<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/NCT02209493</url>
  </required_header>
  <id_info>
    <org_study_id>Nopales-2014</org_study_id>
    <nct_id>NCT02209493</nct_id>
  </id_info>
  <brief_title>Effects of Nopales (Opuntia Spp.) on Lipoprotein Profile and Oxidative Stress in Moderately Hypercholesterolemic Adults</brief_title>
  <official_title>The Efficacy of Nopales (Opuntia Spp.) on Lipoprotein Profile and Oxidative Stress Among Moderately Hypercholesterolemic Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arizona State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arizona State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In light of the high CVD morbidity and mortality, promoting simple interventions to improve&#xD;
      serum lipids and decrease oxidative stress are warranted to help prevent chronic diseases.&#xD;
      Because of their fiber content, nopales (prickly pear cactus pads from the Opuntia species)&#xD;
      are commonly regarded among Mexicans as a medicinal plant for glycemic and cholesterol&#xD;
      control. However, the literature documenting their purported hypocholesterolemic potential is&#xD;
      scarce. Given the unique composition and potential benefits of nopales, their use may be an&#xD;
      ideal approach as an adjunct therapy for the reduction in cardiometabolic risk factors.&#xD;
      Therefore, the aim of this study is to evaluate the efficacy of a 2-week intervention with&#xD;
      nopales pads for the reduction of established CVD risk factors (serum lipids) in comparison&#xD;
      to a control food with lower antioxidant and fiber content (cucumber) among adults with&#xD;
      moderate hypercholesterolemia in a randomized controlled crossover trial. Because limited&#xD;
      data exists on the effects of nopales supplementation on other factors associated with&#xD;
      cardiometabolic risk, an exploratory assessment of how biomarkers of insulin sensitivity,&#xD;
      inflammation (high sensitivity C-reactive protein [hsCRP]) and oxidative stress (LDL&#xD;
      oxidizability and total antioxidant capacity) will also be conducted.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In light of the high cardiovascular disease morbidity and mortality, promoting simple&#xD;
      interventions to improve serum lipids and decrease oxidative stress are warranted to help&#xD;
      prevent chronic diseases. Commonly prescribed dietary interventions for cardiovascular&#xD;
      disease risk reduction include the use of functional foods known to have beneficial effects&#xD;
      on risk factors.&#xD;
&#xD;
      Because of their fiber content, nopales (prickly pear cactus pads from the Opuntia species)&#xD;
      are commonly regarded among Mexicans as a medicinal plant for glycemic and cholesterol&#xD;
      control. However, the literature documenting their purported hypocholesterolemic potential is&#xD;
      scarce. Most studies have focused on the prickly pear fruit, rather than the actual nopales&#xD;
      cactus pads. Given the unique composition and potential benefits of nopales, their use may be&#xD;
      an ideal approach as an adjunct therapy for the reduction in cardiometabolic risk factors.&#xD;
&#xD;
      The aim of this study is to evaluate the efficacy of a 2-week intervention with nopales pads&#xD;
      for the reduction of established CVD risk factors (serum lipids) in comparison to a control&#xD;
      food with lower antioxidant and fiber content (cucumber) among adults with moderate&#xD;
      hypercholesterolemia in a randomized controlled crossover trial. Because limited data exists&#xD;
      on the effects of nopales supplementation on other factors associated with cardiometabolic&#xD;
      risk, an exploratory assessment of how biomarkers of insulin sensitivity, inflammation (high&#xD;
      sensitivity C-reactive protein [hsCRP]) and oxidative stress (LDL oxidizability and total&#xD;
      antioxidant capacity) will also be conducted.&#xD;
&#xD;
      In this randomized crossover trial, healthy adults with moderate hypercholesterolemia&#xD;
      (LDL-cholesterol ≥ 120 mg/dL) but otherwise healthy will be randomly assigned to&#xD;
      supplementation with 2 cups/day of nopales (300 g; intervention) or cucumbers (208 g;&#xD;
      control), divided into two 1 cup daily doses with each of two main meals. After a 3-week&#xD;
      washout period, each group will receive the alternative treatment for an additional 2 weeks.&#xD;
      Participants will be asked to refrain from making any additional changes to their usual diet&#xD;
      throughout the duration of the entire study.&#xD;
&#xD;
      Fasting blood samples will be collected at the beginning and end of each dietary&#xD;
      intervention. At the beginning and end of each dietary intervention an additional fasting&#xD;
      blood sample will be collected at least one day apart from the main blood collection day for&#xD;
      measurement of serum lipids to account for day-to-day variability. Outcome measures include a&#xD;
      complete lipid panel (total cholesterol, HDL-c, LDL-c, and triglycerides), fasting glucose,&#xD;
      insulin, oxidized LDL and LDL susceptibility to oxidation, total antioxidant capacity (TAC),&#xD;
