Tolerance and Digestibility of a New Formula in Healthy Infants

Study Overview
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Brief Summary
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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.

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

Conditions
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Steatorrhea, Growth

Intervention / Treatment
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* Dietary Supplement: dairy lipids and soluble milk proteins


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control formula<br>formula containing only vegetable fats | Dietary Supplement: dairy lipids and soluble milk proteins<br>* one month formula supplementation feces are collected during a 3 days period after 15 and 30 days of formula intake<br>|
| Experimental: new formula<br>new formula with dairy lipids and soluble milk proteins | Dietary Supplement: dairy lipids and soluble milk proteins<br>* one month formula supplementation feces are collected during a 3 days period after 15 and 30 days of formula intake<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tolerance and growth |  | during the 30d of formula intake | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant formula, dairy fat, soluble milk protein