<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/NCT02213523</url>
  </required_header>
  <id_info>
    <org_study_id>ABG AOX-1</org_study_id>
    <nct_id>NCT02213523</nct_id>
  </id_info>
  <brief_title>ABG Oxidative Stress Study Protocol-1</brief_title>
  <official_title>Proof of Concept Study to Evaluate the Effect of Oxidative Stress Response of Plant Concentrate Blends in Healthy Men</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 is a proof of concept study that evaluates the response to oxidative stress in healthy&#xD;
      men after taking plant concentrates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sustained oxidative stress may cause hypertension, insulin resistance, metabolic syndrome,&#xD;
      cardiovascular disease and other chronic conditions. Diets rich in natural antioxidants is&#xD;
      associated with protective effects on the investigators health. The strategy to prevent&#xD;
      chronic disease development and in making up the nutritional gap in the investigators diet&#xD;
      has shifted from vitamins and minerals supplementation to whole foods and whole food&#xD;
      products.&#xD;
&#xD;
      The objectives is to evaluate the effect of oxidative stress response of plant concentrate&#xD;
      blends. Also, we'll confirm that vitamins, minerals and plant concentrates will not influence&#xD;
      the biomarker expression that were monitored in the oxidative stress biomarkers. Lastly,&#xD;
      collecting additional information on whether blends of plant concentrate have other potential&#xD;
      health benefits.&#xD;
&#xD;
      This study will test the dose-response of blends of plant concentrates. Healthy men (n=60)&#xD;
      with low fruit and vegetable intake will participate in a 32 day or 46 days. Each treatment&#xD;
      duration lasts 14 days. Microarray assay and real time-polymerase chain reaction will be&#xD;
      performed.Genes associated with oxidative stress will me monitored. The outcome of this study&#xD;
      will help us understand how to design and develop future antioxidant related products.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">November 2012</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in urine 8-isoprostane</measure>
    <time_frame>Day 1, 15</time_frame>
    <description>Change in antioxidant biomarker from baseline to day 15</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in erythrocyte Superoxide Dismutase</measure>
    <time_frame>1, 15</time_frame>
    <description>Change in antioxidant biomarker from baseline to day 15</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma malondialdehyde</measure>
    <time_frame>Day 1, 15</time_frame>
    <description>Change in antioxidant biomarker from baseline to day 15</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma hemoxygenase-1</measure>
    <time_frame>Day 1, 15</time_frame>
    <description>Change in antioxidant biomarker from baseline to day 15</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erythrocyte glutathione peroxidase</measure>
    <time_frame>Day 1, 15</time_frame>
    <description>Change in antioxidant biomarker from baseline to day 15</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Plant concentrate A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Plant concentrate A containing Rosemary:Quercetin:Turmeric 5:3:1 Low dose (300 mg) to high dose (600 mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Plant concentrate B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Plant concentrate B containing Holy Basil: Wasabi: Broccoli 5:5:1 Low dose (300 mg) to high dose (600 mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Plant concentrate C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Plant concentrate C containing Holy Basil:Rosemary:Broccoli seed:Turmeric 2:2:1:1 Low dose (300 mg) to High dose (600 mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Plant concentrate D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Plant concentrate D containing Rosemary:Licorice:Turmeric 1:1:1 Low dose (300 mg) to High dose (600 mg)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Plant concentrate A</intervention_name>
    <description>Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.</description>
    <arm_group_label>Plant concentrate A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Plant concentrate B</intervention_name>
    <description>Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.</description>
    <arm_group_label>Plant concentrate B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Plant concentrate C</intervention_name>
    <description>Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.</description>
    <arm_group_label>Plant concentrate C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Plant concentrate D</intervention_name>
    <description>Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.</description>
    <arm_group_label>Plant concentrate D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult men between 45-65 yr old with low fruit and vegetable intake&#xD;
&#xD;
          -  Individual with low fruit and vegetable intake and consuming fewer than 12 items found&#xD;
             on the Recommended Foods Check (RFC) (AppendixI) per week. (score &lt;12 pts)&#xD;
&#xD;
          -  Individuals with screening blood and urine laboratory values within 20% of normal&#xD;
             range indicated in the lab report (Appendix IV)&#xD;
&#xD;
          -  Individual should be judged to be in good general health on the basis of an interview&#xD;
             and abbreviated physical exam.&#xD;
&#xD;
          -  Individual understands the procedures and agrees to participate in the study.&#xD;
&#xD;
          -  Individual is willing to maintain their exercise habits and dietary pattern throughout&#xD;
             the duration of the trial.&#xD;
&#xD;
          -  Individual is willing to consume a diet or drink devoid of high content of quercetin&#xD;
             (e.g. apple and onions), rosemary, turmeric, Holy basil, wasabi, broccoli seeds, and&#xD;
             licorice thought the duration of the trial.&#xD;
&#xD;
          -  Individual is able and willing to provide written informed consent and confidentiality&#xD;
             agreement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of dietary supplements within one week of DAy 1. Supplements include any vitamins,&#xD;
