Effect of Nutritional Intervention on Metabolic Response in Infants

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Effect of Nutritional Intervention on Metabolic Response in Infants: A Single-Blind, Randomized, Controlled Trial

Conditions
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Infant Development, Glucose, High Blood

Intervention / Treatment
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* Other: EXPL feeding regimen
* Other: CTRL feeding regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:. Written informed consent has been obtained from both parent / liable parent or legally acceptable representative (LAR), if applicable 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 Infant is no longer breastfeeding or receiving breast milk, has not yet started FUF, and is developmentally ready to begin complementary feeding 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. At screening visit (visit 0), infant is 24 - 26 weeks (5½ - 6 months) old Weight-for-height value >-2 standard deviations from the WHO Child Growth Standards median Exclusion Criteria: 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 Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis) Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, gluten sensitivity or severe food allergies that impact diet Born to mothers with gestational diabetes or type 1 diabetes Major medical/surgical event requiring prolonged hospitalization during the first 6 months 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 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 Currently participating or having participated in another clinical trial within 4 weeks prior to trial start

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 26 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXPL feeding regimen<br>Lower protein / lower estimated glycemic index regimen | Other: EXPL feeding regimen<br>* EXPL FUF (lower protein and 100% lactose) + EXPL IC (whole grains and legumes)<br>|
| Active Comparator: CTRL feeding regimen<br>Standard protein / standard glycemic index regimen | Other: CTRL feeding regimen<br>* CTRL FUF (standard protein content and carbohydrate profile) + CTRL IC (refined grains)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose peak | Average of the glucose peaks measured by a continuous glucose monitor | Study days 85-92 | 

Secondary Outcome Measures

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