<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/NCT01729143</url>
  </required_header>
  <id_info>
    <org_study_id>11-0468</org_study_id>
    <nct_id>NCT01729143</nct_id>
  </id_info>
  <brief_title>Impact of Black Pepper on Energy Expenditure and Substrate Utilization</brief_title>
  <official_title>A Randomized, Cross-Over Trial to Evaluate the Acute Effects of Black Pepper on Energy Expenditure and Fat Oxidation in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Appalachian State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      As obesity rates worldwide continue to increase, there is a focus on identifying active food&#xD;
      ingredients which increase metabolic rate which can be used as a dietary supplement in the&#xD;
      treatment of overweight and obesity. Promising animal and cell studies have suggested a role&#xD;
      for black pepper and an active component of black pepper, piperine, in energy expenditure.&#xD;
      However, the effects of black pepper have not been determined in humans. The investigators&#xD;
      hypothesis if that consumption of 1.5g black pepper (0.5g in each of three meals over one&#xD;
      day) will result in an elevation in 24-h resting energy expenditure when contrasted to a&#xD;
      control day (no black pepper, same diet intake).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">July 2011</completion_date>
  <primary_completion_date type="Actual">July 2011</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Energy expenditure and substrate oxidation</measure>
    <time_frame>24-hours</time_frame>
    <description>A primary outcome of this study was the 24-hour energy expenditure (measured in the metabolic chamber at the UNC NRI) following black pepper and no pepper control.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gut peptides</measure>
    <time_frame>30 minutes after lunch</time_frame>
    <description>Change in gut peptide secretion 30 minutes following a meal containing black pepper compared with no pepper control.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Black pepper</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During the black pepper study day, subjects consumed 1.5g of black pepper (0.5g/meal) in 60.8g of vegetable juice. Black pepper was consumed was a meal on each occasion. 24-hour energy expenditure and substrate utilization will be measured.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No pepper control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>During the no pepper control study day, subjects consumed an identical menu without black pepper. 60.8g of vegetable juice (vehicle) was consumed at each of the three study meals. 24-hour energy expenditure and substrate utilization will be measured.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>24-hour energy expenditure and substrate utilization</intervention_name>
    <description>Subjects spent two x 24-hour periods inside the metabolic chamber at the UNC NRI (black pepper and no pepper control) each separated by one week. Subjects were requested to arrive at the study center each morning in a fasted state (at least 10 hours). During each study day, subjects remained sedentary. All meals were provided and were tailored to each subject's specific energy requirements. Study meals (with the exception of the 1.5g of black pepper) were identical between the black pepper and no pepper control study days.</description>
    <arm_group_label>Black pepper</arm_group_label>
    <arm_group_label>No pepper control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Woman&#xD;
&#xD;
          -  Postmenopausal&#xD;
&#xD;
          -  Aged 50-65 years&#xD;
&#xD;
          -  BMI 25-35kg/m2&#xD;
&#xD;
          -  Not taking blood pressure or anti-inflammatory medications or any other medications&#xD;
             that may impact the results&#xD;
&#xD;
          -  Thyroid hormone profile within the normal reference range&#xD;
&#xD;
          -  No medical condition which may impact the results (e.g. diabetes)&#xD;
&#xD;
          -  Accustomed to eating regular meals including breakfast&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoker&#xD;
&#xD;
          -  Heavy exerciser (defined as &gt;150 minutes/week for more than 3 months)&#xD;
&#xD;
          -  Abuses alcohol or drugs&#xD;
&#xD;
          -  Vegetarian&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew G Swick, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNC Chapel Hill Nutrition Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNC Chapel Hill Nutrition Research Institute</name>
      <address>
        <city>Kannapolis</city>
        <state>North Carolina</state>
        <zip>28081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>April 5, 2016</last_update_submitted>
  <last_update_submitted_qc>April 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>black pepper</keyword>
  <keyword>metabolic chamber</keyword>
  <keyword>respiratory chamber</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/NCT01729143
org study id: 11-0468
nct id: NCT01729143
lead sponsor: 
collaborator: 
has dmc: No
As obesity rates worldwide continue to increase, there is a focus on identifying active food
      ingredients which increase metabolic rate which can be used as a dietary supplement in the
      treatment of overweight and obesity. Promising animal and cell studies have suggested a role
      for black pepper and an active component of black pepper, piperine, in energy expenditure.
      However, the effects of black pepper have not been determined in humans. The investigators
      hypothesis if that consumption of 1.5g black pepper (0.5g in each of three meals over one
      day) will result in an elevation in 24-h resting energy expenditure when contrasted to a
      control day (no black pepper, same diet intake).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Energy expenditure and substrate oxidation
time frame: 24-hours
description: A primary outcome of this study was the 24-hour energy expenditure (measured in the metabolic chamber at the UNC NRI) following black pepper and no pepper control.
measure: Gut peptides
time frame: 30 minutes after lunch
description: Change in gut peptide secretion 30 minutes following a meal containing black pepper compared with no pepper control.
arm group label: Black pepper
arm group type: Active Comparator
description: During the black pepper study day, subjects consumed 1.5g of black pepper (0.5g/meal) in 60.8g of vegetable juice. Black pepper was consumed was a meal on each occasion. 24-hour energy expenditure and substrate utilization will be measured.
arm group label: No pepper control
arm group type: Placebo Comparator
description: During the no pepper control study day, subjects consumed an identical menu without black pepper. 60.8g of vegetable juice (vehicle) was consumed at each of the three study meals. 24-hour energy expenditure and substrate utilization will be measured.
intervention type: Other
intervention name: 24-hour energy expenditure and substrate utilization
description: Subjects spent two x 24-hour periods inside the metabolic chamber at the UNC NRI (black pepper and no pepper control) each separated by one week. Subjects were requested to arrive at the study center each morning in a fasted state (at least 10 hours). During each study day, subjects remained sedentary. All meals were provided and were tailored to each subject's specific energy requirements. Study meals (with the exception of the 1.5g of black pepper) were identical between the black pepper and no pepper control study days.
arm group label: Black pepper
arm group label: No pepper control
criteria: 
gender: Female
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andrew G Swick, PhD
role: Principal Investigator
affiliation: UNC Chapel Hill Nutrition Research Institute
facility: 
country: United States
responsible party type: Sponsor