Please select the arm or intervention descriptions that belong 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: Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Other: Standard infant formula | Arm Label: Test Product; Type: EXPERIMENTAL; Interventions: Other: Infant formula with different level of proteins | Arm Label: Breast Milk; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Standard infant formula; Assigned to Arm(s): Control | Intervention Type: OTHER; Name: Infant formula with different level of proteins; Assigned to Arm(s): Test Product
B: Arm Label: Standard infant formula; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Standard infant formula | Arm Label: Protein reduced formula; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Protein reduced alpha-lactalbumin formula, with higher levels of alpha-lactalbumin | Arm Label: Breast-feeding; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DIETARY_SUPPLEMENT; Name: Standard infant formula; Assigned to Arm(s): Standard infant formula | Intervention Type: DIETARY_SUPPLEMENT; Name: Protein reduced alpha-lactalbumin formula, with higher levels of alpha-lactalbumin; Assigned to Arm(s): Protein reduced formula
C: Arm Label: Group 1: Low protein formula; Type: EXPERIMENTAL; Interventions: Other: Low protein formula | Arm Label: Group 2: high protein formula; Type: EXPERIMENTAL; Interventions: Other: High protein formula | Arm Label: Group Breastfeeding; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Low protein formula; Assigned to Arm(s): Group 1: Low protein formula | Intervention Type: OTHER; Name: High protein formula; Assigned to Arm(s): Group 2: high protein formula
D: Arm Label: Study Formula (SF); Type: EXPERIMENTAL; Interventions: Other: Study Formula (SF), Other: Comparator Formula (CF) | Arm Label: Comparator Formula (CF); Type: ACTIVE_COMPARATOR; Interventions: Other: Study Formula (SF), Other: Comparator Formula (CF) | Arm Label: Human Milk Reference Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Study Formula (SF); Assigned to Arm(s): Comparator Formula (CF), Study Formula (SF) | Intervention Type: OTHER; Name: Comparator Formula (CF); Assigned to Arm(s): Comparator Formula (CF), Study Formula (SF)

Answer: B