<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/NCT01665339</url>
  </required_header>
  <id_info>
    <org_study_id>Effect of preload on weight</org_study_id>
    <secondary_id>IUMS</secondary_id>
    <nct_id>NCT01665339</nct_id>
  </id_info>
  <brief_title>Preload, Weight Management, Risk of Cardiovascular Disease</brief_title>
  <official_title>Effect of Preload on Body Weight and Cardiovascular Risks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Isfahan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Isfahan University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators presumed that preload consumers will have more weight reduction and lower risk&#xD;
      of cardiovascular disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To our knowledge, all previous studies evaluated the energy intake in a dietary meal after&#xD;
      consuming a low-energy-dense preload while none assessed the sustainability of lower amount&#xD;
      of energy intake and body weight changes in a long-term. On the other hand, the&#xD;
      sustainability of lower energy intake in a long term might be affected by higher dietary&#xD;
      diversity score due to considering preload in diets. Notably, increased diet variety is&#xD;
      associated with higher overall dietary energy intake and weight gain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">December 2011</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the amount of weight reduction in two dietary groups</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Body Weight</condition>
  <arm_group>
    <arm_group_label>preload</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects in preload group consumed salad, yogurt and water 15 minutes before the main meal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects in control group consumed salad and yogurt with meal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>preload diet</intervention_name>
    <description>All participants were prescribed a calorie-restricted diet (-200 to -500 kcal/d). Calorie requirements of each subject were estimated based on resting energy expenditure (REE) by using Harris- Benedict equation and also considering the physical activity levels. The diets were constructed to provide similar proportions of carbohydrates (55% energy), protein (15% energy) and total fat (30% energy).</description>
    <arm_group_label>preload</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control diet</intervention_name>
    <description>All participants were prescribed a calorie-restricted diet (-200 to -500 kcal/d). Calorie requirements of each subject were estimated based on resting energy expenditure (REE) by using Harris- Benedict equation and also considering the physical activity levels. The diets were constructed to provide similar proportions of carbohydrates (55% energy), protein (15% energy) and total fat (30% energy).</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 25,&#xD;
&#xD;
          -  older than 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  poor dietary compliance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leila Azadbakht, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Isfahan University of Medical Sciences</affiliation>
  </overall_official>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 1, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>August 14, 2012</last_update_submitted>
  <last_update_submitted_qc>August 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Isfahan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Leila Azadbakht</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>preload</keyword>
  <keyword>anthropometric measures</keyword>
  <keyword>cardiovascular risk factors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
  </condition_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/NCT01665339
org study id: Effect of preload on weight
secondary id: IUMS
nct id: NCT01665339
lead sponsor: 
has dmc: No
Investigators presumed that preload consumers will have more weight reduction and lower risk
      of cardiovascular disease
To our knowledge, all previous studies evaluated the energy intake in a dietary meal after
      consuming a low-energy-dense preload while none assessed the sustainability of lower amount
      of energy intake and body weight changes in a long-term. On the other hand, the
      sustainability of lower energy intake in a long term might be affected by higher dietary
      diversity score due to considering preload in diets. Notably, increased diet variety is
      associated with higher overall dietary energy intake and weight gain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: the amount of weight reduction in two dietary groups
time frame: 3 months
arm group label: preload
arm group type: Experimental
description: subjects in preload group consumed salad, yogurt and water 15 minutes before the main meal.
arm group label: control
arm group type: Experimental
description: subjects in control group consumed salad and yogurt with meal.
intervention type: Other
intervention name: preload diet
description: All participants were prescribed a calorie-restricted diet (-200 to -500 kcal/d). Calorie requirements of each subject were estimated based on resting energy expenditure (REE) by using Harris- Benedict equation and also considering the physical activity levels. The diets were constructed to provide similar proportions of carbohydrates (55% energy), protein (15% energy) and total fat (30% energy).
arm group label: preload
intervention type: Other
intervention name: control diet
description: All participants were prescribed a calorie-restricted diet (-200 to -500 kcal/d). Calorie requirements of each subject were estimated based on resting energy expenditure (REE) by using Harris- Benedict equation and also considering the physical activity levels. The diets were constructed to provide similar proportions of carbohydrates (55% energy), protein (15% energy) and total fat (30% energy).
arm group label: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Leila Azadbakht, PhD
role: Principal Investigator
affiliation: Isfahan University of Medical Sciences
responsible party type: Principal Investigator
investigator affiliation: Isfahan University of Medical Sciences
investigator full name: Leila Azadbakht
investigator title: Principal Investigator
mesh term: Body Weight