Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2001-09-14
2002-12-03
Barts, Samuel (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S023000, C536S001110, C536S004100, C424S757000, C426S656000, C426S658000
Reexamination Certificate
active
06489310
ABSTRACT:
This Application is the National Phase Application of PCT/EP99/10076 filed Dec. 15, 1999.
This invention relates to a fibre blend for enteral compositions. The invention also relates to enteral compositions which contain the fibre blend.
It is now well accepted that dietary fibres should form part of daily food intake. For example, Pilch S. M. (1987
; MD Federation of American Societies for Experimental Biol
., 223, 84, 2059) recommends that the quantity of dietary fibres in daily food intake of healthy people should be of the order of 27 to 40 g.
Dietary fibres can be classified in according to their properties, their chemical and physical structures, their digestibility during the gastrointestinal transit, or to their physiological properties during the gastrointestinal transit.
Chemically, dietary fibres are considered to comprise polysaccharides or lignin. These compounds are not hydrolysed by endogenous secretions during the gastrointestinal transit (T. Schweizer et al.; 1991
; Experimentia
, 44, p 182-186). The constituent polysaccharides of the dietary fibres may be plant membrane polysaccharides, in particular cellulose, hemicellulose or pectin, or other intracellular polysaccharides which are not hydrolysed by the digestive enzymes, such as resistant starch, galactomannans or inulin (Quemener et al., 1994
, Lebensm. Wiss. u. Technol
., 27, p 125-132).
Ordinarily, dietary fibres are classified into two categories depending on their biological and physicochemical properties. These categories are insoluble fibres and soluble fibres.
Insoluble fibres, such as cellulose, maize fibres or insoluble soy fibres, have essentially a mechanical role in the gastrointestinal tract. They are generally only very slightly fermented by the intestinal flora and contribute to reducing the duration of the intestinal transit (Scheppach et al., 1990
, JPEN
, 14, p 202-209).
Soluble fibres, such as pectin, inulin or resistant starch, are a very good fermentation substrate for the intestinal flora. The result of this fermentation is a release of fatty acids, in particular short-chain fatty acids in the colon. This has the effect of reducing the pH value in the colon. The result is a reduction in the growth and development of pathogenic bacteria in the colon.
In general, most humans in industrialised societies do not consume enough dietary fibre. However, in a clinical setting, the problem becomes acute. For example, the administration of an enteral composition free of dietary fibres often causes intestinal disorders such as diarrhea or constipation in patients (Palacio et al., 1990
; Nutrition in clinical practice
, 5, p 99-106,). Therefore it has been proposed to include dietary fibres in enteral compositions for clinical nutrition. For example, European patent application 0591267 describes a fibre system for enteral compositions comprising, by weight, 5-50% of gum arabic, 5-25% of sodium carboxymethylcellulose and 45-80% of oat envelope fibres. Further, European patent application 0756828 describes an enteral compositions which contains dietary fibres for maintaining good intestine function. This composition, which is in liquid form or in dried form, contains, per 2000 kcal, 15-50% of soluble dietary fibres, 15-45% of insoluble dietary fibres and 8-70% of oligosaccharides or of resistant starch.
However, most known enteral compositions do not contain a balance of soluble and insoluble dietary fibres. Further, those compositions which contain higher proportions of soluble fibres are often too viscous for tube feeding. Problems with stability also arise.
Accordingly this invention provides a fibre blend for an enteral composition, the fibre blend comprising pea inner fibres, pea outer envelope fibres, inulin, and fructo-oligosaccharides.
The fibre blend provides the enteral composition with good mechanical properties and good nutritional and biological properties. The mechanical properties include decreasing in the duration of gastrointestinal transit. The nutritional and biological properties include the release of short-chain fatty acids for maintaining bacterial balance in intestinal mucosa and to avoiding the growth and development of pathogenic bacteria. The fibre blend may act on the entire gastrointestinal system, at the level of the stomach, the small intestine and the colon. Further, a balance between soluble and insoluble fibres may be obtained without the enteral composition becoming too viscous.
The fibre blend may contain about 20 to about 50% by weight of pea inner fibres, about 20 to about 50% by weight of pea outer envelope fibres, about 5% to about 30% by weight of inulin, and about 10% to about 40% by weight of fructo-oligosaccharides.
The invention also provides an enteral composition which contains the fibre blend defined above. The enteral composition may also contain a protein source, a carbohydrate source, and a lipid source.
Preferably, the protein source provides about 10% to about 20% of energy, the lipid source provides about 30% to about 50% of energy, and the carbohydrate source provides about 35% to about 55% of energy.
In another aspect, this invention provides an enteral composition which comprises a protein source, a lipid source, a carbohydrate source, and a fibre blend comprising inulin and fructo-oligosaccharides and having 45 to 55% by weight of the blend of soluble fibre and 45 to 55% by weight of the blend of insoluble fibre.
In further aspect, this invention provides an enteral composition which comprises a protein source, a lipid source, a carbohydrate source, and a fibre blend comprising about 20% to about 40% by weight of inulin and about 60% to about 80% by weight of fructo-oligosaccharides.
The enteral composition may be in liquid form or in the form of a soluble powder which is reconstituteable in an aqueous liquid to provide a liquid nutritional composition. The enteral composition may also be in other enterally administrable forms such as desserts, cereals, snack bars, and the like.
Embodiments of the invention are now described, by way of example only.
In this specification, the term “soluble fibre” means those dietary fibres which are characterised as soluble using the method of Prosky et al; 1988
; J. Assoc. Off. Anal. Chem
, 70, 5, 1017. This is the official method of the Association of Official Analytical Chemists. The term “insoluble fibre” means those dietary fibres which are characterised as in soluble using the method of Prosky et al.
The invention provides a fibre blend which contains inulin and fructo-oligosaccharides. This blend has optimum bifidogenic effect and production of short chain fatty acids in the colon. The fibre blend may have roughly equivalent amounts of soluble fibre and insoluble fibre. The fibre blend may also contain pea inner fibres and pea outer envelope fibres.
Within the context of this specification the term “pea inner fibres” is taken to mean fibres from inside the pea outer envelope or testa. They comprise cellulose, hemicellulose and pectin; for example about 15% by weight of cellulose, about 45% by weight of hemicellulose and about 40% by weight of pectin. With this fibre distribution, about 66% by weight of the fibres are insoluble fibres. Therefore pea inner fibres contribute mechanically to gastrointestinal transit by reducing the transit time. Further, components of pea inner fibre are fermented by intestinal flora to release short-chain fatty acids. This release causes a reduction in pH in the colon and, as a result, a decrease in the growth and development of the pathogenic bacteria in the colon. Suitable pea inner fibres are commercially available.
The release of fatty acids is of great importance for patients being treated with antibiotics because, during antibiotic treatment, the integrity and function of the intestinal flora is compromised. A diet high in soluble fibres reduces these effects. Moreover, the release of short-chain fatty acids, such as butyrate, causes the absorption of water coupled with absorption of sodium ions in the colon. This has the effect of diarrhea. Also, butyrate is a hi
Brassart Dominique
Brun Thierry
Jaussan Veronique
Schweizer Thomas
Barts Samuel
Bell Boyd & Lloyd LLC
Henry Michael C.
Nestec S.A.
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