Nutritive Efficacy and Safety of a Modified Infant Formula With a Reduced Protein Content and Improved Protein Quality
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

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.
    

Detailed description: 
      Breast milk is considered the gold standard for early childhood nutrition, it is optimized in
      terms of ingredients to the needs of the infant in the first months of life. Formula differ
      in many ways in their composition to breast milk, e.g. in the structure and concentration of
      the protein contained.

      To ensure adequate supply of the infant with all essential and semi-essential amino acids
      conventional infant 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, and individual amino
      acids are therefore fed in excess.

      The increased intake of protein, and thus the increased intake of some insulinogenic amino
      acids in infancy (e.g. the branched chain amino acids leucine, isoleucine and valine), is now
      considered as a possible co-factor for later disposition to overweight and obesity.
      Breastfeeding induces slower growth of the infant and is proven to be associated with a lower
      risk of being overweight or obese at the time of school entry (von Kries 1999). The higher
      protein intake in bottle-fed babies seems to contribute significantly to the differences that
      can be observed in the growth behavior between breast-fed and bottle-fed children in the
      first years of life.

      Obvious approaches to optimize infant formula are therefore the reduction of protein content,
      while ensuring an adequate supply of all relevant amino acids similar to breast milk.

      Enrichment with alpha-lactalbumin enables the reduction of total protein content in the
      formula through the qualitative upgrading of the protein body and the high content of
      essential amino acids, thereby limiting a surplus of protein intake, but at the same time to
      supply adequate amounts of essential amino acids.

      The aim is to examine the nutritive efficacy and safety of a modified infant formula with a
      reduced protein content and improved protein quality. Primary outcome measures are weight
      gain and growth of young infants under the 12 weeks of dietary intake of the new infant
      formula, and metabolic effects of the qualitative and quantitative changes in the protein
      content of the new formula. 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 body of experimental protein infant formula was 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. In addition, laboratory tests are
      carried out, which will examine the influence of diet on insulin response, protein metabolism
      and specific growth factors.

      In a follow-up long-term effects of nutrition on body composition will be recorded by
      comparing body fat measurements (skinfold thickness-Calipometrie) during the first year of
      life.
    

Intervention name(s): Standard infant formula; Protein reduced alpha-lactalbumin formula, with higher levels of alpha-lactalbumin
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: reduced; protein; formula; Alpha-lactalbumin; infant