WO2015075257A1 - Milk based nutritional composition and gastric comfort - Google Patents

Milk based nutritional composition and gastric comfort Download PDF

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Publication number
WO2015075257A1
WO2015075257A1 PCT/EP2014/075515 EP2014075515W WO2015075257A1 WO 2015075257 A1 WO2015075257 A1 WO 2015075257A1 EP 2014075515 W EP2014075515 W EP 2014075515W WO 2015075257 A1 WO2015075257 A1 WO 2015075257A1
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WO
WIPO (PCT)
Prior art keywords
composition
dry matter
present
milk
stomach
Prior art date
Application number
PCT/EP2014/075515
Other languages
French (fr)
Inventor
Gabriela Bergonzelli Degonda
Laurence Donato-Capel
Magali Faure
Benoit IDIEDER
David Philippe Labbe
Oliver Robert BRICKELL
Original Assignee
Nestec S.A.
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.)
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Publication date
Application filed by Nestec S.A. filed Critical Nestec S.A.
Priority to CN201480064083.9A priority Critical patent/CN105764355A/en
Publication of WO2015075257A1 publication Critical patent/WO2015075257A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
    • A23L2/52—Adding ingredients
    • A23L2/66—Proteins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23C—DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; MAKING THEREOF
    • A23C9/00—Milk preparations; Milk powder or milk powder preparations
    • A23C9/15—Reconstituted or recombined milk products containing neither non-milk fat nor non-milk proteins
    • A23C9/1512—Reconstituted or recombined milk products containing neither non-milk fat nor non-milk proteins containing isolated milk or whey proteins, caseinates or cheese; Enrichment of milk products with milk proteins in isolated or concentrated form, e.g. ultrafiltration retentate
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23C—DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; MAKING THEREOF
    • A23C9/00—Milk preparations; Milk powder or milk powder preparations
    • A23C9/152—Milk preparations; Milk powder or milk powder preparations containing additives
    • A23C9/1522—Inorganic additives, e.g. minerals, trace elements; Chlorination or fluoridation of milk; Organic salts or complexes of metals other than natrium or kalium; Calcium enrichment of milk
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23C—DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; MAKING THEREOF
    • A23C9/00—Milk preparations; Milk powder or milk powder preparations
    • A23C9/152—Milk preparations; Milk powder or milk powder preparations containing additives
    • A23C9/158—Milk preparations; Milk powder or milk powder preparations containing additives containing vitamins or antibiotics
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • 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
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/19—Dairy proteins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the present invention relates generally to the field of maintaining good health and wellbeing.
  • the present invention provides a composition that can be used to alleviate or prevent gastric discomfort.
  • One embodiment of the present invention relates to a composition comprising milk SNF, milk fat, demineralized whey powder, dibasic sodium phosphate, monobasic sodium phosphate, and a cooling agent.
  • the composition is shelf stable at ambient temperatures and can be used to alleviate or prevent gastric discomfort, for example gastritis, its symptoms, or gastritislike symptoms.
  • gastritis gastritis-like symptoms
  • acid reflux a condenum
  • heartburn a composition that can be used to alleviate or prevent gastric discomfort.
  • stomach burning and pain a composition that can be used to alleviate or prevent gastric discomfort.
  • gastritis for example gastritis, its symptoms, or gastritislike symptoms.
  • gastritis or gastritis-like symptoms such as acid reflux, heartburn, and stomach burning and pain.
  • GASTRO PROTECT a fermented milk drink that contains the probiotic strain Lactobacillus johnsonii, Lai.
  • compositions containing probiotic strains can pose challenges, as probiotic strains usually loose viability when stored at room temperature for extended periods of time and are not stable in liquid products.
  • WO 20127020018 discloses a product for the upper gastric sphere of humans, which can address acidity in upper gastric sphere of humans. It is to be administered orally, as food or food supplement.
  • the product comprises a gum, a phospholipid such as lecithin, a base mineral salt, and a dairy solid or liquid matrix.
  • a salivation agent and a mouth and/or throat cooling agent.
  • EP 1010434 and EP 1145644 disclose an inhibitor of Helicobacter pylori colonization in the stomach and a food containing the inhibitor.
  • the inhibitor comprises a mucin or a glycoprotein as an active ingredient.
  • H. pylori is attached to the gastric mucosa and is present in the mucus layer. By adding mucin or glycoprotein, H. pylori may be washed out from the stomach eventually. But a secondary effect of washing out H. pylori may be the apparition of a reflux disease with heatburn.
  • Gaviscon ® A further approach against heartburn that is on the market today is, for example Gaviscon ® .
  • the composition marketed as Gaviscon ® is claimed to neutralize stomach acid and to form a barrier to prevent heartburn. It contains alginic acid and bicarbonate as active ingredients.
  • EP 0286085 discloses an antacid composition which comprises a) a substance which is soluble in water at a neutral or alkaline pH, but which is capable of forming a cohesive gel at an acid pH, b) a substance which is capable of acting as a buffer and which is capable of being captured in the gel structure formed by substance a) at an acid pH, and c) one or more acid neutralising agents capable of being trapped in the gel structure formed by substance a) at an acid pH, at least one of which causes the gel to foam when contacted with an acid, the composition being formulated so that substance a) is dissolved before ingestion of the composition and having raft-forming properties in a gastric environment.
