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EP4648783A1 - Utilisation d'une fraction de lait enrichie en phospholipides dans la prévention d'une infection par le vrs - Google Patents

Utilisation d'une fraction de lait enrichie en phospholipides dans la prévention d'une infection par le vrs

Info

Publication number
EP4648783A1
EP4648783A1 EP24700727.1A EP24700727A EP4648783A1 EP 4648783 A1 EP4648783 A1 EP 4648783A1 EP 24700727 A EP24700727 A EP 24700727A EP 4648783 A1 EP4648783 A1 EP 4648783A1
Authority
EP
European Patent Office
Prior art keywords
phospholipid
enriched milk
milk fraction
fraction
enriched
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP24700727.1A
Other languages
German (de)
English (en)
Inventor
Everarda Helena Maria Kramer
Anouk Leonie FEITSMA
Ruprecht Jules Joost Van Neerven
Renske HOPMAN
Johannes Adrianus Henricus Petrus Bastiaans
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
FrieslandCampina Nederland BV
Original Assignee
FrieslandCampina Nederland BV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by FrieslandCampina Nederland BV filed Critical FrieslandCampina Nederland BV
Publication of EP4648783A1 publication Critical patent/EP4648783A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/20—Milk; Whey; Colostrum
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A23L33/12—Fatty acids or derivatives thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/66—Phosphorus compounds
    • A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
    • A61K31/685—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses

Definitions

  • This invention relates to a milk fraction enriched in phospholipids for use in the prevention of an infection of the respiratory tract with respiratory syncytial virus (RSV).
  • RSV infections are a major disease burden in infants. They are the second most prevalent cause of death in children - especially in in low- and middle-income countries - and a major seasonal burden to healthcare systems.
  • Phospholipids are the main part of the polar lipids fraction in milk, having a polar (charged) head group and apolar tail.
  • Glycerophospholipids contain two fatty acids on a glycerol backbone and a phosphate head group.
  • Phosphosphingolipids have a sphingosine backbone of which the amide group is N-linked to a fatty acid and a phosphate head group.
  • the five types of phospholipids present in milk are phophatidylcholine (PC), phosphatidyletanolamine (PE), phosphatidylserine (PS), phosphatidylinositol (PI) and sphingomyelin (SPM).
  • PC phophatidylcholine
  • PE phosphatidyletanolamine
  • PS phosphatidylserine
  • PI phosphatidylinositol
  • SPM s
  • MFGM milk fat globule membrane
  • MFGM milk fat globule membrane
  • the present invention therefore relates to phospholipid-enriched milk fractions for use in the prevention of a viral infection with respiratory syncytial virus (RSV) and/or prevention of the further development of a viral infection with respiratory syncytial virus (RSV).
  • RSV respiratory syncytial virus
  • phospholipid-enriched milk fraction refers to dairy products that have been obtained by subjecting milk to separation techniques and that contain a higher concentration of phospholipid, based on dry matter, than the milk it has been derived from.
  • the total phospholipid content of raw bovine milk, based on dry matter, is generally around 0.25-0.30 wt%.
  • the phospholipid-enriched milk fraction for use according to the present invention preferably has a total phospholipid content, based on dry matter, of at least 1.0 wt%, preferably at least 1.5 wt%, more preferably 2.5 wt%, even more preferably at least 4 wt%, more preferably at least 6 wt%, even more preferably at least 7 wt%. even more preferably in the range 7-20 wt%, and most preferably in the range 7-15 wt%.
  • This total phospholipid content can be determined by lipid extraction using a Rose- Gotlieb method and the subsequent determination of phosphorus in the lipid extract using ICP (Induced Coupled Plasma).
  • this total phospholipid refers to the content of dairy phospholipids, i.e. phospholipid originating from milk. This can be determined by analysing the sphingomyelin content - a phospholipid not present in vegetable phospholipid sources - with 13 P-NMR.
  • the sphingomyelin content, based on total phopspholipids, is preferably at least 20 wt%, more preferably in the range 20-35 wt%, most preferably in the range 20-30 wt%.
  • the milk from which the phospholipid-enriched milk fractions can be obtained is preferably a ruminant milk.
  • ruminant includes true ruminants, like cattle, sheep, and goats, and pseudo-ruminants, like camels.
  • the milk to be used for the production of phospholipid-enriched milk fractions is preferably obtained from cattle or goats, meaning that bovine milk and goat milk are the preferred sources of the phospholipid-enriched milk fraction. Bovine milk, more in particular cow’s milk, is the most preferred source.
  • the phospholipids When milk is separated in protein-rich, fat-rich (cream), and lactose-rich fractions, the phospholipids mainly end up in the fat-fraction of whey or the whey-fraction of cream.
  • phospholipid-enriched fractions which can be used according to the present invention are cream, sweet buttermilk, alpha-serum, beta-serum, cream serum, and whey protein phospholipid concentrate.
  • Sweet buttermilk is obtained by skimming of milk to obtain skim milk and cream (about 40% fat), followed by churning of the cream fraction into butter and sweet buttermilk.
  • cream When said cream is subjected to centrifugation, it can be separated into a cream with a higher fat content (at least about 65%) and a serum fraction.
  • This serum fraction is called alpha-serum.
  • the obtained cream When the obtained cream is subsequently subjected to phase inversion with an homogeniser, it can be separated into butter oil or anhydrous milk fat (AMF) and another serum fraction: beta-serum.
  • AMF anhydrous milk fat
  • Cream serum is the mixture of alpha-serum and beta-serum.
  • the serum fractions can be further concentrated by, e.g., ultrafiltration and optionally dried to obtain a powder.
  • Whey protein phospholipid concentrate can be obtained by separating the fat fraction of sweet whey protein concentrate or acid whey protein concentrate using one or more microfiltration steps, optionally followed by drying to obtain a powder. Such a process is disclosed in WO 2017/194068 and WO 2022/112552.
  • the phospholipid-enriched milk fraction is selected from beta-serum and whey protein phospholipid concentrate, as these milk fractions have the highest phospholipid content.
  • the phospholipid-enriched milk fraction is a whey protein phospholipid concentrate, as that gives the best protection against RSV infection.
  • the phospholipid-containing compositions can be used in the form of a powder or a liquid concentrate.
  • phospholipid-enriched milk fractions are Lacprodan® MFGM- 10, Vivinal® MFGM, Hilmar TM 7500 MFGM, SureStartTM MFGM, SureStartTM Lipid 70, SureStartTM Lipid 100, Lacprodan® PL-20, Tatua’s PLC1 and BSP2, Fonterra’s BPC- 50, and Corman’s SM2.
  • the phospholipid-enriched milk fraction is added to or is part of an infant formula in order to reach subjects that are most vulnerable to RSV infections: infants and young children, especially infants up to 6 months of age.
  • the phospholipid-enriched milk fraction is preferably present in such infant formula in concentrations of 0.1 -10 wt%, preferably 0.5-8 wt%, even more preferably 1-7 wt%, and most preferably 2-5 wt%, based on dry weight.
  • infant formula refers to a nutritional composition intended for infants and as defined in Codex Alimentarius, (Codex STAN 72-1981 ) and Infant Specialties (incl. Food for Special Medical Purpose) as defined in Codex Alimentarius, (Codex STAN 72-1981 ). It also refers to a foodstuff intended for particular nutritional use by infants during the first months of life and satisfying by itself the nutritional requirements of this category of person (Article 2(c) of the European Commission Directive 2006/141 /EC of 22 December 2006 on infant formulae and follow-on formulae).
  • the infant formulas can encompass the starter infant formulas, the followup or follow-on formulas, and young child formulas.
