WO2008124903A1

WO2008124903A1 - Digestive product and method of production thereof

Info

Publication number: WO2008124903A1
Application number: PCT/BR2008/000099
Authority: WO
Inventors: Sandra Maria Salles Hanszmann
Original assignee: Sandra Maria Salles Hanszmann
Priority date: 2007-04-11
Filing date: 2008-04-09
Publication date: 2008-10-23
Also published as: BRPI0701741A2

Abstract

The present invention patent discloses the production method of an Apple Puree with Chamomile, Cinnamon, Clove and Lemon through the mixing of chamomile, cinnamon, cloves and lemon with apple which has been cooked either directly or through steaming, a process with special nutritional characteristics which achieves the Formula for a Product with Digestive Properties, with the aim of reaching the consumer sector affected by gastritis and diverticulosis and with other gastrointestinal problems.

Description

Digestive product and method of production thereof

DESCRIPTION Technical Field The production process of the present invention patent is the result of the mixing and steaming of specific fruit, herbs and spices. These are apple with chamomile, cinnamon, clove and lemon and they result in a puree which has special nutritional characteristics, focused on meeting the needs of the consumer segment with gastritis e diverticulosis and other gastrointestinal problems, given its attribute of being a source of fibre and other nutrients and compounds, which help in anti-inflammatory treatment of the intestinal and stomach mucosae in providing relief of these mucosae and in the case of diverticulosis, encouraging greater regularity and ease in evacuation, which relieves symptoms, prevents further diverticula and most importantly reduces complications such as diverticulitis. It also has analgesic and antispasmodic attributes which reduce excessive intestinal contraction. Reasoning Behind the Invention

The stomach is an essential part of the digestive system. It is located in the abdomen and connects the lower part of the oesophagus to the proximal part of the small intestine. It is a kind of bag which receives that which is ingested. It is lined with a mucosa, a pink layer similar to that of the mouth. When food enters the stomach its walls carry out a movement known as peristalsis, the aim of which is to mix food and propel it along the digestive tract. At the same time glands located in the wall of the organ produce gastric juices which are rich in hydrochloric acid. Gastric juice is important in digestion as it helps to break food down so that it can be transported to the small intestine where the digestive process continues. Gastritis is the inflammation of the mucosa of the stomach. Acute Gastritis due to stress, the most serious form of the illness is caused by a serious, sudden lesion. The lesion may not be gastric in fact. For example, extensive burns and wounds with extensive bleeding are typical causes.

Chronic erosive gastritis can be caused by irritants such as, for example, medication (particularly acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs), Crohn's Disease, bacterial infections (Helicobacter pylori) and viral infections. Bleeding and ulcers may occur in this type of gastritis which develops slowly in otherwise perfectly healthy individuals. It is most common in alcoholics. Viral or fungicidal gastritis may occur in those suffering from long-term illness or disruption to the immune system. Eosinophilic gastritis can be the result of an allergic reaction to an infestation of nematodes (thread worms). An accumulation of Eosinophil (a type of leukocyte) occurs in the gastrointestinal wall in this type of gastritis. Atrophic gastritis occurs when antibodies attack the gastric lining, leading to its thinning and losing many or all of its acid and enzyme producing cells. There is no other bacteria known, apart from Helicobacter pylori which grow in a normally acidic stomach, but many types of bacteria can grow when the stomach does not produce any acid.

This condition normally affects elderly individuals. It also tends to occur in those who have been submitted to partial removal of the stomach (a procedure known as a partial gastrectomy). Menetrier Disease is a form of gastritis the cause of which is unknown. This disease leads to the stomach walls forming large thick folds, the increase in size of glands and the formation of liquid-filled cists. Acute forms of gastritis are simpler to deal with as they appear suddenly, evolve quickly and are easily associated with a cause. Medication, infections and physical or psychic stress can lead to acute gastritis. Chronic Gastritis can have many causes. It is known that the bacteria Helicobacter pylori can lead to chronic gastritis. In chronic atrophic gastritis where the mucosal cells of the stomach diminish there is a significant reduction in the production gastric acid which is important in 'sterilizing' that which is ingested and in digesting food. Sometimes the bile that the liver releases into the top of the small intestine (known as the duodenum) flows back into the stomach, causing chronic inflammation. These factors acting alone or in conjunction can lead to chronic gastritis.

