<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/NCT02979717</url>
  </required_header>
  <id_info>
    <org_study_id>GIL-1653</org_study_id>
    <nct_id>NCT02979717</nct_id>
  </id_info>
  <brief_title>The Effect of a High Protein, High Fibre Shake Pre-load on Measures of Satiety and Subsequent Energy Intake</brief_title>
  <official_title>The Effect of a High Protein, High Fibre Shake Pre-load on Measures of Satiety and Subsequent Energy Intake in Healthy Overweight and Obese Subjects: An Acute Randomized, Crossover, Double-blind Placebo-controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beachbody</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Glycemic Index Laboratories, Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Beachbody</source>
  <brief_summary>
    <textblock>
      The objective of this study is to determine the effect of a high protein, high fiber&#xD;
      supplement pre-load on energy intake at a subsequent meal compared to a low fiber, high&#xD;
      carbohydrate Control product in healthy overweight and obese subjects. The investigators&#xD;
      hypothesize the high protein, high fiber pre-load will result in reduced energy intake at a&#xD;
      subsequent meal compared to low protein, low fiber.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 23, 2016</start_date>
  <completion_date type="Actual">March 14, 2017</completion_date>
  <primary_completion_date type="Actual">March 14, 2017</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>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Energy intake (total kilocalories) at meal subsequent to intervention pre-load</measure>
    <time_frame>1 hour post-intervention</time_frame>
    <description>Participants will consume an ad-libitum pizza meal for 30 minutes, 30 minutes following ingestion of the pre-load intervention. At the end of the 30 minute pizza meal, total caloric intake will be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale (VAS) Appetite Questionnaire on scale of 0-100</measure>
    <time_frame>pre-intervention; 10, 20, 30, 60 min post-intervention</time_frame>
    <description>A standard VAS Appetite questionnaire will be completed by subjects before pre-load intervention, and at indicated time intervals. The 4 questions assess hunger, fullness, desire to eat, and prospective consumption. Each of the questions on the VAS is a 100 mm line anchored at each end with opposing statements. Participants mark a vertical line on the line at a point that they felt reflect their feelings at the moment the test was taken. Scores will be assessed by measuring the distance between the intersection of the vertical line with the line and the left end of the line.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale (VAS) Cravings Questionnaire on scale of 0-100</measure>
    <time_frame>pre-intervention; 10, 20, 30, 60 min post-intervention</time_frame>
    <description>A standard VAS Cravings questionnaire will be completed by subjects before pre-load intervention, and at indicated time intervals. The 4 questions assess cravings for sweet, salty, savory, and fatty. Each of the questions on the VAS is a 100 mm line anchored at each end with opposing statements. Participants mark a vertical line on the line at a point that they felt reflect their feelings at the moment the test was taken. Scores will be assessed by measuring the distance between the intersection of the vertical line with the line and the left end of the line.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Physical Comfort Questionnaire on scale of 0-100</measure>
    <time_frame>pre-intervention; immediately post-intervention; 30 min post-intervention</time_frame>
    <description>This questionnaire assesses Gastrointestinal symptoms including Bloating, Belching, Nausea, Diarrhea, and Flatulence. Participants identify if they are currently experiencing the symptom (Yes/No) and if yes, rate the severity of the symptom (Low to High) on a 100 mm scale (0-100). Measures will be made from the left side of the scale, similar to Appetite and Cravings questionnaires.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>high protein, high fiber</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive a high protein, high fiber dietary supplement pre-load</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low protein, low fiber</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants receive a low protein, low fiber isocaloric pre-load</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>High protein, high fiber dietary supplement</intervention_name>
    <arm_group_label>high protein, high fiber</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low protein, low fiber comparator</intervention_name>
    <arm_group_label>Low protein, low fiber</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or non-pregnant, non-lactating females, 18-50 years of age, inclusive&#xD;
&#xD;
          2. Body mass index (BMI) between 27 and 33 kg/m² inclusive at screening.&#xD;
&#xD;
          3. Blood pressure &lt; 130/85.&#xD;
&#xD;
          4. Willing to maintain habitual diet, physical activity pattern, and body weight&#xD;
             throughout the trial.&#xD;
&#xD;
          5. Willing to abstain from strenuous exercise, consumption of alcoholic drinks and&#xD;
             caffeine-containing food/drinks 24 hours before study days and during study days&#xD;
             (until study completion for that day).&#xD;
&#xD;
          6. Willing to maintain current dietary supplement (if applicable) use throughout the&#xD;
             trial. On test days, subject agrees not to take any dietary supplements until&#xD;
             dismissal from the GI labs. Failure to comply will result in a rescheduled test visit.&#xD;
&#xD;
          7. Absence of health conditions that would prevent fulfillment of study requirements as&#xD;
             judged by the Investigator on the basis of medical history.&#xD;
&#xD;
          8. Understanding the study procedures and willing to provide informed consent to&#xD;
             participate in the study and authorization to release relevant protected health&#xD;
             information to the study investigator.&#xD;
&#xD;
          9. Female subjects are willing to use a contraceptive method to avoid pregnancy during&#xD;
             the study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Failure to meet any one of the inclusion criteria&#xD;
&#xD;
          2. Smokers&#xD;
&#xD;
          3. Known history of AIDS, hepatitis, a history or presence of clinically important&#xD;
             endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including,&#xD;
             but not limited to, atherosclerotic disease, history of myocardial infarction,&#xD;
             peripheral arterial disease, stroke), pulmonary, biliary or GI disorders.&#xD;
&#xD;
          4. Use of medications known to influence carbohydrate metabolism, gastrointestinal&#xD;
             function or appetite, including, but not limited to adrenergic blockers, blood&#xD;
             thinners, diuretics, thiazolidinediones, metformin, antibiotics and systemic&#xD;
             corticosteroids within 4 weeks of the screening visit, or with any condition which&#xD;
             might, in the opinion of Dr. Wolever, the president of GI labs, either: 1) make&#xD;
             participation dangerous to the subject or to others, or 2) affect the results.&#xD;
&#xD;
          5. Major trauma or surgical event within 3 months of screening.&#xD;
&#xD;
          6. Unwillingness or inability to comply with the experimental procedures and to follow GI&#xD;
             Labs safety guidelines.&#xD;
&#xD;
          7. Known intolerance, sensitivity or allergy to any ingredients in the study products.&#xD;
&#xD;
          8. Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high&#xD;
             protein diets, etc)..&#xD;
&#xD;
          9. Change in body weight of &gt;3.5kg within 4 weeks of the screening visit.&#xD;
&#xD;
         10. Presence of any signs or symptoms of an active infection within 5 d prior to any test&#xD;
             visit. If an infection occurs during the study period, test visits should be&#xD;
             rescheduled until all signs and symptoms have resolved and any treatment (i.e.&#xD;
             antibiotic therapy) has been completed at least 5 d prior to each test visit.&#xD;
&#xD;
         11. History of cancer in the prior two years, except for non-melanoma skin cancer.&#xD;
&#xD;
         12. Exposure to any non-registered drug product within 30 d prior to screening.&#xD;
&#xD;
         13. Pregnancy or breastfeeding&#xD;
&#xD;
         14. Any history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge&#xD;
             eating) diagnosed by a health professional&#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>Thomas Wolever, PhD,DM(Oxon)</last_name>
    <role>Principal Investigator</role>
    <affiliation>Glycemic Index Laboratories, Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Glycemic Index Laboratories, Inc.</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5C 2N8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>March 28, 2017</last_update_submitted>
  <last_update_submitted_qc>March 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>satiety</keyword>
  <keyword>protein</keyword>
  <keyword>fiber</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</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/NCT02979717
org study id: GIL-1653
nct id: NCT02979717
lead sponsor: 
collaborator: 
The objective of this study is to determine the effect of a high protein, high fiber
      supplement pre-load on energy intake at a subsequent meal compared to a low fiber, high
      carbohydrate Control product in healthy overweight and obese subjects. The investigators
      hypothesize the high protein, high fiber pre-load will result in reduced energy intake at a
      subsequent meal compared to low protein, low fiber.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Energy intake (total kilocalories) at meal subsequent to intervention pre-load
time frame: 1 hour post-intervention
description: Participants will consume an ad-libitum pizza meal for 30 minutes, 30 minutes following ingestion of the pre-load intervention. At the end of the 30 minute pizza meal, total caloric intake will be recorded.
measure: Visual Analog Scale (VAS) Appetite Questionnaire on scale of 0-100
time frame: pre-intervention; 10, 20, 30, 60 min post-intervention
description: A standard VAS Appetite questionnaire will be completed by subjects before pre-load intervention, and at indicated time intervals. The 4 questions assess hunger, fullness, desire to eat, and prospective consumption. Each of the questions on the VAS is a 100 mm line anchored at each end with opposing statements. Participants mark a vertical line on the line at a point that they felt reflect their feelings at the moment the test was taken. Scores will be assessed by measuring the distance between the intersection of the vertical line with the line and the left end of the line.
measure: Visual Analog Scale (VAS) Cravings Questionnaire on scale of 0-100
time frame: pre-intervention; 10, 20, 30, 60 min post-intervention
description: A standard VAS Cravings questionnaire will be completed by subjects before pre-load intervention, and at indicated time intervals. The 4 questions assess cravings for sweet, salty, savory, and fatty. Each of the questions on the VAS is a 100 mm line anchored at each end with opposing statements. Participants mark a vertical line on the line at a point that they felt reflect their feelings at the moment the test was taken. Scores will be assessed by measuring the distance between the intersection of the vertical line with the line and the left end of the line.
measure: Subjective Physical Comfort Questionnaire on scale of 0-100
time frame: pre-intervention; immediately post-intervention; 30 min post-intervention
description: This questionnaire assesses Gastrointestinal symptoms including Bloating, Belching, Nausea, Diarrhea, and Flatulence. Participants identify if they are currently experiencing the symptom (Yes/No) and if yes, rate the severity of the symptom (Low to High) on a 100 mm scale (0-100). Measures will be made from the left side of the scale, similar to Appetite and Cravings questionnaires.
arm group label: high protein, high fiber
arm group type: Experimental
description: Participants receive a high protein, high fiber dietary supplement pre-load
arm group label: Low protein, low fiber
arm group type: Placebo Comparator
description: Participants receive a low protein, low fiber isocaloric pre-load
intervention type: Dietary Supplement
intervention name: High protein, high fiber dietary supplement
arm group label: high protein, high fiber
intervention type: Other
intervention name: Low protein, low fiber comparator
arm group label: Low protein, low fiber
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas Wolever, PhD,DM(Oxon)
role: Principal Investigator
affiliation: Glycemic Index Laboratories, Inc
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Overweight