<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/NCT02258776</url>
  </required_header>
  <id_info>
    <org_study_id>PomSkin 14-001011</org_study_id>
    <nct_id>NCT02258776</nct_id>
  </id_info>
  <brief_title>The Effect of Pomegranate on Aging and Inflammation of the Skin</brief_title>
  <acronym>PomSkin</acronym>
  <official_title>Clinical Trial to Determine the Efficacy of Pomegranate for Skin Inflammation and Aging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the efficacy of pomegranate extract and pomegranate&#xD;
      juice on skin inflammation and aging. The information gained from this study may lead to the&#xD;
      development of a pomegranate product that can decrease the effects of aging, inflammation and&#xD;
      harmful bacteria on the skin.&#xD;
&#xD;
      In this study, two pomegranate products (extract and juice) will be compared with a placebo,&#xD;
      a study product that looks like pomegranate extract, but contains no active ingredients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pomegranate (Punica granatum L.) is grown commercially in the Near East, India, Spain, Israel&#xD;
      and the United States (California) where it is of significant economic importance1.&#xD;
      Pomegranate fruits and products, including juice, tea, wine and extracts are widely consumed&#xD;
      and recognized for their health benefits. Pomegranate (Punica granatum L.) fruit possesses&#xD;
      strong antioxidant, anti-inflammatory and antiproliferative properties. In recent years, most&#xD;
      health advantages of pomegranate have been attributed to the presence of ellagitannins,&#xD;
      mainly punicalagins and ellagic acid. Punicalagin is unique to pomegranate and is part of a&#xD;
      family of ellagitannins. The ellagitannins are hydrolyzed to ellagic acid in the gut, and&#xD;
      further metabolized by the colon microflora to form urolith A and B. Investigations using&#xD;
      pure bacterial cultures have shown that pomegranate by-products and punicalagins&#xD;
      significantly inhibited the growth of pathogenic Escherichia coli, Pseudomonas aeruginosa,&#xD;
      clostridia and Staphylococcus aureus.&#xD;
&#xD;
      Oral feeding of pomegranate fruit extract to mice afforded protection to mouse skin against&#xD;
      the adverse effects of ultraviolet-B (UVB) radiation by modulating UVB-induced signaling&#xD;
      pathways.5 Hydroalcoholic extract based-ointment from pomegranate was reported improving&#xD;
      wound healing in vivo. Pomegranate ellagitannins have been demonstrated to have antimicrobial&#xD;
      activity. Punicalagin is unique to pomegranate and is part of a family of ellagitannins. The&#xD;
      ellagitannins are hydrolyzed to ellagic acid in the gut, and further metabolized by the colon&#xD;
      microflora to form urolith A and B. Investigations using pure bacterial cultures have shown&#xD;
      that pomegranate by-products and punicalagins significantly inhibited the growth of&#xD;
      pathogenic Escherichia coli, Pseudomonas aeruginosa, clostridia and Staphylococcus aureus.&#xD;
&#xD;
      Pomegranate Extract (POMx) is made from pomegranate fruit as a byproduct of pomegranate juice&#xD;
      (PJ) production. A second pressing of the fruit liberates a complex mixture of hydrolysable&#xD;
      polyphenolic compounds normally ingested with pomegranate juice, and these are purified by&#xD;
      spray drying. POMx powder is encapsulated for oral administration, with each capsule&#xD;
      containing 1,000 mg of pomegranate polyphenols. The present study will determine whether a&#xD;
      pomegranate product (POMx or PJ) can decrease skin photoaging, inflammation and skin&#xD;
      pathogenic bacteria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2015</start_date>
  <completion_date type="Actual">February 27, 2017</completion_date>
  <primary_completion_date type="Actual">February 27, 2017</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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in inflammatory markers between pomegranate extract and pomegranate juice versus placebo.</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Utilization of a two-sample t-test to compare the change in between the three groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Linear mixed effects models to evaluate effect of treatment of time trends and demographic covariates</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Correlation between outcomes measures (e.g. between acne lesion count and skin microbiota) with mixed effects models</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Skin Photoaging, Inflammation and Skin Pathogenic Bacteria</condition>
  <arm_group>
    <arm_group_label>Pomegranate Extract</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>15 healthy subjects, ages 30-45 years who meet all the eligibility criteria in the screening phase of the study will be assigned to the Pomx arm of the study to evaluate the clinical efficacy of pomegranate extract on skin inflammation and aging. Subjects will be asked to take Pomx 1/day for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pomegranate Juice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>15 healthy subjects, ages 30-45 years who meet all the eligibility criteria in the screening phase of the study will be assigned to the Pomx arm of the study to evaluate the clinical efficacy of pomegranate juice on skin inflammation and aging. Subjects will be asked to take Pomx 1/day for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>15 healthy subjects, ages 30-45 years who meet all the eligibility criteria in the screening phase of the study will be assigned to the Pomx arm of the study to evaluate the clinical efficacy of placebo on skin inflammation and aging. Subjects will be asked to take Pomx 1/day for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Pomegranate Extract</intervention_name>
    <description>Pomegranate extract 1000mg will be taken 1/day for 12 weeks.</description>
    <arm_group_label>Pomegranate Extract</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Pomegranate Juice</intervention_name>
    <description>Pomegranate juice 8oz will be consumed 1/day for 12 weeks.</description>
    <arm_group_label>Pomegranate Juice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo will be taken 1/day for 12 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 30-45 years or older, female and any racial/ethnic group&#xD;
&#xD;
          2. Subjects must understand and sign the informed consent prior to participation&#xD;
&#xD;
          3. Subjects must be in generally good health&#xD;
&#xD;
          4. Subjects must be able and willing to comply with the requirements of the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Oral or topical retinoid use within twelve months of entry into the study&#xD;
&#xD;
          2. Non-compliant subjects&#xD;
&#xD;
          3. Taking any antibiotics or other medication or dietary supplements regularly&#xD;
&#xD;
          4. Subjects with a significant medical history or concurrent condition that the&#xD;
             investigator(s) feel is not safe for the study&#xD;
&#xD;
          5. Subjects who cannot avoid excessive exposure to either natural or artificial sunlight.&#xD;
&#xD;
          6. Allergic to pomegranate products&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhaoping Li, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCLA Department of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA Center for Human Nutrition</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>February 27, 2017</last_update_submitted>
  <last_update_submitted_qc>February 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Zhaoping Li</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02258776
org study id: PomSkin 14-001011
nct id: NCT02258776
lead sponsor: 
has dmc: No
The purpose of this study is to determine the efficacy of pomegranate extract and pomegranate
      juice on skin inflammation and aging. The information gained from this study may lead to the
      development of a pomegranate product that can decrease the effects of aging, inflammation and
      harmful bacteria on the skin.

