WO2008080810A2 - Composition comprising cocoa fibre - Google Patents
Composition comprising cocoa fibre Download PDFInfo
- Publication number
- WO2008080810A2 WO2008080810A2 PCT/EP2007/064041 EP2007064041W WO2008080810A2 WO 2008080810 A2 WO2008080810 A2 WO 2008080810A2 EP 2007064041 W EP2007064041 W EP 2007064041W WO 2008080810 A2 WO2008080810 A2 WO 2008080810A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- composition
- fibre
- cocoa
- weight
- oligofructose
- Prior art date
Links
- 239000000835 fiber Substances 0.000 title claims abstract description 50
- 235000009470 Theobroma cacao Nutrition 0.000 title claims abstract description 48
- 239000000203 mixture Substances 0.000 title claims abstract description 45
- 244000240602 cacao Species 0.000 title 1
- 244000299461 Theobroma cacao Species 0.000 claims abstract description 50
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 23
- 239000003814 drug Substances 0.000 claims abstract description 15
- 235000013376 functional food Nutrition 0.000 claims abstract description 14
- 206010010774 Constipation Diseases 0.000 claims abstract description 13
- 238000002360 preparation method Methods 0.000 claims abstract description 10
- 230000000112 colonic effect Effects 0.000 claims abstract description 4
- 239000010903 husk Substances 0.000 claims description 23
- 235000013305 food Nutrition 0.000 claims description 12
- 235000013618 yogurt Nutrition 0.000 claims description 8
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 5
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 4
- 235000011950 custard Nutrition 0.000 claims description 3
- 239000007788 liquid Substances 0.000 claims description 3
- 235000020166 milkshake Nutrition 0.000 claims description 3
- 235000020124 milk-based beverage Nutrition 0.000 claims description 2
- 229940079593 drug Drugs 0.000 abstract description 7
- 230000013872 defecation Effects 0.000 description 8
- 210000003608 fece Anatomy 0.000 description 7
- 230000000968 intestinal effect Effects 0.000 description 7
- 238000000034 method Methods 0.000 description 5
- 235000013336 milk Nutrition 0.000 description 5
- 239000008267 milk Substances 0.000 description 5
- 210000004080 milk Anatomy 0.000 description 5
- 239000000902 placebo Substances 0.000 description 5
- 229940068196 placebo Drugs 0.000 description 5
- 230000000694 effects Effects 0.000 description 4
- 235000019219 chocolate Nutrition 0.000 description 3
- 239000000796 flavoring agent Substances 0.000 description 3
- 235000019634 flavors Nutrition 0.000 description 3
- 235000013311 vegetables Nutrition 0.000 description 3
- 206010012735 Diarrhoea Diseases 0.000 description 2
- 241000792859 Enema Species 0.000 description 2
- 208000002193 Pain Diseases 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 230000001684 chronic effect Effects 0.000 description 2
- 210000001072 colon Anatomy 0.000 description 2
- 239000000470 constituent Substances 0.000 description 2
- 238000000151 deposition Methods 0.000 description 2
- 230000008021 deposition Effects 0.000 description 2
- 235000013325 dietary fiber Nutrition 0.000 description 2
- 230000008030 elimination Effects 0.000 description 2
- 238000003379 elimination reaction Methods 0.000 description 2
- 239000007920 enema Substances 0.000 description 2
- 239000000686 essence Substances 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- 239000008141 laxative Substances 0.000 description 2
- 229940125722 laxative agent Drugs 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 239000013589 supplement Substances 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 208000004998 Abdominal Pain Diseases 0.000 description 1
- 206010000060 Abdominal distension Diseases 0.000 description 1
- 108010011485 Aspartame Proteins 0.000 description 1
- 241000167854 Bourreria succulenta Species 0.000 description 1
- 235000016623 Fragaria vesca Nutrition 0.000 description 1
- 240000009088 Fragaria x ananassa Species 0.000 description 1
- 235000011363 Fragaria x ananassa Nutrition 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 206010020850 Hyperthyroidism Diseases 0.000 description 1
- 244000290333 Vanilla fragrans Species 0.000 description 1
- 235000009499 Vanilla fragrans Nutrition 0.000 description 1
- 235000012036 Vanilla tahitensis Nutrition 0.000 description 1
