Formula Feeding of Healthy Full Term Infants Clinical Trial
Official title:
Impact of Infant Feeding on Newborn Metabolomic Profile
The purpose of this study is the evaluation with untargeted modalities, of the urine metabolomic profile in a group of infants fed with a standard formula, a group of infants fed with a formula supplemented with functional ingredients and a group of breast-fed infants.
Metabolomics is of particular interest in the field of nutrition, since nutrients interact
with a number of targets, metabolic pathways and functions.
A suitable biofluid to study nutrient intake is urine, which is the most commonly used
biological sample for metabolomic analysis and can be collected with simple and non-invasive
methods.
Up to now, no studies have investigated healthy term infants metabolome and its modulation
according to different dietary regimens such as formula-feeding or breastfeeding.
The aim of this study is to evaluate, with untargeted modalities, the urine metabolomic
profile of a group of infants fed with a standard formula, a group of infants fed with a
formula supplemented with functional ingredients and a group of breast-fed infants.
Formula-fed infants participate to PLA-LENI-09 study (NCT01197365). We have included also a
control group of breast-fed infants, as, from a scientific point of view, they represent the
"gold standard" and no data are available on their metabolomic profile.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03513991 -
Evaluation of Different Protein Content of Formulas on Nutrition Status of Infants.
|
N/A | |
| Completed |
NCT01197365 -
Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides, Beta-palmitate and Acidified Milk
|
N/A |