             minerals, and herbal products, including herbal drink.&#xD;
&#xD;
          -  Presence of, or clinical significant history of, cancer, cardiovascular, endocrine,&#xD;
             kidney, liver, lung, gastrointestinal, metabolic disorder, absorption disorder such as&#xD;
             Celiae or Crohn's disease and/or any other chronic health condition such as diabetes&#xD;
             identified from the finding of the interview.&#xD;
&#xD;
          -  Presence of cardiovascular disease and hypertension with inconsistent medication&#xD;
             regimen, unstable conditions, and without proper physician's supervision identified&#xD;
             from the findings fo the interview.&#xD;
&#xD;
          -  Individual who use medicines such as statins (e.g. simvastatin, fluvastatin), NSAIDS&#xD;
             including aspirin, nitric oxide *eNOS) activators or inhibitors (e.g. selegiline,&#xD;
             Viagra), and angiotensin II receptor blocker (e.g. Telmisartan (blood pressure)), and&#xD;
             take any of these medications within 10 hours prior to the blood and urine sample&#xD;
             collection.&#xD;
&#xD;
          -  Individuals who eat spicy food (e.g. capsaicin from chili pepper) and drink coffee and&#xD;
             tea including herbal teas within 10 hours prior to the blood and urine sample&#xD;
             collection.&#xD;
&#xD;
          -  Participation in another clinical trial within 30 days of enrollment into the study.&#xD;
&#xD;
          -  History of current abuse of nicotine, drugs or alcohol, or intake &gt;3 alcoholic&#xD;
             beverages per day&#xD;
&#xD;
          -  Have known allergy to the ingredients in the tested samples such as quercetin,&#xD;
             rosemary, turmeric, Holy basil, wasabi, broccoli seeds, and licorice.&#xD;
&#xD;
          -  Any condition that the principal Investigator believes amy put the subject under risk.&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>Richard Keech, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southbay Pharma Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quality of Life</name>
      <address>
        <city>Buena Park</city>
        <state>California</state>
        <zip>90620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>
  <!-- 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/NCT02213523
org study id: ABG AOX-1
nct id: NCT02213523
lead sponsor: 
has dmc: Yes
This is a proof of concept study that evaluates the response to oxidative stress in healthy
      men after taking plant concentrates.
Sustained oxidative stress may cause hypertension, insulin resistance, metabolic syndrome,
      cardiovascular disease and other chronic conditions. Diets rich in natural antioxidants is
      associated with protective effects on the investigators health. The strategy to prevent
      chronic disease development and in making up the nutritional gap in the investigators diet
      has shifted from vitamins and minerals supplementation to whole foods and whole food
      products.

      The objectives is to evaluate the effect of oxidative stress response of plant concentrate
      blends. Also, we'll confirm that vitamins, minerals and plant concentrates will not influence
      the biomarker expression that were monitored in the oxidative stress biomarkers. Lastly,
      collecting additional information on whether blends of plant concentrate have other potential
      health benefits.

      This study will test the dose-response of blends of plant concentrates. Healthy men (n=60)
      with low fruit and vegetable intake will participate in a 32 day or 46 days. Each treatment
      duration lasts 14 days. Microarray assay and real time-polymerase chain reaction will be
      performed.Genes associated with oxidative stress will me monitored. The outcome of this study
      will help us understand how to design and develop future antioxidant related products.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Change in urine 8-isoprostane
time frame: Day 1, 15
description: Change in antioxidant biomarker from baseline to day 15
measure: Change in erythrocyte Superoxide Dismutase
time frame: 1, 15
description: Change in antioxidant biomarker from baseline to day 15
measure: Change in plasma malondialdehyde
time frame: Day 1, 15
description: Change in antioxidant biomarker from baseline to day 15
measure: Plasma hemoxygenase-1
time frame: Day 1, 15
description: Change in antioxidant biomarker from baseline to day 15
measure: Erythrocyte glutathione peroxidase
time frame: Day 1, 15
description: Change in antioxidant biomarker from baseline to day 15
arm group label: Plant concentrate A
arm group type: Experimental
description: Plant concentrate A containing Rosemary:Quercetin:Turmeric 5:3:1 Low dose (300 mg) to high dose (600 mg)
arm group label: Plant concentrate B
arm group type: Experimental
description: Plant concentrate B containing Holy Basil: Wasabi: Broccoli 5:5:1 Low dose (300 mg) to high dose (600 mg)
arm group label: Plant concentrate C
arm group type: Experimental
description: Plant concentrate C containing Holy Basil:Rosemary:Broccoli seed:Turmeric 2:2:1:1 Low dose (300 mg) to High dose (600 mg)
arm group label: Plant concentrate D
arm group type: Experimental
description: Plant concentrate D containing Rosemary:Licorice:Turmeric 1:1:1 Low dose (300 mg) to High dose (600 mg)
intervention type: Dietary Supplement
intervention name: Plant concentrate A
description: Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.
arm group label: Plant concentrate A
intervention type: Dietary Supplement
intervention name: Plant concentrate B
description: Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.
arm group label: Plant concentrate B
intervention type: Dietary Supplement
intervention name: Plant concentrate C
description: Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.
arm group label: Plant concentrate C
intervention type: Dietary Supplement
intervention name: Plant concentrate D
description: Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.
arm group label: Plant concentrate D
criteria: 
gender: Male
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard Keech, M.D.
role: Principal Investigator
affiliation: Southbay Pharma Research
facility: 
facility: 
country: United States
responsible party type: Sponsor