<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/NCT04458493</url>
  </required_header>
  <id_info>
    <org_study_id>116302</org_study_id>
    <nct_id>NCT04458493</nct_id>
  </id_info>
  <brief_title>Does Meal Replacement With a Carbohydrates and Protein Supplement Induce Weight Loss in Overweight and/or Obese Adults?</brief_title>
  <official_title>Does Meal Replacement With a Carbohydrates and Protein Supplement Induce Weight Loss in Overweight and/or Obese Adults?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western University, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western University, Canada</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>
      Participants will be randomized into two groups, one group will be the control (no&#xD;
      intervention at all) and the other will be CHO-PRO (meal replacement, Generation UCAN&#xD;
      supplement, 400ml, 20% solution). Prior to the start of the experiment, all participants will&#xD;
      be asked to record their satiety ratings, appetite and desire to eat (10-point visual&#xD;
      analogue scale) 30, 60 and 120 minutes after their regular dinner for 3 days. On the first&#xD;
      day of the experiment, all participants will be asked to measure their waist and hip&#xD;
      circumferences, fasting blood glucose level, maximal number of pushups and body weight using&#xD;
      a scale at home prior to breakfast. Instructions on how to do the measurements properly will&#xD;
      be recorded in a video and distributed to the participants. Participants in the control group&#xD;
      will not receive any intervention. Participants in the CHO-PRO group will be provided with&#xD;
      the supplement and they will be asked to consume the CHO - protein supplement (Generation&#xD;
      UCAN supplement, 250ml, 10% solution) 6 to 7 hours after lunch, in place of their dinner for&#xD;
      6 weeks. They will also be asked to record their satiety ratings, appetite and desire to eat&#xD;
      (10-point visual analogue scale) 30, 60 and 120 minutes after each meal replacement drink.&#xD;
      All participants will be required to complete a dietary record, prior to, and during (at&#xD;
      weeks 2 and 4) intervention. To track adherence of the CHO-PRO group, participants will be&#xD;
      asked to check off the calendar that they did not consume the meal replacement due to various&#xD;
      reasons. On day 43, all participants will be asked measure again waist and hip&#xD;
      circumferences, fasting blood glucose level, maximal number of pushups and body weight using&#xD;
      a scale at home prior to breakfast again.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in body weight</measure>
    <time_frame>1 day prior to the start of the experiment and on the 31st day of the experiment</time_frame>
    <description>body weight will be measured using a scale at home prior to breakfast</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in waist and hip circumferences</measure>
    <time_frame>1 day prior to the start of the experiment and on the 31st day of the experiment</time_frame>
    <description>waist and hip circumferences will be measured using a measuring tape at home prior to breakfast</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in fasted blood glucose</measure>
    <time_frame>1 day prior to the start of the experiment and on the 31st day of the experiment</time_frame>
    <description>blood glucose will be measured through finger pricks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in appetite ratings</measure>
    <time_frame>30, 60 and 120 minutes after each meal replacement drink</time_frame>
    <description>appetite ratings will be asked with the use a 10 point visual analog scale (VAS), 10 being strong desire to consume food and 1 being no desire to consume food at all</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in desire to eat ratings</measure>
    <time_frame>30, 60 and 120 minutes after each meal replacement drink</time_frame>
    <description>desire to eat ratings will be asked with the use a 10 point visual analog scale (VAS), 10 being no desire to eat at all and 1 being strong desire to eat</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>no supplement will be provided on the day of the experiment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Generation UCAN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>carbohydrates - protein (Generation UCAN supplement, 400ml, 20% solution)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>satiety</intervention_name>
    <description>satiety ratings, appetite and desire to eat (10-point visual analogue scale) will be measured at 30, 60 and 120 minutes after each meal replacement drink</description>
    <arm_group_label>Generation UCAN</arm_group_label>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dietary Supplement: Generation UCAN supplementation</intervention_name>
    <description>meal replacement, Generation UCAN supplement, 400ml, 20% solution</description>
    <arm_group_label>Generation UCAN</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  sedentary (&lt;2 moderate exercise bouts/wk)&#xD;
&#xD;
          -  between the ages of 18 to 40y&#xD;
&#xD;
          -  body mass index (BMI) between &gt;25&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  do not eat three meals a day typically&#xD;
