Thoughtfully Navigating the Formula Market

Report
Thoughtfully Navigating the
Formula Market
KIMBERLY MANNEBACH RD,CSP,LD
OCTOBER 20, 2014
Disclosures
 None
Infant Feeding
The Ideal - Breastfeeding
 Breast milk
 Protein – whey:casein is 60:40 to 70:30


Carbohydrate – lactose


Most variable nutrient – higher concentrations when higher
volumes produced
Fat – high in palmitic and oleic acids


Decreases in concentration first 2 months of lactation
Variable due to diet. US diet makes it high in LCPUFAs and low in
DHA
AND all that great other stuff.
Morrow et. Al Pediatr Clin North Am. 2013 February: 60(1): 49-74
Bioactives of Breast milk
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Macrophages – protect against infection
Stem cells – regenerate and repair
IgA – pathogen binding inhibition
IgG – anti-microbial
IgM – complement activation
Cytokines
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
Growth factors

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IL-6 – stimulates acute phase responses
IL-8 – recruits neutrophils
IL-10 – induces antibody production
EGF – stimulates cell proliferation and maturation
IGF – stimulates growth, increased RBS and hemoglobin
HB-EGF – protective against damage from hypoxia and ischemia
Erythropoietin – intestinal development
Hormone somatostatin – regulates gastric epithelial growth
Lactoferrin – chelates iron, anti bacterial, antioxidant
Leptin – regulates energy conversion, appetite regulation
Ghrelin – regulates energy conversion and infant BMI
Oligosaccharides


HMOS – prebiotic for beneficial colonization of gut
Gangliosides – brain development
Morrow et. Al Pediatr Clin North Am. 2013 February: 60(1): 49-74
My client isn’t breastfeeding, now what?
 Enfamil Infant
 Protein – whey:casein 60:40
 Carbohydrate – lactose
 Fat – palm olein, coconut, soy and high oleic sunflower oils
 Other goodies:
DHA/ARA (0.32% fatty acids to match breast milk)
 Dual prebiotics – GOS (galactooligosaccharides) & polydextrose
 GOS feeds top part of bowel
 Polydextrose feeds lower part of bowel

• Synthetic polymer of glucose classified soluble fiber by USDA but
generally used to replace sugar in sugar free foods or increase fiber
in foods.
Similac Advance
 Protein – whey:casein 48:52
 Carbohydrate – lactose
 Fat – high oleic safflower, coconut, soy
 The other goodies:
Prebiotic – GOS
 DHA
 Natural vitamin E for improved absorption
 Lutein – increases carotenoids in brain for learning, intentionally
added vs. other formulas have trace amounts
 Lutein and vitamin E protect DHA from being oxidized by free
radicals so higher amount absorbed

Similac for Supplementation
 Similac Advance formulation with an increase in
amount of prebiotics to help give looser “breast fed
baby” stools.
Why is Similac now 19 kcal/oz?
 Breast milk banking has allowed increased analysis
of caloric contents in breast milk.



Researchers found range of 18.4-19.3
IOM and European Commission found 19.2-19.3
AAP found range to be 18.6-21
 Done in Europe previously without issue
 Not USDA approved so only applies to non WIC
packaged formulas (plastic square containers)
 Decreased slightly all 3 macronutrients
 Alimentum and Neosure unchanged.
I’ve heard some things about palm olein oil…
 Predominant fat in Enfamil products
 When combined with soy oil makes ratio of palmitic and
oleic acids similar to breast milk.
 2 studies:


Koo et al., Reduced bone mineralization in infant fed palm olein
containing formula. Pediatrics. 2003 May.
Young et al., Neonatal and infant feeding: Effect of bond density at 4
years. Journal of Pediatric Gastroenterolgoy and Nutrition. 2005
July.
 Palm olein oil decreases absorption of calcium by binding
calcium to unabsorbed palmitic acid which also creates
insoluble calcium soaps and can worsen constipation.
DHA/ARA
 Long chain polyunsaturated fatty acids (LCPUFA)
 DHA



22 carbon chain
Key for development of structure and function of neural tissues
specifically retina and brain (grey matter)
Can be derived from alpha-linolenic acid
 ARA



20 carbon chain
Key cell membrane component
Synthesized from linoleic acid
 Is they synthetic DHA/ARA used in formula safe?