  • This document relies on the formation of a gel in the stomach to achieve the objective of treating or alleviating upper gastro-intestinal dyspeptic disorders. This may cause an undesirable sensation of a heavy stomach.
  • compositions that can be everyday as a preventive measure, for example as part of a breakfast.
  • composition was milk based and had similar organoleptic properties as milk.
  • active ingredients of Gaviscon ® were not useful for this purpose.
  • the object of the present invention was it, hence, to improve the state of the art and in particular to provide a milk based nutritional solution that allows it to alleviate or prevent gastric discomfort, for example, gastritis, its symptoms, and/or gastritis-like symptoms while being storage stable in powdered or liquid products or to at least provide a useful alternative.
  • gastric discomfort for example, gastritis, its symptoms, and/or gastritis-like symptoms
  • the object of the present invention could be achieved by the subject matter of the independent claims.
  • the dependent claims further develop the idea of the present invention.
  • the present inventors were able to provide a composition comprising a specific buffer system and a cooling agent in a milk based matrix that allowed it to achieve the objective of the present invention.
  • the specific composition of the present invention was tested in around 600 consumers drinking 240 ml of the composition twice a day.
  • the composition was well tolerated and was, e.g., found to induce relief of gastritis-like symptoms in 89% of all tested consumers.
  • the consumers reported less burning sensations, less acidity and/or acid reflux, less stomach pain, and/or less bloating.
  • composition of the present invention was due to the combined action of a specific phosphate buffering system and a cooling agent combined with the beneficial properties of milk, for example low lactose milk.
  • the buffering system in combination with milk acts as an antacid by neutralizing stomach acidity, i.e.: through the increase of pH (Zajac et al. 2013; Osteopathic Family Physician, 5, 79-85) and thus providing relief from the discomfort of acid reflux by ensuring that any regurgitated stomach content is less acidic in nature. This is initially performed through rapid neutralization of both, acid that has already entered the distal oesophagus and of the acidic gastric contents.
  • the buffering capacity of the composition of the present invention that was demonstrated by the study performed with around 600 consumers is derived at least in part from the association of the milk base with the phosphate buffering system.
  • the milk base has a buffering capacity resulting from the sum of the buffering capacities of its individual components, mainly proteins and salts/organic acids (Salaun et al., 2005, International Dairy Journal, 15, 95-109).
  • the present inventors have tested several buffering systems and have finally selected the phosphate buffering system of the present invention as the most efficient solution. Adding the phosphate buffering system of the present invention to the milk base was found to enhance its acid-neutralizing capacity. This ability was proven using an in vitro acid-neutralizing capacity test. The results are shown in Figure 1.
  • a further advantage of the buffering system of the present invention is that phosphate is already part of milk components that contribute to its acid-neutralizing capacity.
  • Cooling agents are naturally present, e.g., in several types of essential oils of plants such as peppermint, spearmint or eucalyptol.
  • the most common natural cooling molecule is menthol.
  • all these cooling agents are not suitable for the purpose of the present invention as they have a minty olfactory component. While menthol flavored drinks may be perceived as pleasant by consumers in particular circumstances, they will not be preferred as everyday choice for breakfast, in particular as milk replacer.
  • Cooling molecules activate specific ThermoTRP cation channels present in trigeminal cold-sensing neurons. These neurons are widely distributed on the tongue, in the nasal cavity, and in the peripheral nervous system (Patapoutian et al. 2003, Nature Reviews Neuroscience, 4, 529-539).
  • the effect of cooling molecules on the reduction of gastritislike symptoms might be explainable as follows: Neuron activation by cooling molecules generates coldness perceived in the nasal cavity and in the oropharyngeal pathway. More broadly, foods containing cooling molecules are perceived as cold, refreshing or arousing and the inventors believe this is linked to their effects on ThermoTRP channels. Cold, refreshing perception alleviate symptoms such as thirst, mouth-dryness and hot feeling. Therefore, the cooling agent can reduce gastric burning by inducing a cold, refreshing sensation through the activation of the ThermoTRP cation channels present in the upper part of the digestive tube.
  • the cooling agent used in the present invention was found to have almost no off-side taste and no odor by itself, but was still able to provide the cooling sensation. Consequently, the present inventors were able to propose a cooling agent that is suitable for applications in everyday milk.
  • the inventors currently explain the rapid relief of heartburn and reflux sensation induced by the composition of the present invention by the combination of milk components with the buffering system and the cooling agent.
  • the buffer effect results in a temporary decrease of stomach acidity that together with the cold refreshing sensation produced by the cooling agent quickly alleviates patients' heartburn and stomach burning sensations after intake.
  • composition comprising a milk base, a buffer system comprising monobasic and dibasic sodium phosphate and a cooling agent.
  • composition of the present invention may be a drinkable composition, for example a composition that is similar to milk in organoleptic properties.
  • composition of the present invention may be for use in alleviating or preventing gastric discomfort.
  • the words "comprises”, “comprising”, and similar words are not to be interpreted in an exclusive or exhaustive sense. In other words, they are intended to mean “including, but not limited to”.
  • Figure 1 shows the results of an acid-neutralizing capacity test of milk base with phosphate buffer salts (black triangles) and without phosphate buffer salts (grey circles).
  • Figure 2 shows the percentage of people reporting the presence of stomach symptoms before and after 2 days consumption of the composition of the present invention.
