<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/NCT03297931</url>
  </required_header>
  <id_info>
    <org_study_id>SPG_Snack Study</org_study_id>
    <nct_id>NCT03297931</nct_id>
  </id_info>
  <brief_title>Comparison of Pulse Chips and Commercial Snacks on Food Intake, Appetite and Blood Glucose in Healthy Young Adults</brief_title>
  <official_title>Comparison of Roasted Pulse Snacks, Pulse Chips and Commercial Snacks on Post-prandial Food Intake, Appetite and Glycemic Response in Healthy Young Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Toronto</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Consumers are often forced to eat fast, convenient foods and snacks (&quot;eat on the go&quot;) in&#xD;
      order to match the pace of their lifestyles. However, these snack options more often than not&#xD;
      offer little health benefit to the consumer. In fact, 55% of calories consumed by Canadians&#xD;
      are ultra processed foods, which are limited in their nutrient profile and only offer empty&#xD;
      calories. Subsequently, these foods lead the consumer to eat more and provides little to no&#xD;
      feelings of satiety or satiation. the proposed objectives of the current project are to&#xD;
      examine the physiological benefit(s) of consuming readily available pulse snacks and compare&#xD;
      them to other commonly consumed snack varieties. This work aims to incentivize consumers to&#xD;
      seek out pulses as valuable snacking options and highlight the benefit of including these as&#xD;
      alternatives to other energy-dense snacks that lack the nutritional composition of pulses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis of the study: Inclusion of pulses as part of a snack will lower appetite and&#xD;
      post-prandial glycemia (PPG) in comparison to commercial, commonly consumed non-pulse snacks.&#xD;
&#xD;
      Overall Objective of the study: To investigate and compare the effects of pulse and non-pulse&#xD;
      snacks served as chips and dip on appetite and PPG in healthy adults.&#xD;
&#xD;
      Specific objectives of the study: To test the acute effects of different pulse snacks on: 1)&#xD;
      PPG and appetite for three hours, and 2) food intake 1 hour following consumption of snacks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 19, 2017</start_date>
  <completion_date type="Anticipated">May 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in blood glucose levels</measure>
    <time_frame>Starting at the beginning of each session (0 minutes, before consumption of treatment) and every 15 - 30 minutes up to 190 minutes (time of completion of each session)</time_frame>
    <description>Each participant will attend 6 sessions in total (randomized 6-arm cross-over design)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective appetite</measure>
    <time_frame>Measured every 15-30 minutes up to 190 minutes</time_frame>
    <description>Measured using Visual Analog Scales (VAS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Food intake</measure>
    <time_frame>65 minutes after completion of treatment, 20 minutes is allocated to allow for pizza consumption</time_frame>
    <description>Food intake is measured by the amount of pizza (in grams) consumed during the 20 minute period (pizza is served ad libitum)</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Obesity</condition>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Commercial corn chips + Onion dip</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Corn chips + onion dip</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Commercial pulse chip + pulse spread</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pinto bean chip + hummus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Novel pulse chip + pulse spread</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Yellow pea chip + hummus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Commercial pulse chip + non-pulse spread</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pinto bean chip + onion dip</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Novel pulse chip + non-pulse spread</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Yellow pea chip + onion dip</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-pulse chip + pulse spread</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Corn chips + hummus</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Corn Chips + Onion Dip</intervention_name>
    <description>Non-pulse chip + non-pulse dip</description>
    <arm_group_label>Commercial corn chips + Onion dip</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Yellow pea chip + hummus</intervention_name>
    <description>Novel pulse chip + pulse spread</description>
    <arm_group_label>Novel pulse chip + pulse spread</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Pinto bean chip + hummus</intervention_name>
    <description>Commercial pulse chip + pulse spread</description>
    <arm_group_label>Commercial pulse chip + pulse spread</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Pinto bean chip + onion dip</intervention_name>
    <description>Commercial pulse chip + non-pulse spread</description>
    <arm_group_label>Commercial pulse chip + non-pulse spread</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Yellow pea chip + onion dip</intervention_name>
    <description>Novel pulse chip + non-pulse spread</description>
    <arm_group_label>Novel pulse chip + non-pulse spread</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Corn chips + hummus</intervention_name>
    <description>Non-pulse chip + pulse spread</description>
    <arm_group_label>Non-pulse chip + pulse spread</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: ≥18 and ≤45 years&#xD;
&#xD;
          -  BMI: ≥ 18.5 and ≤ 29.9 kg/m2&#xD;
&#xD;
          -  Fasting serum glucose: ≤ 5.6 mmol/L&#xD;
&#xD;
          -  Willing to maintain habitual diet, physical activity pattern, and body weight&#xD;
             throughout the trial.&#xD;
&#xD;
          -  Willing to maintain current dietary supplement use throughout the trial. On test days,&#xD;
             subject agrees not to take any dietary supplements until dismissal from the Department&#xD;
             of Nutritional Sciences. Failure to comply will result in a rescheduled test visit.&#xD;
&#xD;
          -  Willing to abstain from alcohol consumption for 24 h prior to all test visits.&#xD;
&#xD;
          -  Willing to avoid vigorous physical activity for 24 h prior to all test visits.&#xD;
&#xD;
          -  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;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fasting blood glucose &gt; 5.6 mmol/L&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Thyroid problems&#xD;
