<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/NCT03038854</url>
  </required_header>
  <id_info>
    <org_study_id>14.16.INF</org_study_id>
    <nct_id>NCT03038854</nct_id>
  </id_info>
  <brief_title>Growing Up Milk (GUM) Intake and Nutrient Status of Toddlers</brief_title>
  <official_title>Effects of Milk Intake on Nutrient Status and Neurocognitive Development in Toddlers: a Partially Randomized and Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Société des Produits Nestlé (SPN)</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 this study is to determine the nutritional and cognitive effects of consuming&#xD;
      Growing Up Milks (GUMs) and cow's milk.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Single-site, double blind, partially randomized, controlled, 4-arm parallel group clinical&#xD;
      trial. The purpose of this study is to determine if consuming nutrient enriched growing up&#xD;
      milk improves the nutrition status and cognitive performance in healthy toddlers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 8, 2017</start_date>
  <completion_date type="Actual">October 31, 2022</completion_date>
  <primary_completion_date type="Actual">July 11, 2022</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>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of blood nutrient markers after 6 months of intervention</measure>
    <time_frame>6 months</time_frame>
    <description>To compare blood status of the key nutrients of interest after 180 days of intervention in toddlers randomized in a double-blind manner to Test GUM compared to standard GUM. A non-randomized group for comparison will drink either cows' milk (comparator group) as currently recommended by Health Canada, or participate in a reference group with no drinking or feeding interventions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Executive function and language development</measure>
    <time_frame>6 months</time_frame>
    <description>To assess the effect of milk/drink on measures of neurological development. Standard and validated tools will be used in the assessment including Bayley Scales of Infant Development III</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual acuity with Teller Acuity Cards</measure>
    <time_frame>6 months</time_frame>
    <description>To characterize the effects of milk/drink on visual acuity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioural development</measure>
    <time_frame>6 months</time_frame>
    <description>To characterize the effects of milk/drink on behavioural development using standard questionnaires including the Child Behaviour Checklist (CBCL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary nutrient intake</measure>
    <time_frame>6 months</time_frame>
    <description>To characterize effects of milk/drink on dietary intake of energy, macronutrients and key nutrients of interest using the Food Frequency Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">310</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Test GUM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will drink a test toddler growing up milk (GUM) with higher amounts of key nutrients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard GUM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will drink a standard toddler growing up milk (GUM)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This group will drink liquid full fat cows' milk</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Population Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will eat and drink their usual foods with no interventions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Test GUM</intervention_name>
    <description>Growing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children.</description>
    <arm_group_label>Test GUM</arm_group_label>
    <other_name>Growing up milk</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard GUM</intervention_name>
    <description>Growing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children.</description>
    <arm_group_label>Standard GUM</arm_group_label>
    <other_name>Growing up milk</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cows' milk</intervention_name>
    <description>Homogenized store-bought full fat cow's milk.</description>
    <arm_group_label>Comparator Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Having obtained his/her parent's(s') or his/her legal guardian written informed&#xD;
             consent and signed and dated informed consent.&#xD;
&#xD;
          2. Age 17 - 18 months at enrolment.&#xD;
&#xD;
          3. Singleton, full-term gestational birth (≥ 37 completed weeks of gestation), with a&#xD;
             birth weight of ≥ 2.5 kg and ≤ 4.5 kg&#xD;
&#xD;
          4. Toddler's parent(s)/guardian is of legal age of consent, has sufficient command of&#xD;
             English language to complete the informed consent and other study documents, and is&#xD;
             willing and able to fulfill the requirements of the study protocol&#xD;
&#xD;
          5. Toddler's parent(s)/guardian can be contacted directly by telephone or email&#xD;