Most chronic cases do not have any symptoms. Whilst complaints associated with acute gastritis are very varied: burning abdominal pain, heartburn, loss of appetite, nauseas and vomiting, digestive bleeding and in complicated cases bleeding can appear in the evacuation of black faeces (melena) and/or vomiting with blood (hematemesis). Atrophic gastritis can present a clinical case related to a deficiency in the absorption of Vitamin B12 and folic acid. As a result pernicious anaemia occurs which manifests as: weakness, a burning tongue (glossitis), irritation in the corner of the mouth (Angular Chelitis), more rarely diarrhoea, and neurological changes involving memory, orientation and coherence.

Diverticulosis is the presence of small pouches which protrude from the intestinal wall. Diverticulitis is the inflammation of a diverticula. Diverticulitis occurs with similar frequency in men and women, increasing with age. One third of people over 50 years old and two thirds of those over 80 have diverticula in the colon, however the vast majority have no symptoms. It is believed that two factors are associated with the appearance of diverticula: an increase in pressure in the inside of the intestine and a weakening of parts of the intestinal wall. Only a minority of individuals have complaints related to diverticulosis. Diverticulitis is the most common complication and occurs at some time in the life of between 10 and 20% of individuals with diverticulosis. The longer they develop and the more extensive the area with diverticula the higher the risk of this complication. Diverticulitis manifests as a strong pain on the lower left side of the abdomen, accompanied with fever and usually constipation. Nausea, vomiting and diarrhoea with mucus, pus or blood may also be associated. Inflamed diverticula may form pus, creating an abscess within and as a consequence they perforate. With perforation pus may or may not spread within the abdomen. If it does spread it leads to peritonitis (inflammation of the whole abdomen) or to a localized abscess. Less frequent complications are bleeding, formation of fistulas (an abnormal connection between two organs or with the outside) and intestinal obstruction. Bleeding is most common in diverticula on the right side of the large intestine and may occur without diverticulitis. After the first incident of bleeding the chance of another is 25%; after a second incident, the chance of further haemorrhaging is up to 50%. Fistulas are due to spontaneous draining of an abscess, which may occur in the bladder or vagina for example. Obstruction of the large intestine is usually due to successive inflammations and scarring of diverticula, leading to fibrosis (deficient scarring) and fixing on the intestine. The symptoms of most cases of diverticulitis are improved with clinical treatment. Fibre-rich diets and or medicines which moisten and increase the volume of faeces, reducing the effort of evacuation, can relieve symptoms, prevent further diverticula and, most importantly, reduce complications such as diverticulitis. Antispasmodic medicines which reduce excessive contractions in the intestine can be used. Background Art

Treatment of gastritis is related to the cause. In cases of acute gastritis associated with the use of anti- inflammatory medication, suspension and/or substitution of those medicines which inhibit or block secretion of stomach acid is the basic treatment.

Currently anti-acid medicine (which neutralize gastric acid) and powerful antiulcer drugs (which reduce or interrupt the production of acid) are what are available on the market for the prevention and treatment of acute gastritis. The composition of anti- acid medicine aims at neutralizing the acid produced by the stomach.

Anti-acid medicine vary in the intensity to which they are absorbed. Those which contain aluminium, calcium or magnesium are absorbed less than those which contain NaHCO3.

Insoluble anti-acids which do not react, pass through the intestine and are eliminated in the faeces. When the products of the anti-acids which react enter the intestine some cations are absorbed.

In individuals with normal renal functioning the subsequent modest accumulations of A13+ and Mg2+ do not cause problems. In those with renal insufficiency A13+ absorbed may contribute to osteoporosis, encephalopathy and proximal myopathy. AI(OH)3 and Mg(OH)2 which do not react are able to pass through the intestine in their original compositions. A13+ is also excreted in faeces, as carbon and hydroxide. Mg2+ is eliminated as a variety of soluble salts. Both cations can form insoluble phosphates and other compositions.

Dietary ingestion of A13+ is normally around lOmg per day of which around 0.1% is absorbed. The use of anti- acids considerably increases this percentage and around 0.1 to 0.5 mg of cation may be absorbed from a standard daily dose of anti-acid containing A13+, depending on dietary factors.

In people with normal renal functioning the ingestion of anti-acids which contain A13+, doubles the average plasma concentration of A13+. As A13+ is eliminated in urine, plasma concentrations increase in renal deficiency, making the occurrence of toxicity possible.

