<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/NCT02227628</url>
  </required_header>
  <id_info>
    <org_study_id>TexasAMU-IRB2010-0797F</org_study_id>
    <secondary_id>IRB2010-0797F</secondary_id>
    <nct_id>NCT02227628</nct_id>
  </id_info>
  <brief_title>Absorption and Antioxidant Effects of Polyphenolics From Acai</brief_title>
  <official_title>Absorption and Antioxidant Effects of Polyphenolics From Acai</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas A&amp;M University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas A&amp;M University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A human clinical consumption trial will be performed in volunteers with increased risk&#xD;
      factors for cardiovascular disease (Metabolic Syndrome), which includes obesity and diabetes&#xD;
      and related conditions over a period of 12 weeks with blood draws at baseline (0 weeks), 4,&#xD;
      8, and 12 weeks and a 24 hr urine collection on each blood draw day.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Experimental Design: Approximately 50 male and female participants between the ages of&#xD;
           18 and 65 years, who were at high risk for cardiovascular disease but have not had a&#xD;
           hospitalization due to cardiovascular disease, were recruited to participate for 12&#xD;
           weeks in this study. All familiarization and testing were conducted at the Exercise &amp;&#xD;
           Sport Nutrition Laboratory (ESNL) in the Department of Health and Kinesiology at Texas&#xD;
           A&amp;M University. Assays were conducted at the Institute of Obesity and Cancer research&#xD;
           Laboratory at Texas A&amp;M University.&#xD;
&#xD;
        2. Screening and familiarization Session:&#xD;
&#xD;
           Participants expressing interest in the study were interviewed by phone to determine&#xD;
           whether they were qualified to participate. The participants who were believed to meet&#xD;
           the eligibility criteria were invited to attend an entry/familiarization session. During&#xD;
           this session, participants completed medical and personal histories, and signed consent&#xD;
           statements in compliance with the Human Participants Guidelines of Texas A&amp;M University&#xD;
           and the American College of Sports Medicine. Participants then underwent a general&#xD;
           physical examination to verify that they met the eligibility criteria. Participants who&#xD;
           satisfied the criteria were familiarized to the study protocol and received a verbal and&#xD;
           written explanation of the study protocol and design. Following baseline measurements,&#xD;
           participants were matched based on gender, age, and BMI and were randomly assigned in a&#xD;
           double-blind manner into control (n=25) or acai supplementation groups (n=25).&#xD;
           Participants were given an appointment time to perform baseline assessments and three&#xD;
           other sessions.&#xD;
&#xD;
        3. Baseline assessments and dietary intervention:&#xD;
&#xD;
           Prior to baseline testing, participants were recommended not to take any herbal&#xD;
           supplements or anti-oxidant juices such as orange, pomegranate, or acai juice. Vitamin&#xD;
           pills, supplemented sports/energy drinks and large amounts of berries were also to be&#xD;
           avoided. In addition, spinach, tomatoes, bell peppers, onions, garlic, carrots,&#xD;
           chocolate, yellow/orange fruits/vegetables and dark green fruits/vegetables were to be&#xD;
           reduced to no more than one serving for 48 hours. Participants were instructed to&#xD;
           refrain from exercise for 48 hours prior to baseline testing. During the baseline&#xD;
           testing, participants recorded all food intake on dietary record forms for four days.&#xD;
           Participants donated 20ml of fasting blood using venipuncture techniques of an&#xD;
           antecubital vein in the forearm. Participants were then asked to drink one 10 oz serving&#xD;
           of the test beverage. A second blood draw was taken two hours after ingestion. All urine&#xD;
           output for the 24 hours leading up to the baseline testing was collected.&#xD;
&#xD;
        4. Supplementation:&#xD;
&#xD;
           Participants were recommended to consume two servings of the test beverage as part of&#xD;
           their current, non-modified diet. Each serving was supplied in a 10 oz bottle, and was&#xD;
           to be consumed both in the morning and in the evening of each day throughout the&#xD;
           duration of the study (12 weeks). Participants in the control group consumed an equal&#xD;
           amount of placebo juice comprised of artificially colored water containing sugar, citric&#xD;
           acid, and a flavor that was identical to the acai beverage, but had no&#xD;
           phytochemical-based constituents throughout the same time period. Participants were&#xD;
           individually instructed on how to adjust their daily caloric intake to account for the&#xD;
           calories of the beverage. All participants picked up weekly supplies of either the acai&#xD;
           beverage or placebo at the Exercise &amp; Sport Nutrition Laboratory.&#xD;
&#xD;
        5. Follow-up testing:&#xD;
&#xD;
           Participants reported back to the lab for follow-up testing at 4, 8, and 12 weeks after&#xD;
           the baseline testing. During each of those testing sessions, the participants completed&#xD;
           the same full battery of tests that were completed during the initial baseline testing.&#xD;
           Participants were asked to maintain a similar diet three days prior to each testing&#xD;
           session in order to monitor the influence of the test beverage. Participants were given&#xD;
           a list of preferred food groups for these three days and asked to stick to them as&#xD;
           closely as possible.&#xD;
