Welcome to the ByHeart Pediatric Nutrition Coalition!
OUR CLINICAL TRIAL

6-Month Randomized Controlled Clinical Trial Exceeds FDA Requirements with Systems Biology Approach

ByHeart ran one of the largest clinical trials for infant formula in 25 years,  published in the Journal of Pediatric Gastroenterology and Nutrition. We included 311 healthy, term infants and assigned them to either ByHeart formula, a leading commercial formula, or a human milk-fed reference group. We were also the first new brand to add a comparison to human milk.

ByHeart is committed to studying the impact of our innovations.

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

 

  • 35 sites
  • 311 healthy term infants
  • 6-month duration 
  • 11 visits
  • Comprehensive analysis
Inspired by human milk, innovated by science

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 EXPERTS
J. Bruce German, PhD
Consultant to ByHeart

J. Bruce German, PhD, is a distinguished professor at the University of California, Davis, where he directs the Foods for Health Institute. His research focuses on understanding the interplay between diet, the human microbiome, and overall health. He utilizes mammalian milk as a model system to investigate the complex relationship between food composition and human physiology, with a particular emphasis on the role of fats and their impact on metabolism and disease. He and his group have published over 500 publications that have been cited over 50,000 times. He founded the International Milk Genomics Consortium in 2004 to bring scientists from around the world to apply the tools of genomics and systems biology to understanding lactation and milk. Dr. German is a leading voice in the field of personalized nutrition, advocating for a deeper understanding of individual needs and responses to food. He and colleagues have founded 4 startup companies to provide products and services to mothers and babies.

Bo Lönnerdal, PhD
Consultant to ByHeart

Dr. Bo Lönnerdal has an active research program in pediatric nutrition at University of California, Davis. He has mentored a large number of undergraduate and graduate students, as well as post-doctoral scholars and visiting scientists from all over the world.

He received his master’s and doctorate degrees in biochemistry from University of Uppsala in Sweden, and has been Professor of Nutrition at UCD since 1980.

Dr. Lönnerdal’s research has focused on bioactive components in breast milk, the effect of breast milk on the recipient infant and mechanisms underlying the protection against infection. His research includes the micronutrients iron and zinc; how they are secreted into milk and how they are utilized by the infant. He has extensive collaborative projects in China, Peru and Sweden.

His honors include:

1977     Henning Throne‑Holst’s Award in Nutritional Physiology

1986     St. Göran’s Annual Lecture in Nutritional Physiology, Karolinska Institute

1987   Underwood Memorial Lecture in Trace Element Research

1990    Borden Award, American Institute of Nutrition

1991    International Award for Modern Nutrition 

2000    Honorary Doctorate (Honoris causa) in Medicine, University of Uppsala, Sweden

2002    Macy-Györgi Award for Research on Human Milk and Lactation

2004    Gabriel Bertrand Prize and Medal for Research on Trace Element Metabolism

2012    Lucille Hurley Lectureship

2019   Robert Suskind and Leslie Lewinter-Suskind Pediatric Nutrition Lifetime Achievement Award, ASN

Dr. Lönnerdal has published more than 600 scientific articles, book chapters and books and is currently a member of the American Society of Nutrition (ASN), the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and the International Society for Research on Human Milk and Lactation (ISRHML). He is on the Editorial Board of several scientific journals and he has served on several Expert Panels for the WHO.

Steven Zeisel, MD, PhD
Consultant to ByHeart

Dr. Zeisel is a scientist and educator in the field of nutrition with more than 40 years of innovation and leadership in his discipline.  He is best known for discovering that people require the nutrient choline (important for fetal development, liver and muscle function).  This discovery led to the US National Academy of Sciences, the European Union Food Safety Authority, and the US Food and Drug Administration setting recommended dietary intakes for choline.  The FDA also required all manufacturers of infant formulas to increase the amount of choline they add. Dr. Zeisel was the first to find that choline is needed by the stem cells that become the nerves in brain, and that low maternal intake of choline led to abnormal brain development in her baby. The American Medical Association and the American Academy of Pediatrics have since issued recommendations that pregnant mothers eat diets that are adequate in choline.  Dr. Zeisel and his research team also discovered that people have common genetic differences that can greatly increase the amount of choline they need.  Dr. Zeisel has authored more than 350 peer-reviewed scientific papers and has authored many chapters in textbooks of nutrition and medicine.  He was President of the American Institute of Nutrition (now the American Society of Nutrition; the premier academic research society in. this discipline from 2002-2003. He was the editor of Frontiers in Nutrigenomics, is on the editorial board of the FASEB Journal, and was the founding editor of the Journal of Nutritional Biochemistry.

Dr. Zeisel received his Bachelor of Science and Doctor of Philosophy degrees from the Massachusetts Institute of Technology, his Doctor of Medicine degree from Harvard Medical School, and completed his internship and residency in pediatrics at Yale.  In 1980, he joined the faculty at Boston University School of Medicine where he rose from assistant to full professor of Pathology and Pediatrics.  In 1990, he moved to the University of North Carolina at Chapel Hill, where is the Kenan Distinguished University Professor of Nutrition and Pediatrics.  He was the Chair of the department of Nutrition from 1990-2005, the Associate Dean for Research of the School of Public Health till 2007, and the Director of the University of North Carolina Nutrition Research Institute (a unit focused on developing the area of Precision Nutrition) from 2008-2022.  Also, he was the Director of the University of North Carolina Nutrition and Obesity Research Center (one of 12 such centers of excellence funded by the US National Institutes of Health) from 1995-2015.

