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Growth of Infants Fed New Starter Formula

2014-08-27 03:15:30 | BioPortfolio

Summary

The purpose of this study is to assess the growth of infants fed a novel starter formula containing synbiotics and different protein levels, compared to a standard starter infant formula, during the first four months of life.

Description

Breastfeeding represents the "gold standard" for infant health, and efforts are being made to support breast feeding at both the international and local levels. After breast milk, infant formulas are the next best source of nutrition for newborn and growing infants. Science and industry are striving to develop formulas that mimic as close as possible the physiological responses to human milk. There are a multitude of factors that make human milk the physiologically ideal for the infant. Among these, two important factors are the level of protein and the presence of pre-and probiotics in breast milk.

The purpose of this study will be to evaluate growth of healthy infants fed a partially hydrolyzed whey protein formula with a level of protein closer to breast milk, with or without synbiotics, during the first four months of life as compared to the growth of infants fed a partially hydrolyzed whey protein formula with a standard protein level (standard formula). Additionally, the infant's digestive tolerance of the starter formula and frequency of morbidity will be investigated until 6 months of age.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Nutrition

Intervention

test starter infant formula, test starter infant formula with synbiotics, control standard formula

Location

Core Faculty, Institute for Health Policy Studies
San Francisco
California
United States
94118

Status

Recruiting

Source

Nestlé Nutrition Corporate

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:30-0400

Clinical Trials [2763 Associated Clinical Trials listed on BioPortfolio]

Digestive Tolerance of Slightly Hydrolyzed Starter Infant Formula With Probiotics

To demonstrate that infants have improved gut comfort when fed a slightly hydrolyzed starter formula containing probiotics compared to infants fed a control hydrolyzed and referenced non-h...

Effects of a Synbiotics-containing Starter Formula on Infant Growth

In this study the investigators want to evaluate the satiety of two infant formulas, one containing prebiotics and the other containing synbiotics. Rate of weight gain, a proxy measurement...

Assessment of Growth of Infants Fed a New Formula

The purpose of this clinical trial is to assess growth (rate of weight gain in grams per day) of infants fed an infant formula with a whey isolate enriched with lactoferrin, during the fir...

Gastrointestinal Tolerance Evaluation of an Infant Formula

Prospective, double-blind, randomized study of 2 infant formulas.

Clinical Safety & Efficacy of a New Infant Formula With Specific Medical Purpose Containing Human Milk Oligosaccharides

The primary objective of the study is to show that infants with cow milk protein allergy (CMPA) fed with a new FSMP infant formula with reduced level of protein & with 2 Human Milk Oligosa...

PubMed Articles [9350 Associated PubMed Articles listed on BioPortfolio]

Protein Digestion and Quality of Goat and Cow Milk Infant Formula and Human Milk Under Simulated Infant Conditions.

To determine the kinetics of true ileal protein digestion and digestible indispensable amino acid score (DIAAS) of a goat milk based infant formula (GIF), a cow milk based infant formula (CIF) and hum...

Effect of a Partially Hydrolysed Whey Infant Formula Supplemented with Starch and Lactobacillus reuteri DSM 17938 on Regurgitation and Gastric Motility.

Functional regurgitation (FR) is common in early infancy and represents a major drain on healthcare resources. This double-blind, randomized controlled trial investigated the effects of a formula cont...

Infant formula feeding practices associated with rapid weight gain: A systematic review.

Excess or rapid weight gain during the first 2 years of life is associated with an increased risk of later childhood and adult overweight and obesity. When compared with breastfed infants, formula fe...

Shift from IgE-mediated cow's milk allergy to food protein induced enterocolitis syndrome in two infants.

A 1-month-old male infant, only breastfed from birth, developed a localized edema of the hands and feet a few minutes after his first ingestion of a cow's milk (CM) formula. A complete allergy work-up...

Growth, Gastrointestinal Tolerance and Stool Characteristics of Healthy Term Infants Fed an Infant Formula Containing Hydrolyzed Whey Protein (63%) and Intact Casein (37%): A Randomized Clinical Trial.

To investigate whether healthy term infants, fed an infant formula containing hydrolyzed whey protein (HWP-F, hydrolyzed whey/intact casein =63/37), differ in growth, gastrointestinal tolerance and st...

Medical and Biotech [MESH] Definitions

The identification of selected parameters in newborn infants by various tests, examinations, or other procedures. Screening may be performed by clinical or laboratory measures. A screening test is designed to sort out healthy neonates (INFANT, NEWBORN) from those not well, but the screening test is not intended as a diagnostic device, rather instead as epidemiologic.

Liquid formulations for the nutrition of INFANTS, useful for those with special needs or MILK HYPERSENSITIVITY or those whose mothers are unable to breastfeed (BREAST FEEDING).

A human infant born before 37 weeks of GESTATION.

An infant born at or after 42 weeks of gestation.

Any observable response or action of a neonate or infant up through the age of 23 months.

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