Infant Formula Evaluating the Safety of New Ingredients (2004) / Chapter Skim
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From page 41... ...
Assessing the safety of ingredients new to infant formulas by comparing the proposed formulas with human milk also presents both regulatory and research issues. From a research standpoint, clinical studies that assess the effects of new ingredients are difficult to design because infants cannot be randomized to consume formulas or human milk.
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Box 3-1 lists the main landmarks in the BOX 3-1 History of Commercially Available Infant Formulas in the United States Cow-milk-based formulas 1867 Formula contained wheat flour, cow milk, malt flour, and potassium bicarbonate 1915 Formula contained cow milk, lactose, oleo oils, and vegetable oils; powdered form 1935 Protein content of formula considered 1959 Iron fortification introduced 1960 Renal solute load considered; formula as a concentrated liquid 1962 Whey:casein ratio similar to human milk 1984 Taurine fortification introduced Late 1990s Nucleotide fortification introduced Early 2000s Long-chain polyunsaturated fatty-acid fortification introduced Noncow-milk-based formulas 1929 Introduction of commercially available soy formula (soy flour) Mid 1960s Isolated soy protein introduced
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. In the 1960s renal solute load began to be considered in the design of infant formulas, although infant formula regulations permit higher loads than are currently recommended by expert panels (no greater than 30 mosm/100 kcal)
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. This chapter is concerned with infant formulas that are being altered to mimic composition or performance of human milk; it does not address the nutritional needs of specific infant populations.
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. Throughout the course of the day, an infant in the United States may consume both human milk and infant formulas in any number of combinations.
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For example, preterm infants fed human milk by nasogastric tube in the newborn intensive care unit have a lower rate of necrotizing enterocolitis (Lucas and Cole, 1990)
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COMPARING INFANT FORMULAS WITH HUMAN MILK 47 TABLE 3-1 Unique Factors in Human Milk That Positively Affect Nutritional Status and Somatic Growth Ingredient Class of Ingredient Function Reference Amylase Enzyme Polysaccharide digestion Howell et al., 1986 Epidermal growth Growth factor/hormone Gastrointestinal growth/ Donovan and Odle, factor differentiation 1994; Dvorak et al., 2003; Howell et al., 1986 Erythropoietin Growth factor/hormone Red cell production; possible Kling, 2002 growth factor for gut and central nervous system Insulin Growth factor/hormone Anabolic hormone promotes Donovan and Odle, carbohydrate, protein, and 1994 fat accretion Insulin-like growth Growth factor/hormone Primary growth hormone of Donovan and Odle, factor-I late fetal/neonatal period 1994 Insulin-like growth Growth factor/hormone Unknown function; thought Donovan and Odle, factor-II to be weak growth hormone 1994 Lactoferrin Carrier protein Increases efficiency of iron Howell et al., 1986 delivery Lipase Enzyme Triglyceride hydrolysis Howell et al., 1986 Nerve growth factor Growth factor/hormone Neuronal growth/ Donovan and Odle, differentiation 1994 Proteases Enzyme Unknown if active in protein Howell et al., 1986 hydrolysis Relaxin Growth factor/hormone Regulates morphological Donovan and Odle, development of the nipple 1994 Transforming growth Growth factor/hormone Gastrointestinal growth Donovan and Odle, factor-alpha 1994; Dvorak et al., 2003 TABLE 3-2 Unique Factors in Human Milk with Anti-Infective or Immunological Properties Class of Ingredient Ingredient Function Reference Antiproteases (e.g., Enzyme Inhibits breakdown of anti- Howell et al., 1986; secretary immuno- infective immunoglobulins IOM, 1991 globulin A and and enzymes trypsin inhibitor) Arylsulfatase Enzyme Degrades leukotrienes Hanson et al., 1988 Catalase Enzyme Degrades hydrogen peroxide; Lindmark-Mansson protects against bacterial and Akesson, 2000 breeches of intestinal barrier Fibronectin Opsonin May present debris to macrophages IOM, 1991; Mestecky et al., 1990 Free fatty acids Lipids Antiviral (coronavirus)
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Soluble intracellular Cytokine Alters adhesion of viral or Xyni et al., 2000 adhesion molecule-1 other molecules to intestinal epithelium Transforming growth Cytokine Produces immunoglobulin A Bottcher et al., 2000 factor-beta and activates B-cells Tumor necrosis Cytokine Mobilizes amino acids Mestecky et al., 1990 factor-alpha Uric acid Small molecular- Antioxidant Van Zoeren-Grobben weight et al., 1994 nitrogenous compound
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. Indeed, the primary impetus for adding LCPUFAs to infant formulas is their postulated effect on brain development.
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Human milk, like cow milk, is very low in vitamin D, with average concentrations of 24 to 68 IU/L. Since infants consume less than 0.5 L of milk/ day in the first months of life, breastfed infants have vitamin D intake well below the Adequate Intake of 200 IU/day.
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This position has been taken by numerous professional bodies and reflects the fact that human milk is species specific and thus uniquely suited for human infant nutrition. It must be recognized, however, that using a human-milk composition or breastfeeding performance standard presents both regulatory and research issues when assessing the addition of ingredients new to infant formulas.
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2001. Growth and development in term infants fed long-chain polyunsaturated fatty acids: A double-masked, randomized, parallel, prospective, multivariate study.
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1993. Energy and protein intakes of breast-fed and formula-fed infants during the first year of life and their association with growth velocity: The DAR LING Study.
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1986. Choline, phosphatidylcholine and sphingomyelin in human and bovine milk and infant formulas.
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