&#xD;
        6. Body composition:&#xD;
&#xD;
           During each baseline measurement and follow-up testing session, height was measured&#xD;
           using standard anthropometry. Total body weight was measured using a Healthometer&#xD;
           (Bridgeview, IL) self-calibrating digital scale with a precision of +/-0.02 kg. Body&#xD;
           composition (excluding the cranium) was determined using a Dual-energy X-ray&#xD;
           absorptiometry (DEXA, Hologic Inc, Waltham, MA, USA).&#xD;
&#xD;
        7. Blood and urine collection: During each of the testing sessions, participants donated&#xD;
           approximately 2 teaspoons of fasting venous blood (10 milliliters). Blood samples were&#xD;
           obtained using standard phlebotomy procedures using standard sterile venipuncture of an&#xD;
           antecubital vein by ESNL laboratory technicians or graduate research assistance trained&#xD;
           in phlebotomy in compliance with guidelines established by the Texas Department of&#xD;
           Health and Human Services.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline in the levels of Inflammatory biomarkers in plasma or urine</measure>
    <time_frame>baseline, 24 hours</time_frame>
    <description>During each of the testing sessions, participants donated approximately 2 teaspoons of fasting venous blood (10 milliliters). All urine output for the 24 hours leading up to the baseline testing was collected. Inflammatory biomarkers in the plasma (hs-C-reactive protein(mg/L), interleukin-6(pg/ml), interleukin-1beta(pg/ml), Interferon-gamma(pg/ml), and Tumor necrosis factor-alpha(pg/ml)) and in the urine (8-isoprostane(ng/mmol creatinine) were measured by enzyme immunoassay using Cayman chemical kits (Ann Arbor, MI).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Cardiovascular Disease</condition>
  <condition>Metabolic Syndrome</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Sugary Beverage</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sugary Beverage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acai beverage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acai Polyphenolics</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Acai polyphenolics</intervention_name>
    <description>Acai beverage was obtained from the Sambazon (San Clemente, CA).</description>
    <arm_group_label>Acai beverage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sugary Beverage</intervention_name>
    <description>An equal amount of placebo juice comprised of artificially colored water containing sugar (5%), citric acid (0.01% to adjust the pH 3.8), and artificial colors (FD&amp;C Red 40 and Blue 1, Tetra Pak, Denten, TX) that was identical to the acai beverage.</description>
    <arm_group_label>Sugary Beverage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elevated waist circumference: ≥102cm in men and ≥ 88 cm in women&#xD;
&#xD;
          -  Elevated triglycerides:≥ 150 mg/dL&#xD;
&#xD;
          -  Reduced HDL-C:&lt;40 mg/dL in men and &lt;50 mg/dL in women&#xD;
&#xD;
          -  Elevated blood pressure:≥ 130 mmHg systolic blood pressure or ≥ 85 mmHg diastolic&#xD;
             blood pressure&#xD;
&#xD;
          -  Elevated fasting glucose:≥ 100 mg/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any relevant acute cardiac event (myocardial infarction, episode of heart&#xD;
             failure)&#xD;
&#xD;
          -  Recent (within 3 months) or recurrent hospitalizations&#xD;
&#xD;
          -  Drug treatment for type II diabetes&#xD;
&#xD;
          -  aspartate aminotransferase or alanine aminotransferase ≥ 2 times the upper limit of&#xD;
             normal&#xD;
&#xD;
          -  Abuse of alcohol or substance, smoking, history of seizures, or other relevant ongoing&#xD;
             or recurrent illness, liver or renal dysfunction, pregnancy (positive urine pregnancy&#xD;
             test) or lactation, known allergy against any of the juices, known infection with&#xD;
             hepatitis B, C, or HIV, intake of vasoactive drugs&#xD;
&#xD;
          -  Individuals participating in regular aerobic exercise training program (&gt;30 minutes, ≥&#xD;
             3 times/wk)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susanne Talcott, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas A&amp;M University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Exercise &amp; Sport Nutrition Laboratory (ESNL) in the Department of Health and Kinesiology at Texas A&amp;M University</name>
      <address>
        <city>College station</city>
        <state>Texas</state>
        <zip>77845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>June 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>October 14, 2016</last_update_submitted>
  <last_update_submitted_qc>October 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Metabolic 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/NCT02227628
org study id: TexasAMU-IRB2010-0797F
secondary id: IRB2010-0797F
nct id: NCT02227628
lead sponsor: 
has dmc: Yes
A human clinical consumption trial will be performed in volunteers with increased risk
      factors for cardiovascular disease (Metabolic Syndrome), which includes obesity and diabetes
      and related conditions over a period of 12 weeks with blood draws at baseline (0 weeks), 4,
      8, and 12 weeks and a 24 hr urine collection on each blood draw day.
1. Experimental Design: Approximately 50 male and female participants between the ages of
           18 and 65 years, who were at high risk for cardiovascular disease but have not had a
           hospitalization due to cardiovascular disease, were recruited to participate for 12
           weeks in this study. All familiarization and testing were conducted at the Exercise &
           Sport Nutrition Laboratory (ESNL) in the Department of Health and Kinesiology at Texas
           A&M University. Assays were conducted at the Institute of Obesity and Cancer research
           Laboratory at Texas A&M University.