- 230000003187 abdominal effect Effects 0.000 description 1
- YGCFIWIQZPHFLU-UHFFFAOYSA-N acesulfame Chemical compound CC1=CC(=O)NS(=O)(=O)O1 YGCFIWIQZPHFLU-UHFFFAOYSA-N 0.000 description 1
- 229960005164 acesulfame Drugs 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 230000003078 antioxidant effect Effects 0.000 description 1
- 125000003118 aryl group Chemical group 0.000 description 1
- 239000000605 aspartame Substances 0.000 description 1
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 description 1
- 229960003438 aspartame Drugs 0.000 description 1
- 235000010357 aspartame Nutrition 0.000 description 1
- 235000019693 cherries Nutrition 0.000 description 1
- 235000020606 chocolate milkshake Nutrition 0.000 description 1
- 235000009508 confectionery Nutrition 0.000 description 1
- 235000011850 desserts Nutrition 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 230000000378 dietary effect Effects 0.000 description 1
- 235000014113 dietary fatty acids Nutrition 0.000 description 1
- 230000029087 digestion Effects 0.000 description 1
- 210000002249 digestive system Anatomy 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 229940095399 enema Drugs 0.000 description 1
- 229940079360 enema for constipation Drugs 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 239000000194 fatty acid Substances 0.000 description 1
- 229930195729 fatty acid Natural products 0.000 description 1
- 150000004665 fatty acids Chemical class 0.000 description 1
- 230000002550 fecal effect Effects 0.000 description 1
- 238000007380 fibre production Methods 0.000 description 1
- 235000003599 food sweetener Nutrition 0.000 description 1
- 235000012055 fruits and vegetables Nutrition 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 230000007407 health benefit Effects 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 229910052500 inorganic mineral Inorganic materials 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 239000011707 mineral Substances 0.000 description 1
- 235000010755 mineral Nutrition 0.000 description 1
- 235000021590 normal diet Nutrition 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 230000035764 nutrition Effects 0.000 description 1
- 235000008935 nutritious Nutrition 0.000 description 1
- 210000003254 palate Anatomy 0.000 description 1
- 230000007170 pathology Effects 0.000 description 1
- 235000017807 phytochemicals Nutrition 0.000 description 1
- 229930000223 plant secondary metabolite Natural products 0.000 description 1
- 230000008092 positive effect Effects 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 230000003449 preventive effect Effects 0.000 description 1
- 239000006041 probiotic Substances 0.000 description 1
- 235000018291 probiotics Nutrition 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 230000004936 stimulating effect Effects 0.000 description 1
- 239000003765 sweetening agent Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 235000020357 syrup Nutrition 0.000 description 1
- 239000006188 syrup Substances 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
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
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/20—Reducing nutritive value; Dietetic products with reduced nutritive value
- A23L33/21—Addition of substantially indigestible substances, e.g. dietary fibres
- A23L33/22—Comminuted fibrous parts of plants, e.g. bagasse or pulp
-
- 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
- A23L33/20—Reducing nutritive value; Dietetic products with reduced nutritive value
- A23L33/21—Addition of substantially indigestible substances, e.g. dietary fibres
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
- A23G1/00—Cocoa; Cocoa products, e.g. chocolate; Substitutes therefor
- A23G1/30—Cocoa products, e.g. chocolate; Substitutes therefor
-
- 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
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
-
- 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
- A23L33/30—Dietetic or nutritional methods, e.g. for losing weight
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
-
- 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
Definitions
- the present invention relates to a composition based on cocoa fibre and a pharmaceutical composition prepared thereof, in addition to its uses.