  • Figure 3 shows the percentage of people reporting the severity scale of their stomach symptoms before and after 2 days consumption of the composition of the present invention
  • the present invention relates in part to a composition
  • a composition comprising at least 3.7 dry matter weight-% milk SNF, at least 0.9 dry matter weight-% milk fat, at least 3.3 dry matter weight-% demineralized whey powder, at least 0.05 dry matter weight-% dibasic sodium phosphate, at least 0.04 dry matter weight-% monobasic sodium phosphate, and at least 0.036 dry matter weight-% of a cooling agent.
  • “Dry matter weight-%” shall mean dry weight of the ingredient% in the total weight of the composition.
  • the present invention also relates to a composition comprising 3.7 - 4.3 dry matter weight-% milk SNF, 0.9 - 1.3 dry matter weight-% milk fat, 3.3 - 3.9 dry matter weight-% demineralized whey powder, 0.05 - 0.07 dry matter weight-% dibasic sodium phosphate, 0.04 - 0.06 dry matter weight-% monobasic sodium phosphate, and 0.036 - 0.051 dry matter weight-% of a cooling agent.
  • Milk SNF stands for Milk Solid Non Fat. It can for example be derived from liquid skimmed milk and may be skimmed milk powder. Milk SNF can be purchased from dairy farms and ingredients suppliers.
  • Demineralized whey powder is a standard ingredient that can be purchased from ingredients suppliers. Demineralized whey powder is more stable than other sources of whey. Also, demineralized whey powder contains less sodium than sweet whey for instance. Given the current desire to reduce the sodium intake, demineralized whey powder is a rather interesting whey source.
  • the cooling agent used in the framework of the present invention may be a substantially tasteless and odourless cooling agent.
  • An agent is substantially tasteless if it imparts no perceived off-taste to the final composition when consumed.
  • An agent is substantially odourless if it imparts no perceived off-odour to the final composition when consumed.
  • it may be selected from the group consisting of substantially tasteless and odourless menthol derivative compounds, acyclic and/or cyclic carboxamides, N- substituted paramenthane carboxamides, phosphine oxides, substituted p-menthanes, menthoxypropane, alpha-keto enamine derivatives, N-substituted p-menthane carboxamide, menthyl half acid ester derivatives, cubebol, and combinations thereof.
  • cooling agents marketed as N E048050 or N E694835 may be used.
  • cooling agent N E485558 is in particular suitable for the purposes of the present invention.
  • N E485558 is L-monomenthyl glutarate, a natural compound.
  • N E485558, N E048050 and N E694835 can be purchased, e.g., from International Flavors & Fragances Inc. (IFF Global Headquarters, 521 West 57th Street, New York, NY 10019, United States), and is thought to be metabolised to menthol (detoxified by conjugation to glucuronic acid and eliminated in the urine) and glutaric acid (normal metabolite).
  • the composition of the present invention may contain 3.9 - 4.1 dry matter weight-% milk SNF, 1.0 - 1.2 dry matter weight-% milk fat, 3.5 - 3.7 dry matter weight-% demineralized whey powder, 0.055 - 0.065 dry matter weight-% dibasic sodium phosphate, 0.045 - 0.055 dry matter weight-% monobasic sodium phosphate, and 0.040 - 0.044 dry matter weight-% of a cooling agent.
  • the composition of the present invention may not contain alginic acid and/or alginate.
  • the composition of the present invention may not contain added phospholipid, such as added lecithin. This avoids the presence of ingredients which, although natural, could be perceived as artificial by the consumer.
  • the composition may be any kind of edible composition.
  • a composition is considered edible if it is approved for human or animal consumption.
  • the composition may be a powdered nutritional formula. Such a formula may be to be reconstituted in water.
  • the composition of the present invention may also be a drinkable composition.
  • it may be a Ready-to-Drink composition.
  • Ready-to-Drink compositions are compositions sold in a prepared form, ready for consumption. If the composition of the present invention is provided as a composition, e.g., as a Ready-to-Drink nutritional composition, this has the advantage that the composition can immediately be used everywhere, while having the guarantee that the composition contains all the active ingredients in the right amounts to be effective.
  • the composition of the present invention may further contain vitamin and/or mineral supplementation. This will ensure a healthy start into the day.
  • composition of the present invention may further contain 0.017- 0.024 dry matter weight-% vitamin C, 0.0005 - 0.0007 dry matter weight-% vitamin A acetate, and/or 0.0003 - 0.0005 dry matter weight-% vitamin D3.
  • composition of the present invention may also contain 25-35 ⁇ g RE vitamin A, 0.4- 0.6 ⁇ g vitamin D and 50-65 mg Calcium per lOOg of the composition.
  • RE stands for retinol equivalent.
  • composition of the present invention has a similar dry matter content to milk.
  • Cow's milk for example, has typically a water content of about 88-86 weight-%.
  • the composition of the present invention comprises 8-12 weight% dry matter, for example, 9-11 weight% dry matter.
  • the composition of the present invention is used regularly.
  • the composition of the present invention may be to be consumed at least 3 times a week, for example daily or twice a day.
  • the composition of the present invention is consumed at the same time every day.
  • the consumption of the composition of the present invention may become part of a daily routine.
  • the composition of the present invention may be to be consumed in the morning, for example as part of the breakfast.
