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

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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.