             throughout the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Toddlers who exhibit one or more of the following criteria are excluded from enrollment in&#xD;
        the study:&#xD;
&#xD;
          1. Chronic infectious, metabolic, genetic illness or other disease including any&#xD;
             condition that impacts feeding or may impact outcome measures&#xD;
&#xD;
          2. Known or suspected cows' milk protein intolerance / allergy or severe food allergies&#xD;
             that impact diet&#xD;
&#xD;
          3. Toddlers fed vegan, vegetarian, or vegetarian plus fish diets&#xD;
&#xD;
          4. Cognitive or developmental disorders&#xD;
&#xD;
          5. Breast milk used exclusively in place of all other milk, and/or milk alternatives at&#xD;
             17-18 months (GUM &amp; cows' milk group exclusion only, eligible for population group)&#xD;
&#xD;
          6. Consuming supplement(s) of relevance to the study outcome relating diet to status,&#xD;
             docosahexaenoic acid (DHA), lutein, and/or choline in amounts &gt;%10 requirements&#xD;
&#xD;
          7. Toddlers or toddlers' family who in the Investigator's judgment cannot be expected to&#xD;
             comply with the protocol or study procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Months</minimum_age>
    <maximum_age>18 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yvonne Lamers, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tim Oberlander, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of British Columbia, Children and Women's Health Centre of British Columbia Branch</name>
      <address>
        <city>Vancouver</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>November 24, 2022</last_update_submitted>
  <last_update_submitted_qc>November 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03038854
org study id: 14.16.INF
nct id: NCT03038854
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the nutritional and cognitive effects of consuming
      Growing Up Milks (GUMs) and cow's milk.
Single-site, double blind, partially randomized, controlled, 4-arm parallel group clinical
      trial. The purpose of this study is to determine if consuming nutrient enriched growing up
      milk improves the nutrition status and cognitive performance in healthy toddlers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Comparison of blood nutrient markers after 6 months of intervention
time frame: 6 months
description: To compare blood status of the key nutrients of interest after 180 days of intervention in toddlers randomized in a double-blind manner to Test GUM compared to standard GUM. A non-randomized group for comparison will drink either cows' milk (comparator group) as currently recommended by Health Canada, or participate in a reference group with no drinking or feeding interventions.
measure: Executive function and language development
time frame: 6 months
description: To assess the effect of milk/drink on measures of neurological development. Standard and validated tools will be used in the assessment including Bayley Scales of Infant Development III
measure: Visual acuity with Teller Acuity Cards
time frame: 6 months
description: To characterize the effects of milk/drink on visual acuity
measure: Behavioural development
time frame: 6 months
description: To characterize the effects of milk/drink on behavioural development using standard questionnaires including the Child Behaviour Checklist (CBCL)
measure: Dietary nutrient intake
time frame: 6 months
description: To characterize effects of milk/drink on dietary intake of energy, macronutrients and key nutrients of interest using the Food Frequency Questionnaire
arm group label: Test GUM
arm group type: Experimental
description: This group will drink a test toddler growing up milk (GUM) with higher amounts of key nutrients
arm group label: Standard GUM
arm group type: Active Comparator
description: This group will drink a standard toddler growing up milk (GUM)
arm group label: Comparator Group
arm group type: Placebo Comparator
description: This group will drink liquid full fat cows' milk
arm group label: Population Group
arm group type: No Intervention
description: This group will eat and drink their usual foods with no interventions.
intervention type: Other
intervention name: Test GUM
description: Growing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children.
arm group label: Test GUM
other name: Growing up milk
intervention type: Other
intervention name: Standard GUM
description: Growing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children.
arm group label: Standard GUM
other name: Growing up milk
intervention type: Other
intervention name: Cows' milk
description: Homogenized store-bought full fat cow's milk.
arm group label: Comparator Group
criteria: 
gender: All
minimum age: 17 Months
maximum age: 18 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Yvonne Lamers, PhD
role: Principal Investigator
affiliation: University of British Columbia
last name: Tim Oberlander, MD
role: Principal Investigator
affiliation: University of British Columbia
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: Undecided