<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/NCT02213588</url>
  </required_header>
  <id_info>
    <org_study_id>ABG AOX-2 Efficacy</org_study_id>
    <nct_id>NCT02213588</nct_id>
  </id_info>
  <brief_title>Effects of Plant Concentrate Blend on Oxidative Stress in Healthy Humans</brief_title>
  <official_title>Effects of Plant Concentrate Blend on Oxidative Stress in Healthy Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Access Business Group</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Access Business Group</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the response to oxidative stress in healthy men and women after taking a&#xD;
      blend of plant concentrate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate how blends of plant concentrates impacts oxidative&#xD;
      stress in humans. Biomarkers of oxidative stress will be measured at three time points in 3&#xD;
      month intervention. Based on our proof of concept dose response study, it was shown that the&#xD;
      plant concentrate at the proposed dose can lower markers of oxidative damage and induce the&#xD;
      production of antioxidant enzymes. We would like to confirm these findings and further&#xD;
      evaluate the implication of increased antioxidative enzymes as seeing in our proof of concept&#xD;
      study. An acute oxidative stress will be induced by a high glycemic drink and short aerobic&#xD;
      exercise and the response during the induction of an acute oxidative stress as well as the&#xD;
      recovery from an acute oxidative stress. Since the induction of antioxidative enzymes not&#xD;
      only is linked to the protection of proteins and lipids from oxidative damage, it is also&#xD;
      linked to the protection of DNA damage. Therefore, in this study, comet assay will be&#xD;
      performed to evaluate the integrity of DNA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">December 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in urine isoprostane</measure>
    <time_frame>Baseline, 3 mo</time_frame>
    <description>Change from baseline in urinary antioxidant biomarker in 3 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in plasma isoprostane</measure>
    <time_frame>baseline, 3 mo</time_frame>
    <description>Change in baseline blood antioxidant marker from baseline to 3 month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in erythrocyte lysate superoxide dismutase</measure>
    <time_frame>baseline, 3.0 mo</time_frame>
    <description>Change in antioxidant biomarker from baseline to 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma superoxide dismutase</measure>
    <time_frame>baseline, 3.0 mo</time_frame>
    <description>Change in antioxidant biomarker from baseline to 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma catalase</measure>
    <time_frame>baseline, 3.0 mo</time_frame>
    <description>Change in antioxidant biomarker from baseline to 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma 3-nitrotyrosine</measure>
    <time_frame>baseline, 3.0 mo</time_frame>
    <description>Change in antioxidant biomarker from baseline to 3 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>AOX blend</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rosemary:Quercetin:Turmeric (300 mg total)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Maltodextrin</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>AOX blend</intervention_name>
    <description>Antioxidant supplement</description>
    <arm_group_label>AOX blend</arm_group_label>
    <other_name>Antioxidant blend</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo sugar pill</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy adult men and women between 18 - 65 yr with low fruit and vegetable intake.&#xD;
&#xD;
          2. Individual with low fruit and vegetable intake and consuming fewer than 12 items found&#xD;
             on the Recommended Foods Checklist (RFC) (APPENDIX I) per week. (score &lt; 12 points&#xD;
&#xD;
          3. Safety data: Blood chemistry results specifically Blood Urea Nitrogen (BUN), Serum&#xD;
             Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT),&#xD;
             Gamma-glutamyl transpeptidase (GGTP), Total Bilirubin and alkaline phosphatase and&#xD;
             urinalysis results, specifically urine pH, protein, glucose, ketone and bilirubin&#xD;
             levels within +/- 20% of normal value indicated in the lab report.&#xD;
&#xD;
          4. Subjects with laboratory test results exceeding by &gt;20% of the upper limit of the&#xD;
             reference range in Creatine Phosphokinase, uric acid or blood glucose may be included&#xD;
             in the study if the Principal Investigator decides those subjects are sufficiently&#xD;
             healthy to participate safely in the study.&#xD;
&#xD;
          5. Individual should be judged to be in good general health on the basis of an interview&#xD;
             and a physician will perform an abbreviated physical exam.&#xD;
&#xD;
          6. Individual understands the procedures and agrees to participate in the study.&#xD;
&#xD;
          7. Individual is willing to maintain their exercise habits and dietary pattern throughout&#xD;
             the duration of the trial except as instructed to avoid high content of quercetin (for&#xD;
             example, quercetin can be found in apple and onion), rosemary, turmeric throughout the&#xD;
             duration of the trial.&#xD;
&#xD;
          8. Individual is willing to consume a diet or drinks devoid with high content of&#xD;
             quercetin (for example, quercetin can be found in apple and onion), rosemary, turmeric&#xD;
             throughout the duration of the trial.&#xD;
&#xD;
          9. Individual is able and willing to provide written informed consent and confidentiality&#xD;
             agreement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons will be excused from participating in the study if any of the following&#xD;
