<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/NCT02193438</url>
  </required_header>
  <id_info>
    <org_study_id>10.24.MET</org_study_id>
    <nct_id>NCT02193438</nct_id>
  </id_info>
  <brief_title>Physiologic Effect of Spices Ingestion</brief_title>
  <official_title>Physiologic Effect of Spices Ingestion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Société des Produits Nestlé (SPN)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Human studies have shown that capsaicin, a compound extracted from chilly peppers, can&#xD;
      stimulate certain physiologic functions (for example, energy expenditure, thermogenesis,&#xD;
      lipid oxidation, heart rate, etc.).&#xD;
&#xD;
      The purpose of this study is to measure the impact of ingesting various spicy molecules on a&#xD;
      set of physiologic parameters compared to a placebo. The molecules were selected for their&#xD;
      different sensory properties.&#xD;
&#xD;
      The results of this study will allow us to implement an effective method for measuring the&#xD;
      impact of ingesting spices on certain body functions (for example, metabolism and autonomic&#xD;
      nervous system activity). This study will also allow us to identify the beneficial properties&#xD;
      of eating certain spices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary objective and outcome:&#xD;
&#xD;
      The main objective of this study is to establish a methodology to evaluate the acute impact&#xD;
      of spice ingestion on metabolism and autonomic nervous system activity.&#xD;
&#xD;
      Primary outcomes:&#xD;
&#xD;
      Impact of the spice on autonomic nervous system activity: Power spectra analysis on heart&#xD;
      rate variability (HRV) changes during the 90 post ingestive minutes (measured by ECG).&#xD;
&#xD;
      Impact of the spice on metabolism: Energy expenditure changes during the 90 post ingestive&#xD;
      minutes (measured by indirect calorimetry).&#xD;
&#xD;
      As secondary outcomes blood pressure changes and facial temperature changes on specific area&#xD;
      (nose, cheeks and forehead) will be evaluated. Substrate oxidation (carbohydrates and fat&#xD;
      utilization) and the respiratory quotient (RQ) will be calculated using indirect calorimetry&#xD;
      data for energy expenditure measure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 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>Crossover Assignment</intervention_model>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Resting energy expenditure</measure>
    <time_frame>change from baseline to 90 minutes following product intake</time_frame>
    <description>Calculation of the resting energy expenditure from continuous measurement of oxygen consumption and carbon dioxid production (indirect calorimetry).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Change from baseline to 90 minutes following product intake</time_frame>
    <description>Power spectral analysis of heart rate variability from continuous measurement of very low, low and high frequency range electrocardiographic signals.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Substrat oxidation</measure>
    <time_frame>Change from baseline to 90 minutes following product intake</time_frame>
    <description>Carbohydrate oxidation, lipid oxidation, and respiratory quotient from continuous measurements by indirect calorimetryof oxygen consumption and carbon dioxide production.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>every 15 minutes over 90 minutes of recording following product intake</time_frame>
    <description>Standard blood pressure monitoring using an arm cuff</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Facial skin temperature modification</measure>
    <time_frame>Change from baseline to 90 minutes following product intakeover 90 min</time_frame>
    <description>Measurement of the skin temperature of the face using an infrared camera (FLIR A325)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Spice 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Red chili pepper extract</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spice 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cinnamon extract</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spice 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Refreshing agent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Tomato juice</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Spices intake</intervention_name>
    <description>Each subject had to ingest a single dose of each of the spices and placebo. Recording of outcomes was realized throughout the 90 minutes following ingestion.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>3 different spices</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Tomato juice intake</description>
    <arm_group_label>Spice 1</arm_group_label>
    <arm_group_label>Spice 2</arm_group_label>
    <arm_group_label>Spice 3</arm_group_label>
    <other_name>Tomato juice</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  BMI: 19-25 kg/m2, ≥ 60 kg body weight&#xD;
&#xD;
          -  Moderate spicy food eaters&#xD;
&#xD;
          -  Having signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any gastrointestinal disorder&#xD;
&#xD;
          -  Subject sensitive or not used to eat spicy food&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Subject with beard or mustache&#xD;
&#xD;
          -  Abnormal thyroid function&#xD;
&#xD;
          -  Intake of medication that could affect body weight and/or energy expenditure&#xD;
&#xD;
          -  Weight loss &gt; 5% in the last 3 months&#xD;
&#xD;
          -  Under antibiotics or regular treatments (medical or nutritional program) affecting&#xD;
             body weight, appetite, energy expenditure, lipid-lowering, hypertension or&#xD;
             inflammation or glucose control for the last 3 months or taking hormone replacement&#xD;
             therapy&#xD;
&#xD;
          -  History of allergy&#xD;
&#xD;
          -  Physical activity level &gt; 300 min of moderate or intense exercise per week&#xD;
&#xD;
          -  Have a alcohol consumption higher than than 1 drink/day&#xD;
&#xD;
          -  Consumption of illicit drugs&#xD;
&#xD;
          -  Subject who cannot be expected to comply with the study procedures, including&#xD;
             consuming the test products&#xD;
&#xD;
          -  Currently participating or having participated in another clinical trial during the&#xD;
             last 4 weeks prior to the beginning of this study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stéphanie Michlig Gonzalez, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Société des Produits Nestlé (SPN)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maurice Beaumont, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Société des Produits Nestlé (SPN)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NESTEC / Metabolic Unit</name>
      <address>
        <city>Lausanne</city>
        <zip>1026</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>July 16, 2014</last_update_submitted>
  <last_update_submitted_qc>July 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heart rate variability</keyword>
  <keyword>Resting energy expenditure</keyword>
  <keyword>Facial thermography</keyword>
  <keyword>Blood pressure</keyword>
  <keyword>Spices ingestion</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/NCT02193438
org study id: 10.24.MET
nct id: NCT02193438
lead sponsor: 
has dmc: No
Human studies have shown that capsaicin, a compound extracted from chilly peppers, can
      stimulate certain physiologic functions (for example, energy expenditure, thermogenesis,
      lipid oxidation, heart rate, etc.).

