<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/NCT04483453</url>
  </required_header>
  <id_info>
    <org_study_id>18.17.INF</org_study_id>
    <nct_id>NCT04483453</nct_id>
  </id_info>
  <brief_title>Effect of Nutritional Intervention on Metabolic Response in Infants</brief_title>
  <official_title>Effect of Nutritional Intervention on Metabolic Response in Infants: A Single-Blind, Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </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 glucose response of complementary feeding&#xD;
      regimens consisting of two different follow-up formulas (FUFs) and infant cereals (ICs).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, single-blind, controlled, 2-arm parallel group trial in&#xD;
      infants aged 6 months (26 weeks) at enrollment, who are no longer breastfed, and who are&#xD;
      ready but have not yet started complementary feeding. They will be fed one of two different&#xD;
      isocaloric feeding regimens (Experimental [EXPL] or Control [CTRL]) consisting of different&#xD;
      follow-up formulas (FUFs) and infant cereals (ICs). The main purpose of this study is to&#xD;
      determine the glucose response of these two different complementary feeding regimens. All&#xD;
      enrolled infants will participate in the trial for approximately 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2020</start_date>
  <completion_date type="Actual">June 9, 2021</completion_date>
  <primary_completion_date type="Actual">April 29, 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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glucose peak</measure>
    <time_frame>Study days 85-92</time_frame>
    <description>Average of the glucose peaks measured by a continuous glucose monitor</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glycemic response</measure>
    <time_frame>Study days 85-92</time_frame>
    <description>Incremental area under the blood glucose response curve</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose response variability</measure>
    <time_frame>Study days 85-92</time_frame>
    <description>Mean amplitude of glycemic excursions, standard deviation, J-index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skinfold thickness</measure>
    <time_frame>age 6 months, 9 months, and 12 months</time_frame>
    <description>Subscapular and triceps skinfold thicknesses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>age 6 months, 9 months, and 12 months</time_frame>
    <description>Weight (g)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length</measure>
    <time_frame>age 6 months, 9 months, and 12 months</time_frame>
    <description>Length (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Head circumference</measure>
    <time_frame>age 6 months, 9 months, and 12 months</time_frame>
    <description>Head circumference (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index (BMI)</measure>
    <time_frame>age 6 months, 9 months, and 12 months</time_frame>
    <description>Weight and height will be combined to report BMI in kg/m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight-for-age z-score</measure>
    <time_frame>age 6 months, 9 months, and 12 months</time_frame>
    <description>Weight-for-age z-score based on World Health Organization (WHO) growth charts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight-for-length z-score</measure>
    <time_frame>age 6 months, 9 months, and 12 months</time_frame>
    <description>Weight-for-length z-score based on WHO growth charts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length-for-age z-score</measure>
    <time_frame>age 6 months, 9 months, and 12 months</time_frame>
    <description>Length-for-age z-score based on WHO growth charts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Head circumference-for-age z-score</measure>
    <time_frame>age 6 months, 9 months, and 12 months</time_frame>
    <description>Head circumference-for-age z-score based on WHO growth charts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI-for-age z-score</measure>
    <time_frame>age 6 months, 9 months, and 12 months</time_frame>
    <description>BMI-for-age z-score based on WHO growth charts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin secretion</measure>
    <time_frame>age 6 months, 9 months, and 12 months</time_frame>
    <description>Urinary C-peptide:creatinine ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intake</measure>
    <time_frame>age 6 months, 9 months, and 12 months</time_frame>
    <description>Total energy, carbohydrate and protein intake calculated from food recalls / diaries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool microbiota composition</measure>
    <time_frame>age 6 months, 7.5 months, 9 months, and 12 months</time_frame>
    <description>Fecal microbiota composition assessed using next generation sequencing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool pH</measure>
    <time_frame>age 6 months, 7.5 months, 9 months, and 12 months</time_frame>
    <description>Stool pH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool microbiota metabolism</measure>
    <time_frame>age 6 months, 7.5 months, 9 months, and 12 months</time_frame>
    <description>Stool organic acids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal (GI) tolerance</measure>