  • a starter formula is for infants from birth as breast-milk substitute, and a follow-up or follow-on formula from the 6th month onwards. So, an infant formula may be dedicated for infants of 0 to 6 months, 6 to 12 months, 12 months an older.
  • the infant formula will contain its regular ingredients, including a carbohydrate fraction, a protein fraction, and a lipid fraction.
  • the protein fraction in the composition for use of the current invention may comprise plant proteins or milk proteins such as whey proteins and/or casein.
  • the carbohydrate fraction may comprise digestible and non-digestible saccharides.
  • Digestible saccharides include glucose, galactose, sucrose, maltose, dextrin, and lactose.
  • Non-digestible oligosaccharides can be selected from the group consisting of fructo-oligosaccharides, galacto-oligosaccharides, arabino-oligosaccharides, arabinogalacto-oligosaccharides, gluco-oligosaccharides, chito-oligosaccharides, glucomanno-oligosaccharides, galactomanno-oligosaccharides, mannanoligosaccharides, fucosylated oligosaccharides, sialylated oligosaccharides and N- acetylglucosamine-functional oligosaccharides; more preferably selected from the group consisting of fructo-oligosaccharides and galacto-oligosaccharides.
  • fructo-oligosaccharides include inulin. All such non-digestible oligosaccharides are readily commercially available.
  • the carbohydrate fraction may also comprise one or more human milk oligosaccharides (HMOs), as these are known for their various health effects.
  • HMOs human milk oligosaccharides
  • the one or more HMOs are selected from the group consisting of 2’- fucosy I lactose (2’-FL), 3-fucosyl lactose (3-FL), di-fucosy I lactose (DFL), 3’- galactosyllactose (3’-GL), 6’-galactosyllactose (6’-GL), 3’-sialyllactose (3’-SL), 6’- sialyllactose (6’-SL), Lacto-N-tetraose (LNT), Lacto-N-neotetraose (LNnT), and combinations thereof.
  • the total amount of HMOs in the infant formula is at least 0.1 wt%, more preferably at least 0.5 wt%. The total amount
  • the lipid fraction may comprise a mixture of different fats and oils, such as a mixture of vegetable oils, or a mixture of vegetable oils and milk fat.
  • LC-PUFA long chain poly unsaturated fatty acids
  • DHA DHA
  • ARA ARA
  • EPA EPA
  • the lipid fraction has a fatty acid composition wherein at least 0.6 wt% of the fatty acid acyl groups consists of 4 carbon atoms, preferably at least 1 .2 wt%, more preferably at least 1 .5 wt%; and/or wherein at least 10% of the fatty acid acyl groups present in the lipid fraction is a palmitoyl group (CH 3 (CH 2 )i4C(O)) and at least 30% of the palmitoyl groups is esterified to the sn-2 position of a triglyceride based on total palmitoyl groups.
  • a palmitoyl group CH 3 (CH 2 )i4C(O)
  • Suitable milk fat for the composition of the invention is ruminant milk fat, preferably from cow’s milk, sheep milk, or goat milk, most preferably from cow’s milk.
  • cow’s milk For example whole milk, cream, butter, anhydrous milk fat and the like.
  • the amount of milk fat in the lipid fraction of the composition of the invention is at least 20 wt% of the lipid fraction, preferably at least 30 wt%, more preferably at least 40 wt%, even more preferably at least 60 wt%.
  • Figure 1 displays the percentage of in vitro RSV inhibition of infection as a function of the concentration of different phospholipid-enriched milk fractions.
  • Figure 2 displays the percentage of in vitro RSV inhibition of infection as a function of the phospholipid concentration in two types of phospholipid-enriched milk fractions: a whey protein phospholipid concentrate and a beta-serum.
  • Figure 3 displays the percentage of in vitro RSV inhibition of infection as a function of the protein concentration for two whey protein compositions: a phospholipid-enriched whey protein concentrate and a regular whey protein isolate.
  • Vivinal® MFGM ex- FrieslandCampina phospholipid content on dry matter: 7.4 wt%) and three commercially available competitor products: A (phospholipid content: 7.5 wt%), B (phospholipid content: 5.7 wt%), and C (phospholipid content: 6.4 wt%).
  • beta-serum was used as phospholipid-enriched milk fraction.
  • WPI whey protein isolate
  • the phospholipid-enriched milk fractions and the comparative WPI were solubilized in a complete F12 medium (F12 Nut mix + glutamax + 0.3% BSA, 0.1 %FCS, penicillin/ streptomycin, and 20 mM HEPES). After solubilization of the samples - 30 minutes at 50°C with frequent vortexing - the samples displayed in figure 1 were centrifuged for 30 minutes 3220 g and filter sterilized over a 0.2 uM PES filter. The samples displayed in figure 2 and figure 3 were not centrifuged and filter sterilized after solubilization.
  • F12 Nut mix + glutamax + 0.3% BSA, 0.1 %FCS, penicillin/ streptomycin, and 20 mM HEPES After solubilization of the samples - 30 minutes at 50°C with frequent vortexing - the samples displayed in figure 1 were centrifuged for 30 minutes 3220 g and filter sterilized over a 0.2 uM PES filter. The samples displayed in figure
  • Figure 1 displays the percentage of inhibition of RSV infection compared to control (set to 100%) as function of the product concentration. This figure clearly illustrates that various commercial whey protein phospholipid concentrates are able to inhibit RS virus infections.
  • Figure 2 displays the percentage of inhibition of RSV infection compared to control (set to 100%) as function of the phospholipid content of a whey protein phospholipid concentrate (“whey-derived MFGM) and a beta-serum (“beta-serum MFGM”).
  • whey-derived MFGM whey protein phospholipid concentrate
  • beta-serum MFGM beta-serum
  • Figure 3 displays the percentage of inhibition of RSV infection compared to control (set to 100%) as function of the product concentration. This figure clearly illustrates that, in contrast to whey protein phospholipid concentrate, regular WPI is not able to inhibit RS virus infections.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Virology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Mycology (AREA)
  • Nutrition Science (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pediatric Medicine (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne une fraction de lait enrichie en phospholipides destinée à être utilisée dans la prévention d'une infection virale par le virus respiratoire syncytial (VRS) et/ou la prévention de la progression d'une infection virale par le virus respiratoire syncytial (VRS).
EP24700727.1A 2023-01-11 2024-01-10 Utilisation d'une fraction de lait enrichie en phospholipides dans la prévention d'une infection par le vrs Pending EP4648783A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP23151113 2023-01-11
PCT/EP2024/050494 WO2024149806A1 (fr) 2023-01-11 2024-01-10 Utilisation d'une fraction de lait enrichie en phospholipides dans la prévention d'une infection par le vrs

