Nutramigen® LIPIL®
Hypoallergenic Protein Hydrolysate Formula
Description
Nutramigen® LIPIL® is a hypoallergenic formula for infants who are sensitive to the intact protein found in milk-based and soy-based formulas. Nutramigen LIPIL contains extensively hydrolyzed protein proven effective for colic and other symptoms due to cow's milk protein allergy. The formula includes docosahexaenoic acid (DHA) and arachidonic acid (ARA), nutrients also found in breast milk, that promote brain and eye development.
Product Features
· Hypoallergenic, lactose-free, and sucrose-free
· Clinically proven to resolve colic symptoms due to cow's milk protein allergy in 48 hours1,2*
· Proven effective in the dietary management of infants with allergic manifestations, including GI, skin, and respiratory symptoms
· Includes LIPIL, our blend of DHA and ARA, nutrients also found in breast milk, that promote brain and eye development3-10
· Fatty acid profile patterned after breast milk11,12†
· Increased level of choline to be closer to the level found in breast milk.‡ Choline is an essential nutrient found in breast milk that, like DHA, is important for baby's brain development.13,14
* Studied before the addition of LIPIL, our blend of DHA and ARA.
†Comparison based on fatty acid profile of typical mature U.S. breastmilk.
‡As calculated from the mean choline content of human milk determined by the Institute of Medicine.
Indications
Nutramigen LIPIL is an iron-fortified, lactose-free, sucrose-free, hypoallergenic infant formula for term infants who are sensitive to the intact proteins in cow's milk and soy formulas, as well as other foods. Such infants may have colic, rhinitis, wheezing, vomiting, diarrhea, bloody stools, mucus in stools, rash, or eczema. Nutramigen LIPIL is also appropriate for infants with galactosemia.
Breast milk is the standard for infant nutrition and the American Academy of Pediatrics (AAP) recommends breastfeeding for most infants.15 According to the AAP, iron-fortified infant formula should be used if breastfeeding is not chosen, is discontinued during the first year, or if a supplement to breast milk is desired.16 Cow's milk is not recommended for infants before their first birthday.
Long-Term Usage
Nutramigen LIPIL is designed to provide a sole source of nutrition for infants up to age 6 months, and provide a major source of nutrition through 12 months of age. Normally, in feeding infants, gradual introduction of solid foods after 4—6 months of age is an important developmental as well as nutritional step.
In cases of severe and multiple food allergies or intolerances, Nutramigen LIPIL is sometimes continued as a milk substitute in the diet of children. This and similar supplemental use of Nutramigen LIPIL in the diet beyond 12 months of age may make a significant contribution to maintenance of good nutrition in such patients. When Nutramigen LIPIL is used as a milk substitute, the total calcium content of the diet should be assessed.
Although detrimental effects of prolonged use of Nutramigen LIPIL as the sole source of diet beyond 6 months of age have not been reported, there is no basis on which to recommend such a practice. Extended use of Nutramigen LIPIL (or other infant formulas) as a sole source of diet is most appropriately monitored by physicians and nutritionists on a case-by-case basis, with attention to developmental as well as nutritional implications of such a dietary regimen.
