk walking at least 30 minutes per day&#xD;
&#xD;
        -  Alcohol intake should be limited&#xD;
&#xD;
      Dietary Approaches to Stop Hypertension. The first-line approach to hypertension refractory&#xD;
      to lifestyle modification remains pharmacologic therapy in combination with the low-salt DASH&#xD;
      diet. However, a wide variety of alternative therapies are available for using to improve BP&#xD;
      control. Dietary supplements and modification, as well as herbal supplements, may be useful&#xD;
      under the right circumstances. Unfortunately, the efficacy of adding dietary, herbal, or&#xD;
      alternative therapies is not well established. While combinations of antihypertensive drugs&#xD;
      from different classes is a recommended approach that results in an additive benefit, it is&#xD;
      not clear whether combinations of herbal or dietary supplements will also be additive.&#xD;
&#xD;
      Many of the studies evaluating the supplements referenced here are small and data are often&#xD;
      derived from pooled analysis. In particular, studies to date evaluating garlic as well as&#xD;
      many of the alternative approaches have significant limitations in study design. Should they&#xD;
      prove efficacious and safe their use as a first-line therapy may come into play Thus, it&#xD;
      remains unknown, however, whether the use of dietary supplements in association with life&#xD;
      style interventions has any additive effect in subjects with Pre-hypertension.&#xD;
&#xD;
      Purpose The primary objective of this study is to compare the efficacy and tolerability of a&#xD;
      life-style modifications protocol versus a protocol including life-style modifications along&#xD;
      with a novel combination of dietary supplement in the management of subjects diagnosed as&#xD;
      having pre-hypertension.&#xD;
&#xD;
      The novel formulation includes: Allium sativum (Dosage: 1,000 mg/day), Crataegus monogyna&#xD;
      (Dosage: 500 mg/day), Orthosiphon (Dosage: 300 mg/day), Hibiscus sabdariffa (Dosage: 250&#xD;
      mg/day)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>Phase 4</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in blood pressure levels as compared with baseline at 1 year</measure>
    <time_frame>1 year</time_frame>
    <description>Changes in systolic and diastolic blood pressure levels as compared with baseline at 1 year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reasons for treatment discontinuation</measure>
    <time_frame>1 year</time_frame>
    <description>Reasons for treatment discontinuation during the 1-year study period</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Prehypertension</condition>
  <arm_group>
    <arm_group_label>Life-style modifications</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lifestyle modifications will include:&#xD;
Weight loss of as little as 10 lbs (4.5 kg) Adoption of the Dietary Approaches to Stop Hypertension (DASH) eating plan Dietary sodium should be reduced to no more than 2.4 g of sodium per day Regular aerobic physical activity (at least 30 minutes per day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dietary supplements</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Life-style modifications along with a novel combination of dietary supplements that includes: Allium sativum (Dosage: 1,000 mg/day), Crataegus monogyna (Dosage: 500 mg/day), Orthosiphon (Dosage: 300 mg/day), Hibiscus sabdariffa (Dosage: 250 mg/day)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Life-style modifications</intervention_name>
    <description>Weight loss of as little as 10 lbs (4.5 kg) Adoption of the Dietary Approaches to Stop Hypertension (DASH) eating plan Dietary sodium should be reduced to no more than 2.4 g of sodium per day Regular aerobic physical activity (at least 30 minutes per day)</description>
    <arm_group_label>Life-style modifications</arm_group_label>
    <other_name>Adoption of healthy lifestyles</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dietary supplements</intervention_name>
    <description>combined pill (1 capsule/day containing Allium sativum (Dosage: 1,000 mg/day), Crataegus monogyna (Dosage: 500 mg/day), Orthosiphon (Dosage: 300 mg/day), Hibiscus sabdariffa (Dosage: 250 mg/day)</description>
    <arm_group_label>Dietary supplements</arm_group_label>
    <other_name>Life-style modifications and dietary supplements</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Otherwise healthy subjects with &quot;prehypertension&quot;, that is blood pressures ranging&#xD;
             from 120-139 mmHg systolic and/or 80-89 mmHg diastolic-&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women of child bearing potential patients must demonstrate a negative pregnancy test&#xD;
             performed within 24 hours before CT&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francesco Pelliccia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sapienza University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Francesco Pelliccia, MD</last_name>
    <phone>+39064997</phone>
    <phone_ext>123</phone_ext>
    <email>f.pelliccia@mclink.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sapienza University</name>
      <address>
        <city>Rome</city>
        <zip>00166</zip>
        <country>Italy</country>
      </address>
    </facility>
    <contact>
      <last_name>Francesco Pelliccia, MD</last_name>
      <phone>+39064997</phone>
      <phone_ext>123</phone_ext>
      <email>f.pelliccia@mclink.it</email>
    </contact>
    <investigator>
      <last_name>Francesco Pelliccia, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>March 6, 2013</last_update_submitted>
  <last_update_submitted_qc>March 6, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 7, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
    <investigator_full_name>Francesco Pelliccia</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Prehypertension</keyword>
  <keyword>Life-style modifications</keyword>
  <keyword>Dietary supplementation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prehypertension</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/NCT01682291
org study id: 450-B/2012/D
nct id: NCT01682291
lead sponsor: 
has dmc: Yes
The primary objective of this study is to compare the efficacy and tolerability of a
      life-style modifications protocol versus a protocol including life-style modifications along
      with a novel combination of dietary supplement in the management of subjects diagnosed as
      having pre-hypertension.

