Growth of Infants Fed New Starter Formula

Assessment of Growth of Infants Fed Starter Formulas With Modified Protein and Synbiotics

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.

Study Overview

• Status: Completed
• Conditions: Dietary Intervention
• Intervention / Treatment: Other: control standard formula; Other: test starter infant formula; Other: test starter infant formula with synbiotics

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 297
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94118
      • UCSF Institute for Health Policy Studies/Pediatrics
  • Florida
    • Orlando, Florida, United States, 32822
      • Florida Institute for Clinical Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68504
      • Midwest Children's Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy newborn infant
• Full-term (> 37 weeks gestation)
• Birth weight > 2500 and < 4500 g
• 14±3 days of age on enrollment
• Singleton birth
• Infant's mother has elected not to breastfeed prior to enrollment
• Has not received solid foods
• Having obtained his/her legal representative's informed consent

Exclusion Criteria:

• Known or suspected cow-milk allergy
• Congenital illness or malformation that may affect infant feeding and/or growth
• Significant prenatal and/or postnatal disease
• Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
• Receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
• Has received oral or intravenous antibiotic therapy in the last 7 days
• Has received probiotics in the last 7 days
• Currently participating in another clinical study
• Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: standard starter infant formula	Other: control standard formula; infant are fed 6 months with this formula
Experimental: test starter formula; test infant formula	Other: test starter infant formula; infants are fed for 6 months with this starter formula
Experimental: test starter formula with synbiotics; starter formula with synbiotics and adapted protein levels	Other: test starter infant formula with synbiotics; infant are fed for 6 months with this formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Weight gain will be assessed in grams per day, in the period of 14 to 112 days of life (4 months)	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Tolerance, morbidity, protein status, metabolic markers	6 months

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Michael Cabana, MD, MPH, Institute for Health Policy Studies, University of California

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: March 2, 2010
• First Submitted That Met QC Criteria: March 2, 2010
• First Posted (Estimate): March 3, 2010

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: infant formula, synbiotics, probiotics, nutrition
• Other Study ID Numbers: 09.04.INF