Nutrients§
Normal Dilution / Per 100 Calories (5 fl oz) / Per 100 grams PowderProtein, g / 2.8 / 13.9
Fat, g / 5.3 / 26
Linoleic acid, mg / 860 / 4300
Linolenic acid, mg / 85 / 420
DHA, mg / 17 / 84
ARA, mg / 34 / 169
Carbohydrate, g / 10.3 / 51
Water, g / 133 / 3
Vitamins⁄Other Nutrients
Vitamin A, IU / 300 / 1490
Vitamin D, IU / 50 / 250
Vitamin E, IU / 2 / 9.9
Vitamin K, mcg / 8 / 40
Thiamin (Vitamin B1), mcg / 80 / 400
Riboflavin (Vitamin B2), mcg / 90 / 450
Vitamin B6, mcg / 60 / 300
Vitamin B12, mcg / 0.3 / 1.49
Niacin, mcg / 1000 / 5000
Folic acid (Folacin), mcg / 16 / 79
Pantothenic acid, mcg / 500 / 2500
Biotin, mcg / 3 / 14.9
Vitamin C (Ascorbic acid), mg / 12 / 60
Choline, mg / 24 / 119
Inositol, mg / 17 / 84
Carnitine, mg / 2 / 9.9
Taurine, mg / 6 / 30
Minerals
Calcium, mg / 94 / 470
Phosphorus, mg / 52 / 260
Magnesium, mg / 11 / 55
Iron, mg / 1.8 / 8.9
Zinc, mg / 1 / 5
Manganese, mcg / 25 / 124
Copper, mcg / 75 / 370
Iodine, mcg / 15 / 74
Selenium, mcg / 2.8 / 13.9
Sodium, mg / 47 / 230
Potassium, mg / 110 / 550
Chloride, mg / 86 / 430
Molybdenum, mcg / NA / NA
Chromium, mcg / NA / NA
§ Product nutrient values and ingredients are subject to change. Please see product label for current information.
Nutrient Facts
Nutrient Density / 20 Calories⁄fl ozProtein (% Calories) / 11
Fat (% Calories) / 48
Carbohydrate (% Calories) / 41
Potential Renal Solute Load (mOsm⁄100 Calories)17 / 25
Potential Renal Solute Load (mOsm⁄100 mL)17 / 16.8
Osmolality (mOsm⁄kg water) / 320 (Liq) 300 (Pwd)
Osmolarity (mOsm⁄L) / 290 (Liq) 270 (Pwd)
Gluten-Free / Yes
Lactose-Free / Yes
Galactose-Free / Yes
Product Characteristics
Fat
The fat content in Nutramigen® LIPIL® is 48% of total calories. The fat blend consists of approximately:
· 44% palm olein oil
· 19.5% soy oil
· 19.5% coconut oil
· 14.5% high oleic sunflower oil
· 2.5% single-cell oil blend rich in docosahexaenoic acid (DHA) and arachidonic acid (ARA)
The levels of total fat and saturated, monounsaturated, and polyunsaturated fatty acids in Nutramigen LIPIL are patterned after levels found in mature U.S. breast milk.11,12 Human milk contains, on average, between 20% and 24% of the fatty acids as palmitic acid.11 Using palm olein oil in the fat blend results in Nutramigen LIPIL having palmitic acid levels similar to breast milk.11 Linoleic acid provides about 17% of the total fatty acids in Nutramigen LIPIL, which is within the range of means found in average, mature U.S. breast milk (14%—19%).11
DHA and ARA
Nutramigen LIPIL includes DHA and ARA, two nutrients also found in breast milk that are important building blocks for a baby's brain and eyes.3-10 The level of DHA in Nutramigen LIPIL is similar to that found in average worldwide breast milk11,18-20|| as well as levels specified by expert groups.21-24
|| Middle of worldwide breast milk averages (25th-75th percentile range of 0.20% to 0.40% of total fatty acids), assuming about 50% of calories from fat.
Protein
Protein provides 11% of total calories in Nutramigen LIPIL. The hypoallergenic protein source is extensively hydrolyzed casein that is supplemented with three amino acids—L-cystine, L-tyrosine, and L-tryptophan—to provide an appropriate balance of amino acids to the infant. The protein source provides a high percentage of free amino acids with the remainder as small peptides. The protein efficiency ratio (PER) for Nutramigen LIPIL is greater than the PER for casein.25 Thus, the protein in Nutramigen LIPIL is of very high quality.
Every batch of protein hydrolysate used in Nutramigen LIPIL is tested for antigenicity using a procedure that detects the ability of a peptide to bind to a casein-specific antibody. The hydrolysates used in Nutramigen LIPIL result in an approximately 1 million-fold reduction in antigenicity compared with unmodified casein.