    <time_frame>age 6 months, 9 months, and 12 months</time_frame>
    <description>GI tolerance assessed using the Infant Gastrointestinal Symptom Questionnaire (IGSQ). IGSQ scores range from 13 to 65, with lower scores indicating lower GI symptom burden.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>age 6 months, 9 months, and 12 months</time_frame>
    <description>Health-related quality of life using the Infant and Toddler Quality of Life Questionnaire Short Form (ITQOL-SF47). ITQOL-SF47 scores range from 0 to 100, with higher scores indicating a more favorable health-related quality of life.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Insulin-like growth factor-1 (IGF-1)</measure>
    <time_frame>age 6 months, 9 months, and 12 months</time_frame>
    <description>Urinary IGF-1</description>
  </other_outcome>
  <other_outcome>
    <measure>Urinary metabolomic profile</measure>
    <time_frame>age 6 months, 9 months, and 12 months</time_frame>
    <description>Untargeted analysis of urine metabolites by H1-nuclear magnetic resonance (NMR) spectroscopy.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Infant Development</condition>
  <condition>Glucose, High Blood</condition>
  <arm_group>
    <arm_group_label>EXPL feeding regimen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lower protein / lower estimated glycemic index regimen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CTRL feeding regimen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard protein / standard glycemic index regimen</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EXPL feeding regimen</intervention_name>
    <description>EXPL FUF (lower protein and 100% lactose) + EXPL IC (whole grains and legumes)</description>
    <arm_group_label>EXPL feeding regimen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CTRL feeding regimen</intervention_name>
    <description>CTRL FUF (standard protein content and carbohydrate profile) + CTRL IC (refined grains)</description>
    <arm_group_label>CTRL feeding regimen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:.&#xD;
&#xD;
          1. Written informed consent has been obtained from both parent / liable parent or legally&#xD;
             acceptable representative (LAR), if applicable&#xD;
&#xD;
          2. Healthy infant who was singleton, full-term gestational birth (≥ 37 completed weeks of&#xD;
             gestation) with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg&#xD;
&#xD;
          3. Infant is no longer breastfeeding or receiving breast milk, has not yet started FUF,&#xD;
             and is developmentally ready to begin complementary feeding&#xD;
&#xD;
          4. Infant's parent(s)/guardian is of legal age of consent, must understand the informed&#xD;
             consent form and other study documents, and is willing and able to fulfill the&#xD;
             requirements of the study protocol.&#xD;
&#xD;
          5. At screening visit (visit 0), infant is 24 - 26 weeks (5½ - 6 months) old&#xD;
&#xD;
          6. Weight-for-height value &gt;-2 standard deviations from the WHO Child Growth Standards&#xD;
             median&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Chronic infectious, metabolic, or other disease including any condition that in the&#xD;
             opinion of the investigator may impact feeding, growth or adherence to study&#xD;
             procedures&#xD;
&#xD;
          2. Major congenital or chromosomal abnormality known to affect growth (e.g., congenital&#xD;
             heart disease, cystic fibrosis)&#xD;
&#xD;
          3. Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance,&#xD;
             gluten sensitivity or severe food allergies that impact diet&#xD;
&#xD;
          4. Born to mothers with gestational diabetes or type 1 diabetes&#xD;
&#xD;
          5. Major medical/surgical event requiring prolonged hospitalization during the first 6&#xD;
             months&#xD;
&#xD;
          6. Receiving or having received insulin, growth hormone or any other medication known to&#xD;
             affect glucose or carbohydrate metabolism or pre- or probiotics known to affect fecal&#xD;
             microbiota prior to enrollment&#xD;
&#xD;
          7. Subjects or subjects' parent(s) or legal representative who are not willing and not&#xD;
             able to comply with scheduled visits and the requirements of the study protocol&#xD;
&#xD;
          8. Currently participating or having participated in another clinical trial within 4&#xD;
             weeks prior to trial start&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Weeks</minimum_age>
    <maximum_age>26 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Las Piñas Doctors Hospital</name>
      <address>
        <city>Las Piñas</city>
        <zip>1742</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Philippines</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>October 4, 2021</last_update_submitted>
  <last_update_submitted_qc>October 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2021</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/NCT04483453
org study id: 18.17.INF
nct id: NCT04483453
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the glucose response of complementary feeding
      regimens consisting of two different follow-up formulas (FUFs) and infant cereals (ICs).