The use of anti-acids containing aluminium, except in the form of phosphate is not advised during the first trimester of pregnancy and in patients with hypophosphatemia due to the aluminium salts' property of attaching to phosphate, depleting it. The use of anti-acids containing aluminium is not advised in patients with symptoms of appendicitis as this medication can increase the risk of perforation, due to the constipating effect, nor in children under 6 years of age, except when recommended by a doctor nor for undiagnosed gastrointestinal or rectal haemorrhage.

In altering gastric and urinary pH, anti- acids can change the dissolving and absorption rates, bioavailability and renal elimination of various substances. The compounds of A13+ and Mg2+ alter gastric motility, therefore altering the speed at which pharmacals touch the absorbent surface of the small intestine. The compounds of A13+ are notable for their propensity in absorbing pharmacals and in forming complex insolubles which are not absorbed. Unless bioavailability is also affected, altered absorption rates are of little clinical importance when pharmacals are given long term in multiple doses. In general it is prudent to avoid simultaneous administration of anti-acids and pharmacals which will be systemically absorbed. The majority of interactions can be avoided by taking anti-acids two hours before or after ingestion of other medication.

So, for a combination of factors many anti- acids reduce bioavailability of drugs. Cases when reduction could be clinically significant include, iron, teophiline, quinolone antibiotics, tetracycline, izoniazide and ketoconazol (solvency reduced by increase in pH). There is also evidence that anti-acids reduce the bioavailability of ethambutol, of some antimuscarinic agents, de benzodiazepines, phenothiazines, ranitidine, indomethacine, phenotoine, nitrophurantoine, vitamin A, fluoride, phospate, prednisone and procainamide. The anti-acids listed reduce the bioavailability of atenolol and of propranolol, but increases that of metoprolol. Anti-acids increase the solution and absorption of acid forms of susphonamides, the absorption rate of L-Dopa and the blood level of valproic acid.

As alkaline urine affects renal depuration of pharmacals which are acid or weak bases, simultaneous treatment with anti-acids increases the elimination rate of salicylates and of phenobarbital and reduces the elimination of amphetamine, ephedrine, mecamylamine, pseudo-ephedrine and quinidine. Anti-acids decrease the hepatic metabolism of ranitidine and reduce the efficiency of nitrophurantoine in the treatment of urinary tract infections. In the case of gastritis caused by the

Helicobacter pylori bacteria infection can be controlled and eliminated with the association of bismute and antibiotics (for example, amoxicillin and metronidazole). Sometimes the elimination of Helicobacter pylori from the stomach can be difficult. Atrophic gastritis has no cure. The majority of individuals with this problem have to receive injections of vitamin B12 supplement. Menetrier's Disease can be cured through the removal of the stomach (partially or totally) but no effective medicinal cure exists. Plasmic cell gastritis can be treated with antiulcer drugs which block the secretion of gastric acid.

Currently, the suggested medication, available on the market for the treatment of diverticulitis are anti- spasmodic drugs whose principal effect is to provoke the reduction of intestinal movement. Their main side effects are the appearance of visual and urinary problems. Substances derived from morphine are also used against diarrhoea and can cause sleepiness and dependency. Codeine and its derivatives stand out amongst these. Antibiotics are also necessary. Technical Problem

The aim of the present invention patent was developed to help in the treatment and the prevention of gastritis and of diverticulosis, either substituting or in addition to the choice of products available for this treatment. Technical Solution

The present invention teaches a production method for apple purees with chamomile, cinnamon, clove and lemon, a mixture of fruit, herbs and spices which has been able to help and enhance the desired balance, regeneration of mucosae and regular intestinal functioning. This mixture which is rich in soluble fibre contains several minerals, as well as other compounds which make this product a foodstuff with nutraceutical characteristics which has a mass-forming action due to the presence of fibres and has a calming effect on the mucosae, without, however, having any contra-indication for prolonged use. The average composition of purees consists of 97.5% apple pulp, 0 to 1.6% lemon juice, 0.65 to 0.85% Chamomile, 0 to 0.85% Cinnamon, 0 to 0.325% Clove and 0 to 0.1 % Preservatives. Advantageous Effects

The formulation of the digestive product of the present patent presents a number of advantages, given that, as already stated, as well as fibre it contains compounds which aid digestive functions, such as quercetine, eugenol, chamazulene, matricine, cymene, cineol, linalol, phelandrene, pinene, bisabolol, vanilla, tanine, citric acid, cinnamic acid, chlorogenic acid and cafeic acid. It does not have any contraindications or side effects and it also looks attractive and tastes extremely pleasant. The product, a puree or mixture of cooked fruits, herbs and spices is composed of apple, lemon, chamomile, cinnamon and clove. Each of the ingredients provides its own particular properties to the product. The aforementioned fruit, herb and spices were chosen principally because they are known to have a calming effect, they do not contain any component which is an irritant to intestinal mucosae and also, apple particularly, because it forms faecal matter, making its use possible for the widest possible variety of groups of people, from children through to pregnant women, making it a product with a huge, unique potential in the market.

