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Welcome to the ByHeart Pediatric Nutrition Coalition!

A Better Formula for Formula®

ByHeart is an infant nutrition company built from the ground up to deliver novel innovation on behalf of babies and parents.

Inspired By Human Milk, Innovated By Science
  • Easy digestion for babies—always.

Designed for healthy full-term infants 0-12 months of age, ByHeart’s Whole Nutrition Infant Formula is made with a patented protein blend that gets closest to human milk, organic grass-fed whole milk (never skim), carbohydrates from lactose (like human milk), and certified-clean* ingredients with no corn syrup, soy or palm oil. ByHeart is clinically proven** for easier digestion, less spit-up, softer stools, and more efficient growth.

* Based on Clean Label Project, Purity Award certification
**Compared to a leading infant formula

Not All Formula Is The Same
  • Research-backed ingredients set us apart.
Patented Protein Blend Closest to Human Milk
An 80:20 whey-to-casein ratio, human milk’s two most abundant proteins—alpha-lactalbumin and lactoferrin—partially hydrolyzed proteins and organic, grass-fed whole milk.
80:20 whey-to-casein ratio like early human milk

Whey and casein are the two major classes of protein in mammalian milks.¹ They are digested and absorbed differently – whey remains liquid in the stomach and is digested faster, while casein forms curds and is digested more slowly.² These differences in gastric emptying speed can impact digestion and absorption. Our formula mimics the 80:20 whey-to-casein ratio found in colostrum³ to support digestion and tolerability.

Alpha-lactalbumin: A Protein High in Essential Amino Acids

Alpha-lactalbumin (alpha-lac) is a high-quality whey protein that has been shown to promote growth, digestion, and tolerability.⁴ Rich in essential amino acids, alpha-lac is the most abundant protein in mature human milk and it can be isolated from bovine milk and added to infant formula.⁴ We’re the only US-made* infant formula to intentionally add alpha-lactalbumin and to include it at mature human milk levels.

*With globally sourced ingredients

Lactoferrin: An Immune-Supporting Protein

Lactoferrin is an iron-binding glycoprotein found in high levels in colostrum. Lactoferrin has many biological roles including, but not limited to, iron absorption and transport, immune system modulation, antimicrobial and antiviral activities, cognition and gut health support.⁵ We add lactoferrin at levels approved by the FDA.

Combination of Intact & Partially Hydrolyzed Proteins

Human milk contains both intact (whole) proteins and partially hydrolyzed (broken down) proteins – in fact, proteases in the mammary gland selectively pre-digest proteins before they are consumed by the infant!⁶ Both types of proteins offer unique benefits in terms of nutrition and properties that affect functionality and tolerability outcomes like reflux, gassiness and fussiness.⁶ While you will commonly see either intact or hydrolyzed proteins in infant formula, we include both.

¹Davoodi, SH et al. (2016). Iran J Pharm Res. 15(3):573. ²Boirie, Y et al. (1997). Proc Natl Acad Sci U S A. 94(26):14930-14935. ³Liao, Y et al. (2017). J Proteome Res. 16(11):4113-4121. ⁴Layman, DK et al. (2018). Nutr Rev. 76(6):444-460. ⁵Lönnerdal, B et al. (2009). Curr Opin Clin Nutr Metab Care. 12(3):293-297. ⁶Nielsen, SD et al. (2017). J Mammary Gland Biol Neoplasia. 22(4):251-261.

