Tolerance and Digestibility of a New Formula in Healthy Infants

Study of Tolerance and Lipid Digestibility of a Formula in Healthy 3 Months Infants

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01184378

Enrollment

100

Registered

2010-08-18

Start date

2008-11-30

Completion date

2011-01-31

Last updated

2011-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth, Steatorrhea

Keywords

infant formula, dairy fat, soluble milk protein

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTdairy 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Months to 4 Months

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).

Design outcomes

Primary

Measure	Time frame	Description
digestibility of lipids in formula	during the 30d consumption period	lipid content determination in feces during a 3 days period of collection after 15d and 30d of formula intake

Secondary

Measure	Time frame
tolerance and growth	during the 30d of formula intake

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026