- the invention also relates to a functional food that comprises the cocoa fibre-based composition.
- artificial flavours are increasingly being added to pharmaceutical compositions in order to make their administration more pleasant, such as strawberry, cherry, orange, etc.; or said compositions are camouflaged as functional foods, such as yoghurts, milk shakes, etc.
- Patent EP0068229 There have been multiple attempts to produce compositions based on fibre that improve digestion while being pleasant to the palate.
- An example of these is the fibre production method disclosed Patent EP0068229, according to which cocoa seed husks are subjected to moistening, drying and granulation phases prior to being added to foods. This procedure is aimed at increasing the amount of dietary fibre in foods to improve intestinal transit.
- EP0068229 also mentions that cocoa is a good option for the production of fibre-rich foods which, in addition to being appealing, have the added advantage of being easily digested.
- EP0068229 proposes the use of fibre-rich, cocoa- based materials in the manufacture of, for example, chocolate, cocoa drinks or sweets. A limited number of controlled clinical trials have been performed to evaluate the effectiveness of fibre-rich supplements, and even less in the paediatric field.
- the object of the present invention is a great step forward in the preparation of medicines for the treatment of constipation, while resolving the aforementioned administration problems.
- the invention also improves current fibre administration procedures for the infant population.
- the cocoa fibre-based composition is characterized in that it is comprised of cocoa seed husk fibre and oligofructose.
- the composition contains 60% to 80% by weight of cocoa seed husk fibre with respect to the total composition; and 10% to 25% by weight of oligofructose with respect to the total composition.
- composition of the present invention is characterized in that the percentage by weight of cocoa seed husk fibre is contained in the range of 65% to 80%. Similarly, the percentage by weight of oligofructose is contained in the range of 15% to 20%.
- Another object of the present invention is a cocoa fibre-based pharmaceutical composition, characterized in that it is comprised of cocoa seed husk fibre and oligofructose, together with the adequate quantities of excipients, in accordance with the desired administration route.
- cocoa seed husk fibre is contained in the range of 60% to 80% by weight with respect to the total composition, while oligofructose is contained in the range of 10% to 25% by weight with respect to the total composition.
- cocoa seed husk fibre is contained in the range of 65% to 80%.
- the percentage by weight of oligofructose is contained in the range of 15% to 20%.
- the pharmaceutical composition according to the invention is designed for oral administration.
- Another object of the present invention is the use of a pharmaceutical composition comprised of cocoa seed husk fibre and oligofructose, in the preparation of a medicine for the treatment of constipation and/or slow intestinal transit.
- the use, according to the invention is characterized in that it is intended for a medicine to treat chronic idiopathic constipation.
- the use of the pharmaceutical composition is intended for the preparation of a medicine for human use.
- Another object of the present invention is a cocoa-based functional food comprised of cocoa seed husk fibre and oligofructose.
- said functional food is characterized in that it contains 5% to 80% by weight of cocoa seed husk fibre with respect to total food composition and 1% to 50% by weight of oligofructose with respect to total food composition.
- “functional food” is understood as those foods that are consumed as part of a normal diet and which contain biologically active components or offer health benefits, thereby reducing the risk of illness. That is, foods which, apart from providing the nutritious substances that must normally be provided by such foods, provide additional positive effects that go beyond basic nutrition. Said effects are usually preventive or protective, or aimed at lowering the risk of suffering from certain pathologies.
- functional foods those rich in determined minerals, vitamins, fatty acids or dietary fibre must be highlighted; foods to which biologically active substances have been added, such as phytochemical or other antioxidant substances; and probiotics, which contain live cultures of beneficial microorganisms.
- composition of the present invention is based on cocoa seed husk fibre and oligofructose. Said pharmaceutical composition is highly effective in the treatment of constipation and is especially indicated as an infant medicine, precisely due to its - A -
- Example 1 shows, in an illustrative and unlimitative way, a cocoa-based pharmaceutical composition and its constituent ingredients. Said composition is presented as a pharmaceutical preparation in single-dose sachets dissolvable in milk.