  • composition is to be consumed twice a day, it is preferred if the composition is consumed in the morning, e.g., as part of breakfast, and in the evening, e.g., as part of dinner or after dinner.
  • the composition of the present invention combines the goodness of milk with its beneficial effect on the alleviation and/or prevention of gastric discomfort. Because it contains the goodness of milk and also has similar organoleptic properties as milk, the composition of the present invention may be used, for example as a milk replacer. As such, the composition of the present invention may be used to replace a part of the daily milk consumption.
  • composition of the present invention may be sold as gallons, 2-liter packs, liter packs or single portions.
  • the composition may be provided in amounts of 500 ml - II, for example in amounts of 750 ml.
  • composition of the present invention can be sterilized and aseptically packaged.
  • One advantage of the present invention is that the composition of the present invention may be kept at ambient conditions.
  • the composition may be to be stored at ambient temperature.
  • Ambient temperature means the temperature of the surroundings. Consequently, the composition of the present invention has the advantage that its storage does not require extra cooling.
  • the composition of the present invention is intended for adults or teenagers.
  • Adults are 18 years old or older and teenagers are between 14 and 18 years old. Consequently, the composition of the present invention may be to be administered to adults.
  • the composition of the present invention may be for use in the alleviating or preventing gastric discomfort.
  • the present invention also relates to the use of the composition of the present invention for the preparation of a product to alleviate or prevent gastric discomfort.
  • Gastric discomfort may include stomach burning, increased stomach acidity, acid reflux, heartburn, stomach pain, stomach swelling and/or a combination thereof.
  • composition of the present invention may be for use in the alleviation or prevention of gastritis and/or the symptoms thereof.
  • One embodiment of the present invention relates to the use of the composition of the present invention in the prevention of gastritis, its symptoms and/or gastritis-like symptoms .
  • Gastritis may be a an acute or a chronic gastritis.
  • Acute gastritis may be, for example, a consequence of alcohol consumption, spicy food consumption, the use of nonsteroidal anti-inflammatory drugs such as aspirin or ibuprofen.
  • Symptoms of gastritis include, but are not limited to, abdominal upset or pain, indigestion, abdominal bloating, nausea, vomiting, a feeling of fullness and/or a burning sensation in the upper abdomen ("Gastritis”. Merck. January 2007). As such, heartburn and acid regurgitation are symptoms of gastritis.
  • Gastritis-like symptoms are symptoms that are known to appear in connection with gastritis, irrespective of whether they are actually caused by gastritis or not. As such, the above mentioned symptoms are gastritis-like symptoms if they are not actually caused by gastritis.
  • heartburn The prevalence of heartburn is 10% to 20% worldwide, with higher prevalence in westernized countries. According to the Canadian Digestive Health Foundation, 1 out of 6 Canadians experience heartburn and/or acid regurgitation at least once each week. About 42% of the United States population has experienced heartburn.
  • composition for use of the present invention allows it that the beneficial effect of the composition is felt by at least 8 out of 10, for example by 9 out of 10 consumers.
  • Those skilled in the art will understand that they can freely combine all features of the present invention disclosed herein. In particular, features described for the composition of the present invention may be combined with the intended use of the present invention and vice versa. Further, features described for different embodiments of the present invention may be combined.
  • stomach discomfort Pain, inflammation, reflux, burning
  • saliva saliva, inflammation, reflux, burning
  • the dairy ready-to-drink composition of the present invention containing the buffering system and the cooling agent twice a day, once in the morning for breakfast and once in the evening, this for 2 days.
  • People consuming anti-acids at the time of the first visit were excluded.

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Abstract

The invention relates generally to the field of maintaining good health and wellbeing. A composition is provided that can be used to alleviate or prevent gastric discomfort, and which may comprise milk SNF, milk fat, demineralized whey powder, dibasic sodium phosphate, monobasic sodium phosphate, and a cooling agent. In particular, the composition is shelf stable at ambient temperatures, stable in liquid products, and can be used to alleviate or prevent gastritis, its symptoms and/or gastritis-like symptoms.

Description

MILK BASED NUTRITIONAL COMPOSITION AND GASTRIC COMFORT
The present invention relates generally to the field of maintaining good health and wellbeing. In particular, the present invention provides a composition that can be used to alleviate or prevent gastric discomfort. One embodiment of the present invention relates to a composition comprising milk SNF, milk fat, demineralized whey powder, dibasic sodium phosphate, monobasic sodium phosphate, and a cooling agent. In particular, the composition is shelf stable at ambient temperatures and can be used to alleviate or prevent gastric discomfort, for example gastritis, its symptoms, or gastritislike symptoms. Around 60% of the Mexican population suffers from gastritis or gastritis-like symptoms, such as acid reflux, heartburn, and stomach burning and pain. Stressful everyday life, dietary habits, tobacco and alcohol consumption, for example, may contribute to an irritation of the stomach and can result in the gastric symptoms described above. If the symptoms are mild to moderate and if there is no associated pathology, such as a gastric ulcer, for example, a nutritional approach can result in symptom reduction and therefore in a better quality of life.
One such nutritional approach marketed today is, for example, GASTRO PROTECT, a fermented milk drink that contains the probiotic strain Lactobacillus johnsonii, Lai.
For ambient solutions, however, compositions containing probiotic strains can pose challenges, as probiotic strains usually loose viability when stored at room temperature for extended periods of time and are not stable in liquid products.