Carbohydrate
Carbohydrate provides 41% of total calories in Nutramigen LIPIL and the product is both lactose-free and sucrose-free. The carbohydrate blend in the powder is 86% corn syrup solids and 14% modified corn starch. The blend in the liquids is 75% corn syrup solids and 25% modified corn starch. The carbohydrates in Nutramigen LIPIL are readily digested and well tolerated by infants whose ability to digest other carbohydrates, such as lactose and sucrose, is impaired.26 The production of corn syrup solids and modified corn starch includes filtration and purification procedures that remove protein, the allergenic component of corn; therefore, these carbohydrate sources are considered hypoallergenic.27
Vitamins and Minerals
Nutramigen LIPIL meets U.S. Food and Drug Administration requirements for vitamins and minerals as mandated by the U.S. Infant Formula Act and the associated Code of Federal Regulations 21 C.F.R. part 107.28
Calcium and Phosphorus
Nutramigen LIPIL contains 94 mg calcium⁄100 calories and 52 mg phosphorus⁄100 Calories. The calcium:phosphorus ratio is about 1.8:1, which is in the range specified by the Infant Formula Act.28
Iron
Nutramigen LIPIL provides 12.2 mg iron/L. The AAP states that infants who are not breastfed should receive iron-fortified formula.16
Electrolytes—Sodium, Potassium, and Chloride
The electrolyte levels in Nutramigen LIPIL are within the ranges specified by U.S. Food and Drug Administration regulations as mandated by the Infant Formula Act.28 The sodium, potassium, and chloride levels are 47 mg⁄100 Calories, 110 mg⁄100 Calories, and 86 mg⁄100 Calories, respectively.
Clinical Experience
Nutramigen was introduced in 1942 and numerous clinical experiences with the formula have been recorded since that time. Several of these experiences are summarized below.¶
Efficacy Studies
Serologic response studies in healthy infants and children have shown that feeding Nutramigen results in lower immunology responses to proteins derived from cow's milk and soy.29,30 Many well-controlled studies have also shown that use of Nutramigen is associated with lower prevalence of cow's milk protein allergy symptoms in infants at high risk for allergy.31-34
Numerous clinical research studies also promote the use of Nutramigen in children with symptoms of allergy. Both double-blind placebo-controlled and single-blind studies provide evidence that most infants and children with cow's milk hypersensitivity are able to tolerate Nutramigen without adverse reactions.35-37 Serologic and dermatologic studies have also shown that extensively hydrolyzed formulas such as Nutramigen elicit much less reactivity in children with documented cow's milk allergy than cow's milk formulas.38,39 Furthermore, multiple studies have demonstrated that children with colic1,2,40,41 and enterocolitis42-44 caused by allergy to cow's milk or soy protein respond to Nutramigen feeding with improvement or resolution of symptoms. Although rare, allergic reactions to extensively hydrolyzed casein formulas have been reported.45-47
¶Studied before the addition of LIPIL, our blend of DHA and ARA.
Growth
Studies conducted in healthy infants demonstrate that Nutramigen® promotes growth. In a 112-day growth study, 22 healthy male and female infants fed Nutramigen grew similar to historical control infants fed milk-based formula.48 Metabolic balance studies were also conducted in male infants (mean age 7.7 months, n=6) who were recovering from malnutrition. The diet promoted adequate catch-up weight gain and maintained satisfactory serum albumin concentrations. Nitrogen absorption and retention were excellent. Fat and energy balances and stool characteristics were all within the expected normal ranges.49
Safety and Tolerance
Because of the special characteristics of Nutramigen, it does not taste like cow's milk and soy-based formulas; however, most infants quickly adjust to the taste. A study evaluated infants' responses to Nutramigen as a novel food at 1-2 months of age or 7-8 months of age. Infants <2 months of age showed a slight reduction in intake of Nutramigen compared with their regular formula but continued to drink substantial and satiating amounts of Nutramigen. Older infants rejected the Nutramigen when it was offered. The investigators stated that acceptance of Nutramigen can be achieved in older infants, although not usually on the first presentation.50
The sources of DHA and ARA in Nutramigen LIPIL® are well tolerated. In clinical studies comparing infants fed formulas including LIPIL with infants fed formulas without LIPIL, there were no Clinically significant differences in tolerance and the addition of LIPIL had no effect on the incidence of adverse events.51-53 The sources of DHA and ARA in Nutramigen LIPIL are Generally Recognized as Safe (GRAS) for use in infant formulas by the U.S. Food and Drug Administration.54,55
Composition
Ingredients: Powder: Corn syrup solids (46%), vegetable oil (palm olein, soy, coconut, and high oleic sunflower oils) (25%), casein hydrolysate (from milk)# (17%), modified corn starch (7%), and less than 2%: Mortierella alpina oil,** Crypthecodinium cohnii oil,†† acetylated monoglycerides, vitamin A palmitate, vitamin D3, vitamin E acetate, vitamin K1, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, vitamin B12, niacinamide, folic acid, calcium pantothenate, biotin, ascorbic acid, choline chloride, inositol, calcium citrate, calcium hydroxide, calcium phosphate, magnesium oxide, ferrous sulfate, zinc sulfate, manganese sulfate, cupric sulfate, sodium iodide, sodium selenite, sodium citrate, potassium citrate, potassium chloride, L-cystine, L-tyrosine, L-tryptophan, taurine, L-carnitine.