- EXAMPLE 1 Pharmaceutical composition in single-dose sachet form.
- Example 1 Although in Example 1 the single-dose sachets contain 5.1 grams of pharmaceutical composition, it is obvious that this quantity may vary depending on the desired presentation and/or marketing format.
- excipients used include synthentic sweeteners such as aspartame and acesulfame.
- aromatic essences in the composition is provided, such as vanilla and chocolate, in order to make intake thereof more attractive and pleasant, especially for children.
- the percentage by weight of cocoa seed husk fibre in Example 1 is 78.4% with respect to the total composition.
- Oligofructose content represents 19.4% and the rest (approximately 2%), corresponds to excipients.
- the composition of Example 1 corresponds to a pharmaceutical composition designed for oral administration, specifically provided in sachet form, as previously indicated.
- the patient is instructed to dissolve the sachet's contents in a glass of milk, i.e. approximately 200 ml.
- the pharmaceutical composition of the present invention may also be presented under other galenic forms, such as syrups or jar bulk powder, in which case the patient is instructed with regard to the quantity to be dissolved in milk.
- Other presentation formats of the cocoa fibre and oligofructose-based composition that fall within the scope of the present invention include prepared cocoa drinks and yoghurt.
- Example 2 below details the constituent ingredients and quantities of a yoghurt conceived as a functional food.
- the cocoa fibre-based composition of the present invention is appealing to patients, and especially to the infant population, which makes it a good medicine, supplement or functional food for this type of patients.
- the chronic constipation was determined by the detection of the following symptoms: pain in more than 25% of defecations; presence of hard faeces in 25% or more of defecations; feeling of incomplete evacuation in more than 25% of defecations; feeling of obstruction in more than 25% of defecations; need for manual manipulation to facilitate defecation in more than 25% of defecations; and less than three defecations per week.
- Example 1 i.e. composition based on cocoa seed husk fibre and oligofructose, was administered randomly over four weeks (Test Group); and, on the other, a placebo comprised of glucose, cocoa essence and flavouring and other excipients (Control Group). Both the test and control group were trained to apply standardized hygiene procedures.
- Example 1 Both the composition of Example 1 and the placebo were distributed in 5.1 gram single-dose sachet form and the children's parents were instructed to dissolve their contents in approximately 200 ml of milk.
- CTT was measured after the children swallowed ten radio-opaque markers at nine every morning during six days. Abdominal x-rays were then made on the seventh day in order to view the number of markers still present in the digestive system. CTT was calculated based on the following formula:
- Table 1 shows the analyzed results of intestinal transit evolution throughout the study of those children whose total intestinal transit time was above that of the 50th percentile of the population at the start of said study.
- Table 2 shows the intestinal movement measurement and faeces consistency results. The personal impressions of the children's parents in relation to pain during defecation are also listed.
- Table 2 reveals that those children who were administered the pharmaceutical composition of the present invention tended to increase the number of depositions to a greater degree than those of the placebo group, although the differences were not substantial.
- the parameter that showed the most substantial differences between the two groups was that of faeces of hard consistency.
- children from the test group substantially reduced the number of faeces of hard consistency (from 95.8% to 41.7%). Additionally, many children, or their parents, indicated that they had noticed improvement in faeces consistency.
- compositions such as those of the present invention are highly effective in improving slow colonic transit.
- cocoa fibre-based compositions such as those of the present invention offer great advantages as regards treatment with other types of fibre-based compositions which, due to their organoleptic characteristics and side effects (diarrhoea, gas, abdominal pain, etc.), are eventually abandoned by the infant population.