The need for the development of a food compound was perceived, given the complexity of the problem and the great discomfort and repercussions that it causes the individual. This compound contains fibre and other nutrients and compounds which help treat the mucosa of the stomach and the intestine and which provide relief of the symptoms of these mucosa and in the case of diverticulosis giving bulk to the faecal matter providing more regularity and ease in evacuation, which can relieve symptoms, prevent new diverticula and principally reduce complications such as diverticulitis. It also has analgesic and antispasmodic benefits which reduce excessive intestinal contractions and it does not cause any, so it can be used with greater freedom by the widest variety of groups of people, whereas many products available should not be used over a long period of time nor in physiological conditions such as, for example, pregnancy and childhood, while using certain medication or in the case of renal deficiency. DETAILED DESCRIPTION OF THE INVENTION

The starting point for the development of the present invention is based on the properties of the fruit, herb and spices which make up the mixture of the product.

Apple which is a fruit from regions with moderate temperatures, is not only tasty but also has significant nutritional value. It provides a high quantity of soluble fibre which means it increases the volume of faecal matter and thus improves the capacity of the intestinal muscle to push it along the intestine. It also contains ellagic, chlorogenic and cafeic acids which help anticarcinogenic action. It also contains quercetine which is a flavonoid with antioxidant, anti-inflammatory and antihistaminic (anti-allergic) properties. One of the most active flavonoids which is recognized as protecting against cardio-vascular diseases, sweeps radical frees and prevents carcinogenesis, as well as acting as a gastric protector as it increases the production of mucus in the stomach. Apple is important for its high level of vitamins B complex, C and E, beta carotene (precursor of vitamin A), calcium, chlorine, magnesium, phosphorus, potassium, sulphur and fibres. It contains vitamins Bl, B2 and Niacine. Apple has a beneficial, protective effect on the digestive mucosae. It is able to resolve many disruptions in the digestive tract, from childhood diarrhoea in newborn babies through to certain persistent abnormalities in the adult intestine. Apple can also reduce cholesterol levels in the blood. An apple weighing around 100 grams provides the following quantities of nutrients: Phosphorus (llmg); Copper (0,27mg); Iron (0.12mg); Fibre (2,4g); Potassium (107mg); Calcium (6mg); Carbohydrates (13.8mg); Sodium (lmg), Vitamin A (3mg), Vitamin B (0.04mg) and Vitamin C (4mg). The origin of the citrus fruits is intertwined, over time with the history of man. It is known that most citrus fruits originate from the regions between India and the south-east of the Himalayas where varieties of lime tree, citron trees, pummelo trees, grapefruit trees, sharp and sweet orange trees and other citrus fruits have either been introduced or are native to the region. Lemons are a fruit with prodigious virtues. The compounds of the lemon are citric acid, Vitamin C and bioflavonoids/Vitamin P, as well as mineral salts such as calcium, phosphorus and iron. Lemons can be used for feverish conditions (influenza and common colds), coughs, blood circulation (thread veins), stomach conditions, such as digestion, against mouth ulcers, wounds, dry, opaque skin (face and neck), flaking and weak nails and dry cuticles.

Cinnamon is a plant from the Laurel family. It originates from Ceylon, present day Sri Lanka, from Burma and India and was discovered more than 2500 years AD ago by the Chinese. Cinnamon is one of the most ancient spices known to humankind. Its scientific name, 'cinnamomum', according to references, is derived from the Indonesian word ^λkayu manis' which means 'sweet wood'. It later received the Hebrew name of ^Λquinnamon' which evolved into the Greek ^Λkinnamon'. This ancient spice which was highly prized by the Portuguese in the XVI century, was passed on to the Dutch with the East India Company when they removed the Portuguese from Ceylon in 1656, and later passed into the hands of the English some time after 1796 when they occupied the island. Its chemical composition is: eugenol acetate, cinnamic acid, sugars, benzenic aldehyde, cinnamic aldehyde, cuminic aldehyde, benzyl benzoate, cymene, cineol, elegene, eugenol, phelandrene, phurol, gum, linalol, mucilage, calcium oxalate, pinene, resin, sacharose, tanine and vanilla. Parts Used: Essential oil and dried peel. Medicinal properties are attributed to cinnamon, amongst others antiseptic and digestive ones.