Publications (1)

Publication Number Publication Date
EP4648783A1 true EP4648783A1 (fr) 2025-11-19

Family

ID=84923331

Family Applications (1)

Application Number Title Priority Date Filing Date
EP24700727.1A Pending EP4648783A1 (fr) 2023-01-11 2024-01-10 Utilisation d'une fraction de lait enrichie en phospholipides dans la prévention d'une infection par le vrs

Country Status (5)

Country Link
EP (1) EP4648783A1 (fr)
CN (1) CN120456913A (fr)
AU (1) AU2024207111A1 (fr)
MX (1) MX2025008061A (fr)
WO (1) WO2024149806A1 (fr)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ560524A (en) * 2007-08-09 2011-04-29 Fonterra Co Operative Group Treating or preventing rotavirus infection using conjugated linoleic acid
SE537951C2 (sv) * 2013-07-01 2015-12-01 Hero Ag Profylaktisk användning av modersmjölksersättning mot otit
WO2017194068A1 (fr) 2016-05-12 2017-11-16 Arla Foods Amba Préparation de lactosérum permettant d'améliorer le développement du cerveau
ES3003732T3 (en) 2020-11-27 2025-03-21 Arla Foods Amba Novel cholesterol-enriched milk lipid composition suitable for infant nutrition, method of production, and nutritional compositions comprising the milk lipid composition

Also Published As

Publication number Publication date
WO2024149806A1 (fr) 2024-07-18
AU2024207111A1 (en) 2025-05-29
MX2025008061A (es) 2025-08-01
CN120456913A (zh) 2025-08-08

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