Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides, Beta-palmitate and Acidified Milk - Full Text View

Purpose

The purpose of this study is to determine the safety and efficacy of an infant formula supplemented with galacto-oligosaccharides (GOS), beta-palmitate and acidified milk in improving the gastrointestinal health and immune response in healthy term infants.

Condition	Intervention
Formula Feeding of Healthy Full Term Infants	Other: Infant formula with GOS, beta-palmitate, acidified milk Other: Standard infant formula without functional ingredients

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	Double-blind Randomized Controlled Study for the Evaluation of Nutritional Outcomes of a Cow's Milk Based Infant Formula Containing Galacto-oligosaccharides, Beta-palmitate and Acidified Milk

Resource links provided by NLM:

MedlinePlus related topics: Infant and Newborn Nutrition

U.S. FDA Resources

Further study details as provided by Heinz Italia SpA:

Primary Outcome Measures:

The nutritional safety of the study formula is evaluated through measure of anthropometric parameters and record of gastrointestinal symptoms [ Time Frame: Anthropometric parameters: at birth, at enrolment, after 60 and 135 days of life. Gastrointestinal symptoms: recorded daily in the infant's diary. ] [ Designated as safety issue: No ]
Anthropometric parameters: body weight, recumbent length and head circumference change. Gastrointestinal symptoms: diarrhea, constipation, stool frequency and consistency, bowel cramps, abdominal distension, intestinal gas.

Secondary Outcome Measures:

Immune-modulatory activity [ Time Frame: At enrolment, after 60 and 135 days of life ] [ Designated as safety issue: No ]
Quantification of salivary IgA
Prebiotic effect [ Time Frame: At enrolment and after 135 days of life ] [ Designated as safety issue: No ]
Microbiological analysis of feces

Estimated Enrollment:	136
Study Start Date:	August 2010
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: STUDY GROUP Infant formula supplemented with functional ingredients (galacto-oligosaccharides, beta-palmitate, acidified milk. Infant formula with functional ingredients is in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae	Other: Infant formula with GOS, beta-palmitate, acidified milk Infant formula supplemented with functional ingredients (galacto-oligosaccharides, beta-palmitate, acidified milk. Infant formula with functional ingredients is in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae
CONTROL GROUP Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients	Other: Standard infant formula without functional ingredients Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients

Detailed Description:

Infant formulae are the only alternatives to breast milk for infants when, for whatever reason, human milk becomes unavailable.

New-generation infant formulae contain functional ingredients able to mimic some benefits of human milk.

The study formula is supplemented with galacto-oligosaccharides, which favor intestinal positive microflora growth, beta-palmitate, enhancing fat and calcium absorption and softer stool formation, and acidified milk which contributes to immune system maturation.

The aim of this study is to verify the safety of the study formula in healthy term infants and to deepen the efficacy of the functional ingredient blend in term of prebiotic effect, gastrointestinal tolerance and immune response improvement.

Eligibility

Ages Eligible for Study:	up to 21 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Infants of both sexes born to natural or cesarean delivery
Gestational age between 37 and 42 completed weeks
Birth weight between 10th and 90th percentile of birth weight for gestational age, according to the North-Italian growth charts
Single birth
Caucasian parents
Infants being exclusively formula-fed by the 21st day of life

Exclusion Criteria:

Infants with genetic and/or congenital diseases
Infants receiving antibiotic therapy
Infants with neonatal diseases requiring hospitalisation for longer than 7 days
Infants at risk for atopy and/or having familial history for atopy
Mothers with metabolic or chronic diseases
Infant selected for another clinical study
Parents refusing to sign a written informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197365

Contacts

Contact: Andrea Budelli

0039 02 52563332

andrea.budelli@it.hjheinz.com

Locations

Italy
Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva	Recruiting
Pavia, PV, Italy, 27100

Sponsors and Collaborators

Heinz Italia SpA

Fondazione IRCCS Policlinico San Matteo - Struttura Complessa di Neonatologia, Patologia Neonatale e Terapia Intensiva (Prof. Mauro Stronati)

Centro di Immunità e Nutrizione - Università degli Studi di Pavia (Prof.ssa Annamaria Castellazzi)

AAT (Advanced Analytical Technologies) (Dr. Elena Bessi/Sara Soldi)

Investigators

Principal Investigator:

Mauro Stronati, Prof.

FONDAZIONE IRCCS POLICLINICO "SAN MATTEO" - STRUTTURA COMPLESSA DI NEONATOLOGIA, PATOLOGIA NEONATALE E TERAPIA INTENSIVA

More Information

Publications:

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López-López A, Castellote-Bargalló AI, Campoy-Folgoso C, Rivero-Urgël M, Tormo-Carnicé R, Infante-Pina D, López-Sabater MC. The influence of dietary palmitic acid triacylglyceride position on the fatty acid, calcium and magnesium contents of at term newborn faeces. Early Hum Dev. 2001 Nov;65 Suppl:S83-94.

Nelson CM, Innis SM. Plasma lipoprotein fatty acids are altered by the positional distribution of fatty acids in infant formula triacylglycerols and human milk. Am J Clin Nutr. 1999 Jul;70(1):62-9.

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Fanaro S, Marten B, Bagna R, Vigi V, Fabris C, Peña-Quintana L, Argüelles F, Scholz-Ahrens KE, Sawatzki G, Zelenka R, Schrezenmeir J, de Vrese M, Bertino E. Galacto-oligosaccharides are bifidogenic and safe at weaning: a double-blind randomized multicenter study. J Pediatr Gastroenterol Nutr. 2009 Jan;48(1):82-8.

Napoli JE, Brand-Miller JC, Conway P. Bifidogenic effects of feeding infant formula containing galacto-oligosaccharides in healthy formula-fed infants. Asia Pac J Clin Nutr. 2003 Nov;12(Suppl):S60.

Ben XM, Zhou XY, Zhao WH, Yu WL, Pan W, Zhang WL, Wu SM, Van Beusekom CM, Schaafsma A. Supplementation of milk formula with galacto-oligosaccharides improves intestinal micro-flora and fermentation in term infants. Chin Med J (Engl). 2004 Jun;117(6):927-31.

Responsible Party:	Heinz Italia SpA
ClinicalTrials.gov Identifier:	NCT01197365 History of Changes
Other Study ID Numbers:	PLA-LENI-09
Study First Received:	September 7, 2010
Last Updated:	May 24, 2012
Health Authority:	Italy: Ethics Committee

Keywords provided by Heinz Italia SpA:

Acidified milk
Beta-palmitate
Bifidobacteria
Infant formula

Galacto-oligosaccharides
Growth
Infants
Prebiotics

ClinicalTrials.gov processed this record on May 22, 2013