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- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Polymers & Plastics (AREA)
- Food Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- Mycology (AREA)
- Nutrition Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Botany (AREA)
- Molecular Biology (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicines Containing Plant Substances (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Cocoa fibre-based pharmaceutical composition comprised of cocoa fibre and oligofructose. The invention also relates to the use of this composition in the preparation of medicines, specifically in the preparation of medicines for constipation and/or slow colonic transit. Functional food comprised of a cocoa fibre and oligfructose-based composition.
Description
D E S C R I P T I O N
"COMPOSITION COMPRISING COCOA FIBRE"
Technical field of the invention
The present invention relates to a composition based on cocoa fibre and a pharmaceutical composition prepared thereof, in addition to its uses. The invention also relates to a functional food that comprises the cocoa fibre-based composition.
Background of the invention
It is well known that intake of vegetable fibre improves intestinal transit, partly due to the fact that vegetable fibre absorbs water and increases fecal ball size, thus stimulating its elimination.
In addition to the convenience of consuming fibre-rich foods, such as fruit and vegetables, in patients with faeces elimination problems, such as constipation and lazy colon, pharmaceutical preparations containing vegetable fibre are recommended or prescribed. Said preparations are usually administered dissolved in water or other liquids.
In the case of constipation in children, the problem is aggravated by the fact that they are not particularly receptive to the administration of drugs or pharmaceutical and/or dietary preparations, generally due to their unpleasant taste or psychological factors when associated to other medicines.
In this way, artificial flavours are increasingly being added to pharmaceutical compositions in order to make their administration more pleasant, such as strawberry, cherry, orange, etc.; or said compositions are camouflaged as functional foods, such as yoghurts, milk shakes, etc.
There have been multiple attempts to produce compositions based on fibre that improve digestion while being pleasant to the palate. An example of these is the fibre production method disclosed Patent EP0068229, according to which cocoa seed husks are subjected to moistening, drying and granulation phases prior to being added to foods. This procedure is aimed at increasing the amount of dietary fibre in foods to improve intestinal transit.
EP0068229 also mentions that cocoa is a good option for the production of fibre-rich foods which, in addition to being appealing, have the added advantage of being easily digested. In this way, EP0068229 proposes the use of fibre-rich, cocoa- based materials in the manufacture of, for example, chocolate, cocoa drinks or sweets.
A limited number of controlled clinical trials have been performed to evaluate the effectiveness of fibre-rich supplements, and even less in the paediatric field.
The problem with said clinical trials derives not only from the difficulty of performing them, as they require standardized hygiene procedures, but also from the difficulty in regularly administering any type of drug to infant patients, and amongst these minors under the age of three. Moreover when said drugs consist of laxatives or enemas that subject the patient to an unpleasant situation.
The object of the present invention is a great step forward in the preparation of medicines for the treatment of constipation, while resolving the aforementioned administration problems. The invention also improves current fibre administration procedures for the infant population.
Explanation of the invention
In essence, the cocoa fibre-based composition is characterized in that it is comprised of cocoa seed husk fibre and oligofructose.
According to another characteristic, the composition contains 60% to 80% by weight of cocoa seed husk fibre with respect to the total composition; and 10% to 25% by weight of oligofructose with respect to the total composition.
The composition of the present invention is characterized in that the percentage by weight of cocoa seed husk fibre is contained in the range of 65% to 80%. Similarly, the percentage by weight of oligofructose is contained in the range of 15% to 20%.
Another object of the present invention is a cocoa fibre-based pharmaceutical composition, characterized in that it is comprised of cocoa seed husk fibre and oligofructose, together with the adequate quantities of excipients, in accordance with the desired administration route.
In the pharmaceutical composition according to the invention, cocoa seed husk fibre is contained in the range of 60% to 80% by weight with respect to the total composition, while oligofructose is contained in the range of 10% to 25% by weight with respect to the total composition.
More specifically, the percentage by weight of cocoa seed husk fibre is contained in the range of 65% to 80%.
According to another characteristic of the cocoa-based pharmaceutical composition, the percentage by weight of oligofructose is contained in the range of 15% to 20%.