Chamomile (Matricaria chamomilla) is also one of the most ancient herbs used by humanity. The intense aroma awakened interest in the plant and ancient researchers ended up discovering several of the properties which have made chamomile so well known. The ancient Egyptians treated a disease similar to malaria with a tea made from the flowers. A kind of wine with the aroma of chamomile flowers which was used as a digestive also became very well known in Spain. In popular culture the plant is used for digestive problems, intestinal gases, gastritis and insomnia. Chamomile tea is well known and is used in caring for babies, in treating colic. The chamomile flowers contain potent concentrations of volatile oils which are responsible for fighting sharp muscular contraction (anti-spasmodic) and fever. It helps to expel intestinal gases and is also used for stomach problems. It has a mild calming effect. It is used externally as a wound healer in cases of dermatitis, anal fissures and eczema, common wounds and sunburn. Its chemical composition: Essential oil containing chamazulene, matricine, bisabolol, flavonoids and choline.

Clove (Syzygium aromaticum) is a native tree of the Maluku Islands of Indonesia. Nowadays it is grown in other regions of the world such as the islands of Madagascar and Granada. The dried bud of the flower has been used as a spice since the ancient times, in cooking and in the production of medication. Its oil has antiseptic and anaesthetic properties and is widely used in Dentistry. It was one of the most valuable spices on the market at the beginning of the XVI century and one kilo of clove was worth seven grams of gold. Clove has also been used, for over 2000 years as a medicinal plant. Oil of clove is a powerful antiseptic. Its medicinal effects include the treatment of nausea, flatulence, indigestion and diarrhoea. It has antibacterial properties and is also used as an anaesthetic and antiseptic in the relief of toothache. Professor Gary Elmer, Ph. D. Of the department of Medicinal Chemistry at the University of Washington School of Pharmacy, in Seattle, stresses that " eugenol really does kill viruses and bacteria ". The total content of oil in clove (of good quality) is up to 15%. Basically, this oil is constituted of eugenol (70 to 80%), acetyl eugenol (15%) and beta-caryophylline (5 to 12%). This oil is used as raw material in the pharmaceutical, cosmetic and odontological industry.

Therefore, from analysis of all the afore- mentioned data it is clear that the composition of the puree or fruit mixture with spices and herbs can be highly beneficial, particularly in treating mucosae and good intestinal functioning, both highly desirable.

It is suggested that treatment of the mucosae will be mainly through compounds such as eugenol, quercetine, cymene, cineol, linalol, phelandrene, pinene, chamazulene, matricine, bisabolol, vanilla and tanine, citric acid, chlorogenic acid and cafeic acid which have healing, antibacterial, antispasmodic, anaesthetic, antiseptic and digestive properties. Whilst regulation of the intestine will be achieved mainly through the increased consumption of fibre. Description of Drawings

The main stages of the production method will be described. Although it will be evident to specialists in the field that it will be possible to make adaptations without altering the concept of the invention, due to the form of presentation of the raw material. The principal stages are: a) Clean containers; b) Leave the apples in water with sufficient solution for cleaning for twenty minutes, after wash under running water, peel, remove seeds and cut into pieces; c) Place the water, cinnamon and clove in jacketed pan 1 and allow to boil. After 10 minutes of boiling, turn off the heat under the jacketed pan and add the chamomile. Leave for 10 minutes. Sieve and place into jacketed pan 2 with the apple; d) Leave to cook until the apples are soft.

Remove, beat in an industrial liquidizer and return to jacketed pan 2 and measure pH. Slowly add lemon juice until a pH of between 3.7 and 3.9 is reached. The flavour of the lemon is very strong so only the quantity of natural lemon juice is added which is needed to reduce the pH. If necessary the preservative should be added at this time. Heat to 20° of Brix. Alternative measurements of Brix: 19° to 21°; e) Bottle whilst hot and leave the product for 20 minutes in a bain-marie of boiling water. After 20 minutes begin to cool the containers so that the temperature is reduced within 40 minutes of the start time in the bain-marie. This cooling method is the only way to avoid the development of thermophilic bacteria, so it should be started immediately after the twenty minutes in the bain-marie or substituted with an autoclave for sterilisation or pasteurisation and in the latter case with cooling afterwards.