However, as cooling systems are not available to everyone and everywhere, a composition that can be used to alleviate or prevent gastritis and gastritis-like symptoms that can be stored at room temperature and that is stable in liquid products for extended periods of time would be beneficial.
WO 20127020018 discloses a product for the upper gastric sphere of humans, which can address acidity in upper gastric sphere of humans. It is to be administered orally, as food or food supplement. The product comprises a gum, a phospholipid such as lecithin, a base mineral salt, and a dairy solid or liquid matrix. Optionally, it contains a salivation agent, and a mouth and/or throat cooling agent.
EP 1010434 and EP 1145644 disclose an inhibitor of Helicobacter pylori colonization in the stomach and a food containing the inhibitor. The inhibitor comprises a mucin or a glycoprotein as an active ingredient.
However, H. pylori is attached to the gastric mucosa and is present in the mucus layer. By adding mucin or glycoprotein, H. pylori may be washed out from the stomach eventually. But a secondary effect of washing out H. pylori may be the apparition of a reflux disease with heatburn. A further approach against heartburn that is on the market today is, for example Gaviscon®. The composition marketed as Gaviscon® is claimed to neutralize stomach acid and to form a barrier to prevent heartburn. It contains alginic acid and bicarbonate as active ingredients.
For instance, EP 0286085 discloses an antacid composition which comprises a) a substance which is soluble in water at a neutral or alkaline pH, but which is capable of forming a cohesive gel at an acid pH, b) a substance which is capable of acting as a buffer and which is capable of being captured in the gel structure formed by substance a) at an acid pH, and c) one or more acid neutralising agents capable of being trapped in the gel structure formed by substance a) at an acid pH, at least one of which causes the gel to foam when contacted with an acid, the composition being formulated so that substance a) is dissolved before ingestion of the composition and having raft-forming properties in a gastric environment. This document relies on the formation of a gel in the stomach to achieve the objective of treating or alleviating upper gastro-intestinal dyspeptic disorders. This may cause an undesirable sensation of a heavy stomach.
However, it would be useful to have available a composition that can be everyday as a preventive measure, for example as part of a breakfast. As such, it would be beneficial if the composition was milk based and had similar organoleptic properties as milk. The active ingredients of Gaviscon®, however, were not useful for this purpose.
It would therefore be desirable to have available a milk based composition that allows it to optimally alleviate or prevent gastritis, its symptoms and/or gastritis like symptoms, while avoiding at least some of the disadvantages of the state of the art, for example by being stable at ambient temperatures and/or in liquid dairy products. Any reference to prior art documents in this specification is not to be considered an admission that such prior art is widely known or forms part of the common general knowledge in the field.
The object of the present invention was it, hence, to improve the state of the art and in particular to provide a milk based nutritional solution that allows it to alleviate or prevent gastric discomfort, for example, gastritis, its symptoms, and/or gastritis-like symptoms while being storage stable in powdered or liquid products or to at least provide a useful alternative. The inventors were surprised to see that the object of the present invention could be achieved by the subject matter of the independent claims. The dependent claims further develop the idea of the present invention.
In particular, the present inventors were able to provide a composition comprising a specific buffer system and a cooling agent in a milk based matrix that allowed it to achieve the objective of the present invention. The specific composition of the present invention was tested in around 600 consumers drinking 240 ml of the composition twice a day. The composition was well tolerated and was, e.g., found to induce relief of gastritis-like symptoms in 89% of all tested consumers. In particular the consumers reported less burning sensations, less acidity and/or acid reflux, less stomach pain, and/or less bloating.
Without wishing to be bound by theory, the present inventors currently believe that the effectiveness of the composition of the present invention was due to the combined action of a specific phosphate buffering system and a cooling agent combined with the beneficial properties of milk, for example low lactose milk.
The inventors currently believe that the buffering system in combination with milk acts as an antacid by neutralizing stomach acidity, i.e.: through the increase of pH (Zajac et al. 2013; Osteopathic Family Physician, 5, 79-85) and thus providing relief from the discomfort of acid reflux by ensuring that any regurgitated stomach content is less acidic in nature. This is initially performed through rapid neutralization of both, acid that has already entered the distal oesophagus and of the acidic gastric contents.
The buffering capacity of the composition of the present invention that was demonstrated by the study performed with around 600 consumers is derived at least in part from the association of the milk base with the phosphate buffering system. The milk base has a buffering capacity resulting from the sum of the buffering capacities of its individual components, mainly proteins and salts/organic acids (Salaun et al., 2005, International Dairy Journal, 15, 95-109). The present inventors have tested several buffering systems and have finally selected the phosphate buffering system of the present invention as the most efficient solution. Adding the phosphate buffering system of the present invention to the milk base was found to enhance its acid-neutralizing capacity. This ability was proven using an in vitro acid-neutralizing capacity test. The results are shown in Figure 1. A further advantage of the buffering system of the present invention is that phosphate is already part of milk components that contribute to its acid-neutralizing capacity.
Cooling agents are naturally present, e.g., in several types of essential oils of plants such as peppermint, spearmint or eucalyptol. The most common natural cooling molecule is menthol. However, all these cooling agents are not suitable for the purpose of the present invention as they have a minty olfactory component. While menthol flavored drinks may be perceived as pleasant by consumers in particular circumstances, they will not be preferred as everyday choice for breakfast, in particular as milk replacer.
