<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/NCT03757962</url>
  </required_header>
  <id_info>
    <org_study_id>5157</org_study_id>
    <nct_id>NCT03757962</nct_id>
  </id_info>
  <brief_title>Evaluation of Food Additive Contributions to Obesity - Feasibility Study 1</brief_title>
  <official_title>Evaluation of Food Additive Contributions to Obesity - Feasibility Study 1</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</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 effects of food additives on body weight in humans are largely unknown. This is a&#xD;
      before-and-after feasibility study in 5 obese adults who will be followed for 5 months.&#xD;
      Eligible participants will meet with the study team and will be taught how to limit the&#xD;
      exposure to the studied food additives in their diet. Participants will also be asked to&#xD;
      limit eating out to a maximum of 2 days per week. Primary outcomes in this study are&#xD;
      recruitment rate, retention rate and adherence to the proposed dietary intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2018</start_date>
  <completion_date type="Actual">July 16, 2019</completion_date>
  <primary_completion_date type="Actual">July 16, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment rate</measure>
    <time_frame>0 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention rate</measure>
    <time_frame>5 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to the dietary intervention</measure>
    <time_frame>2 to 4 months</time_frame>
    <description>Proportion of meals/beverages suspected to contain the studied food additives on 3 unannounced 24-hour dietary recalls conducted at 2, 3 and 4 months</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Dietary intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dietary intervention</intervention_name>
    <description>Limiting dietary exposure to benzoic acid, sorbic acid, polysorbates and related food additives; limiting eating out to a maximum of 2 days per week.</description>
    <arm_group_label>Dietary intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI&gt;/=30 kg/m2&#xD;
&#xD;
          -  willingness and ability to follow the proposed dietary intervention&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous or planned bariatric surgery in the next 1 year&#xD;
&#xD;
          -  current or planned participation in any structured weight-loss programs in the next 6&#xD;
             months&#xD;
&#xD;
          -  current or recent (within the last 6 months) use of weight-loss-inducing drugs or&#xD;
             systemic steroids&#xD;
&#xD;
          -  bipolar disorder or attention deficit hyperactivity disorder&#xD;
&#xD;
          -  current use of anti-depressant or anti-psychotic medications&#xD;
&#xD;
          -  eating disorder or any other active disorder that may lead to significant weight&#xD;
             changes&#xD;
&#xD;
          -  working night shifts&#xD;
&#xD;
          -  pregnancy or planned pregnancy in the next 1 year&#xD;
&#xD;
          -  uncontrolled diabetes mellitus or diabetes requiring treatment with &gt;2 oral diabetes&#xD;
             medications or with insulin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>McMaster University</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S 4K1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>August 18, 2019</last_update_submitted>
  <last_update_submitted_qc>August 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Natalia McInnes</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>dietary modification</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT03757962
org study id: 5157
nct id: NCT03757962
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The effects of food additives on body weight in humans are largely unknown. This is a
      before-and-after feasibility study in 5 obese adults who will be followed for 5 months.
      Eligible participants will meet with the study team and will be taught how to limit the
      exposure to the studied food additives in their diet. Participants will also be asked to
      limit eating out to a maximum of 2 days per week. Primary outcomes in this study are
      recruitment rate, retention rate and adherence to the proposed dietary intervention.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recruitment rate
time frame: 0 months
measure: Retention rate
time frame: 5 months
measure: Adherence to the dietary intervention
time frame: 2 to 4 months
description: Proportion of meals/beverages suspected to contain the studied food additives on 3 unannounced 24-hour dietary recalls conducted at 2, 3 and 4 months
arm group label: Dietary intervention
arm group type: Experimental
intervention type: Other
intervention name: Dietary intervention
description: Limiting dietary exposure to benzoic acid, sorbic acid, polysorbates and related food additives; limiting eating out to a maximum of 2 days per week.
arm group label: Dietary intervention
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Natalia McInnes
investigator title: Associate Professor
mesh term: Obesity
sharing ipd: No