             conditions exist:&#xD;
&#xD;
               1. Use of dietary supplements within one week of Day 1. Supplements include any&#xD;
                  vitamins, minerals, and herbal products, including herbal drinks.&#xD;
&#xD;
               2. Presence of, or clinical significant history of, cancer, cardiovascular,&#xD;
                  endocrine, kidney, liver, lung, gastrointestinal, metabolic disorder, absorption&#xD;
                  disorder such as Celiac or Crohn's disease and/or any other chronic health&#xD;
                  condition such as diabetes identified from the findings of the interview.&#xD;
&#xD;
               3. Presence of gallstones or history of gallbladder disease.&#xD;
&#xD;
               4. Presence or history of diabetes.&#xD;
&#xD;
               5. Presence of cardiovascular disease and hypertension with inconsistent medication&#xD;
                  regimen, unstable conditions, and without proper physician's supervision&#xD;
                  identified from the findings of the interview.&#xD;
&#xD;
               6. Ten hours prior to the blood and urine sample collection, subjects should refrain&#xD;
                  from using medications such as statins (e.g., simvastatin, fluvastatin), NSAIDS&#xD;
                  including aspirin, nitric oxide (eNOS) activators or inhibitors (e.g.,&#xD;
                  selegiline, Viagra), and angiotensin II receptor blocker (e.g., Telmisartan&#xD;
                  (blood pressure)), take any of these medications Participant who eats spicy food&#xD;
                  (e.g., capsaicin from chili pepper) and/or drinks coffee and teas including&#xD;
                  herbal teas within 10 hours prior to the blood and urine sample collection.&#xD;
&#xD;
               7. Participation in another clinical trial within 30 days of enrollment into the&#xD;
                  study.&#xD;
&#xD;
               8. History or current abuse of nicotine, drugs or alcohol, or intake &gt; 3 alcoholic&#xD;
                  beverages per day&#xD;
&#xD;
               9. Have known allergy to the ingredients in the tested samples such as quercetin,&#xD;
                  rosemary, turmeric, Holy basil, wasabi, broccoli seed, and licorice.&#xD;
&#xD;
              10. Any condition that the Principal Investigator believes may put the subject at&#xD;
                  undue risk.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Keech, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southbay Pharma Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southbay Pharma Research</name>
      <address>
        <city>Buena Park</city>
        <state>California</state>
        <zip>90620</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 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>August 7, 2014</last_update_submitted>
  <last_update_submitted_qc>August 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Antioxidant</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antioxidants</mesh_term>
  </intervention_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/NCT02213588
org study id: ABG AOX-2 Efficacy
nct id: NCT02213588
lead sponsor: 
has dmc: Yes
This study evaluates the response to oxidative stress in healthy men and women after taking a
      blend of plant concentrate.
The purpose of this study is to evaluate how blends of plant concentrates impacts oxidative
      stress in humans. Biomarkers of oxidative stress will be measured at three time points in 3
      month intervention. Based on our proof of concept dose response study, it was shown that the
      plant concentrate at the proposed dose can lower markers of oxidative damage and induce the
      production of antioxidant enzymes. We would like to confirm these findings and further
      evaluate the implication of increased antioxidative enzymes as seeing in our proof of concept
      study. An acute oxidative stress will be induced by a high glycemic drink and short aerobic
      exercise and the response during the induction of an acute oxidative stress as well as the
      recovery from an acute oxidative stress. Since the induction of antioxidative enzymes not
      only is linked to the protection of proteins and lipids from oxidative damage, it is also
      linked to the protection of DNA damage. Therefore, in this study, comet assay will be
      performed to evaluate the integrity of DNA.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in urine isoprostane
time frame: Baseline, 3 mo
description: Change from baseline in urinary antioxidant biomarker in 3 months.
measure: Change in plasma isoprostane
time frame: baseline, 3 mo
description: Change in baseline blood antioxidant marker from baseline to 3 month
measure: Change in erythrocyte lysate superoxide dismutase
time frame: baseline, 3.0 mo
description: Change in antioxidant biomarker from baseline to 3 months
measure: Change in plasma superoxide dismutase
time frame: baseline, 3.0 mo
description: Change in antioxidant biomarker from baseline to 3 months
measure: Change in plasma catalase
time frame: baseline, 3.0 mo
description: Change in antioxidant biomarker from baseline to 3 months
measure: Change in plasma 3-nitrotyrosine
time frame: baseline, 3.0 mo
description: Change in antioxidant biomarker from baseline to 3 months
arm group label: AOX blend
arm group type: Active Comparator
description: Rosemary:Quercetin:Turmeric (300 mg total)
arm group label: Placebo
arm group type: Placebo Comparator
description: Maltodextrin
intervention type: Dietary Supplement
intervention name: AOX blend
description: Antioxidant supplement
arm group label: AOX blend
other name: Antioxidant blend
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo
other name: Placebo sugar pill
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard Keech, M.D.
role: Principal Investigator
affiliation: Southbay Pharma Research
facility: 
country: United States
responsible party type: Sponsor
mesh term: Antioxidants