        2. Screening and familiarization Session:

           Participants expressing interest in the study were interviewed by phone to determine
           whether they were qualified to participate. The participants who were believed to meet
           the eligibility criteria were invited to attend an entry/familiarization session. During
           this session, participants completed medical and personal histories, and signed consent
           statements in compliance with the Human Participants Guidelines of Texas A&M University
           and the American College of Sports Medicine. Participants then underwent a general
           physical examination to verify that they met the eligibility criteria. Participants who
           satisfied the criteria were familiarized to the study protocol and received a verbal and
           written explanation of the study protocol and design. Following baseline measurements,
           participants were matched based on gender, age, and BMI and were randomly assigned in a
           double-blind manner into control (n=25) or acai supplementation groups (n=25).
           Participants were given an appointment time to perform baseline assessments and three
           other sessions.

        3. Baseline assessments and dietary intervention:

           Prior to baseline testing, participants were recommended not to take any herbal
           supplements or anti-oxidant juices such as orange, pomegranate, or acai juice. Vitamin
           pills, supplemented sports/energy drinks and large amounts of berries were also to be
           avoided. In addition, spinach, tomatoes, bell peppers, onions, garlic, carrots,
           chocolate, yellow/orange fruits/vegetables and dark green fruits/vegetables were to be
           reduced to no more than one serving for 48 hours. Participants were instructed to
           refrain from exercise for 48 hours prior to baseline testing. During the baseline
           testing, participants recorded all food intake on dietary record forms for four days.
           Participants donated 20ml of fasting blood using venipuncture techniques of an
           antecubital vein in the forearm. Participants were then asked to drink one 10 oz serving
           of the test beverage. A second blood draw was taken two hours after ingestion. All urine
           output for the 24 hours leading up to the baseline testing was collected.

