<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/NCT03289507</url>
  </required_header>
  <id_info>
    <org_study_id>IRB2017-086</org_study_id>
    <nct_id>NCT03289507</nct_id>
  </id_info>
  <brief_title>Longvida Curcumin Human Pharmacokinetics Study</brief_title>
  <acronym>CRC</acronym>
  <official_title>Longvida Curcumin Human Pharmacokinetics (PK) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinical Nutrition Research Center, Illinois Institute of Technology</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Verdure Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Clinical Nutrition Research Center, Illinois Institute of Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to characterize the curcumin metabolites of 2 different&#xD;
      capsule formulations of curcumin relative to unformulated Curcuma longa extract of Rhizomes&#xD;
      including assessing relative bioavailability and absorption/kinetic profile of curcumonoids&#xD;
      and their metabolites in human plasma and urine after acute consumption.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized, 3-arm, double-blinded, within subject cross-over trial focused on&#xD;
      understanding pharmacokinetic profile of curcuminoids and their metabolites after intake of&#xD;
      curcumin supplement with different capsule formulations.&#xD;
&#xD;
      A planned sample size of 6 will be enrolled into the study. This study will require one&#xD;
      initial screening visit and 3 weekly visits. This study will take approximately 4 weeks per&#xD;
      subject to complete.&#xD;
&#xD;
      The initial screening visit will provide subject with the informed consent document and&#xD;
      determine subject eligibility through anthropometric measurements, vital signs, fasting blood&#xD;
      glucose test (finger prick), and completion of a survey relate to general eating, health, and&#xD;
      exercise habits.&#xD;
&#xD;
      If willing and eligible to participate, subjects will be invited to participate in the study&#xD;
      for 3 study days. Subjects will be instructed to maintain their usual diet pattern and&#xD;
      physical activity throughout study duration.&#xD;
&#xD;
      Subject will arrive at the center in a fasted state for at least 10 hours, well hydrated and&#xD;
      rested. Each study visit will require blood draws throughout the visit. After evaluation of&#xD;
      subject's health status (via anthropometric, vital sign and blood glucose measurements and&#xD;
      in-person interview), a Licensed health Care Professional will place a catheter in subject's&#xD;
      arm for the purpose of multiple blood sample collections and take the initial blood draw in&#xD;
      the fasting state. Subjects will be randomized to receive a curcumin supplement based on&#xD;
      randomized treatment sequences for 3 study visits immediately after fasting blood draw. The&#xD;
      sequences of receiving the supplement at each visit will be randomly assigned based on&#xD;
      treatment sequences.&#xD;
&#xD;
      Each study visit will involve with blood samples collection at time points 0 (fasting), 0.5,&#xD;
      1, 2, 4, 6, and 8 hour (h) for assessment of change in plasma curcuminoids and metabolites. A&#xD;
      standard breakfast will be provided immediately after the 0.5 h blood collection and standard&#xD;
      lunch after 6 h blood collection. Urine samples will be collected at 0 (fasting), 4 and 8 h.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2017</start_date>
  <completion_date type="Actual">January 30, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in plasma curcumin metabolites among 3 different treatments</measure>
    <time_frame>8 hours Postprandial Study</time_frame>
    <description>Differences in plasma metabolites among 3 treatments</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in urine metabolites among 3 different treatments</measure>
    <time_frame>8 hours Postprandial Study</time_frame>
    <description>Differences in urine metabolites among 3 treatments</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Treatment1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Longvida Capsule formulation A</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Longvida Capsule formulation B</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Curcuma longa extract of Rhizomes</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Treatment1</intervention_name>
    <description>Longvida Capsule formulation A</description>
    <arm_group_label>Treatment1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Treatment2</intervention_name>
    <description>Longvida Capsule formulation B</description>
    <arm_group_label>Treatment 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Treatment3</intervention_name>
    <description>Curcuma longa extract of Rhizomes</description>
    <arm_group_label>Treatment3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Men or women, 20-45 years of age with body mass index (BMI) in range from 18.5 to&#xD;
             24.9 kg/m2&#xD;
&#xD;
               -  Nonsmokers (Past smokers can be allowed if they have abstinence for minimum of 2&#xD;
                  years)&#xD;
&#xD;
               -  No clinical evidence of cardiovascular, metabolic, respiratory, renal,&#xD;
                  gastrointestinal or hepatic disease that may interfere with study outcomes&#xD;
&#xD;
               -  Not taking any medications that would interfere with outcomes of the study, i.e.&#xD;
                  lipid lowering medications, gastrointestinal medications, antibiotics,&#xD;
                  anti-inflammatory drugs, dietary supplements including fiber supplements,&#xD;
                  prebiotics and probiotics, etc.&#xD;
&#xD;
               -  Able to provide informed consent&#xD;
&#xD;
               -  Able to comply and perform the procedures requested by the protocol (including&#xD;
                  dietary restrictions, consumption of study treatments, blood and urine sample&#xD;
                  collection procedures and study visit schedule)&#xD;
&#xD;
               -  Minimum weight of 45 kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Men and women who smoke&#xD;
&#xD;
               -  Men and women with known or suspected intolerance, allergies or hypersensitivity&#xD;
                  to study foods or treatments&#xD;
&#xD;
               -  Men and women known to have/diagnosed with diabetes mellitus&#xD;
&#xD;
               -  Men and women who have fasting blood glucose concentrations &gt; 125 mg/dL&#xD;
&#xD;
               -  Men and women who have uncontrolled blood pressure &gt;160 mmHg (systolic) or 100&#xD;
                  mmHg (diastolic)&#xD;
&#xD;
               -  Men and women with documented vascular disease, e.g., heart failure, myocardial&#xD;
                  infarction, stroke, angina, related surgeries, etc. that, in the opinion of the&#xD;
                  investigator, could interfere with the interpretation of the study results&#xD;
&#xD;
               -  Men and women with cancer other than non-melanoma skin cancer in previous 5 years&#xD;
&#xD;
               -  Men and women diagnosed with chronic constipation, diarrhea or other chronic&#xD;
                  gastrointestinal complaint (e.g. irritable bowel syndrome)&#xD;
&#xD;
               -  Women who are known to be pregnant (pregnancy test will be completed for female&#xD;
                  subjects) or who are intending to become pregnant over the course of the study&#xD;
&#xD;
               -  Women who are lactating&#xD;
&#xD;
               -  Taking medication or dietary supplements that may interfere with the outcomes of&#xD;
                  the study; e.g., antioxidant supplement, anti-inflammation, lipid lowering&#xD;
                  medication, blood pressure lowering medication, etc... Subjects may choose to go&#xD;
                  off dietary supplements (requires 30 days washout); e.g., fish oil, probiotics,&#xD;
                  etc...&#xD;
&#xD;
               -  Men and women who has participated in prebiotics or laxative trial within 3&#xD;
                  months prior to enrollment or any other clinical trial within 1 month&#xD;
&#xD;
               -  Men and women who have donated blood within 3 months of the Screening Visit and&#xD;
                  blood donors/participants for whom participation in this study will result in&#xD;
                  having donated more than 1500 milliliters of blood in the previous 12 months.&#xD;
&#xD;
               -  Men and women who are vegans&#xD;
&#xD;
               -  History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge&#xD;
                  eating) diagnosed by a health professional&#xD;
&#xD;
               -  Substance (alcohol or drug) abuse within the last 2 years&#xD;
&#xD;
               -  Excessive coffee and tea consumers (&gt; 5 cups/day)&#xD;
&#xD;
               -  Men and women who do excessive exercise regularly or athlete&#xD;
&#xD;
               -  Unstable weight: gained or lost weight +/- 5 kg (11 lbs) in previous 2 months&#xD;
&#xD;
               -  Women who are taking unstable dose and brand of hormonal contraceptives and/or&#xD;
                  stable dose and brand less than 6 months&#xD;
&#xD;
               -  Unusual working hours i.e., working overnight (e.g. 3rd shift)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Britt M Burton-Freeman, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Illinois Institute of Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Nutrition Research Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Longvida Curcumin</keyword>
  <keyword>Pharmacokinetics</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/NCT03289507
org study id: IRB2017-086
nct id: NCT03289507
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of the study is to characterize the curcumin metabolites of 2 different
      capsule formulations of curcumin relative to unformulated Curcuma longa extract of Rhizomes
      including assessing relative bioavailability and absorption/kinetic profile of curcumonoids
      and their metabolites in human plasma and urine after acute consumption.
This study is a randomized, 3-arm, double-blinded, within subject cross-over trial focused on
      understanding pharmacokinetic profile of curcuminoids and their metabolites after intake of
      curcumin supplement with different capsule formulations.

