Please select the eligibility criteria that correspond to the clinical trial below.
Title: Nutritive Efficacy and Safety of a Modified Infant Formula With a Reduced Protein: Content and Improved Protein Quality: LactPro-Minus
Brief Summary: Formula contains significantly higher total protein concentrations than breast milk. Therefore formula-fed infants have a significantly higher total protein intake in the first few months compared to exclusively breast-fed infants.

The aim is to examine the nutritive efficacy and safety of a modified infant formula with a reduced protein content and improved protein quality in a prospective, double-blind, controled, randomized study. Primary outcome measures are weight gain and growth of young infants under 12 weeks of dietary intake of the new infant formula. Metabolic effects of the qualitative and quantitative changes in the protein content of the new formula will be recorded. Two groups of healthy bottle-fed infants will be compared. The treatment group will be fed for 3 months with an infant formula with decreased protein content. At the same time the protein body of the new formula is modified by enrichment with bovine alpha-lactalbumin.

A control group receives a isocaloric conventional infant formula and a protein body consisting of whey protein and casein in a ratio of 60:40, without specific accumulation of alpha-lactalbumin over the same time-period.

A group of breastmilk fed infants will serve as a reference group. In regular anthropometric controls growth and thriving of the study participants is documented and compared between the different groups.


Options:
A: Inclusion Criteria:

* Gestational age at least 37 weeks
* Singleton birth
* Birth weight between 2500g and 4500g
* Weight at enrolment is at or above the 5th percentile (CDC)
* Infant has been exclusively formula fed for at least the last 14 days
* Having obtained informed consent of legal representative

Exclusion Criteria:

* Congenital illness or malformation that affects infant feeding and/or growth
* Significant pre-natal and/or post-natal disease
* Suspected or confirmed allergy to cow milk protein
* In the investigators assessment, infant's family cannot be expected to comply with treatment (feeding regimen)
* Currently participating in another clinical trial
B: Inclusion Criteria:

* At the time of study enrollment apparently healthy newborns / infants without pronounced hyper- or hypotrophy (age-appropriate weight percentiles \> 3 and \< 97 according to Voigt et al.)
* Maternal decision against breastfeeding (for Formula Groups)

Exclusion Criteria:

* Congenital gastrointestinal malformations, metabolic disease, chromosomal aberration, syndromic disease with significant impact on growth, development, nutrition, immune competence
* Manifestation of a serious disease, which is expected to be accompanied by growth retardation, intestinal transit disruption or the need for special dietary treatment (e.g. hypertrophic pyloric stenosis, cystic fibrosis, Hirschsprung's disease, cow's milk protein intolerance.)
* Decision to administer HA (hypoallergenic) formula due to family atopies (defined by atopic disease of at least one 1 st degree relative: bronchial asthma, atopic dermatitis, pollinosis)
* Participation in another nutritional study
C: Inclusion Criteria:

. 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 Criteria:

* 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
D: Inclusion Criteria:

* Subjects who enrolled and completed the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"

Exclusion Criteria:

* Subjects who did not enroll in the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"

Answer: B