<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/NCT03307681</url>
  </required_header>
  <id_info>
    <org_study_id>REB2017-330 II</org_study_id>
    <nct_id>NCT03307681</nct_id>
  </id_info>
  <brief_title>Effect of White Potatoes on Glycemic Response, Satiety and Food Intake in Children</brief_title>
  <official_title>Effect of White Potatoes on Glycemic Response, Satiety and Food Intake in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Toronto Metropolitan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Toronto Metropolitan 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 purpose of the present study is to explore the influence of cooking methods on&#xD;
      post-prandial glycaemia and its impact on satiety in children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each of the 5 study sessions will be at least 7 days apart. Either meal skipping, or one of&#xD;
      three treatments of white potatoes (a) baked (with skin), (b) mashed, (c) fried French fries,&#xD;
      or white bread, prepared on the day of testing, will be served to healthy children (9-14&#xD;
      years). Participants will consume the equivalent to 1 medium sized potato (~280 kcal) or an&#xD;
      equivalent amount of calories from white bread. Glycemic response, insulin, incretin hormones&#xD;
      (glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic peptide (GIP)), dipeptidyl&#xD;
      peptidase 4 (DPP4), and cholecystokinin (CCK) will be measured for 2 h (0, 15, 30, 45, 60, 90&#xD;
      and 120 min) following meal consumption, as well as mood and subjective appetite. An ad&#xD;
      libitum test meal will be provided at 120 min to assess food intake suppression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2018</start_date>
  <completion_date type="Actual">June 21, 2020</completion_date>
  <primary_completion_date type="Actual">June 21, 2020</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ad libitum food intake (lunch, at 120 minutes)</measure>
    <time_frame>at 120 minutes post morning meal consumption</time_frame>
    <description>Food intake will be determined by weighing the meal before and after serving. The net weight of the test meal will be converted to calories</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline glycemic response</measure>
    <time_frame>15, 30, 45, 60, 90, and 120 minutes after meal consumption</time_frame>
    <description>Blood glucose (mmol/L). Blood glucose will be measured in whole blood using YSI 2300 STAT PLUS (YSI Incorporated, Yellow Springs, OH)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline insulin</measure>
    <time_frame>15, 30, 45, 60, 90, and 120 minutes after meal consumption</time_frame>
    <description>Blood insulin (pmol/L). Insulin concentration in serum will be determined in duplicate via enzyme-linked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline subjective appetite</measure>
    <time_frame>15, 30, 45, 60, 90, and 120 minutes after meal consumption</time_frame>
    <description>Measured using visual analogue scale (mm). Each VAS is a 100 mm line where they will place a pencil mark to describe their feelings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline mood</measure>
    <time_frame>15, 30, 45, 60, 90, and 120 minutes after meal consumption</time_frame>
    <description>Measured using visual analogue scale (mm). Each VAS is a 100 mm line where they will place a pencil mark to describe their feelings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline cholecystokinin (CCK)</measure>
    <time_frame>15, 30, 45, 60, 90, and 120 minutes after meal consumption</time_frame>
    <description>Blood CCK (pmol/L). CCK concentration in serum will be determined in duplicate via enzyme-linked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline dipeptidyl peptidase 4 (DPP4)</measure>
    <time_frame>15, 30, 45, 60, 90, and 120 minutes after meal consumption</time_frame>
    <description>Blood DPP4 (ng/mL). DPP4 concentration in serum will be determined in duplicate via enzyme-linked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline glucose-dependent insulinotropic peptide (GIP)</measure>
    <time_frame>15, 30, 45, 60, 90, and 120 minutes after meal consumption</time_frame>
    <description>Blood GIP (pmol/L). GIP concentration in serum will be determined in duplicate via enzyme-linked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline glucagon-like peptide-1 (GLP-1)</measure>
    <time_frame>15, 30, 45, 60, 90, and 120 minutes after meal consumption</time_frame>
    <description>Blood GLP-1 (pmol/L). GLP-1 concentration in serum will be determined in duplicate via enzyme-linked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>White bread</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Matched for energy content and available carbohydrate content of potato treatments</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Baked potato with skin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Baked russet potato</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mashed potato served hot</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mashed potatoes prepared from frozen, matched for available carbohydrate content of baked potato</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fried French fries</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Matched for available carbohydrate content of baked potato</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Meal skipping</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>No food given</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>White bread</intervention_name>
    <description>Toasted, with canola oil added to match for fat content of French fries (13.9 grams), as well as being matched for energy (280 kilocalories) and available carbohydrate content (33 grams) of potato treatments.</description>
    <arm_group_label>White bread</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Baked potato with skin</intervention_name>
    <description>Baked russet potato with canola oil added once baked to match for fat content of French fries, and also matched for the salt content of white bread (280 milligrams).</description>
    <arm_group_label>Baked potato with skin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mashed potato served hot</intervention_name>
    <description>Mashed potatoes prepared from frozen, with canola oil added to match for fat content of French fries, as well as being matched for energy and available carbohydrate content of the baked potato.</description>
    <arm_group_label>Mashed potato served hot</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fried French fries</intervention_name>
    <description>Prepared from frozen, matched for energy and available carbohydrate content of baked potato and salt content of white bread.</description>
    <arm_group_label>Fried French fries</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Meal skipping</intervention_name>
    <description>No food given</description>
    <arm_group_label>Meal skipping</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  be between 9 and 14 years of age&#xD;
&#xD;
          -  be healthy, and have been born at term&#xD;
&#xD;
          -  be a native English speaker&#xD;
&#xD;
          -  not be taking any medications&#xD;
&#xD;
          -  not have allergies to potatoes, rice, or beans.&#xD;
&#xD;
          -  normal body weight (between the 5th and 85th BMI percentile for age and gender)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  anyone with food sensitivities or allergies to potatoes or potato-products,&#xD;
&#xD;
          -  smokers&#xD;
&#xD;
          -  diabetic or overweight/obese individuals.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nick Bellissimo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Toronto Metropolitan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Nutrition, Ryerson University</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 2K3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>September 28, 2020</last_update_submitted>
  <last_update_submitted_qc>September 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Toronto Metropolitan University</investigator_affiliation>
    <investigator_full_name>Nick Bellissimo</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>White potatoes</keyword>
  <keyword>Children</keyword>
  <keyword>Satiety</keyword>
  <keyword>Glycaemia</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03307681
org study id: REB2017-330 II
nct id: NCT03307681
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the present study is to explore the influence of cooking methods on
      post-prandial glycaemia and its impact on satiety in children.