      The novel formulation includes: Allium sativum (Dosage: 1,000 mg/day), Crataegus monogyna
      (Dosage: 500 mg/day), Orthosiphon (Dosage: 300 mg/day), Hibiscus sabdariffa (Dosage: 250
      mg/day)
Prehypertension. Prehypertension is an American classification for those subjects with a
      normal-elevated blood pressure (BP) that does not reach the level considered to be
      hypertension.

      Because of the new data on lifetime risk of hypertension and the impressive increase in the
      risk of cardiovascular complications associated with levels of BP previously considered to be
      normal, the JNC 7 report has introduced a new classification that includes the term
      "prehypertension" for those with BPs ranging from 120-139 mmHg systolic and/or 80-89 mmHg
      diastolic.

      This new designation is intended to identify those individuals in whom early intervention by
      adoption of healthy lifestyles could reduce BP, decrease the rate of progression of BP to
      hypertensive levels with age, or prevent hypertension entirely.

      Data from the 1999 and 2000 National Health and Nutrition Examination Survey (NHANES III)
      estimated that the prevalence of prehypertension among adults in the United States was
      approximately 31%. The prevalence is higher among men than women (39 and 23 percent,
      respectively).] People with prehypertension are at a higher risk for developing hypertension
      and target organ damages (i.e. left ventricular hypertrophy), as compared to people with
      normal blood pressure. Furthermore, similar to hypertension, prehypertension can increase the
      risk for heart attacks, strokes, congestive heart failure, and renal failure. Researchers
      have found that a prehypertensive person is 3 times more likely to have a heart attack and
      1.7 times more likely to have heart disease than a person with normal blood pressure.

      Management of Prehypertension.

        -  Prehypertension is not a disease category. Rather, it identifies individuals at high
           risk of developing hypertension, so that both patients and clinicians are alerted to
           this risk and encouraged to intervene and prevent or delay the disease from developing.

        -  Individuals who are prehypertensive are not candidates for drug therapy based on their
           level of BP and should be firmly and unambiguously advised to practice lifestyle
           modification in order to reduce their risk of developing hypertension.

        -  Moreover, individuals with prehypertension, who also have diabetes or kidney disease,
           should be considered candidates for appropriate drug therapy if a trial of lifestyle
           modification fails to reduce their BP to 130/80 mmHg or less.

      Lifestyle Modifications. The goal for individuals with prehypertension and no compelling
      indications is to lower BP to normal levels with lifestyle changes, and prevent the
      progressive rise in BP using the recommended lifestyle modifications.

      Also, adoption of healthy lifestyles is an indispensable part of the management of those with
      hypertension.