Organic, Grass-fed Whole Milk
There’s a whole lot to love about whole milk: MFGM, palmitic acid in the optimal SN-2 position, and PUFAs naturally derived from organic, grass-fed whole milk.
MFGM from Whole Milk

The main purpose of the milk fat globule (MFG) is to deliver fatty acids to their intended destinations in the body; however, components of the membrane, also known as the milk fat globule membrane (MFGM) such as sphingomyelin, choline, cholesterol, and phospholipids, also support metabolic function, cognitive development, immune and gut health.¹ Given that the triglycerides in human milk and whole cow’s milk are surrounded by the MFGM, it follows that skimming milk removes the fat (triglycerides) and the MFGM along with it. This is an important concept because infants require fatty acids for growth and development, so the practice of skimming milk means that lipids must come from extraneous sources like vegetable oils. Using whole milk as a formula ingredient retains innate lipids and the MFGM and lessens the reliance on vegetable oils to provide essential fatty acids.

Palmitic Acid from Whole Milk in The Optimal SN-2 Configuration

The positioning of fatty acids in the triglycerides of a fat source can impact outcomes. For example, SN-2 palmitic acid is important for softer stools and better absorption of fatty acids and minerals.² A quick refresher on triglyceride science tells us that triglycerides are composed of three fatty acids esterified (bound) in the SN-1, SN-2, and/or SN-3 positions on a glycerol backbone. The highest percentage of triglycerides in human milk are composed of palmitic acid in the SN-2 position.³ Conversely, many infant formulas contain palm oil, which has a very low proportion of palmitic acid in the SN-2 position and a higher proportion in the SN-1 or SN-3 positions, which are associated with calcium soaps and constipation.² Whole cow’s milk provides an innate source of palmitic acid in the SN-2 position, comparatively more than vegetable oils.

More PUFAs from Grass-fed Cows

Omega-3 and Omega-6 polyunsaturated fatty acids (PUFAS) are foundational nutrients for brain and nerve cell development.⁴ Babies need a delicate balance of omega-6 to omega-3’s for growth and development, where common sources of these fatty acids in infant formula are seed oils and whole milk. Oils are necessary to include in infant formula to meet fatty acid requirements, yet the use of organic whole milk from grass-fed cows lessens the reliance on seed oils.⁵˒⁶ We include DHA (an omega-3) within the World Health Organization’s recommended range.

¹Kosmerl E et al. (2021). Microorganisms. 9(2):1-22. ²Yao, M et al. (2014). J Pediatr Gastroenterol Nutr. 59(4):440. ³3Hunter, JE et al. (2001). Lipids. 36(7):655-668. ⁴Huffman, SL et al. (2011). Matern Child Nutr. 7 Suppl 3(Suppl 3):44-65. ⁵Simopoulos AP. (2002). Biomed Pharmacother. 56(8):365-379. ⁶Daley, CA et al. (2010). Nutr J. 2010;9(1):10.

Carbohydrates From Lactose
The same carbohydrate source as human milk.

Lactose is the predominant carbohydrate source in human milk and it supports growth, digestion, immune and gut health.¹ Up to 98% of the lactose in human milk is used to support normal growth and development, while a small fraction remains undigested and helps to soften stools and provide a food source for commensal gut bacteria.² Many standard infant formulas rely on maltodextrin or corn syrup solids as carbohydrate sources instead of lactose, which have potential implications on the gut microbiome,³ preference for sweet taste,⁴ and maladaptive metabolic responses.⁵

Nearly all infants are equipped with adequate lactase (the intestinal brush border enzyme that hydrolyzes lactose); therefore, while lactose can be easy to blame for formula-related tolerance issues, true lactose intolerance in infants is exceedingly rare and infant formulas containing lactose are well-tolerated by most term infants.⁶ While there are clinical classifications of lactose intolerance in infants (e.g., developmental lactase deficiency in infants <34 weeks gestation, secondary lactose intolerance, or congenital lactase deficiency), these conditions are uncommon and low-lactose and lactose-free formulas for healthy, term infants are rarely indicated.⁷

¹Ballard, O et al. (2013). Pediatr Clin North Am. 60(1):49-74. ²Jakobsen, LMA et al. (2019). J Proteome Res. 18(8):3086-3098. ³Jones, RB et al. (2020). Gut Microbes. 12(1). ⁴Hampson, HE et al. (2022). Nutrients. 14(5):1115. ⁵Anderson, CE et al. (2022). Am J Clin Nutr. 116(4):1002-1009. ⁶DI Costanzo M et al. (2018). Ann Nutr Metab. 73 Suppl 4(Suppl 4):30-37. ⁷Heine RG et al. (2017). World Allergy Organ J.10(1).