The pharmaceutical composition according to the invention is designed for oral
administration.
Another object of the present invention is the use of a pharmaceutical composition comprised of cocoa seed husk fibre and oligofructose, in the preparation of a medicine for the treatment of constipation and/or slow intestinal transit. The use, according to the invention, is characterized in that it is intended for a medicine to treat chronic idiopathic constipation.
According to another characteristic of the present invention, the use of the pharmaceutical composition is intended for the preparation of a medicine for human use. Another object of the present invention is a cocoa-based functional food comprised of cocoa seed husk fibre and oligofructose.
According to the invention, said functional food is characterized in that it contains 5% to 80% by weight of cocoa seed husk fibre with respect to total food composition and 1% to 50% by weight of oligofructose with respect to total food composition.
Within the context of the present invention, "functional food" is understood as those foods that are consumed as part of a normal diet and which contain biologically active components or offer health benefits, thereby reducing the risk of illness. That is, foods which, apart from providing the nutritious substances that must normally be provided by such foods, provide additional positive effects that go beyond basic nutrition. Said effects are usually preventive or protective, or aimed at lowering the risk of suffering from certain pathologies. Amongst the different examples of functional foods, those rich in determined minerals, vitamins, fatty acids or dietary fibre must be highlighted; foods to which biologically active substances have been added, such as phytochemical or other antioxidant substances; and probiotics, which contain live cultures of beneficial microorganisms.
In the same way, functional foods in the form of milk-based drinks or milk shakes, yoghurts, liquid yoghurts or custards rich in cocoa fibre, and specifically cocoa seed husk fibre together with oligofructose, also fall within the scope of the present invention.
Detailed description of the invention
A detailed description of the pharmaceutical composition of the present invention has been provided below, which is based on cocoa seed husk fibre and oligofructose. Said pharmaceutical composition is highly effective in the treatment of constipation and is especially indicated as an infant medicine, precisely due to its
- A -
cocoa flavour.
Example 1 below shows, in an illustrative and unlimitative way, a cocoa-based pharmaceutical composition and its constituent ingredients. Said composition is presented as a pharmaceutical preparation in single-dose sachets dissolvable in milk.
EXAMPLE 1 : Pharmaceutical composition in single-dose sachet form.
Although in Example 1 the single-dose sachets contain 5.1 grams of pharmaceutical composition, it is obvious that this quantity may vary depending on the desired presentation and/or marketing format.
The excipients used, amongst others already known to persons skilled in the art, include synthentic sweeteners such as aspartame and acesulfame.
The use of aromatic essences in the composition is provided, such as vanilla and chocolate, in order to make intake thereof more attractive and pleasant, especially for children.
According to the invention, the percentage by weight of cocoa seed husk fibre in Example 1 is 78.4% with respect to the total composition. Oligofructose content represents 19.4% and the rest (approximately 2%), corresponds to excipients. The composition of Example 1 corresponds to a pharmaceutical composition designed for oral administration, specifically provided in sachet form, as previously indicated.
For correct administration, the patient is instructed to dissolve the sachet's contents in a glass of milk, i.e. approximately 200 ml. The pharmaceutical composition of the present invention may also be presented under other galenic forms, such as syrups or jar bulk powder, in which case the patient is instructed with regard to the quantity to be dissolved in milk.
Other presentation formats of the cocoa fibre and oligofructose-based composition that fall within the scope of the present invention include prepared cocoa drinks and yoghurt. Example 2 below details the constituent ingredients and quantities of a yoghurt conceived as a functional food.
EXAMPLE 2: Chocolate yoghurt.
Other examples of functional foods include chocolate milk shakes, custards, milk-based desserts, etc.
In any case, it has been verified that the cocoa fibre-based composition of the present invention is appealing to patients, and especially to the infant population, which makes it a good medicine, supplement or functional food for this type of patients.
