Please select the eligibility criteria that correspond to the clinical trial below.
Title: Lower Protein Intake and Long-term Risk of Obesity and Cardiovascular Disease: A Multi-centred, Randomised, Controlled Trial
Brief Summary: The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and cardiovascular disease.


Options:
A: Inclusion Criteria:

* Previous participation in infant formula controlled protein study
* Body composition data from 6 month of age available
* Consent obtained from legal representative
* Within age parameters specified in protocol around the 3 and 5 year age points

Exclusion Criteria:

* Unable to endure testing procedures upon evaluation of the Investigator
* Outside the age range of the study
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 term infant
* Infant is aged 14 weeks (+/- 1 week)
* Infant is exclusively formula feeding or predominantly breast-feeding at age 14 weeks

Exclusion Criteria:

* Any adverse maternal, fetal or infant medical history that may have effects on growth and/or development
* Infant born with congenital disease or malformation affecting growth and/or development
* Food allergy to any trial products (e.g. milk, soy)
D: Inclusion Criteria:

Healthy infants will be enrolled in the study provided they meet the following inclusion criteria:

1. Having obtained his/her parents' (or his/her legally accepted representative's \[LAR's\]) written informed consent and having evidence of personally signed and dated informed consent document indicating that the infant's parents/LAR have been informed of all pertinent aspects of the study.
2. Age ≤ 7 days after birth (date of birth = Day 0)
3. Full-term gestational birth (≥ 37 and ≤ 42 weeks)
4. Born to mothers with pre-pregnancy body mass index (BMI) ≥ 18.5 and \< 26 kg/m2
5. Born to mothers who independently elected, before study enrollment, not to breastfeed (not applicable for infants in the HM-fed comparator group)
6. Weight ≥ 2'500 g and ≤ 4'200 g
7. Infant's parent(s)/LAR is of legal age of consent, has sufficient command of French language to complete the informed consent and other study documents, and is willing and able to fulfill the requirements of the study protocol
8. Infant's parent(s)/LAR is able to be contacted directly by telephone throughout the study

Exclusion Criteria:

Infants who exhibit one or more of the following criteria are excluded from enrollment in the study:

1. Born to mothers with hormonal or metabolic disease (e.g. Type-1, Type-2, or gestational diabetes diagnosed according to standardized criteria)
2. Born to mothers who smoked \> 10 cigarettes per day during pregnancy
3. Born to mothers who used illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (\> 3 alcoholic beverages per week) during pregnancy
4. Cognitive or physical developmental disorders (e.g. malabsorptive disorders such as short bowel syndrome; neurological and congenital disorders that may delay growth such as cerebral palsy, agenesis of the corpus callosum, spina bifida, Down Syndrome, Cri Du Chat; disorders that may lead to obesity such as Prader willi syndrome, Angelman syndrome; other renal, hepatic, pancreatic, or cardiovascular disorders)
5. Received radiation therapy (eg. scannography or interventional radiology)
6. Participation in any other clinical trial prior to enrollment
7. Infants or infant's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures

Answer: C