Tests have proven no levels of hexane in formula however no true
research completed.
Enfamil Reguline
 Designed for constipated babies.
 Partially hydrolyzed protein
 Dual prebiotics – GOS and polydextrose
 1.5mg/100kcal instead of 1.8mg (not low iron but low end of
mandated range)
 Should not be used if baby gassy as prebiotics could
worsen.
 Continues to have DHA and choline for development
equivalent to Enfamil Infant.
Soy Formulas
 Enfamil Prosobee or Similac Soy Isomil
 Milk and lactose free – corn syrup solids for



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carbohydrate
To be used for patients with lactose deficiency or
intolerance or those wishing to maintain vegetarian
lifestyle.
Marketed towards fussiness and gas.
Over used compared to number of people in US with true
lactose intolerance.
NIH Nat’l Institute of Environmental Health Sciences
reviewed research on soy and hormonal changes found in
animal studies.

Found minimal concern for adverse affects of soy formula
Enfamil Gentlease
 Designed to improve fussiness and gas
 Partially broken down proteins with 60:40 whey:casein ratio
 20% carbohydrates from lactose
 Can sometimes be enough to help refluxing baby
also.
Total Comfort vs. Sensitive
 Similac Total Comfort


Marketed to discomfort
from persistent feeding
issues.
Partially hydrolyzed whey
proteins.
 Similac Sensitive


Marketed to fussiness and
gas.
Reduced lactose for mild
intolerance symptoms.
Added Rice formulas
 Enfamil AR



Marketed to spit up or
reflux babies.
AR = added rice starch
Increases viscosity
without thickening
through nipple.
 Similac for Spit-Up


Marketed to spit up or
reflux babies.
Reduced lactose with
added rice starch.
*These formulas only work in patient isn’t on medications
for reflux. (ranitidine or prevacid)
Does adding rice to bottles help reflux?
 Quick answer – we don’t think so.
 No evidenced based research confirms rice cereal helps.
 Issues with adding:
 Very high in carbohydrates/calories once added



Rice cereal is 15kcal/T which makes 20kcal/oz formula
~30kcal/oz
Makes distribution of fat, protein and carbs wrong so possibly
will increase fat stores due to high carb diet.
Asking infant intestines to digest something it shouldn’t be to
digest yet.
What about the corn syrup?
 Corn syrup solids are main carbohydrate used in
formulas when lactose removed

Ex: Gentlease, Spit-Up, Sensative
 Corn syrup solids not equivalent to high fructose
corn syrup.
 International Formula Council statement
 So what are corn syrup solids?


Deyhdrated corn syrup to powder form
Primary sugar is dextrose which is ¾ as sweet as sugar
 HFCS sweeter than cane sugar and more processed
than corn syrup solids.
Formulas for Patients with Allergies
 Nutramigen (Enflora LGG)
 Extensively hydrolyzed
proteins for those allergic to
intact cow or soy protein
 Lactose free
 Powder contains probiotic
LGG – liquid does not.
 Does not contain dual
prebiotics.
 Marketed to allergies or
colic
 Osmolality 300
 Expert Care Alimentum
 Hydrolyzed casein plus
free amino acids
 Lactose free
 RTF is corn free
 33% fat as MCT for
improved fat absorption
 Does not contain
prebiotics
 Marketed to allergies,
colic and fat
malabsorption
 Osmolality 370
Formulas for Patients with Allergies
 Pregestimil
 Marketed to patients with fat malabsorption who are also
sensitive to intact proteins.
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Ex: CF, short bowel syndrome, intractable diarrhea
Lactose free
Does not contain prebiotics
55% fat as MCT
Osmolality 320
*24kcal would be excellent formula for
CF population.
Formulas for Severe Allergies - $$$$
 PurAmino (Nutramigen
AA)
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Hypoallergenic – protein
down to amino acids
Can be used up to 24
months
Osmolality 350
 Neocate Infant
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Made by Nutricia,
predominately European
company.
Hypoallergenic
45 clinic trials to back
No palm olein oil
Can use for severe
milk/soy allergy, SBS, EE,
malabsorption
Osmolality 375
Formulas for Severe Allergies - $$$$
 Elecare
 Hypoallergenic to be used for protein maldigestion,
malabsorption, severe food allergies, SBS, EE
 33% fat as MCT
 Lactose free
 Osmolality 350
Preterm Formulas – Discharge Formulas
 Should be used on any patient born before 37 weeks GA
 AAP recommends continuation until 6-12 months
corrected age
 Can’t base changing to term formula on wt-for-ln as
weight catches up faster than height.

