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EP-4510845-B1 - INFANT FORMULA WITH SPECIAL LIPID ARCHITECTURE FOR REDUCING CHILDHOOD BLOOD PRESSURE

EP4510845B1EP 4510845 B1EP4510845 B1EP 4510845B1EP-4510845-B1

Inventors

  • ABRAHAMSE-BERKEVELD, MARIEKE
  • SHAFAEIZADEH, Shila

Dates

Publication Date
20260506
Application Date
20230420

Claims (13)

  1. A nutritional composition selected from an infant formula and a follow on formula comprising lipid, protein and digestible carbohydrate, wherein the nutritional composition comprises lipid globules that have a volume-weighted mode diameter of at least 1.0 µm and/or wherein least 45 vol.% of the lipid globules have a diameter from 2 to 12 µm and wherein the lipid globules have a coating comprising phospholipids, for use in reducing the risk of elevated blood pressure in childhood, in a child having an age of <13 years.
  2. The nutritional composition for use according to claim 1, wherein reducing the risk of elevated blood pressure in childhood is when compared to a similar child who consumed an infant formula or follow on formula comprising lipid globules with a mode diameter, based on volume of about 0.5 µm and that do not have a coating comprising phospholipids.
  3. The nutritional composition for use according to any one of the preceding claims, wherein the blood pressure is diastolic blood pressure or arterial blood pressure, or diastolic blood pressure and arterial blood pressure.
  4. A nutritional composition selected from an infant formula and a follow on formula comprising lipid, protein and digestible carbohydrate, wherein the nutritional composition comprises lipid globules that have a volume-weighted mode diameter of at least 1.0 µm and/or wherein least 45 vol.% of the lipid globules have a diameter from 2 to 12 µm and wherein the lipid globules have a coating comprising phospholipids, for use in preventing paediatric hypertension in a child having an age of <13 years.
  5. The nutritional composition for use according to any one of the preceding claims, wherein the nutritional composition is administered to an infant having an age of 0 to 6 months, preferably 0 to 4 months.
  6. The nutritional composition for use according to claim 5, wherein the infant is a term born infant.
  7. The nutritional composition for use according to claim 5 or 6, wherein the infant is a healthy infant.
  8. The nutritional composition for use according to any one of the preceding claims which comprises at least 0.5 wt% phospholipids based on total lipid.
  9. The nutritional composition for use according to any one of the preceding claims wherein the phospholipids comprise at least 5 wt% sphingomyelin based on total phospholipids.
  10. The nutritional composition for use according to any one of the preceding claims, wherein the phospholipids are derived from milk lipids.
  11. The nutritional composition for use according to any one of the preceding claims, wherein the lipid comprises triglycerides that comprise at least 10 wt% palmitic acid based on total fatty acids, and wherein at least 15 wt% of the palmitic acid, based on total palmitic acid, is present at the sn-2 position of triglycerides.
  12. The nutritional composition for use according to any one of the preceding claims, wherein the lipid comprises at least 10 wt% milk fat, preferably cow's milk fat, based on total lipid.
  13. The nutritional composition for use according to any one of the preceding claims, wherein the formula is a powder, suitable to reconstitute with water to provide a ready to drink formula.

Description

FIELD OF THE INVENTION The invention relates to nutrition for infants, in particular infant formula, for use in reducing blood pressure in childhood. BACKGROUND OF THE INVENTION Infant or follow on formulas are commonly used when breastfeeding is inadequate or unsuccessful for medical reasons, or because of a choice not to breastfeed. Commercial infant formulas are commonly used to provide supplemental or sole source of nutrition in early life. These formulas comprise a range of nutrients to meet the nutritional needs of the growing infant, and typically include fat, carbohydrate, protein, vitamins, minerals, and other nutrients helpful for optimal infant growth and development. Nutritional experiences during an infant's first months of life can affect their susceptibility to chronic diseases in adulthood. Early nutritional experience during early periods of development can lead to regulatory mechanism programming: a phenomenon named metabolic imprinting. High blood pressure is one of the leading health risk factors in the world. Blood pressure in adulthood is shown to be predicted by childhood pressure, tracking from childhood throughout adolescence and into adulthood. It has been shown that elevated blood pressure in childhood is associated with hypertension risk in adulthood (Yang et al., 2020, J Hypertens 38: 2346-2355). Observational studies have shown that higher maternal pre-pregnancy BMI, maternal hypertension, a relatively lower birth weight, shorter gestational age (preterm born), limited duration of breastfeeding and more rapid BMI gain in early life contribute to higher childhood blood pressure at 6 years of age. Human milk lipids have a distinct physical structure composed of large lipid globules with an average volume-based mode diameter of about 4 µm existing of a triglyceride core coated by a tri-layer of membranes, the milk fat globule membrane (MFGM). The volume-based mode diameter of lipid droplets in standard infant formula is about 0.3-0.5 µm due to the industrial processing procedures to achieve stable and reproducible end products and is not surrounded by MFGM but mostly by proteins such as casein. Standard commercially available formulas also mostly contain vegetable oils and have small lipid droplets with proteins adhering to the surface. Infant formulas with lipid globules with an architecture more similar to the lipid globules in human milk have been described. In WO 2012/173467 the use of specifically designed lipid component with optimal fatty acid profile, an enhanced portion of the palmitic acid residues at the sn-2 position and present as lipid globules with a certain size and/or coating is disclosed for an early in life diet for improving the development of a healthy body composition, in particular prevention of obesity, later in life. In the prior art in the field of infant nutrition in relation to childhood blood pressure, it is clear that the dietary supplementation of infant formulas with long-chain poly-unsaturated fatty acids (LCPUFAs) is associated with lower blood pressure in later childhood at 6 years of age (Forsyth et al. BMJ 2003 volume 326, bmj.com 2003;326:953). In addition, supplementation of infant formula with milk fat globule membrane (MFGM) components resulted in serum lipid status closer to breastfed infants at 12 months of age (intervention 0-6 months; Timby et al. Pediatr Res 2014, 76(4):394-400). This may be linked to lipid status later in life, but this particular clinical trial does not provide any information beyond 12 months of age. WO2013/153071 discloses a nutritional composition comprising MFGM and milk fat in the context of, among others, blood pressure and other relevant cardiovascular and metabolic diseases, although no effects on blood pressure in childhood is mentioned, and the composition does not contain large lipid globules. WO2013/191542 relates to an infant formula comprising milk fat, phospholipid coated large lipid globules, and MFGM as a source for phospholipids. Effects on obesity and body composition are the focus, although metabolic syndrome and cardiovascular disease are mentioned. Effects of the composition on blood pressure in childhood is not mentioned. WO2013/36122 also describes phospholipid coated large lipid globules and MFGM in the context of reducing the level of total blood cholesterol later on in life, including associated conditions such as high blood pressure. Primary paediatric or childhood hypertension is associated with targeted organ damage, especially damage to the heart. Therefore it is crucial to look for potential precautions against developing elevated blood pressure in childhood and/or primary childhood hypertension. SUMMARY OF THE INVENTION Following a nutritional intervention with the experimental formula in healthy term infants for the first 4 months of life, the inventors measured the blood pressure during follow-up at 5 years of age. The experimental infant formula comprised a lipid component in the f