Precisely, in order to exemplify the effectiveness of this type of compositions, the clinical trial performed is detailed below.
Trial:
Patients between 3 and 10 years of age suffering from chronic constipation were selected. A double-blind, randomized and parallel trial was performed to compare the effects of the composition of Example 2 with those of a placebo.
The chronic constipation was determined by the detection of the following symptoms: pain in more than 25% of defecations; presence of hard faeces in 25% or more of defecations; feeling of incomplete evacuation in more than 25% of defecations; feeling of obstruction in more than 25% of defecations; need for manual manipulation to facilitate defecation in more than 25% of defecations; and less than three defecations per week.
The following patients were excluded from the trial: those who had required an enema seven days prior to the start of the trial; those who had received fibre or laxatives in the two previous weeks; or those whose constipation was due to organic or anatomic causes, such as hyperthyroidism.
On one hand, the composition of Example 1 , i.e. composition based on cocoa seed husk fibre and oligofructose, was administered randomly over four weeks (Test Group); and, on the other, a placebo comprised of glucose, cocoa essence and flavouring and other excipients (Control Group). Both the test and control group were trained to apply standardized hygiene procedures.
Both the composition of Example 1 and the placebo were distributed in 5.1 gram single-dose sachet form and the children's parents were instructed to dissolve their contents in approximately 200 ml of milk.
After the four weeks had elapsed, the following parameters were evaluated: physical examination of the patients; determination of total and segmental colonic transit time (CTT); number of depositions and consistency of faeces; and subjective evaluation of the parents in relation to the effectiveness of the treatment.
CTT was measured after the children swallowed ten radio-opaque markers at nine every morning during six days. Abdominal x-rays were then made on the seventh day in order to view the number of markers still present in the digestive system. CTT was calculated based on the following formula:
CTT = (sum of markers x [time between administration / number of markers swallowed]) = sum of markers x 2.4
Table 1 below shows the analyzed results of intestinal transit evolution throughout the study of those children whose total intestinal transit time was above that of the 50th percentile of the population at the start of said study.
TABLE 1
As revealed by Table 1 , substantial differences were observed with regard to evolution in terms of both total transit time and right colon transit amongst the intervention groups. The decrease in intestinal transit time was greater in the group treated with fibre.
Below, Table 2 shows the intestinal movement measurement and faeces consistency results. The personal impressions of the children's parents in relation to pain during defecation are also listed.
TABLE 2
Table 2 data were produced from the study of the previously indicated parameters in 24 children from each of the test and placebo groups (n=24).
Table 2 reveals that those children who were administered the pharmaceutical composition of the present invention tended to increase the number of depositions to a
greater degree than those of the placebo group, although the differences were not substantial. The parameter that showed the most substantial differences between the two groups was that of faeces of hard consistency. As revealed by Table 2, children from the test group substantially reduced the number of faeces of hard consistency (from 95.8% to 41.7%). Additionally, many children, or their parents, indicated that they had noticed improvement in faeces consistency.
It is worth pointing out that, after administration of the pharmaceutical composition of the present invention, no adverse side effects were detected, such as abdominal distensions, diarrhoea, gas, etc. Consequently, the Trial indicates that cocoa seed husk fibre and oligofructose- based compositions are highly beneficial to chronic idiopathic constipation patients.
The data presented also reveal that compositions such as those of the present invention are highly effective in improving slow colonic transit.
Additionally, its must be noted that the Trial's success was partly based on the fact that it was followed by a large number of the selected patients, mainly due to the composition's cocoa flavour and smell. Consequently, cocoa fibre-based compositions such as those of the present invention offer great advantages as regards treatment with other types of fibre-based compositions which, due to their organoleptic characteristics and side effects (diarrhoea, gas, abdominal pain, etc.), are eventually abandoned by the infant population.
Claims
1.- Cocoa fibre-based composition comprised of at least cocoa seed husk fibre and oligofructose.