Extra nutrients of formula needed to catch up height otherwise
nutritionally shunted patients growth.
 Can be used in combination with breastfeeding upon
discharge.

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2-3 formula bottles/day if supply not adequate
Use as “fortifier” in expressed breast milk.

24kcal/oz - 70mL breast milk: 1tsp powder
 Commercially prepared human milk fortifier is for in
hospital use only. Request for it should be red flag.
Preterm Infants – Discharge Formulas
 Enfacare
 22kcal/oz to help with
catch up growth
 2.8g/100 cal protein vs.
2.1g
 120mg Calcium vs. 78mg
 66mg Phos vs. 43mg
 Same levels of DHA, ARA,
omega 6 and 3 and Infant
 20% fat as MCT
 Neosure
 22kcal/oz
 If used until 12mo showed
sig increase in body mass
w/ less fat mass than
preterm babies fed term
formula (Groh-Wargo
2005)
 2.8g Pro vs 2.07g
 105mg Calcium vs 78mg
 62mg Phos vs 42mg
 25% fat as MCT
 DHA, ARA and Lutein
Preterm – Hospital Use Formulas
 Enfamil Premature and Similac Special Care
 Comes in 20, 24 and 30kcal/oz 2oz nursettes as designed to
mix any calorie level needed in NICU
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No lactose as lactase enzyme not mature until >34 weeks.
Why high protein?
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24 + 30 = 27kcal/oz
Protein needs of up to 4-5g/kg in preterm infants. New research
showing high protein more important than high calorie intakes.
General NICU population should not come home with one of
these formulas.

Possibly used for BPD or other fluid restriction if other formulas
not tolerated.
The other guys…
 Enfamil 24kcal/oz
 Used for cardiac patients with increased needs and fluid
restriction or FTT patient that family not able to mix reliably.
 Enfaport
 84% fat as MCT for chylothorax patients.
 0-12 months
 Monogen
 90% fat MCT for chylothorax or other lymphatic disorders.
 >1 year old
The rest of the other guys…
 RCF
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Carbohydrate free formula for seizure disorders requiring Ketogenic
diet
Designed for infants.
 Calcilo XD – low Ca & vit. D free
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Abbott product
Used for hypercalcemia due to Williams syndrome or neonatal
hyperparathyroidism
 PM 60/40
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For patient with renal dysfunction requiring low mineral intake
Ca:Phos designed to manage serum calcium disorders
Low iron – if required may need supplement
Pediatric Formulas
Toddler Formulas
 Enfagrow Transitions
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Gentlease
Soy
 Nutramigen with Enflora Toddler
 Should not be used if toddler/pediatric formula needed
in long term.
 Nutramigen and Gentlease may be used as work to find
milk source that patient will tolerate well.
 If patient table food intake not age appropriate may help
balance diet.
 Comparable calories to whole milk.
Pediasure & Boost Kids Essentials
 30kcal/oz
 Nutritionally completed for 1-8 yo at 1000mL and 9-13 yo
1500mL
 If 100% formula intake recommend fiber
 If used as supplement recommend no more than 50% needs
for age to encourage eating.