Cooling molecules activate specific ThermoTRP cation channels present in trigeminal cold-sensing neurons. These neurons are widely distributed on the tongue, in the nasal cavity, and in the peripheral nervous system (Patapoutian et al. 2003, Nature Reviews Neuroscience, 4, 529-539). The effect of cooling molecules on the reduction of gastritislike symptoms might be explainable as follows: Neuron activation by cooling molecules generates coldness perceived in the nasal cavity and in the oropharyngeal pathway. More broadly, foods containing cooling molecules are perceived as cold, refreshing or arousing and the inventors believe this is linked to their effects on ThermoTRP channels. Cold, refreshing perception alleviate symptoms such as thirst, mouth-dryness and hot feeling. Therefore, the cooling agent can reduce gastric burning by inducing a cold, refreshing sensation through the activation of the ThermoTRP cation channels present in the upper part of the digestive tube.
The cooling agent used in the present invention was found to have almost no off-side taste and no odor by itself, but was still able to provide the cooling sensation. Consequently, the present inventors were able to propose a cooling agent that is suitable for applications in everyday milk.
The inventors currently explain the rapid relief of heartburn and reflux sensation induced by the composition of the present invention by the combination of milk components with the buffering system and the cooling agent. The buffer effect results in a temporary decrease of stomach acidity that together with the cold refreshing sensation produced by the cooling agent quickly alleviates patients' heartburn and stomach burning sensations after intake.
Consequently, the subject matter of the present invention relates to a composition comprising a milk base, a buffer system comprising monobasic and dibasic sodium phosphate and a cooling agent.
The composition of the present invention may be a drinkable composition, for example a composition that is similar to milk in organoleptic properties.
The composition of the present invention may be for use in alleviating or preventing gastric discomfort. As used in this specification, the words "comprises", "comprising", and similar words, are not to be interpreted in an exclusive or exhaustive sense. In other words, they are intended to mean "including, but not limited to". Figure 1 shows the results of an acid-neutralizing capacity test of milk base with phosphate buffer salts (black triangles) and without phosphate buffer salts (grey circles).
Figure 2 shows the percentage of people reporting the presence of stomach symptoms before and after 2 days consumption of the composition of the present invention. Figure 3 shows the percentage of people reporting the severity scale of their stomach symptoms before and after 2 days consumption of the composition of the present invention
Consequently the present invention relates in part to a composition comprising at least 3.7 dry matter weight-% milk SNF, at least 0.9 dry matter weight-% milk fat, at least 3.3 dry matter weight-% demineralized whey powder, at least 0.05 dry matter weight-% dibasic sodium phosphate, at least 0.04 dry matter weight-% monobasic sodium phosphate, and at least 0.036 dry matter weight-% of a cooling agent.
"Dry matter weight-%" shall mean dry weight of the ingredient% in the total weight of the composition. The present invention also relates to a composition comprising 3.7 - 4.3 dry matter weight-% milk SNF, 0.9 - 1.3 dry matter weight-% milk fat, 3.3 - 3.9 dry matter weight-% demineralized whey powder, 0.05 - 0.07 dry matter weight-% dibasic sodium phosphate, 0.04 - 0.06 dry matter weight-% monobasic sodium phosphate, and 0.036 - 0.051 dry matter weight-% of a cooling agent. Milk SNF stands for Milk Solid Non Fat. It can for example be derived from liquid skimmed milk and may be skimmed milk powder. Milk SNF can be purchased from dairy farms and ingredients suppliers. Demineralized whey powder is a standard ingredient that can be purchased from ingredients suppliers. Demineralized whey powder is more stable than other sources of whey. Also, demineralized whey powder contains less sodium than sweet whey for instance. Given the current desire to reduce the sodium intake, demineralized whey powder is a rather interesting whey source.
The cooling agent used in the framework of the present invention may be a substantially tasteless and odourless cooling agent.
An agent is substantially tasteless if it imparts no perceived off-taste to the final composition when consumed. An agent is substantially odourless if it imparts no perceived off-odour to the final composition when consumed.
For example, it may be selected from the group consisting of substantially tasteless and odourless menthol derivative compounds, acyclic and/or cyclic carboxamides, N- substituted paramenthane carboxamides, phosphine oxides, substituted p-menthanes, menthoxypropane, alpha-keto enamine derivatives, N-substituted p-menthane carboxamide, menthyl half acid ester derivatives, cubebol, and combinations thereof.
For example, the cooling agents marketed as N E048050 or N E694835 may be used.
The inventors have found that cooling agent N E485558 is in particular suitable for the purposes of the present invention. N E485558 is L-monomenthyl glutarate, a natural compound. N E485558, N E048050 and N E694835 can be purchased, e.g., from International Flavors & Fragances Inc. (IFF Global Headquarters, 521 West 57th Street, New York, NY 10019, United States), and is thought to be metabolised to menthol (detoxified by conjugation to glucuronic acid and eliminated in the urine) and glutaric acid (normal metabolite).
For example, the composition of the present invention may contain 3.9 - 4.1 dry matter weight-% milk SNF, 1.0 - 1.2 dry matter weight-% milk fat, 3.5 - 3.7 dry matter weight-% demineralized whey powder, 0.055 - 0.065 dry matter weight-% dibasic sodium phosphate, 0.045 - 0.055 dry matter weight-% monobasic sodium phosphate, and 0.040 - 0.044 dry matter weight-% of a cooling agent.