Each of the 5 study sessions will be at least 7 days apart. Either meal skipping, or one of
      three treatments of white potatoes (a) baked (with skin), (b) mashed, (c) fried French fries,
      or white bread, prepared on the day of testing, will be served to healthy children (9-14
      years). Participants will consume the equivalent to 1 medium sized potato (~280 kcal) or an
      equivalent amount of calories from white bread. Glycemic response, insulin, incretin hormones
      (glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic peptide (GIP)), dipeptidyl
      peptidase 4 (DPP4), and cholecystokinin (CCK) will be measured for 2 h (0, 15, 30, 45, 60, 90
      and 120 min) following meal consumption, as well as mood and subjective appetite. An ad
      libitum test meal will be provided at 120 min to assess food intake suppression.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Ad libitum food intake (lunch, at 120 minutes)
time frame: at 120 minutes post morning meal consumption
description: Food intake will be determined by weighing the meal before and after serving. The net weight of the test meal will be converted to calories
measure: Change from baseline glycemic response
time frame: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
description: Blood glucose (mmol/L). Blood glucose will be measured in whole blood using YSI 2300 STAT PLUS (YSI Incorporated, Yellow Springs, OH)
measure: Change from baseline insulin
time frame: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
description: Blood insulin (pmol/L). Insulin concentration in serum will be determined in duplicate via enzyme-linked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).
measure: Change from baseline subjective appetite
time frame: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
description: Measured using visual analogue scale (mm). Each VAS is a 100 mm line where they will place a pencil mark to describe their feelings.
measure: Change from baseline mood
time frame: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
description: Measured using visual analogue scale (mm). Each VAS is a 100 mm line where they will place a pencil mark to describe their feelings.
measure: Change from baseline cholecystokinin (CCK)
time frame: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
description: Blood CCK (pmol/L). CCK concentration in serum will be determined in duplicate via enzyme-linked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).
measure: Change from baseline dipeptidyl peptidase 4 (DPP4)
time frame: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
description: Blood DPP4 (ng/mL). DPP4 concentration in serum will be determined in duplicate via enzyme-linked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).
measure: Change from baseline glucose-dependent insulinotropic peptide (GIP)
time frame: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
description: Blood GIP (pmol/L). GIP concentration in serum will be determined in duplicate via enzyme-linked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).
measure: Change from baseline glucagon-like peptide-1 (GLP-1)
time frame: 15, 30, 45, 60, 90, and 120 minutes after meal consumption
description: Blood GLP-1 (pmol/L). GLP-1 concentration in serum will be determined in duplicate via enzyme-linked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).
arm group label: White bread
arm group type: Experimental
description: Matched for energy content and available carbohydrate content of potato treatments
arm group label: Baked potato with skin
arm group type: Experimental
description: Baked russet potato
arm group label: Mashed potato served hot
arm group type: Experimental
description: Mashed potatoes prepared from frozen, matched for available carbohydrate content of baked potato
arm group label: Fried French fries
arm group type: Experimental
description: Matched for available carbohydrate content of baked potato
arm group label: Meal skipping
arm group type: Experimental
description: No food given
intervention type: Other
intervention name: White bread
description: Toasted, with canola oil added to match for fat content of French fries (13.9 grams), as well as being matched for energy (280 kilocalories) and available carbohydrate content (33 grams) of potato treatments.
arm group label: White bread
intervention type: Other
intervention name: Baked potato with skin
description: Baked russet potato with canola oil added once baked to match for fat content of French fries, and also matched for the salt content of white bread (280 milligrams).
arm group label: Baked potato with skin
intervention type: Other
intervention name: Mashed potato served hot
description: Mashed potatoes prepared from frozen, with canola oil added to match for fat content of French fries, as well as being matched for energy and available carbohydrate content of the baked potato.
arm group label: Mashed potato served hot
intervention type: Other
intervention name: Fried French fries
description: Prepared from frozen, matched for energy and available carbohydrate content of baked potato and salt content of white bread.
arm group label: Fried French fries
intervention type: Other
intervention name: Meal skipping
description: No food given
arm group label: Meal skipping
criteria: 
gender: All
minimum age: 9 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nick Bellissimo, PhD
role: Principal Investigator
affiliation: Toronto Metropolitan University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Toronto Metropolitan University
investigator full name: Nick Bellissimo
investigator title: Associate Professor
sharing ipd: Undecided