<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/NCT01682343</url>
  </required_header>
  <id_info>
    <org_study_id>32AN2</org_study_id>
    <nct_id>NCT01682343</nct_id>
  </id_info>
  <brief_title>Effect of High-calcium Intake on Appetite, Insulinemia and Incretins</brief_title>
  <official_title>Effect of High-calcium Intake on Appetite, Insulinemia and Incretins</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northumbria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northumbria University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the appetite, insulin and incretin hormone&#xD;
      responses to a high-calcium meal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be provided with control and high-calcium meals. Insulin, appetite,&#xD;
      glucagon-like peptide-1 and glucose-dependent insulinotropic peptide responses will be&#xD;
      assessed, along with rates of substrate oxidation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subjective appetite ratings</measure>
    <time_frame>3 hour</time_frame>
    <description>Subjective ratings of appetite assessed by visual analogue scales.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum insulin concentration</measure>
    <time_frame>2 hour</time_frame>
    <description>2 hour area under the curve for serum insulin following breakfast consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma glucose-dependent insulinotropic peptide concentration</measure>
    <time_frame>2 hour</time_frame>
    <description>2 hour area under the curve for plasma glucose-dependent insulinotropic peptide following breakfast consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma glucagon-like peptide-1 concentration</measure>
    <time_frame>2 hour</time_frame>
    <description>2 hour area under the curve for plasma glucagon-like peptide-1 following breakfast consumption</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Total fat oxidised during 60 min of exercise (g)</measure>
    <time_frame>1 hour</time_frame>
    <description>Assessed by indirect calorimetry</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Nutritional and Metabolic Diseases</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Breakfast consisting of milk-based porridge with a normal calcium content.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-Calcium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>As control, but with a high-calcium content.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Calcium</intervention_name>
    <description>Milk-calcium supplement</description>
    <arm_group_label>High-Calcium</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  recreationally active&#xD;
&#xD;
          -  male&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  food intolerances/allergies&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Javier T Gonzalez, MRes</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northumbria University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northumbria University</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <state>Tyne on Wear</state>
        <zip>NE1 8ST</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>September 10, 2012</last_update_submitted>
  <last_update_submitted_qc>September 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northumbria University</investigator_affiliation>
    <investigator_full_name>Javier Gonzalez</investigator_full_name>
    <investigator_title>PhD Student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01682343
org study id: 32AN2
nct id: NCT01682343
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the appetite, insulin and incretin hormone
      responses to a high-calcium meal.
Participants will be provided with control and high-calcium meals. Insulin, appetite,
      glucagon-like peptide-1 and glucose-dependent insulinotropic peptide responses will be
      assessed, along with rates of substrate oxidation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Subjective appetite ratings
time frame: 3 hour
description: Subjective ratings of appetite assessed by visual analogue scales.
measure: Serum insulin concentration
time frame: 2 hour
description: 2 hour area under the curve for serum insulin following breakfast consumption
measure: Plasma glucose-dependent insulinotropic peptide concentration
time frame: 2 hour
description: 2 hour area under the curve for plasma glucose-dependent insulinotropic peptide following breakfast consumption
measure: Plasma glucagon-like peptide-1 concentration
time frame: 2 hour
description: 2 hour area under the curve for plasma glucagon-like peptide-1 following breakfast consumption
measure: Total fat oxidised during 60 min of exercise (g)
time frame: 1 hour
description: Assessed by indirect calorimetry
arm group label: Placebo
arm group type: Placebo Comparator
description: Breakfast consisting of milk-based porridge with a normal calcium content.
arm group label: High-Calcium
arm group type: Experimental
description: As control, but with a high-calcium content.
intervention type: Dietary Supplement
intervention name: Calcium
description: Milk-calcium supplement
arm group label: High-Calcium
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Javier T Gonzalez, MRes
role: Principal Investigator
affiliation: Northumbria University
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Northumbria University
investigator full name: Javier Gonzalez
investigator title: PhD Student
mesh term: Metabolic Diseases
mesh term: Calcium