Remarkably, the composition of the present invention may not contain alginic acid and/or alginate. Remarkably, the composition of the present invention may not contain added phospholipid, such as added lecithin. This avoids the presence of ingredients which, although natural, could be perceived as artificial by the consumer.
The composition may be any kind of edible composition. A composition is considered edible if it is approved for human or animal consumption. For example, the composition may be a powdered nutritional formula. Such a formula may be to be reconstituted in water.
The composition of the present invention may also be a drinkable composition. For example, it may be a Ready-to-Drink composition. Ready-to-Drink compositions are compositions sold in a prepared form, ready for consumption. If the composition of the present invention is provided as a composition, e.g., as a Ready-to-Drink nutritional composition, this has the advantage that the composition can immediately be used everywhere, while having the guarantee that the composition contains all the active ingredients in the right amounts to be effective. The composition of the present invention may further contain vitamin and/or mineral supplementation. This will ensure a healthy start into the day.
For example, the composition of the present invention may further contain 0.017- 0.024 dry matter weight-% vitamin C, 0.0005 - 0.0007 dry matter weight-% vitamin A acetate, and/or 0.0003 - 0.0005 dry matter weight-% vitamin D3.
The composition of the present invention may also contain 25-35 μg RE vitamin A, 0.4- 0.6 μg vitamin D and 50-65 mg Calcium per lOOg of the composition. RE stands for retinol equivalent.
Advantageously, the composition of the present invention has a similar dry matter content to milk. Cow's milk, for example, has typically a water content of about 88-86 weight-%.
In view of achieving similar organoleptic properties in comparison to milk it may be preferred if the composition of the present invention comprises 8-12 weight% dry matter, for example, 9-11 weight% dry matter. To ensure optimal effectiveness as preventive measure, it is preferred if the composition of the present invention is used regularly. For example, the composition of the present invention may be to be consumed at least 3 times a week, for example daily or twice a day.
To ensure regularity, it is preferred if the composition of the present invention is consumed at the same time every day. As such, the consumption of the composition of the present invention may become part of a daily routine. For example, the composition of the present invention may be to be consumed in the morning, for example as part of the breakfast.
If the composition is to be consumed twice a day, it is preferred if the composition is consumed in the morning, e.g., as part of breakfast, and in the evening, e.g., as part of dinner or after dinner.
The composition of the present invention combines the goodness of milk with its beneficial effect on the alleviation and/or prevention of gastric discomfort. Because it contains the goodness of milk and also has similar organoleptic properties as milk, the composition of the present invention may be used, for example as a milk replacer. As such, the composition of the present invention may be used to replace a part of the daily milk consumption.
For example, the composition of the present invention may be sold as gallons, 2-liter packs, liter packs or single portions.
If provided as single portion, the single portion format may comprise 50-330ml, for example 100 to 300 ml or 200 to 250 ml.
For multiple portions, the composition may be provided in amounts of 500 ml - II, for example in amounts of 750 ml.
To ensure ambient shelf stability the composition of the present invention can be sterilized and aseptically packaged. One advantage of the present invention is that the composition of the present invention may be kept at ambient conditions. For example, the composition may be to be stored at ambient temperature. Ambient temperature means the temperature of the surroundings. Consequently, the composition of the present invention has the advantage that its storage does not require extra cooling. The composition of the present invention is intended for adults or teenagers. For the purposes of the present invention, Adults are 18 years old or older and teenagers are between 14 and 18 years old. Consequently, the composition of the present invention may be to be administered to adults. The composition of the present invention may be for use in the alleviating or preventing gastric discomfort.
The present invention also relates to the use of the composition of the present invention for the preparation of a product to alleviate or prevent gastric discomfort.
Gastric discomfort may include stomach burning, increased stomach acidity, acid reflux, heartburn, stomach pain, stomach swelling and/or a combination thereof.
For example, the composition of the present invention may be for use in the alleviation or prevention of gastritis and/or the symptoms thereof.
One embodiment of the present invention relates to the use of the composition of the present invention in the prevention of gastritis, its symptoms and/or gastritis-like symptoms .
Gastritis may be a an acute or a chronic gastritis. For example it may be an acute gastritis. Acute gastritis may be, for example, a consequence of alcohol consumption, spicy food consumption, the use of nonsteroidal anti-inflammatory drugs such as aspirin or ibuprofen. Symptoms of gastritis include, but are not limited to, abdominal upset or pain, indigestion, abdominal bloating, nausea, vomiting, a feeling of fullness and/or a burning sensation in the upper abdomen ("Gastritis". Merck. January 2007). As such, heartburn and acid regurgitation are symptoms of gastritis.
Gastritis-like symptoms are symptoms that are known to appear in connection with gastritis, irrespective of whether they are actually caused by gastritis or not. As such, the above mentioned symptoms are gastritis-like symptoms if they are not actually caused by gastritis.
The prevalence of heartburn is 10% to 20% worldwide, with higher prevalence in westernized countries. According to the Canadian Digestive Health Foundation, 1 out of 6 Canadians experience heartburn and/or acid regurgitation at least once each week. About 42% of the United States population has experienced heartburn.