&#xD;
          -  Previous history of cardiovascular disease, diabetes, liver or kidney disease,&#xD;
             inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive&#xD;
             syndrome, pancreatitis, gallbladder or biliary disease.&#xD;
&#xD;
          -  Presence of gastrointestinal disorder or surgeries within the past year.&#xD;
&#xD;
          -  Consuming prescription or non-prescription drug, herbal or nutritional supplements&#xD;
             known to affect blood glucose or that could affect the outcome of the study as per&#xD;
             investigator's judgement.&#xD;
&#xD;
          -  Patients who have undergone bariatric surgery at any point.&#xD;
&#xD;
          -  Known to be pregnant or lactating.&#xD;
&#xD;
          -  Unwillingness or inability to comply with the experimental procedures&#xD;
&#xD;
          -  Known intolerance, sensitivity or allergy to pulses or dairy.&#xD;
&#xD;
          -  Extreme dietary habits (ie. Atkins diet, very high protein diets, etc.).&#xD;
&#xD;
          -  Uncontrolled hypertension (systolic blood pressure ≥ 140 mm Hg or diastolic blood&#xD;
             pressure ≥ 90 mm Hg) as defined by the average blood pressure measured at screening.&#xD;
&#xD;
          -  Weight gain or loss of at least 10 lbs in previous three months.&#xD;
&#xD;
          -  Excessive alcohol intake (more than 2 drinks per day or more than 9 drinks per week)&#xD;
&#xD;
          -  Restrained Eaters&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harvey G Anderson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Toronto</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5S 3E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>June 28, 2021</last_update_submitted>
  <last_update_submitted_qc>June 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Toronto</investigator_affiliation>
    <investigator_full_name>G. Harvey Anderson</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Pulse</keyword>
  <keyword>Snack</keyword>
  <keyword>Post-prandial glycemia</keyword>
  <keyword>Appetite</keyword>
  <keyword>Food intake</keyword>
  <keyword>Young adults</keyword>
  <keyword>Satiety</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iproplatin</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/NCT03297931
org study id: SPG_Snack Study
nct id: NCT03297931
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Consumers are often forced to eat fast, convenient foods and snacks ("eat on the go") in
      order to match the pace of their lifestyles. However, these snack options more often than not
      offer little health benefit to the consumer. In fact, 55% of calories consumed by Canadians
      are ultra processed foods, which are limited in their nutrient profile and only offer empty
      calories. Subsequently, these foods lead the consumer to eat more and provides little to no
      feelings of satiety or satiation. the proposed objectives of the current project are to
      examine the physiological benefit(s) of consuming readily available pulse snacks and compare
      them to other commonly consumed snack varieties. This work aims to incentivize consumers to
      seek out pulses as valuable snacking options and highlight the benefit of including these as
      alternatives to other energy-dense snacks that lack the nutritional composition of pulses.
Hypothesis of the study: Inclusion of pulses as part of a snack will lower appetite and
      post-prandial glycemia (PPG) in comparison to commercial, commonly consumed non-pulse snacks.

      Overall Objective of the study: To investigate and compare the effects of pulse and non-pulse
      snacks served as chips and dip on appetite and PPG in healthy adults.

      Specific objectives of the study: To test the acute effects of different pulse snacks on: 1)
      PPG and appetite for three hours, and 2) food intake 1 hour following consumption of snacks.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Change in blood glucose levels
time frame: Starting at the beginning of each session (0 minutes, before consumption of treatment) and every 15 - 30 minutes up to 190 minutes (time of completion of each session)
description: Each participant will attend 6 sessions in total (randomized 6-arm cross-over design)
measure: Subjective appetite
time frame: Measured every 15-30 minutes up to 190 minutes
description: Measured using Visual Analog Scales (VAS)
measure: Food intake
time frame: 65 minutes after completion of treatment, 20 minutes is allocated to allow for pizza consumption
description: Food intake is measured by the amount of pizza (in grams) consumed during the 20 minute period (pizza is served ad libitum)
arm group label: Commercial corn chips + Onion dip
arm group type: Active Comparator
description: Corn chips + onion dip
arm group label: Commercial pulse chip + pulse spread
arm group type: Experimental
description: Pinto bean chip + hummus
arm group label: Novel pulse chip + pulse spread
arm group type: Experimental
description: Yellow pea chip + hummus
arm group label: Commercial pulse chip + non-pulse spread
arm group type: Experimental
description: Pinto bean chip + onion dip
arm group label: Novel pulse chip + non-pulse spread
arm group type: Experimental
description: Yellow pea chip + onion dip
arm group label: Non-pulse chip + pulse spread
arm group type: Experimental
description: Corn chips + hummus
intervention type: Dietary Supplement
intervention name: Corn Chips + Onion Dip
description: Non-pulse chip + non-pulse dip
arm group label: Commercial corn chips + Onion dip
intervention type: Dietary Supplement
intervention name: Yellow pea chip + hummus
description: Novel pulse chip + pulse spread
arm group label: Novel pulse chip + pulse spread
intervention type: Dietary Supplement
intervention name: Pinto bean chip + hummus
description: Commercial pulse chip + pulse spread
arm group label: Commercial pulse chip + pulse spread
intervention type: Dietary Supplement
intervention name: Pinto bean chip + onion dip
description: Commercial pulse chip + non-pulse spread
arm group label: Commercial pulse chip + non-pulse spread
intervention type: Dietary Supplement
intervention name: Yellow pea chip + onion dip
description: Novel pulse chip + non-pulse spread
arm group label: Novel pulse chip + non-pulse spread
intervention type: Dietary Supplement
intervention name: Corn chips + hummus
description: Non-pulse chip + pulse spread
arm group label: Non-pulse chip + pulse spread
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Harvey G Anderson, PhD
role: Principal Investigator
affiliation: University of Toronto
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Toronto
investigator full name: G. Harvey Anderson
investigator title: Professor
mesh term: Iproplatin