      In this study, two pomegranate products (extract and juice) will be compared with a placebo,
      a study product that looks like pomegranate extract, but contains no active ingredients.
Pomegranate (Punica granatum L.) is grown commercially in the Near East, India, Spain, Israel
      and the United States (California) where it is of significant economic importance1.
      Pomegranate fruits and products, including juice, tea, wine and extracts are widely consumed
      and recognized for their health benefits. Pomegranate (Punica granatum L.) fruit possesses
      strong antioxidant, anti-inflammatory and antiproliferative properties. In recent years, most
      health advantages of pomegranate have been attributed to the presence of ellagitannins,
      mainly punicalagins and ellagic acid. Punicalagin is unique to pomegranate and is part of a
      family of ellagitannins. The ellagitannins are hydrolyzed to ellagic acid in the gut, and
      further metabolized by the colon microflora to form urolith A and B. Investigations using
      pure bacterial cultures have shown that pomegranate by-products and punicalagins
      significantly inhibited the growth of pathogenic Escherichia coli, Pseudomonas aeruginosa,
      clostridia and Staphylococcus aureus.

      Oral feeding of pomegranate fruit extract to mice afforded protection to mouse skin against
      the adverse effects of ultraviolet-B (UVB) radiation by modulating UVB-induced signaling
      pathways.5 Hydroalcoholic extract based-ointment from pomegranate was reported improving
      wound healing in vivo. Pomegranate ellagitannins have been demonstrated to have antimicrobial
      activity. Punicalagin is unique to pomegranate and is part of a family of ellagitannins. The
      ellagitannins are hydrolyzed to ellagic acid in the gut, and further metabolized by the colon
      microflora to form urolith A and B. Investigations using pure bacterial cultures have shown
      that pomegranate by-products and punicalagins significantly inhibited the growth of
      pathogenic Escherichia coli, Pseudomonas aeruginosa, clostridia and Staphylococcus aureus.

      Pomegranate Extract (POMx) is made from pomegranate fruit as a byproduct of pomegranate juice
      (PJ) production. A second pressing of the fruit liberates a complex mixture of hydrolysable
      polyphenolic compounds normally ingested with pomegranate juice, and these are purified by
      spray drying. POMx powder is encapsulated for oral administration, with each capsule
      containing 1,000 mg of pomegranate polyphenols. The present study will determine whether a
      pomegranate product (POMx or PJ) can decrease skin photoaging, inflammation and skin
      pathogenic bacteria.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Change in inflammatory markers between pomegranate extract and pomegranate juice versus placebo.
time frame: Baseline and 12 weeks
description: Utilization of a two-sample t-test to compare the change in between the three groups
measure: Linear mixed effects models to evaluate effect of treatment of time trends and demographic covariates
time frame: Baseline and 12 weeks
description: Correlation between outcomes measures (e.g. between acne lesion count and skin microbiota) with mixed effects models
arm group label: Pomegranate Extract
arm group type: Active Comparator
description: 15 healthy subjects, ages 30-45 years who meet all the eligibility criteria in the screening phase of the study will be assigned to the Pomx arm of the study to evaluate the clinical efficacy of pomegranate extract on skin inflammation and aging. Subjects will be asked to take Pomx 1/day for 12 weeks.
arm group label: Pomegranate Juice
arm group type: Active Comparator
description: 15 healthy subjects, ages 30-45 years who meet all the eligibility criteria in the screening phase of the study will be assigned to the Pomx arm of the study to evaluate the clinical efficacy of pomegranate juice on skin inflammation and aging. Subjects will be asked to take Pomx 1/day for 12 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: 15 healthy subjects, ages 30-45 years who meet all the eligibility criteria in the screening phase of the study will be assigned to the Pomx arm of the study to evaluate the clinical efficacy of placebo on skin inflammation and aging. Subjects will be asked to take Pomx 1/day for 12 weeks.
intervention type: Dietary Supplement
intervention name: Pomegranate Extract
description: Pomegranate extract 1000mg will be taken 1/day for 12 weeks.
arm group label: Pomegranate Extract
intervention type: Dietary Supplement
intervention name: Pomegranate Juice
description: Pomegranate juice 8oz will be consumed 1/day for 12 weeks.
arm group label: Pomegranate Juice
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo will be taken 1/day for 12 weeks.
arm group label: Placebo
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zhaoping Li, M.D., Ph.D.
role: Principal Investigator
affiliation: UCLA Department of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Zhaoping Li
investigator title: Professor of Medicine
mesh term: Inflammation
sharing ipd: No