Tolerance and Digestibility of a New Formula in Healthy Infants

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

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
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


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

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).
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Please refer to this study by its identifier: NCT01184378

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

No publications provided

Responsible Party: Pascale le Ruyet PhD, Lactalis RetD 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:
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Malabsorption Syndromes
Metabolic Diseases processed this record on October 13, 2015