      and vitamin C.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">August 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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma lipids</measure>
    <time_frame>Pre- and post- each 2-week phase</time_frame>
    <description>Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glucose</measure>
    <time_frame>Pre- and post- each 2-week phase</time_frame>
    <description>Plasma glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of cholesterol in LDL and HDL subfractions</measure>
    <time_frame>After each 2-week phase</time_frame>
    <description>Distribution of cholesterol among seven LDL and ten HDL subfractions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidized LDL</measure>
    <time_frame>Pre- and post- each 2-week phase</time_frame>
    <description>Amount of oxidized LDL as measured by ELISA and LDL oxidizability as measured by conjugated diene formation.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Vitamin C</measure>
    <time_frame>Pre- and post- each 2-week phase</time_frame>
    <description>Vitamin C concentration in plasma to assess compliance</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Food supplementation: nopales</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consumption of 2 cups/day of cooked nopales (prickly pear cactus leaves) with each of two main meals for 2 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Food supplementation: cucumber</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Consumption of 2 cups/day peeled and chopped cucumber with each of two main meals for 2 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Food supplementation: nopales</intervention_name>
    <description>Consumption of 2 cups/day of test food: nopales</description>
    <arm_group_label>Food supplementation: nopales</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Food supplementation: cucumber</intervention_name>
    <description>Consumption of 2 cups/day of test food: cucumber</description>
    <arm_group_label>Food supplementation: cucumber</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Moderate hypercholesterolemia (LDL cholesterol ≥ 120 mg/dL)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of hypolipidemic medications&#xD;
&#xD;
          -  Regular physical activity (≥ 30 min /day for ≥ 5 days/week)&#xD;
&#xD;
          -  Presence of known chronic diseases (e.g., diabetes, CVD, cancer, hepatitis,&#xD;
             inflammatory conditions, gastrointestinal disorders)&#xD;
&#xD;
          -  Consumption of &gt; 4 servings/day of fruits and vegetables&#xD;
&#xD;
          -  Following a restrictive diet (e.g., carbohydrate restriction, veganism) or having any&#xD;
             condition likely to require specialized dietary modifications&#xD;
&#xD;
          -  Use of supplements (antioxidants, fiber and botanicals)&#xD;
&#xD;
          -  Latex allergy&#xD;
&#xD;
          -  Fear of needles&#xD;
&#xD;
          -  Breastfeeding, pregnancy, or intent to become pregnant&#xD;
&#xD;
          -  Unwillingness to comply with study protocol&#xD;
&#xD;
          -  Participation in other research studies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sonia Vega-López, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Arizona State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nutrition Laboratory at Arizona State University</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>August 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Arizona State University</investigator_affiliation>
    <investigator_full_name>Sonia Vega-Lopez</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Dietary intervention</keyword>
  <keyword>Hypercholesterolemic adults</keyword>
  <keyword>Vegetable intake</keyword>
  <keyword>Functional food</keyword>
  <keyword>Prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT02209493
org study id: Nopales-2014
nct id: NCT02209493
lead sponsor: 
has dmc: No
In light of the high CVD morbidity and mortality, promoting simple interventions to improve
      serum lipids and decrease oxidative stress are warranted to help prevent chronic diseases.
      Because of their fiber content, nopales (prickly pear cactus pads from the Opuntia species)
      are commonly regarded among Mexicans as a medicinal plant for glycemic and cholesterol
      control. However, the literature documenting their purported hypocholesterolemic potential is
      scarce. Given the unique composition and potential benefits of nopales, their use may be an
      ideal approach as an adjunct therapy for the reduction in cardiometabolic risk factors.
      Therefore, the aim of this study is to evaluate the efficacy of a 2-week intervention with
      nopales pads for the reduction of established CVD risk factors (serum lipids) in comparison
      to a control food with lower antioxidant and fiber content (cucumber) among adults with
      moderate hypercholesterolemia in a randomized controlled crossover trial. Because limited
      data exists on the effects of nopales supplementation on other factors associated with
      cardiometabolic risk, an exploratory assessment of how biomarkers of insulin sensitivity,
      inflammation (high sensitivity C-reactive protein [hsCRP]) and oxidative stress (LDL
      oxidizability and total antioxidant capacity) will also be conducted.
