Randomized, controlled study consisting of three parallel arms to investigate the effects of novel infant formula on growth, gut health, immune function, and sleep status in healthy infants and young children aged 12-18 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
120
The infant formula is provided in powdered form that provides the appropriate amount of protein, carbohydrates, fats, vitamins, and minerals
The infant formula is provided in powdered form that provides the appropriate amount of protein, carbohydrates, fats, vitamins, and minerals
Shenzhen University
Shenzhen, Guangdong, China
RECRUITINGChange in Height
Measured in centimeters (cm)
Time frame: Baseline (Day -7) to Day 90
Change in Weight
Measured in kilograms (kg)
Time frame: Baseline (Day -7) to Day 90
Comprehensive Nutritional Development Assessment
(1) Annual growth rate (cm/year); (2) MUAC to head circumference ratio; (3) Weight-for-age Z-score (WAZ); (4) Length-for-age Z-score (LAZ); (5) Weight-for-length Z-score (WLZ); (6) BMI-for-age Z-score (BAZ).
Time frame: Baseline (Day -7) to Day 90
Change in Salivary sIgA
Saliva sample collected in microliters (µL)
Time frame: Baseline (Day -7) to Day 90
Change in Salivary Lysozyme
Saliva sample collected in microliters (µL)
Time frame: Baseline (Day -7) to Day 90
Change in Fecal sIgA
Stool sample collected
Time frame: Baseline (Day -7) to Day 90
Change in Fecal Calprotectin
Stool sample collected
Time frame: Baseline (Day -7) to Day 90
Change in Fecal Alpha-1 Antitrypsin (AAT)
Stool sample collected
Time frame: Baseline (Day -7) to Day 90
Change in Gut Microbiome Composition (Metagenomics)
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Stool sample collected for metagenomic sequencing
Time frame: Baseline (Day -7) to Day 90
Change in Fecal Metabolome (Non-targeted Metabolomics)
Stool sample collected for metabolomic analysis
Time frame: Baseline (Day -7) to Day 90
Change in IGSQ Score
Questionnaire administered by site staff
Time frame: Baseline (Day -7) to Day 90
Change in Stool Consistency (Brussels Infant Stool Hardness Scale)
Questionnaire administered by site staff
Time frame: Baseline (Day -7) to Day 90
Change in TSAS Score
Questionnaire administered by site staff
Time frame: Baseline (Day -7) to Day 90