Ingredients: Concentrated Liquid: Water (75%), corn syrup solids (10%), vegetable oil (palm olein, soy, coconut, and high oleic sunflower oils) (7%), casein hydrolysate (from milk)# (4%), modified corn starch (3%), and less than 1%: Mortierella alpina oil,** Crypthecodinium cohnii oil,†† acetylated monoglycerides, carrageenan, vitamin A palmitate, vitamin D3, vitamin E acetate, vitamin K1, thiamin hydochloride, riboflavin, vitamin B6 hydrochloride, vitamin B12, niacinamide, folic acid, calcium pantothenate, biotin, ascorbic acid, choline chloride, inositol, calcium carbonate, calcium phosphate, magnesium oxide, ferrous sulfate, zinc sulfate, manganese sulfate, cupric sulfate, sodium iodide, sodium selenite, sodium citrate, potassium citrate, potassium chloride, citric acid, taurine, L-cystine, L-tyrosine, L-tryptophan, L-carnitine.
Ingredients: Ready To Use 32 fl oz and 6 fl oz: Water (87%), corn syrup solids (5%), vegetable oil (palm olein, soy, coconut, and high oleic sunflower oils) (3%), casein hydrolysate (from milk)# (2%), modified corn starch (2%), and less than 1%: Mortierella alpina oil,** Crypthecodinium cohnii oil,†† acetylated mono-glycerides, carrageenan, vitamin A palmitate, vitamin D3, vitamin E acetate, vitamin K1, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, vitamin B12, niacinamide, folic acid, calcium pantothenate, biotin, ascorbic acid, choline chloride, inositol, calcium carbonate, calcium phosphate, magnesium oxide, ferrous sulfate, zinc sulfate, manganese sulfate, cupric sulfate, sodium iodide, sodium selenite, sodium citrate, potassium citrate, potassium chloride, citric acid, taurine, L-cystine, L-tyrosine, L-tryptophan, L-carnitine.
Ingredients: Ready To Use 2 fl oz: Water (85%), corn syrup solids (6%), vegetable oil (palm olein, soy, coconut, and high oleic sunflower oils) (3%), casein hydrolysate (from milk)# (2%), modified corn starch (2%), and less than 1%: Mortierella alpina oil,** Crypthecodinium cohnii oil,†† acetylated mono-glycerides, carrageenan, vitamin A palmitate, vitamin D3, vitamin E acetate, vitamin K1, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, vitamin B12, niacinamide, folic acid, calcium pantothenate, biotin, ascorbic acid, choline chloride, inositol, calcium carbonate, calcium phosphate, magnesium oxide, ferrous sulfate, zinc sulfate, manganese sulfate, cupric sulfate, sodium iodide, sodium selenite, sodium citrate, potassium citrate, potassium chloride, citric acid, taurine, L-cystine, L-tyrosine, L-tryptophan, L-carnitine.