Organic Prebiotics
Galacto-oligosaccharide (GOS): A well-studied prebiotic for gut health.

Galacto-oligosaccharide (GOS) is a well-studied prebiotic fiber that promotes beneficial Lactobacilli and Bifidobacteria, enhances gut barrier function, inhibits pathogen adhesion, and promotes softer stools.¹˒² GOS is derived from lactose and may be included in infant formula to improve tolerance and achieve gut health outcomes more similar to infants fed human milk.

¹Ambrogi, V et al. (2023). Crit Rev Food Sci Nutr. 63(6):753-766. ²Ratsika, A et al. (2021). Nutrients. 13(2):1-33.

Certified-Clean Ingredients
The first and only infant formula to win three Clean Label Project awards.

The Clean Label Project is a consumer protection group that independently evaluates products for substances not found on the product label (e.g., heavy metals, pesticides, and more). We are the first and only infant formula company to win all three Clean Label Project awards: The CLP First 1,000 Days Promise, CLP Purity Award, and CLP Certified Pesticide Free.

End-to-End Ownership
We control every step, from research and development to ingredient sourcing to fulfillment, shipment, and the final product that arrives at caregivers’ doors.

As the first new US infant formula manufacturer in 15 years (we’re one of only five in the entire country) we are fully integrated—meaning we have sole responsibility of our product from initial design, to delivery, to the customer. This is a big deal. Because what you own, you can control.

Our Clinical Trial
  • A clinical trial 25 years in the making

We ran one of the largest clinical trials for infant formula in 25 years. We included 311 healthy, term infants and assigned them to either ByHeart formula or a leading commercial formula. We’re also the only new brand to add a comparison to human milk.

Our 6 month randomized, double blind, multi-center trial exceeded FDA requirements with a systems biology approach.

Less Spit-up
Parent reported number of spit-ups per day
Less Spit-up
Statistically significant difference compared with infants fed a leading infant formula (P=0.01).
Softer Stools
Parent reported stool consistency
Softer Stools
Statistically significant difference compared with infants fed a leading infant formula (P<0.001).
Higher Energetic Efficiency
Efficiency of growth for weight
14%
Higher energetic efficiency for weight gain
13%
Higher energetic efficiency for length (data not shown)
18%
Higher energetic efficiency for head circumference (data not shown)
Higher Energetic Efficiency
Statistically significant difference compared with infants fed a leading infant formula (P=0.02).
Higher Serum Essential Amino Acids
Concentration of essential and conditionally essential amino acids
Higher Serum Essential Amino Acids
Statistically significant difference compared with infants fed a leading infant formula (P=0.048).
Longer Stretches Between Nighttime Feeds at Four Months of Age
Parent reported time between feeds
32 mins
Longer between nighttime feeds at 4 months of age
Longer Stretches Between Nighttime Feeds at Four Months of Age
Statistically significant difference compared with infants fed a leading infant formula (P=0.02).
Events
  • Come along to see where we’ve been, and meet us at future events.

Share ByHeart With Your Patients

Give your patients 50% off their first purchase* with the ByHeart Starter Program.

*2 or more cans (6 cans max) at ByHeart.com

Available Retailers
  • Parents can shop ByHeart in-stores nationwide, and 24/7 at byheart.com.
SNAP eligible in-store

Join the Pediatric Nutrition Coalition!

Stay up-to-date on the latest infant nutrition science & research and gain early access to exciting educational opportunities and events, alongside a network of thousands of pediatric healthcare professionals. You don’t want to miss this.

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