Alternatively the apples can be chopped into pieces before cooking, eliminating the need to remove them from the jacketed pan after cooking to beat them in the industrial liquidizer.

Preferably use lemon juice as the acidulant, as it is natural and adds a pleasant flavour to the mixture. However the flavour of lemon is very strong which is why natural lemon juice is added and only the necessary amount to reduce the pH. A preservative, if necessary, should also be added. The preservative can be ascorbic acid or its sodium, potassium and calcium salts, benzoic acid and its sodium and potassium salts or another which is permitted by legislation.

Whenever the packaging allows and there is the appropriate equipment, bottling should be done hot. After bottling submit the product to a bain-marie with boiling water, whenever the material will stand this, for the required time for the size of the container, in a way that the heat reaches all the product for the necessary amount of time for sterilisation.

After pasteurisation start the cooling of the product in an appropriate way so that room temperature is reached, around 20° Celsius or less. This cooling method is the only way to avoid the development of thermophilic bacteria, so it should be started immediately after the twenty minutes in the bain-marie or substituted with an autoclave for commercial sterilisation or pasteurisation and in the latter case with cooling afterwards.

The version of the product in puree form is the formula which obtained the best result and acceptance. It is sufficiently active without causing undesirable reactions, is easy to eat, is low in calories, as well as having an extremely pleasant, mild flavour, as would be expected for consumption before and between meals. Best Mode for Invention

So that the invention may be better understood it will be illustrated through the following Examples, showing the complete sequence of stages of presentation of the purees. It is worth stressing however that these examples are not considered to have a limiting effect on the invention. Example 1:

In research carried out to reach the ideal formulation a number of formulae were tested. The following were the best accepted:

Apple Puree with Chamomile, Cinnamon and Lemon

The following steps were followed: 3kg of cored and peeled apple 500ml to llitre of water Up to 50 of lemon juice 20 grams of chamomile tea 20 grams of cinnamon stick Process sequence adopted: a) Clean the containers. b) Leave the apples in water with sufficient solution for cleaning for twenty minutes, after wash under running water, peel, remove seeds and cut into pieces. c) Place water and cinnamon in jacketed pan 1 and allow to boil.

After 10 minutes of boiling turn off the heat under the jacketed pan and add the chamomile. Leave for 10 minutes. Sieve and place in jacketed pan 2 with the apple. Leave to cook until the apple is soft. Remove, beat in an industrial liquidiser and return to jacketed pan 2 and measure pH. Slowly add lemon juice until a pH between 3.7 and 3.9 is reached. The flavour of lemon is very strong which is why natural lemon juice is added and only the necessary amount to reduce the pH. If necessary preservative should be added at this time. Heat to 20° of Brix. Alternative measurements of Brix: 19° to 21°. Bottle whilst hot and leave the product for 20 minutes in a bain-marie of boiling water. After 20 minutes begin to cool the containers so that the temperature is reduced within 40 minutes of the start time in the bain-marie. This cooling method is the only way to avoid the development of thermophilic bacteria, so it should be started immediately after the twenty minutes in the bain-marie or substituted with an autoclave for sterilisation or pasteurisation and in the latter case with cooling afterwards.

The apples should preferably have a more acidic quality and be ripe as when they are too unripe they make the product unpalatable. They should be peeled and deseeded so that no type of residue such as peel or seeds affects patients with diverticulitis. The ideal consistency of the puree is reached due to the percentage of apple in the formulation thus dispensing with the need for addition of starch or pectin. In addition the apple gives the puree a mild taste, is not a very expensive fruit and is available to buy the whole year round.

Lemons should preferably be ripe as this adds a pleasant flavour to the final product. It is the second fruit in terms of percentage in the formulation. In the quantity indicated it provides the expected benefits, acting as a natural acidulant, making the use of chemical acidulants and preservatives unnecessary, as the product will be pasteurised or sterilised. Lemon is not a very expensive fruit and can be found available to buy the whole year round.

Chamomile tea (Matricaria chamomilla) should be made in the quantity indicated as this concentrate, made using the small, delicate flowers where the potent volatile oils can be found, is responsible for the anti-inflammatory, antiseptic, sedative and anti- spasmodic effect. The tea should be sieved leaving no type of residue which could affect patients with diverticulitis.

Cinnamon must be in sticks so that the tea can be made without leaving any type of residue which could affect patients with diverticulitis. The quantity indicated is enough to give the expected antiseptic and digestive benefits.

