Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Evaluation of the Impact of Infant Formulas With Different Protein Content on Growth, Gastrointestinal Tolerance, and B-casomorphin Concentration of Infants.
Brief Summary: Human milk (HM) is the gold standard of early infant nutrition. The World Health Organization (WHO) recommend that newborns be exclusively breastfed for the first 6 months of life. It has beed reported that an exclusive breast feeding at 6 months of age range from 10 to 46%. Thus, the intake of infant formulas (IF) is quite widespread, including infants that have less than 6 months that are not receiving breast milk. Most of the commercial IF are cow's milk-based formulas that have a higher concentration of protein than breast milk and have a different protein composition. Commercial IF have a low proportion of alpha lactoalbumin, and A1 β-casein; during its digestion, a β-casomorphin 7 peptide is produced. In addition, it has a high concentration of β-lactoglobulin. Both, β-casomorphin 7 and β-lactoglobulin have been associated with a higher risk of diabetes obesity and allergies. Human β-casein does not produce β-casomorphin 7 during its digestion, it has a high concentration of alpha-lactoalbumin and does not have β-lactoglobulin.

The purpose of this study is to evaluate growth, gastrointestinal tolerance, and β-casomorphin 7 in urine of infants that are exclusively breastfed compared to infants fed three IF with different proteint content.


Options:
A: Arm Label: Previously marketed infant formula; Type: ACTIVE_COMPARATOR; Interventions: Other: Previously marketed infant formula | Arm Label: Previously marketed formula using a similar protein; Type: EXPERIMENTAL; Interventions: Other: Previously marketed formula using a similar protein | Intervention Type: OTHER; Name: Previously marketed infant formula; Assigned to Arm(s): Previously marketed infant formula | Intervention Type: OTHER; Name: Previously marketed formula using a similar protein; Assigned to Arm(s): Previously marketed formula using a similar protein
B: Arm Label: IF-VLP (very low protein); Type: EXPERIMENTAL; Interventions: Other: Infant formula | Arm Label: IF-LP (low protein); Type: OTHER; Interventions: Other: Infant formula | Arm Label: IF-CSP (control standard protein); Type: OTHER; Interventions: Other: Infant formula | Arm Label: HM (human milk); Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Infant formula; Assigned to Arm(s): IF-CSP (control standard protein), IF-LP (low protein), IF-VLP (very low protein)
C: Arm Label: 1; Type: PLACEBO_COMPARATOR; Interventions: Other: standard infant formula | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Other: Test formula | Arm Label: 3; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: standard infant formula; Assigned to Arm(s): 1 | Intervention Type: OTHER; Name: Test formula; Assigned to Arm(s): 2
D: Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Other: Control | Arm Label: Investigational; Type: EXPERIMENTAL; Interventions: Other: Investigational | Arm Label: Mother's-own Breast Milk; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Control; Assigned to Arm(s): Control | Intervention Type: OTHER; Name: Investigational; Assigned to Arm(s): Investigational

Answer: B