      Lifestyle modifications include:

        -  Weight loss of as little as 10 lbs (4.5 kg) reduces BP and/or prevents hypertension

        -  Adoption of the Dietary Approaches to Stop Hypertension (DASH) eating plan94 which is a
           diet rich in fruits, vegetables, and low fat dairy products

        -  Dietary sodium should be reduced to no more than 100 mmol per day (2.4 g of sodium).

        -  Regular aerobic physical activity such as brisk walking at least 30 minutes per day

        -  Alcohol intake should be limited

      Dietary Approaches to Stop Hypertension. The first-line approach to hypertension refractory
      to lifestyle modification remains pharmacologic therapy in combination with the low-salt DASH
      diet. However, a wide variety of alternative therapies are available for using to improve BP
      control. Dietary supplements and modification, as well as herbal supplements, may be useful
      under the right circumstances. Unfortunately, the efficacy of adding dietary, herbal, or
      alternative therapies is not well established. While combinations of antihypertensive drugs
      from different classes is a recommended approach that results in an additive benefit, it is
      not clear whether combinations of herbal or dietary supplements will also be additive.

      Many of the studies evaluating the supplements referenced here are small and data are often
      derived from pooled analysis. In particular, studies to date evaluating garlic as well as
      many of the alternative approaches have significant limitations in study design. Should they
      prove efficacious and safe their use as a first-line therapy may come into play Thus, it
      remains unknown, however, whether the use of dietary supplements in association with life
      style interventions has any additive effect in subjects with Pre-hypertension.

      Purpose The primary objective of this study is to compare the efficacy and tolerability of a
      life-style modifications protocol versus a protocol including life-style modifications along
      with a novel combination of dietary supplement in the management of subjects diagnosed as
      having pre-hypertension.

      The novel formulation includes: Allium sativum (Dosage: 1,000 mg/day), Crataegus monogyna
      (Dosage: 500 mg/day), Orthosiphon (Dosage: 300 mg/day), Hibiscus sabdariffa (Dosage: 250
      mg/day)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Changes in blood pressure levels as compared with baseline at 1 year
time frame: 1 year
description: Changes in systolic and diastolic blood pressure levels as compared with baseline at 1 year
measure: Reasons for treatment discontinuation
time frame: 1 year
description: Reasons for treatment discontinuation during the 1-year study period
arm group label: Life-style modifications
arm group type: Active Comparator
description: Lifestyle modifications will include:
Weight loss of as little as 10 lbs (4.5 kg) Adoption of the Dietary Approaches to Stop Hypertension (DASH) eating plan Dietary sodium should be reduced to no more than 2.4 g of sodium per day Regular aerobic physical activity (at least 30 minutes per day)
arm group label: Dietary supplements
arm group type: Active Comparator
description: Life-style modifications along with a novel combination of dietary supplements that includes: Allium sativum (Dosage: 1,000 mg/day), Crataegus monogyna (Dosage: 500 mg/day), Orthosiphon (Dosage: 300 mg/day), Hibiscus sabdariffa (Dosage: 250 mg/day)
intervention type: Behavioral
intervention name: Life-style modifications
description: Weight loss of as little as 10 lbs (4.5 kg) Adoption of the Dietary Approaches to Stop Hypertension (DASH) eating plan Dietary sodium should be reduced to no more than 2.4 g of sodium per day Regular aerobic physical activity (at least 30 minutes per day)
arm group label: Life-style modifications
other name: Adoption of healthy lifestyles
intervention type: Dietary Supplement
intervention name: Dietary supplements
description: combined pill (1 capsule/day containing Allium sativum (Dosage: 1,000 mg/day), Crataegus monogyna (Dosage: 500 mg/day), Orthosiphon (Dosage: 300 mg/day), Hibiscus sabdariffa (Dosage: 250 mg/day)
arm group label: Dietary supplements
other name: Life-style modifications and dietary supplements
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Francesco Pelliccia, MD
role: Principal Investigator
affiliation: Sapienza University
last name: Francesco Pelliccia, MD
phone: +39064997
phone ext: 123
email: f.pelliccia@mclink.it
facility: 
contact: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Roma La Sapienza
investigator full name: Francesco Pelliccia
investigator title: Assistant Professor
mesh term: Prehypertension