The clove tea should be made using the dried bud of the flower, the oil of which provides antiseptic, antibacterial and anaesthetic properties. The quantity indicated is enough to give the expected benefits. The tea should be sieved, without leaving any type of residue which may affect patients with diverticulitis. Example 2:

Apple Puree with Chamomile, Cinnamon, Clove and Lemon

The following steps were followed: 3kg of peeled and deseeded apple 500ml to llitre of water

Up to 50 of lemon juice 20 grams of chamomile tea 20 grams of cinnamon stick 10 grams of cloves

As in the previous example, the production process stages of the product are in the following order: a) Clean the containers. b) Leave the apples in water with sufficient solution for cleaning for twenty minutes, after wash under running water, peel, remove seeds and cut into pieces. c) Put the water, the cinnamon and the clove in jacketed pan 1 and allow to boil. After 10 minutes of boiling turn off the heat under the jacketed pan and add the chamomile. Leave for 10 minutes.

Sieve and place in jacketed pan 2 with the apple. Leave to cook until the apple is soft. Remove, beat in an industrial liquidiser and return to jacketed pan 2 and measure pH. Slowly add lemon juice until a pH between 3.7 and 3.9 is reached. The flavour of lemon is very strong which is why natural lemon juice is added and only the necessary amount to reduce the pH. If necessary preservative should be added at this time. Heat to 20° of Brix. Alternative measurements of Brix: 19° to 21°. Bottle whilst hot and leave the product for 20 minutes in a bain-marie of boiling water. After 20 minutes begin to cool the containers so that the temperature is reduced within 40 minutes of the start time in the bain-marie. This cooling method is the only way to avoid the development of thermophilic bacteria, so it should be started immediately after the twenty minutes in the bain-marie or substituted with an autoclave for sterilisation or pasteurisation and in the latter case with cooling afterwards. Example 3:

Apple Puree with Chamomile, Clove and Lemon

The following steps were followed: 3kg of cored and peeled apple

500ml to llitre of water Up to 50 of lemon juice 20 grams of chamomile tea 10 grams of cloves

The procedure adopted for preparation of the puree was the same as described in the previous examples.

The stages of the production process are in the following order: d) Clean the containers. e) Leave the apples in water with sufficient solution for cleaning for twenty minutes, after wash under running water, peel, remove seeds and cut into pieces. a) Place water and cloves in jacketed pan 1 and allow to boil. After 10 minutes of boiling turn off the heat under the jacketed pan and add the chamomile. Leave for 10 minutes. Sieve and place in jacketed pan 2 with the apple. Leave to cook until the apple is soft. Remove, beat in an industrial liquidiser and return to jacketed pan 2 and measure PH. Slowly add lemon juice until a PH between 3.7 and 3.9 is reached. The flavour of lemon is very strong which is why natural lemon juice is added and only the necessary amount to reduce the PH. If necessary preservative should be added at this time. Heat to 20° of Brix. Alternative measurements of Brix: 19° to 21°. Bottle whilst hot and leave the product for 20 minutes in a bain-marie of boiling water. After 20 minutes begin to cool the containers so that the temperature is reduced within 40 minutes of the start time in the bain-marie. This cooling method is the only way to avoid the development of thermophilic bacteria, so it should be started immediately after the twenty minutes in the bain-marie or substituted with an autoclave for sterilisation or pasteurisation and in the latter case with cooling afterwards.

Example 4:

Apple Puree with Chamomile and Lemon The following steps were followed:

3kg of peeled and deseeded apple 500ml to llitre of water Up to 50 of lemon juice 20 grams of chamomile tea

The procedure adopted for the preparation of the puree was the same as described in the previous examples.

The production process stages are in the following order: d) Clean the containers. a) Leave the apples in water with sufficient solution for cleaning for twenty minutes, after wash under running water, peel, remove seeds and cut into pieces. b) Put the water in jacketed pan 1 and allow to boil. After 10 minutes of boiling turn off the heat under the jacketed pan and add the chamomile. Leave for 10 minutes. Sieve and place in jacketed pan 2 with the apple. Leave to cook until the apple is soft. Remove, beat in an industrial liquidiser and return to jacketed pan 2 and measure pH. Slowly add lemon juice until a pH between 3.7 and 3.9 is reached. The flavour of lemon is very strong which is why natural lemon juice is added and only the necessary amount to reduce the pH. If necessary preservative should be added at this time. Heat to 20° of Brix. Alternative measurements of Brix: 19° to 21°. Bottle whilst hot and leave the product for 20 minutes in a bain-marie of boiling water. After 20 minutes begin to cool the containers so that the temperature is reduced within 40 minutes of the start time in the bain-marie. This cooling method is the only way to avoid the development of thermophilic bacteria, so it should be started immediately after the twenty minutes in the bain-marie or substituted with an autoclave for sterilisation or pasteurisation and in the latter case with cooling afterwards.