2.- Composition, according to claim 1 , characterized in that it contains 60% to 80% by weight of cocoa seed husk fibre with respect to the total composition and 10% to 25% by weight of oligofructose with respect to the total composition.
3.- Composition, according to claim 2, characterized in that the percentage by weight of cocoa seed husk fibre is in the range of 65% to 80%.
4.- Composition, according to claim 2, characterized in that the percentage by weight of oligofructose is in the range of 15% to 20%.
5.- Cocoa fibre-based pharmaceutical composition comprised of cocoa seed husk fibre and oligofructose and adequate quantities of excipients, in accordance with the desired administration route.
6.- Pharmaceutical composition, according to claim 5, characterized in that it contains 60% to 80% by weight of cocoa seed husk fibre with respect to the total composition and 10% to 25% by weight of oligofructose with respect to the total composition.
7.- Pharmaceutical composition, according to claim 6, characterized in that the percentage by weight of cocoa seed husk fibre is in the range of 65% to 80%.
8.- Pharmaceutical composition, according to claim 6, characterized in that the percentage by weight of oligofructose is in the range of 15% to 20%.
9.- Pharmaceutical composition, according to any of claims 5 to 8, characterized in that it is designed for oral administration.
10.- Use of a composition, according to any of claims 5 to 8, in the preparation of a medicine for the treatment of constipation and/or slow colonic transit.
1 1.- Use, according to claim 10, in the preparation of a medicine for the treatment of chronic idiopathic constipation.
12.- Use, according to claims 10 or 1 1 , in the preparation of a medicine for human use.
13.- Pharmaceutical preparation having a composition in accordance with any of claims 5 to 8.
14.- Pharmaceutical preparation, according to claim 13, characterized in that it is presented in single-dose sachet form.
15.- Cocoa fibre-based functional food comprised of cocoa seed husk fibre and oligofructose.
16.- Functional food, according to claim 15, characterized in that it contains 5% to 80% by weight of cocoa seed husk fibre with respect to total food composition and 1% to 50% by weight of oligofructose with respect to total food composition.
17.- Functional food, according to claims 15 or 16, characterized in that it is presented in the form of milk-based drinks or milk shakes, yoghurts, liquid yoghurts or custards.
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ESP200603306 | 2006-12-29 | ||
ES200603306A ES2302463B1 (en) | 2006-12-29 | 2006-12-29 | "COMPOSITION BASED ON FIBER OF COCOA". |
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WO2008080810A3 WO2008080810A3 (en) | 2008-10-23 |
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PCT/EP2007/064041 WO2008080810A2 (en) | 2006-12-29 | 2007-12-17 | Composition comprising cocoa fibre |
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WO (1) | WO2008080810A2 (en) |
Cited By (2)
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US20100086663A1 (en) * | 2008-10-08 | 2010-04-08 | Bernhard Brandstetter | Acidified Dairy Food |
CN105230904A (en) * | 2015-10-29 | 2016-01-13 | 光明乳业股份有限公司 | Chocolate fermented light cream and preparation method thereof |
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Cited By (6)
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US20100086663A1 (en) * | 2008-10-08 | 2010-04-08 | Bernhard Brandstetter | Acidified Dairy Food |
EP2174555A1 (en) * | 2008-10-08 | 2010-04-14 | Kraft Foods R & D, Inc. | Acidified dairy food comprising cocoa shells |
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CN105230904A (en) * | 2015-10-29 | 2016-01-13 | 光明乳业股份有限公司 | Chocolate fermented light cream and preparation method thereof |
CN105230904B (en) * | 2015-10-29 | 2019-01-29 | 光明乳业股份有限公司 | A kind of chocolate fermentation dilute cream and preparation method thereof |
Also Published As
Publication number | Publication date |
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ES2302463B1 (en) | 2009-06-05 |
WO2008080810A3 (en) | 2008-10-23 |
ES2302463A1 (en) | 2008-07-01 |
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