      The purpose of this study is to measure the impact of ingesting various spicy molecules on a
      set of physiologic parameters compared to a placebo. The molecules were selected for their
      different sensory properties.

      The results of this study will allow us to implement an effective method for measuring the
      impact of ingesting spices on certain body functions (for example, metabolism and autonomic
      nervous system activity). This study will also allow us to identify the beneficial properties
      of eating certain spices.
Primary objective and outcome:

      The main objective of this study is to establish a methodology to evaluate the acute impact
      of spice ingestion on metabolism and autonomic nervous system activity.

      Primary outcomes:

      Impact of the spice on autonomic nervous system activity: Power spectra analysis on heart
      rate variability (HRV) changes during the 90 post ingestive minutes (measured by ECG).

      Impact of the spice on metabolism: Energy expenditure changes during the 90 post ingestive
      minutes (measured by indirect calorimetry).

      As secondary outcomes blood pressure changes and facial temperature changes on specific area
      (nose, cheeks and forehead) will be evaluated. Substrate oxidation (carbohydrates and fat
      utilization) and the respiratory quotient (RQ) will be calculated using indirect calorimetry
      data for energy expenditure measure.
allocation: Randomized
intervention model: Crossover Assignment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Resting energy expenditure
time frame: change from baseline to 90 minutes following product intake
description: Calculation of the resting energy expenditure from continuous measurement of oxygen consumption and carbon dioxid production (indirect calorimetry).
measure: Heart rate variability
time frame: Change from baseline to 90 minutes following product intake
description: Power spectral analysis of heart rate variability from continuous measurement of very low, low and high frequency range electrocardiographic signals.
measure: Substrat oxidation
time frame: Change from baseline to 90 minutes following product intake
description: Carbohydrate oxidation, lipid oxidation, and respiratory quotient from continuous measurements by indirect calorimetryof oxygen consumption and carbon dioxide production.
measure: Blood pressure
time frame: every 15 minutes over 90 minutes of recording following product intake
description: Standard blood pressure monitoring using an arm cuff
measure: Facial skin temperature modification
time frame: Change from baseline to 90 minutes following product intakeover 90 min
description: Measurement of the skin temperature of the face using an infrared camera (FLIR A325)
arm group label: Spice 1
arm group type: Active Comparator
description: Red chili pepper extract
arm group label: Spice 2
arm group type: Active Comparator
description: Cinnamon extract
arm group label: Spice 3
arm group type: Active Comparator
description: Refreshing agent
arm group label: Placebo
arm group type: Placebo Comparator
description: Tomato juice
intervention type: Other
intervention name: Spices intake
description: Each subject had to ingest a single dose of each of the spices and placebo. Recording of outcomes was realized throughout the 90 minutes following ingestion.
arm group label: Placebo
other name: 3 different spices
intervention type: Other
intervention name: Placebo
description: Tomato juice intake
arm group label: Spice 1
arm group label: Spice 2
arm group label: Spice 3
other name: Tomato juice
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stéphanie Michlig Gonzalez, PhD
role: Study Director
affiliation: Société des Produits Nestlé (SPN)
last name: Maurice Beaumont, MD, PhD
role: Principal Investigator
affiliation: Société des Produits Nestlé (SPN)
facility: 
country: Switzerland
responsible party type: Sponsor