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Tolerance and Digestibility of a New Formula in Healthy Infants

This study has been completed.
Sponsor:
Information provided by:
Lactalis
ClinicalTrials.gov Identifier:
NCT01184378
First received: August 17, 2010
Last updated: January 25, 2011
Last verified: January 2011
  Purpose

The great majority of infants formula contain fats exclusively from vegetable oil. Nevertheless, the use of both vegetable and dairy lipids is on a real interest to obtain an infant formula closer to the nutritional composition of maternal milk.


Condition Intervention Phase
Steatorrhea
Growth
Dietary Supplement: dairy lipids and soluble milk proteins
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Study of Tolerance and Lipid Digestibility of a Formula in Healthy 3 Months Infants

Resource links provided by NLM:


Further study details as provided by Lactalis:

Primary Outcome Measures:
  • digestibility of lipids in formula [ Time Frame: during the 30d consumption period ] [ Designated as safety issue: No ]
    lipid content determination in feces during a 3 days period of collection after 15d and 30d of formula intake


Secondary Outcome Measures:
  • tolerance and growth [ Time Frame: during the 30d of formula intake ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2008
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: control formula
formula containing only vegetable fats
Dietary Supplement: dairy lipids and soluble milk proteins
one month formula supplementation feces are collected during a 3 days period after 15 and 30 days of formula intake
Experimental: new formula
new formula with dairy lipids and soluble milk proteins
Dietary Supplement: dairy lipids and soluble milk proteins
one month formula supplementation feces are collected during a 3 days period after 15 and 30 days of formula intake

  Eligibility

Ages Eligible for Study:   2 Months to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • normal growth;
  • considered as healthy by the investigator according to the medical interrogation and the clinical examination;
  • receiving exclusively infant formula for at least 15 days.
  • without any solid food during the month of the study

Exclusion Criteria:

  • Premature born children or small born weights;
  • Children breast-fed or weaned for less than 15 days;
  • Children with solid food
  • Food allergy, particularly in milk proteins allergy , and lactose intolerance ;
  • Tumoral, inflammatory, cardiac, lung, renal, digestive diseases(syndrome of malabsorption);
  • Digestive pathology previous to the inclusion, in particular infectious (rotavirus, gastroenteritis) or functional symptoms (important stomach pains, colicky) having required a lot of change in formula quality;
  • Children under medical treatment (ex: paracetamol).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01184378

Locations
France
Faculté de Médecine
Dijon, France, 21078
Hopital Mère-Enfants
Rennes, France, 35000
Sponsors and Collaborators
Lactalis
  More Information

No publications provided

Responsible Party: Pascale le Ruyet PhD, Lactalis RetD
ClinicalTrials.gov Identifier: NCT01184378     History of Changes
Other Study ID Numbers: LRD-08-15
Study First Received: August 17, 2010
Last Updated: January 25, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Lactalis:
infant formula
dairy fat
soluble milk protein

Additional relevant MeSH terms:
Steatorrhea
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Malabsorption Syndromes
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014