The patent application is built on data from a trial on piglets that showed, “lactoferrin not only decreased the incidence and severity of diarrhoea, but also delayed the onset of diarrhoea”.
“These findings show that dietary lactoferrin supplementation improves gut comfort and is beneficial for the gut maturation process for young mammals,” Nestlé wrote in its application lodged via a Chinese patent office.
Via extrapolation, Nestlé said the piglet results were applicable to, “in particular non-infectious weaning diarrhea of infants or children.”
“This finding is in particular important because long lasting diarrhea is seen as a common cause of mortality in infants and children.”
In 2012 the European Food Safety Authority (EFSA) responded to an application from FrieslandCampina and concluded that lactoferrin, one of four primary human milk proteins was safe for use in food supplements.
EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) said there were no safety issues for the single polypeptide chain, iron-binding glycoprotein in a range of matrices including food supplements, infant and follow-on formulae, dietetic food for special medical purposes and sports nutrition, and for foods such as non-alcoholic beverages, cakes and pastries, products derived from cheese, milk-based products, cold snacks and sweets.
With this safety assessment it won EU novel foods approval but the protein has been rejected by the NDA for immunity-based health claims.
In its application Nestlé said lactoferrin had, “antioxidant activity and plays a role in the intestinal iron uptake and the regulation of immune response”.
It said diarrhea and associated malnutrition accounted for 13m deaths among children under 5 years of age worldwide each year.
In the piglet study, the researchers noted the beneficial lactoferrin effect was, “due to the ability of a lactoferrin molecule to bind two ferric iron molecules.”
“This might help to prevent biofilm formation of pathogenic microbes. As a consequence, lactoferrin may be considered a part of the protection machinery conferred to the infants by mothers.”
The lactoferrin extract could be delivered at varying strengths as a, “pure compound” or, “a fraction of a natural food product”.
The piglet study involved 72 3-day-old male domestic piglets from 5 litters randomly allocated to 1-4 treatments according to weight and litter. The piglets were monitored 24 hours a day by video surveillance.
Bovine milk lactoferrin supplied by DMV international was given to the 3-38 day old piglets in a sow milk replacement containing protein of soy/whey/casein (50:38:12). They were split into four groups.
Lactoferrin content varied from 0.05g/L (group 1, the control group with no added lactoferrin); 0.5g/L (group 2, sufficient dose), lg/L (group 3, high dose). All of these groups faced learning challenges except group 4 which had the same lactoferrin dose as group 3.
Multiple feeding times meant daily dosages came to 15mg, 145mg and 285 mg/kg body weight/day for each group.
“Lactoferrin supplementation significantly delayed the onset of diarrhea in formula fed piglets during the first 38 days of life,” the researchers concluded after measuring endpoints like stool consistency.
“Compared with control group, the onset of non-infectious diarrhea was delayed in formula fed piglets in response to lactoferrin in a dose-dependent manner.”