Effect of Nutritional Intervention on Metabolic Response in Infants

Overview

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).

Full Title of Study: “Effect of Nutritional Intervention on Metabolic Response in Infants: A Single-Blind, Randomized, Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Single (Investigator)
  • Study Primary Completion Date: April 29, 2021

Detailed Description

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.

Interventions

  • Other: EXPL feeding regimen
    • EXPL FUF (lower protein and 100% lactose) + EXPL IC (whole grains and legumes)
  • Other: CTRL feeding regimen
    • CTRL FUF (standard protein content and carbohydrate profile) + CTRL IC (refined grains)

Arms, Groups and Cohorts

  • Experimental: EXPL feeding regimen
    • Lower protein / lower estimated glycemic index regimen
  • Active Comparator: CTRL feeding regimen
    • Standard protein / standard glycemic index regimen

Clinical Trial Outcome Measures

Primary Measures

  • Glucose peak
    • Time Frame: Study days 85-92
    • Average of the glucose peaks measured by a continuous glucose monitor

Secondary Measures

  • Glycemic response
    • Time Frame: Study days 85-92
    • Incremental area under the blood glucose response curve
  • Glucose response variability
    • Time Frame: Study days 85-92
    • Mean amplitude of glycemic excursions, standard deviation, J-index
  • Skinfold thickness
    • Time Frame: age 6 months, 9 months, and 12 months
    • Subscapular and triceps skinfold thicknesses
  • Weight
    • Time Frame: age 6 months, 9 months, and 12 months
    • Weight (g)
  • Length
    • Time Frame: age 6 months, 9 months, and 12 months
    • Length (cm)
  • Head circumference
    • Time Frame: age 6 months, 9 months, and 12 months
    • Head circumference (cm)
  • Body mass index (BMI)
    • Time Frame: age 6 months, 9 months, and 12 months
    • Weight and height will be combined to report BMI in kg/m^2
  • Weight-for-age z-score
    • Time Frame: age 6 months, 9 months, and 12 months
    • Weight-for-age z-score based on World Health Organization (WHO) growth charts
  • Weight-for-length z-score
    • Time Frame: age 6 months, 9 months, and 12 months
    • Weight-for-length z-score based on WHO growth charts
  • Length-for-age z-score
    • Time Frame: age 6 months, 9 months, and 12 months
    • Length-for-age z-score based on WHO growth charts
  • Head circumference-for-age z-score
    • Time Frame: age 6 months, 9 months, and 12 months
    • Head circumference-for-age z-score based on WHO growth charts
  • BMI-for-age z-score
    • Time Frame: age 6 months, 9 months, and 12 months
    • BMI-for-age z-score based on WHO growth charts
  • Insulin secretion
    • Time Frame: age 6 months, 9 months, and 12 months
    • Urinary C-peptide:creatinine ratio
  • Dietary intake
    • Time Frame: age 6 months, 9 months, and 12 months
    • Total energy, carbohydrate and protein intake calculated from food recalls / diaries
  • Stool microbiota composition
    • Time Frame: age 6 months, 7.5 months, 9 months, and 12 months
    • Fecal microbiota composition assessed using next generation sequencing
  • Stool pH
    • Time Frame: age 6 months, 7.5 months, 9 months, and 12 months
    • Stool pH
  • Stool microbiota metabolism
    • Time Frame: age 6 months, 7.5 months, 9 months, and 12 months
    • Stool organic acids
  • Gastrointestinal (GI) tolerance
    • Time Frame: age 6 months, 9 months, and 12 months
    • 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.
  • Health-related quality of life
    • Time Frame: age 6 months, 9 months, and 12 months
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

. 1. Written informed consent has been obtained from both parent / liable parent or legally acceptable representative (LAR), if applicable 2. Healthy infant who was singleton, full-term gestational birth (≥ 37 completed weeks of gestation) with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg 3. Infant is no longer breastfeeding or receiving breast milk, has not yet started FUF, and is developmentally ready to begin complementary feeding 4. Infant's parent(s)/guardian is of legal age of consent, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol. 5. At screening visit (visit 0), infant is 24 – 26 weeks (5½ – 6 months) old 6. Weight-for-height value >-2 standard deviations from the WHO Child Growth Standards median Exclusion Criteria:

1. Chronic infectious, metabolic, or other disease including any condition that in the opinion of the investigator may impact feeding, growth or adherence to study procedures 2. Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis) 3. Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, gluten sensitivity or severe food allergies that impact diet 4. Born to mothers with gestational diabetes or type 1 diabetes 5. Major medical/surgical event requiring prolonged hospitalization during the first 6 months 6. Receiving or having received insulin, growth hormone or any other medication known to affect glucose or carbohydrate metabolism or pre- or probiotics known to affect fecal microbiota prior to enrollment 7. Subjects or subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol 8. Currently participating or having participated in another clinical trial within 4 weeks prior to trial start

Gender Eligibility: All

Minimum Age: 24 Weeks

Maximum Age: 26 Weeks

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Société des Produits Nestlé (SPN)
  • Provider of Information About this Clinical Study
    • Sponsor

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