Paolo Manzoni, MD, PhD
Consultant to ByHeart

Paolo Manzoni is a Neonatologist and Pediatrician, founding Board Member of the Italian Society of Neonatal Infectious Diseases since 2003, and founding Board Member of the international Excellence Research Network on RSV named “Resvinet” since 2014 (www.resvinet.org). After being Faculty Staff at the Neonatology and NICU Division at S.Anna Hospital in Torino from 1997 to 2018, he became Head of the Maternal-Infant Medicine Department at the University of Torino Hospital “Degli Infermi”  in Biella, holding a position of Associate Professor of Pediatrics and Neonatology at the School of Medicine, University of Torino. Dr Manzoni’s primary research interests include a wide range of disciplines related to nutrition, infections and immunity in preterm and term neonates and young infants. As such, he is active in the areas of pediatric and neonatal infectious diseases, fungal infections, human milk bioactive nutrients, RSV-related diseases, Covid-19 in neonates and infants, retinopathy of prematurity, and neonatal nutrition. He has been appointed by 20 Universities in 18 countries, and authored some 240 research articles published in peer-reviewed international leading Journals.

Catherine J. Field PhD, RD, FCHAS and Tier I Chair in Nutrition and Metabolism
Consultant to ByHeart

Department of Agriculture, Food and Nutritional Science
Faculty of Agriculture, Life and Environment Science
College of Natural and Applied Sciences
University of Alberta, Edmonton, Alberta Canada

Catherine Field is a Registered Dietitian and Full Professor at the University of Alberta. Her research program centers on the effect of nutrition on the development of the infant immune system and the importance of the diet in the prevention of food allergies.  She is a co-PI for the large maternal infant cohort, APrON (Alberta Pregnancy Outcomes and Nutrition). Dr. Field also studies the role of specific fatty acids in the treatment of breast cancer. She holds a Canada Research Chair in Human Nutrition and Metabolism and is a fellow of the Canadian Academy of Health Sciences and the Canadian Nutrition Society. She has published more than 350 peer reviewed publications and received the McCalla and Killam Professorships from the University of Alberta, and the Earl Willard McHenry Award for Leadership in Nutrition from the Canadian Nutrition Society.  She has presented her work at many National and International conferences and been involved in guidelines for infant formula.  Dr. Field is an Associate Editor for Advances in Nutrition and is a past president of the American Society for Nutrition.

Sharon M. Donovan, PhD, RD
Consultant to ByHeart

Sharon M. Donovan, PhD, RD is the Melissa M. Noel Endowed Chair in Nutrition and Health at the University of Illinois Urbana-Champaign. She received her Ph.D. in Nutrition at the University of California at Davis and completed a postdoctoral fellowship in Pediatric Endocrinology at the Stanford University School of Medicine.Since July 2020, she has served as the inaugural director of the Personalized Nutrition Initiative at the University of Illinois. This initiative facilitates transdisciplinary collaborative efforts across campus to answer fundamental questions regarding how personalized nutrition influences health and disease across the lifespan and to translate that information to clinical care and the public.  Research in her laboratory centers on optimizing nutrition in the first 1000 days of life, specifically focusing on the coordinated development of the gut microbiome, immune system, and cognitive function in infants. She is particularly interested in bioactive components in human milkShe served as President of the American Society for Nutrition from 2011-2012 and the International Society for Research on Human Milk and Lactation from 2018-2020. She was a member of the Food and Nutrition Board between 2012 and 2018 and was elected to the National Academy of Medicine in 2017. Dr. Donovan also served on the 2020-2025 Dietary Guidelines for Americans Advisory Committee, where she chaired the Pregnancy and Lactation subcommittee and was a member of the Birth to 24 months subcommittee.

Devon Kuehn, MD
Chief Medical Officer of ByHeart

Devon is a board-certified pediatrician and neonatologist and the Chief Medical Officer at ByHeart, a fully integrated baby nutrition company dedicated to empowering parents with choice. As the CMO, Devon leads all innovation and product development, clinical research, nutrition science, medical affairs and education, post market surveillance, and regulatory activities for the company. Prior to joining ByHeart, Devon was Chief Medical Officer at Paidion Research, the only dedicated pediatric clinical research organization in the US. Devon’s medical academic career was primarily at East Carolina University, as a neonatologist and Vice Chair for Research for the Department of Pediatrics. Devon earned her medical degree from the Uniformed Services University and completed her pediatric residency and neonatal fellowship training at Walter Reed Army Medical Center. During her fellowship, Devon conducted research at NIH, NICHD, Division of Epidemiology, Statistics, and Prevention Research. Devon has co-authored over 35 peer-reviewed publications with a focus on pregnancy and early life exposures and the impact on growth and development.

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