In light of the high cardiovascular disease morbidity and mortality, promoting simple
      interventions to improve serum lipids and decrease oxidative stress are warranted to help
      prevent chronic diseases. Commonly prescribed dietary interventions for cardiovascular
      disease risk reduction include the use of functional foods known to have beneficial effects
      on risk factors.

      Because of their fiber content, nopales (prickly pear cactus pads from the Opuntia species)
      are commonly regarded among Mexicans as a medicinal plant for glycemic and cholesterol
      control. However, the literature documenting their purported hypocholesterolemic potential is
      scarce. Most studies have focused on the prickly pear fruit, rather than the actual nopales
      cactus pads. Given the unique composition and potential benefits of nopales, their use may be
      an ideal approach as an adjunct therapy for the reduction in cardiometabolic risk factors.

      The aim of this study is to evaluate the efficacy of a 2-week intervention with nopales pads
      for the reduction of established CVD risk factors (serum lipids) in comparison to a control
      food with lower antioxidant and fiber content (cucumber) among adults with moderate
      hypercholesterolemia in a randomized controlled crossover trial. Because limited data exists
      on the effects of nopales supplementation on other factors associated with cardiometabolic
      risk, an exploratory assessment of how biomarkers of insulin sensitivity, inflammation (high
      sensitivity C-reactive protein [hsCRP]) and oxidative stress (LDL oxidizability and total
      antioxidant capacity) will also be conducted.

      In this randomized crossover trial, healthy adults with moderate hypercholesterolemia
      (LDL-cholesterol ≥ 120 mg/dL) but otherwise healthy will be randomly assigned to
      supplementation with 2 cups/day of nopales (300 g; intervention) or cucumbers (208 g;
      control), divided into two 1 cup daily doses with each of two main meals. After a 3-week
      washout period, each group will receive the alternative treatment for an additional 2 weeks.
      Participants will be asked to refrain from making any additional changes to their usual diet
      throughout the duration of the entire study.

      Fasting blood samples will be collected at the beginning and end of each dietary
      intervention. At the beginning and end of each dietary intervention an additional fasting
      blood sample will be collected at least one day apart from the main blood collection day for
      measurement of serum lipids to account for day-to-day variability. Outcome measures include a
      complete lipid panel (total cholesterol, HDL-c, LDL-c, and triglycerides), fasting glucose,
      insulin, oxidized LDL and LDL susceptibility to oxidation, total antioxidant capacity (TAC),
      and vitamin C.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Plasma lipids
time frame: Pre- and post- each 2-week phase
description: Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides.
measure: Glucose
time frame: Pre- and post- each 2-week phase
description: Plasma glucose
measure: Distribution of cholesterol in LDL and HDL subfractions
time frame: After each 2-week phase
description: Distribution of cholesterol among seven LDL and ten HDL subfractions.
measure: Oxidized LDL
time frame: Pre- and post- each 2-week phase
description: Amount of oxidized LDL as measured by ELISA and LDL oxidizability as measured by conjugated diene formation.
measure: Vitamin C
time frame: Pre- and post- each 2-week phase
description: Vitamin C concentration in plasma to assess compliance
arm group label: Food supplementation: nopales
arm group type: Experimental
description: Consumption of 2 cups/day of cooked nopales (prickly pear cactus leaves) with each of two main meals for 2 weeks
arm group label: Food supplementation: cucumber
arm group type: Sham Comparator
description: Consumption of 2 cups/day peeled and chopped cucumber with each of two main meals for 2 weeks
intervention type: Behavioral
intervention name: Food supplementation: nopales
description: Consumption of 2 cups/day of test food: nopales
arm group label: Food supplementation: nopales
intervention type: Behavioral
intervention name: Food supplementation: cucumber
description: Consumption of 2 cups/day of test food: cucumber
arm group label: Food supplementation: cucumber
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sonia Vega-López, PhD
role: Principal Investigator
affiliation: Arizona State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Arizona State University
investigator full name: Sonia Vega-Lopez
investigator title: Assistant Professor
mesh term: Cardiovascular Diseases