Status:
COMPLETED
Effect of the Level of Dietary Protein on the Infant Hormonal Profile and Body Composition
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Healthy
Eligibility:
All Genders
1-7 years
Phase:
NA
Brief Summary
A double blind, controlled, randomized, single site clinical trial of 2 parallel groups (Low protein formula =LoF and High protein formula =HiF) with a breastfeeding group (BF) as reference from birth...
Detailed Description
The primary objective of this clinical trial is to show that infants taking (from birth) either a formula with a low protein content (LoF) or breast milk will have an IGF-1 level, at 4 months, 25% low...
Eligibility Criteria
Inclusion
- . Healthy newborn infant
- Full term infant (= 37 weeks gestation; = 42 weeks gestation)
- Birth weight = 2500 g and \< 4200 g
- Singleton birth
- Infant is = 7 days of age at the time of enrollment
- For the BF group: The infant's mother has elected to exclusively breastfeed her baby, from enrollment to 4 months of age For the FF groups: The infant's mother has elected to exclusively formula feed her baby, from enrollment to 4 months of age
- Having obtained his/her or his/her legal representative's consent
Exclusion
- Newborn whose mother's BMI was normal (\<20 or = 25) at start of pregnancy
- Newborn whose mother had developed gestational diabetes during pregnancy
- Newborn whose mother has diabetes of type-1 or type-2
- Newborn whose mother smoked \> 5 cigarettes / day during pregnancy
- Newborn whose mother had a drug dependence during pregnancy
- Newborn whose mother has a chronic infectious disease
- Newborn whose parents / caregivers cannot be expected to comply with treatment
- Newborn currently participating in another clinical trial
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT02282488
Start Date
April 1 2006
End Date
December 1 2012
Last Update
November 4 2014
Active Locations (1)
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1
Hôpital de la Croix-Rouse
Lyon, France, 69317