The following comments on the various formulae can be made after carrying out experiments with the compositions:

1. The version of Apple Puree with

Chamomile, Cinnamon and Lemon is efficient in relation to digestive benefits as well as having an easily accepted flavour, especially for those who enjoy the flavour of cinnamon.

2. The version Apple Puree with

Chamomile, Cinnamon, Clove and Lemon has a stronger effect in terms of digestive and anaesthetic benefits, as well as having a more distinct flavour. 3. The version of Apple Puree with

Chamomile, Clove and Lemon has a good effect with regards to digestive and anaesthetic benefits, as well as having a distinct flavour of clove so serves those who do not enjoy the flavour of cinnamon.

4. The version Apple Puree with Chamomile and Lemon has quite a gentle effect in digestive terms, as well as having an easily accepted flavour, especially for those who do not enjoy the flavour of cloves and cinnamon, such as small children.

Claims

1. COMPOSITION OF DIGESTIVE

PRODUCT characterised as consisting of a puree with special nutraceutical characteristics, composed of apple, chamomile, cinnamon, cloves and lemon, resulting from the mixing of chamomile tea and/or cinnamon and/or cloves with apple pulp and lemon juice, cooked directly and indirectly in steam;

2. COMPOSITION OF DIGESTIVE PRODUCT according to CLAIM 1, characterised as consisting of an average of 97.5% apple pulp, 1.6% lemon juice, 0.65% to 0.85% chamomile tea, 0.85% cinnamon tea and 0.32% cloves;

3. COMPOSITION OF DIGESTIVE

PRODUCT according to CLAIM 1, characterised as a puree resulting from the mixing of chamomile, cinnamon and clove tea with apple pulp and lemon juice, cooked directly or indirectly in steam;

4. COMPOSITION OF DIGESTIVE

PRODUCT according to CLAIM 1, characterised as a puree resulting from the mixing of chamomile tea and cinnamon with apple pulp and lemon juice, cooked directly or indirectly in steam.

5. COMPOSITION OF DIGESTIVE

PRODUCT according to CLAIM 1, characterised as a puree resulting from the mixing of chamomile tea and cloves with apple pulp and lemon juice, cooked directly or indirectly in steam.

6. COMPOSITION OF DIGESTIVE PRODUCT according to CLAIM 1, characterised as a puree resulting from the mixing of chamomile tea with apple pulp and lemon juice, cooked directly or indirectly in steam.

7. COMPOSITION OF DIGESTIVE PRODUCT, characterised for its use as a digestive product.

8. "PRODUCTION METHOD OF

DIGESTIVE PRODUCT", characterised bv the following sequence: a) Clean the containers. b) Leave the apples in water with sufficient solution for cleaning for twenty minutes, after wash under running water, peel, remove seeds and cut into pieces. c) Put the water, cinnamon and cloves in jacketed pan 1 and allow to boil. After 10 minutes of boiling turn off the heat under the jacketed pan and add the chamomile. Leave for 10 minutes. Sieve and place in jacketed pan 2 with the apple; d) Leave to cook until the apple is soft. Remove, beat in an industrial liquidiser and return to jacketed pan 2 and measure pH. Slowly add lemon juice until a pH between 3.7 and 3.9 is reached. The flavour of lemon is very strong which is why natural lemon juice is added and only the necessary amount to reduce the pH. If necessary preservative should be added at this time. Heat to 20° of Brix. Alternative measurements of Brix:

e) Bottle whilst hot and leave the product for 20 minutes in a bain- marie of boiling water. After 20 minutes begin to cool the containers so that the temperature is reduced within 40 minutes of the start time in the bain-marie. This cooling method is the only way to avoid the development of thermophilic bacteria, so it should be started immediately after the twenty minutes in the bain-marie or substituted with an autoclave for sterilisation or pasteurisation and in the latter case with cooling afterwards.

9. "PRODUCTION METHOD OF

DIGESTIVE PRODUCT", according to CLAIM 3, characterised as. alternatively the apples may be chopped into small pieces after peeling and before cooking so eliminating the need after cooking of removing from the jacketed pan and beating in an industrial liquidizer.