        4. Supplementation:

           Participants were recommended to consume two servings of the test beverage as part of
           their current, non-modified diet. Each serving was supplied in a 10 oz bottle, and was
           to be consumed both in the morning and in the evening of each day throughout the
           duration of the study (12 weeks). Participants in the control group consumed an equal
           amount of placebo juice comprised of artificially colored water containing sugar, citric
           acid, and a flavor that was identical to the acai beverage, but had no
           phytochemical-based constituents throughout the same time period. Participants were
           individually instructed on how to adjust their daily caloric intake to account for the
           calories of the beverage. All participants picked up weekly supplies of either the acai
           beverage or placebo at the Exercise & Sport Nutrition Laboratory.

        5. Follow-up testing:

           Participants reported back to the lab for follow-up testing at 4, 8, and 12 weeks after
           the baseline testing. During each of those testing sessions, the participants completed
           the same full battery of tests that were completed during the initial baseline testing.
           Participants were asked to maintain a similar diet three days prior to each testing
           session in order to monitor the influence of the test beverage. Participants were given
           a list of preferred food groups for these three days and asked to stick to them as
           closely as possible.

        6. Body composition:

           During each baseline measurement and follow-up testing session, height was measured
           using standard anthropometry. Total body weight was measured using a Healthometer
           (Bridgeview, IL) self-calibrating digital scale with a precision of +/-0.02 kg. Body
           composition (excluding the cranium) was determined using a Dual-energy X-ray
           absorptiometry (DEXA, Hologic Inc, Waltham, MA, USA).

        7. Blood and urine collection: During each of the testing sessions, participants donated
           approximately 2 teaspoons of fasting venous blood (10 milliliters). Blood samples were
           obtained using standard phlebotomy procedures using standard sterile venipuncture of an
           antecubital vein by ESNL laboratory technicians or graduate research assistance trained
           in phlebotomy in compliance with guidelines established by the Texas Department of
           Health and Human Services.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Changes from baseline in the levels of Inflammatory biomarkers in plasma or urine
time frame: baseline, 24 hours
description: During each of the testing sessions, participants donated approximately 2 teaspoons of fasting venous blood (10 milliliters). All urine output for the 24 hours leading up to the baseline testing was collected. Inflammatory biomarkers in the plasma (hs-C-reactive protein(mg/L), interleukin-6(pg/ml), interleukin-1beta(pg/ml), Interferon-gamma(pg/ml), and Tumor necrosis factor-alpha(pg/ml)) and in the urine (8-isoprostane(ng/mmol creatinine) were measured by enzyme immunoassay using Cayman chemical kits (Ann Arbor, MI).
arm group label: Sugary Beverage
arm group type: Placebo Comparator
description: Sugary Beverage
arm group label: Acai beverage
arm group type: Experimental
description: Acai Polyphenolics
intervention type: Dietary Supplement
intervention name: Acai polyphenolics
description: Acai beverage was obtained from the Sambazon (San Clemente, CA).
arm group label: Acai beverage
intervention type: Dietary Supplement
intervention name: Sugary Beverage
description: An equal amount of placebo juice comprised of artificially colored water containing sugar (5%), citric acid (0.01% to adjust the pH 3.8), and artificial colors (FD&C Red 40 and Blue 1, Tetra Pak, Denten, TX) that was identical to the acai beverage.
arm group label: Sugary Beverage
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Susanne Talcott, PhD
role: Principal Investigator
affiliation: Texas A&M University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Metabolic Syndrome