Stressful everyday life, dietary habits such as spicy and/or salty food, tobacco and alcohol consumption contribute to irritate the stomach and can result in the gastric symptoms described above. Furthermore, these symptoms can be aggravated by the use of non-steroidal anti-inflammatory drugs such as aspirin or ibuprofen. If the symptoms are mild to moderate and there is no associated pathology such as a gastric ulcer, a nutritional approach such as the one proposed in this invention will result in symptom improvement and therefore in a better quality of life.
The consumer test prepared during the inventors long and detailed studies revealed that about 89% of about 600 consumers tested felt the beneficial effect of the present invention.
Consequently, the composition for use of the present invention allows it that the beneficial effect of the composition is felt by at least 8 out of 10, for example by 9 out of 10 consumers. Those skilled in the art will understand that they can freely combine all features of the present invention disclosed herein. In particular, features described for the composition of the present invention may be combined with the intended use of the present invention and vice versa. Further, features described for different embodiments of the present invention may be combined.
Although the invention has been described by way of example, it should be appreciated that variations and modifications may be made without departing from the scope of the invention as defined in the claims. Furthermore, where known equivalents exist to specific features, such equivalents are incorporated as if specifically referred in this specification. Further advantages and features of the present invention are apparent from the figures and non-limiting examples. Example:
People (25-45 years old, n=621) reporting to suffer regularly from stomach discomfort (pain, inflammation, reflux, burning) of an intensity scored as being, at minimum, moderate but affecting their daily activities, were included in the study. They then consumed 250 ml of the dairy ready-to-drink composition of the present invention containing the buffering system and the cooling agent twice a day, once in the morning for breakfast and once in the evening, this for 2 days. People consuming anti-acids at the time of the first visit were excluded. People were asked to report on the frequency and intensity of the following stomach symptoms: stomach swelling, stomach ache, stomach burning, acid reflux, burps, and their reported scores after 2 days of treatment were compared with that of baseline, at inclusion. At inclusion, 100% of the people reported to suffer from stomach swelling, stomach ache, stomach burning, acid reflux, and 57 % reported to suffer from burps (Figure 2). After 2 days consumption of the product, stomach swelling, stomach ache, stomach burning, acid reflux, and burps were reported by only 54%, 52%, 52%, 50%, and 41% of the people, respectively. The intensity of their symptoms was also strongly reduced, as shown in Figure 3. Indeed, 100% of subjects reported a minimal severity score of stomach swelling, stomach ache, stomach burning, and acid reflux as being moderate but affecting their daily activities before consuming the product, vs. 40%, 38%, 33% and 37%, respectively, after consuming the product for 2 days. Similarly, 93% of people reported to suffer from burps at a minimal severity score being moderate but affecting their daily activities before consuming the product, vs 32% after consuming the product for 2 days. One of three consumers perceived an immediate relief. While 17% of consumers perceived the effect for less than 2 hours, 83% of them perceived that the effect lasted more than 3 hours after consumption of the product, with a median value of 4 hours. Overall, the composition was well tolerated and was found to induce relief of gastritis-like symptoms in 89% of all tested consumers.

Claims

1. Composition comprising 3.7 - 4.3 dry matter weight-% milk SNF, 0.9-1.3 dry matter weight-% milk fat, 3.3 - 3.9 dry matter weight-% demineralized whey powder, 0.05-0.07 dry matter weight-% dibasic sodium phosphate, 0.04-0.06 dry matter weight-% monobasic sodium phosphate, and 0.036-0.051 dry matter weight-% of a substantially tasteless and odourless cooling agent.
2. Composition according to claim 1, wherein the composition is a drinkable composition, for example a Ready-to-Drink composition.
3. Composition according to claim 1 or 2, wherein the composition further contains 25-35 μg RE vitamin A, 0.4-0.6 μg vitamin D and 50-65 mg Calcium per lOOg of the composition.
4. Composition according to any one of claims 1 to 3, wherein the composition comprises 8-12 weight% dry matter.
5. Composition according to any one of claims 1 to 4, wherein the composition is to be used as milk replacer.
6. Composition according to any one of claims 1 to 5, wherein the composition is provided as single portion format.
7. Composition according to any one of claims 1 to 6, wherein the composition is sterilized.
8. Composition according to any one of claims 1 to 7, wherein the composition is to be stored at ambient temperature.
9. Composition according to any one of claims 1 to 8, wherein the composition is to be administered to adults.
10. Composition according to any one of claims 1 to 9, wherein the composition is to be consumed at least three times a week.
11. Composition according to any one of claims 1 to 10, wherein the composition is to be consumed in the morning, for example as part of breakfast.
12. Composition according to any one of claims 1 to 11, for use in alleviating or preventing gastric discomfort.
13. Composition for use according to claim 12, wherein the gastric discomfort is stomach burning, increased stomach acidity, acid reflux, heartburn, stomach pain, stomach swelling and/or a combination thereof.
14. Composition for use according to claim 12 or 13, wherein the composition is for the alleviation or prevention of gastritis, its symptoms or gastritis-like symptoms.
15. Composition for use according to any one of claims 12 to 14, wherein the beneficial effect of the composition is felt by at least 8 out of 10, for example by 9 out of 10 consumers.
PCT/EP2014/075515 2013-11-25 2014-11-25 Milk based nutritional composition and gastric comfort WO2015075257A1 (en)

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