&#xD;
          -  taking medication that affects their eating patterns&#xD;
&#xD;
          -  have metabolic and gastrointestinal diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Lemon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Crystal Lee, BSc</last_name>
    <phone>519 6612111</phone>
    <email>plee263@uwo.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Manuel Manuel, MSc</last_name>
    <phone>519 6612111</phone>
    <email>mquinon2@uwo.ca</email>
  </overall_contact_backup>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western University, Canada</investigator_affiliation>
    <investigator_full_name>Peter Lemon</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</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/NCT04458493
org study id: 116302
nct id: NCT04458493
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Participants will be randomized into two groups, one group will be the control (no
      intervention at all) and the other will be CHO-PRO (meal replacement, Generation UCAN
      supplement, 400ml, 20% solution). Prior to the start of the experiment, all participants will
      be asked to record their satiety ratings, appetite and desire to eat (10-point visual
      analogue scale) 30, 60 and 120 minutes after their regular dinner for 3 days. On the first
      day of the experiment, all participants will be asked to measure their waist and hip
      circumferences, fasting blood glucose level, maximal number of pushups and body weight using
      a scale at home prior to breakfast. Instructions on how to do the measurements properly will
      be recorded in a video and distributed to the participants. Participants in the control group
      will not receive any intervention. Participants in the CHO-PRO group will be provided with
      the supplement and they will be asked to consume the CHO - protein supplement (Generation
      UCAN supplement, 250ml, 10% solution) 6 to 7 hours after lunch, in place of their dinner for
      6 weeks. They will also be asked to record their satiety ratings, appetite and desire to eat
      (10-point visual analogue scale) 30, 60 and 120 minutes after each meal replacement drink.
      All participants will be required to complete a dietary record, prior to, and during (at
      weeks 2 and 4) intervention. To track adherence of the CHO-PRO group, participants will be
      asked to check off the calendar that they did not consume the meal replacement due to various
      reasons. On day 43, all participants will be asked measure again waist and hip
      circumferences, fasting blood glucose level, maximal number of pushups and body weight using
      a scale at home prior to breakfast again.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: changes in body weight
time frame: 1 day prior to the start of the experiment and on the 31st day of the experiment
description: body weight will be measured using a scale at home prior to breakfast
measure: changes in waist and hip circumferences
time frame: 1 day prior to the start of the experiment and on the 31st day of the experiment
description: waist and hip circumferences will be measured using a measuring tape at home prior to breakfast
measure: changes in fasted blood glucose
time frame: 1 day prior to the start of the experiment and on the 31st day of the experiment
description: blood glucose will be measured through finger pricks
measure: changes in appetite ratings
time frame: 30, 60 and 120 minutes after each meal replacement drink
description: appetite ratings will be asked with the use a 10 point visual analog scale (VAS), 10 being strong desire to consume food and 1 being no desire to consume food at all
measure: changes in desire to eat ratings
time frame: 30, 60 and 120 minutes after each meal replacement drink
description: desire to eat ratings will be asked with the use a 10 point visual analog scale (VAS), 10 being no desire to eat at all and 1 being strong desire to eat
arm group label: control
arm group type: Experimental
description: no supplement will be provided on the day of the experiment
arm group label: Generation UCAN
arm group type: Experimental
description: carbohydrates - protein (Generation UCAN supplement, 400ml, 20% solution)
intervention type: Behavioral
intervention name: satiety
description: satiety ratings, appetite and desire to eat (10-point visual analogue scale) will be measured at 30, 60 and 120 minutes after each meal replacement drink
arm group label: Generation UCAN
arm group label: control
intervention type: Dietary Supplement
intervention name: Dietary Supplement: Generation UCAN supplementation
description: meal replacement, Generation UCAN supplement, 400ml, 20% solution
arm group label: Generation UCAN
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Peter Lemon, PhD
role: Principal Investigator
affiliation: Western University
last name: Crystal Lee, BSc
phone: 519 6612111
email: plee263@uwo.ca
last name: Manuel Manuel, MSc
phone: 519 6612111
email: mquinon2@uwo.ca
responsible party type: Principal Investigator
investigator affiliation: Western University, Canada
investigator full name: Peter Lemon
investigator title: Principal Investigator
mesh term: Overweight
mesh term: Body Weight
mesh term: Weight Loss
sharing ipd: No