      A planned sample size of 6 will be enrolled into the study. This study will require one
      initial screening visit and 3 weekly visits. This study will take approximately 4 weeks per
      subject to complete.

      The initial screening visit will provide subject with the informed consent document and
      determine subject eligibility through anthropometric measurements, vital signs, fasting blood
      glucose test (finger prick), and completion of a survey relate to general eating, health, and
      exercise habits.

      If willing and eligible to participate, subjects will be invited to participate in the study
      for 3 study days. Subjects will be instructed to maintain their usual diet pattern and
      physical activity throughout study duration.

      Subject will arrive at the center in a fasted state for at least 10 hours, well hydrated and
      rested. Each study visit will require blood draws throughout the visit. After evaluation of
      subject's health status (via anthropometric, vital sign and blood glucose measurements and
      in-person interview), a Licensed health Care Professional will place a catheter in subject's
      arm for the purpose of multiple blood sample collections and take the initial blood draw in
      the fasting state. Subjects will be randomized to receive a curcumin supplement based on
      randomized treatment sequences for 3 study visits immediately after fasting blood draw. The
      sequences of receiving the supplement at each visit will be randomly assigned based on
      treatment sequences.

      Each study visit will involve with blood samples collection at time points 0 (fasting), 0.5,
      1, 2, 4, 6, and 8 hour (h) for assessment of change in plasma curcuminoids and metabolites. A
      standard breakfast will be provided immediately after the 0.5 h blood collection and standard
      lunch after 6 h blood collection. Urine samples will be collected at 0 (fasting), 4 and 8 h.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Changes in plasma curcumin metabolites among 3 different treatments
time frame: 8 hours Postprandial Study
description: Differences in plasma metabolites among 3 treatments
measure: Changes in urine metabolites among 3 different treatments
time frame: 8 hours Postprandial Study
description: Differences in urine metabolites among 3 treatments
arm group label: Treatment1
arm group type: Active Comparator
description: Longvida Capsule formulation A
arm group label: Treatment 2
arm group type: Active Comparator
description: Longvida Capsule formulation B
arm group label: Treatment3
arm group type: Experimental
description: Curcuma longa extract of Rhizomes
intervention type: Dietary Supplement
intervention name: Treatment1
description: Longvida Capsule formulation A
arm group label: Treatment1
intervention type: Dietary Supplement
intervention name: Treatment2
description: Longvida Capsule formulation B
arm group label: Treatment 2
intervention type: Dietary Supplement
intervention name: Treatment3
description: Curcuma longa extract of Rhizomes
arm group label: Treatment3
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Britt M Burton-Freeman, Ph.D
role: Principal Investigator
affiliation: Illinois Institute of Technology
facility: 
country: United States
responsible party type: Sponsor