Can also encourage eating by using as snacks rather than around meal
time.
 Is there a difference between enteral and oral?
 Yes – less sweetened/flavored so osmolality difference of ~130
 Enteral can be good for 1 year old as less sweet when not yet used to
strongly sweetened foods.
 Can you switch from brand to brand or fiber to no fiber?
 Many children yes however some kids are definite no. Family typically
knows if tried and tolerated vs. not.
Compleat Pediatric
 Made from real food ingredients including chicken,
fruit, vegetables and cranberry juice.
 May good for child who has feeding intolerance of
unknown cause – especially those with
developmental disabilities.
 30kcal/oz – nutritionally complete
 Contains Nutrisource Fiber – soluble fiber to help
with regular bowel functions.
Higher Calorie Formulas
 BKE and Pediasure 1.5
 Can be used for extremely underweight/increased needs,
volume limitations or fluid restrictions.
 Use with caution as oral supplement unless significantly
behind in growth as can fill up to point that patient doesn’t eat
anything as little as 2 cans/day.
 Nutren 2.0
 Adult formula typically for those >13 years but may use in
special circumstances younger
 Used highly by CF patients especially those with Gtubes to get
large amounts of calories in low volume so not too filling.
Reduced Calorie Formulas
 Compleat Pediatric Reduced Calorie
 Pediasure Sidekicks
 0.6kcal/mL
 Used for patients with especially low calorie needs or
those needing low calorie oral supplements.
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Cerebal Palsy
HIE
Oral aversion to certain food groups
Bright Beginnings Soy
 Soy based supplement for 1-13 years of age
 30kcal/oz
 Nutritionally complete
 If infant required soy formula typically will retest
with standard formula before beginning unless
allergy testing confirms.
Peptide Based Formulas
 Peptamen Junior
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Available in 1 and 1.5
100% hydrolyzed whey
protein – thought to
improve gastric emptying
rates
60:40 MCT:LCT ratio
With Prebio has FOS and
inulin added
 Pediasure Peptide
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Available in 1 and 1.5
100% hydrolyzed with
70:30 whey:casein
60% fat structured lipids
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Middle molecule on TG
backbone LCT to sneak
into MCT absorption
50:50 MCT:LCT ratio
Prebiotic scFOS (short
chain fructooligosaccharides)
Elemental Formulas
 Elecare Junior
 Designed for >1 year
 100% free amino acids
 33% fat as MCT
 Powder so flexibility in
calorie concentrations
mixed.
 Osmolality 590
 Neocate Junior
 For children 1-10
 High protein for GI tissue
repair
 Higher micronutrients for
malabsorptive conditions
 35% fat as MCT
 Available with Prebiotics
of FOS and inulin
 Powder so flexibility in
calorie concentrations
mixed
 Osmolality 570
Elemental Formulas
 Vivonex Pediatric
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
Available powder packets
or RTF
Lower osmolality at 360
compared to Neocate and
Elecare
 Neocate Splash (EO28)
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Clear – grape, tropical or
orange
100% free amino acids
Good for oral supplement
for children with severe
allergies.
The other guys….
 Boost Breeze

Clear supplement for children that refuse milk like texture of other
supplements

Especially accepted by patients with autism
 Ketocal 3:1 or 4:1
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Ratio = fat gm: carb+pro gms
Used for children with seizure disorders, epilepsy, pyruvate
dehydrogenase deficiency requiring Ketogenic diet
 Portagen
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Not nutritionally complete
Used for children and adults with defective lymphatic system,
decreased pancreatic lipase or bile salts or defective mucosal fat
absorption
87% fat as MCT
And more of the other guys…
 Suplena
 Designed for people with stage 3 or 4 CKD
 Can be complete source of nutrition or supplement
 Duocal
 Fat and carbohydrate only nutrition powder
 Helpful to add calories when unable to add more protein
 25kcal/scoop
 May be mixed into food or formulas
 Use regularly for cardiac condition infants needing >30kcal/oz
formula or children not growing that prefer low calorie foods
Questions?
Thank you!

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