This is a prospective, randomized, single-blind, controlled, 2-arm parallel group trial in
      infants aged 6 months (26 weeks) at enrollment, who are no longer breastfed, and who are
      ready but have not yet started complementary feeding. They will be fed one of two different
      isocaloric feeding regimens (Experimental [EXPL] or Control [CTRL]) consisting of different
      follow-up formulas (FUFs) and infant cereals (ICs). The main purpose of this study is to
      determine the glucose response of these two different complementary feeding regimens. All
      enrolled infants will participate in the trial for approximately 6 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
measure: Glucose peak
time frame: Study days 85-92
description: Average of the glucose peaks measured by a continuous glucose monitor
measure: Glycemic response
time frame: Study days 85-92
description: Incremental area under the blood glucose response curve
measure: Glucose response variability
time frame: Study days 85-92
description: Mean amplitude of glycemic excursions, standard deviation, J-index
measure: Skinfold thickness
time frame: age 6 months, 9 months, and 12 months
description: Subscapular and triceps skinfold thicknesses
measure: Weight
time frame: age 6 months, 9 months, and 12 months
description: Weight (g)
measure: Length
time frame: age 6 months, 9 months, and 12 months
description: Length (cm)
measure: Head circumference
time frame: age 6 months, 9 months, and 12 months
description: Head circumference (cm)
measure: Body mass index (BMI)
time frame: age 6 months, 9 months, and 12 months
description: Weight and height will be combined to report BMI in kg/m^2
measure: Weight-for-age z-score
time frame: age 6 months, 9 months, and 12 months
description: Weight-for-age z-score based on World Health Organization (WHO) growth charts
measure: Weight-for-length z-score
time frame: age 6 months, 9 months, and 12 months
description: Weight-for-length z-score based on WHO growth charts
measure: Length-for-age z-score
time frame: age 6 months, 9 months, and 12 months
description: Length-for-age z-score based on WHO growth charts
measure: Head circumference-for-age z-score
time frame: age 6 months, 9 months, and 12 months
description: Head circumference-for-age z-score based on WHO growth charts
measure: BMI-for-age z-score
time frame: age 6 months, 9 months, and 12 months
description: BMI-for-age z-score based on WHO growth charts
measure: Insulin secretion
time frame: age 6 months, 9 months, and 12 months
description: Urinary C-peptide:creatinine ratio
measure: Dietary intake
time frame: age 6 months, 9 months, and 12 months
description: Total energy, carbohydrate and protein intake calculated from food recalls / diaries
measure: Stool microbiota composition
time frame: age 6 months, 7.5 months, 9 months, and 12 months
description: Fecal microbiota composition assessed using next generation sequencing
measure: Stool pH
time frame: age 6 months, 7.5 months, 9 months, and 12 months
description: Stool pH
measure: Stool microbiota metabolism
time frame: age 6 months, 7.5 months, 9 months, and 12 months
description: Stool organic acids
measure: Gastrointestinal (GI) tolerance
time frame: age 6 months, 9 months, and 12 months
description: GI tolerance assessed using the Infant Gastrointestinal Symptom Questionnaire (IGSQ). IGSQ scores range from 13 to 65, with lower scores indicating lower GI symptom burden.
measure: Health-related quality of life
time frame: age 6 months, 9 months, and 12 months
description: Health-related quality of life using the Infant and Toddler Quality of Life Questionnaire Short Form (ITQOL-SF47). ITQOL-SF47 scores range from 0 to 100, with higher scores indicating a more favorable health-related quality of life.
measure: Insulin-like growth factor-1 (IGF-1)
time frame: age 6 months, 9 months, and 12 months
description: Urinary IGF-1
measure: Urinary metabolomic profile
time frame: age 6 months, 9 months, and 12 months
description: Untargeted analysis of urine metabolites by H1-nuclear magnetic resonance (NMR) spectroscopy.
arm group label: EXPL feeding regimen
arm group type: Experimental
description: Lower protein / lower estimated glycemic index regimen
arm group label: CTRL feeding regimen
arm group type: Active Comparator
description: Standard protein / standard glycemic index regimen
intervention type: Other
intervention name: EXPL feeding regimen
description: EXPL FUF (lower protein and 100% lactose) + EXPL IC (whole grains and legumes)
arm group label: EXPL feeding regimen
intervention type: Other
intervention name: CTRL feeding regimen
description: CTRL FUF (standard protein content and carbohydrate profile) + CTRL IC (refined grains)
arm group label: CTRL feeding regimen
criteria: 
gender: All
minimum age: 24 Weeks
maximum age: 26 Weeks
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Philippines
responsible party type: Sponsor
sharing ipd: Undecided