Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of the Level of Dietary Protein on the Infant Hormonal Profile and Body Composition
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 to 1 year of age and a follow up period from 1 year to 5 years of age.


Options:
A: Inclusion Criteria:

* 10-18 days of age
* 37-42 weeks gestation
* birth weight 2500 g or more
* consuming one source of nutrition

Exclusion Criteria:

* metabolic or chronic disease
* acute infection
* feeding difficulties
* consumed complementary foods or donor milk
* steroid use
B: Inclusion Criteria:

* Having obtained his/her parents' (or his/her legally accepted representative \[LAR's\] written informed consent and having evidence of personally signed and dated informed consent document indicating that the child's parents/LAR have been informed of all pertinent aspects of the study
* Child was born full term (≥ 37 weeks of gestation)
* Age at enrollment: between 11.5 months and 13.5 months of age
* 2.5 kg ≤ birth weight ≤ 4.5 kg
* Born from a singleton pregnancy
* Child's parent(s)/LAR is of legal age of consent, has sufficient local language skills to complete the informed consent and other study documents, is able to be contacted directly by telephone throughout the study, and is willing and able to fulfill the requirements of the study protocol.

Exclusion Criteria:

* Diagnosed disorder considered to interfere with nutrition or growth (e.g. malabsorptive disorders as short bowel syndrome, inflammatory bowel disease; neurological and congenital disorders that may delay growth as cerebral palsy, agenesis of the corpus callosum, spina bifida, Down Syndrome, Cri Du Chat; disorders that may lead to obesity: Prader willi syndrome, Angelman syndrome, etc.)
* Cows' milk allergy
* Lactose intolerance
* Participation in any other interventional clinical trial during the 4 weeks prior to enrollment
* Infant who is being breastfed at the time of enrollment
* Infant who does not usually drink 300ml of cow's and/or formula milk per day
* Institutionalized children
* Child or child's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures
C: Inclusion Criteria:

* Infant is judged to be in good health.
* Infant is a singleton from a full term birth.
* Infant's birth weight was \> 2490 g (\~5 lbs 8 oz.
* Infant is between 0 and 8 days of age at enrollment.
* Infants using medications, home remedies ,herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled.
* Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.

Exclusion Criteria:

* An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
* Infant has been treated with antibiotics.
* Infant has received probiotics.
D: 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

Answer: D