Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing
Reexamination Certificate
2001-03-29
2003-07-15
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Whole live micro-organism, cell, or virus containing
C426S072000, C426S583000, C426S590000, C426S648000, C426S656000, C426S658000
Reexamination Certificate
active
06592863
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a composition for a nutritional supplement; a method of production of the composition; use of the composition in the manufacture of a functional food or medicament for the nutrition, prevention or treatment of convalescing patients recovering from illness or surgery, those with limited appetite such as the elderly, or anorexic patients, or those who have impaired ability to digest other sources of protein such as persons having chronic gastritis who have a reduced gastric pepsin digestion; and a method of providing nutrition or treatment which comprises administering an effective amount of the composition.
Many people do not take in sufficient nutrients for a nutritionally complete diet. In order to assist these people, nutritional supplements have been developed. Nutritional supplements are usually not intended to provide all the nutrients necessary for a nutritionally complete diet; instead they are generally intended to supplement the diet such that it becomes more nutritionally complete. However, in some instances they may provide complete nutrition.
There are many targets for nutritional supplements; for example sick patients, convalescing patients, anorexic patients and the elderly. For sick and convalescing patients, the spontaneous intake of food is often lower than normal and insufficient to meet nutritional needs. Recovery and restoration of strength may therefore be impaired. A significant proportion of the elderly, on the other hand, tend to eat too little to meet all of their nutritional needs. This is usually due to reduced energy needs following reduction in body weight and diminished physical activity. Anorexic patients by definition suffer a loss of appetite and do not take in sufficient nutrients. In all cases, supplementation to provide missing nutrients can offer advantages.
Various nutritional supplements are available. A family of supplements commonly found in North America is sold under the name ENSURE by Ross Laboratories. The protein source used is predominantly caseinate and soy protein isolates. Another family which is commercially available is sold under the name RESOURCE by Novartis Nutrition Ltd. In this case, the protein source is based on caseinates. Another family which is commercially available is sold under the name NUBASICS by Nestlé Clinical Nutrition. In general, the protein source used in products of this family is caseinate. However, it is found that these products suffer from the problem that they do not necessarily result in a consumer receiving sufficient nutrients; either because an insufficient amount of the product is consumed or insufficient other foods are consumed. This is especially the case with convalescing patients, the elderly and other anorexic patients where loss of appetite leads to insufficient nutrients being consumed.
Nutritional supplements which are based on other protein sources, such as whey protein, are also available or have been described in the literature. In general, the nutritional supplements based upon whey protein are provided in the form of fruit juices; for example as described in European patent application 0486425 and U.S. Pat. No. 5,641,531. However, these products suffer from the problem that they generally do not provide a lipid source despite the fact that lipids are essential for adequate nutrition.
Therefore, a need exists for a nutritional supplement which contains protein, lipid and carbohydrate sources. In addition, a need exists for a composition that is capable of providing the special nutritional requirements of those with limited appetite such as the elderly or those who have impaired ability to digest other sources of protein such as persons having chronic gastritis who have a reduced gastric pepsin digestion.
SUMMARY OF THE INVENTION
Remarkably, a composition has now been found that addresses the problems set out above and enables such persons to retain or regain their strength.
In a first aspect the invention provides a composition for a nutritional supplement which comprises (i) a protein source which provides at least about 8%, total calories of the composition and which includes at least about 50% by weight of whey protein comprising a fraction of at least partially hydrolyzed whey protein; (ii) a lipid source having an omega 3:6 fatty acid ratio of about 5:1 to about 10:1 and which provides at least about 18% of the total calories of the composition; (iii) a carbohydrate source which provides the remaining calories of the composition; and (iv) a balanced macronutrient profile comprising at least vitamin E and vitamin C.
Within the context of this specification the word “comprises” is taken to mean “includes, among other things”. It is not intended to be construed as “consists of only”.
In a second aspect the invention provides a method of production of the composition which comprises blending the components in the required amounts.
In a third aspect the invention provides use of a composition according to an embodiment of the invention in the manufacture of a functional food or medicament for the nutrition, prevention or treatment of convalescing patients recovering from illness or surgery, those with limited appetite such as the elderly, or anorexic patients, or those who have impaired ability to digest other sources of protein such as persons having chronic gastritis who have a reduced gastric pepsin digestion.
In a fourth aspect the invention provides a method of nutrition, prevention or treatment of convalescing patients recovering from illness or surgery, those with limited appetite such as the elderly, children or anorexic patients, or those who have impaired ability to digest other sources of protein such as persons having chronic gastritis who have a reduced gastric pepsin digestion which comprises administering an effective amount of a composition according to an embodiment of the invention.
Surprisingly it has now been found that a composition for a nutritional supplement in accordance with the invention, because it contains whey protein, is easier to digest and less prone to induce satiety. Therefore the problem of a patient not consuming a sufficient amount of the supplement may be reduced. Similarly, the problem of a patient not consuming sufficient other foods may be reduced. Further, the composition has a well balanced lipid profile which provides a readily available energy source.
Preferably an embodiment of the composition includes whey protein as the primary source of protein (amino acids). The whey protein can be sweet whey or acid whey or a combination thereof. Preferably it is in the form of a whey protein partial hydrolysate produced by enzymatic treatment, preferably with trypsin, Alcalase or Novozyme, of whey protein and therefore is less viscous, lighter and provides the advantage that it is more easily digested than known compositions for fortified beverages and nutritional supplements.
It should be appreciated that the present invention is not limited to a whey protein hydrolysate. For example, a non-hydrolyzed whey protein can be used, preferably when the composition is made in a powder form.
The partial hydrolysis of whey protein with one or more of the above enzymes could be carried out at a pH ranging from about 6.6 to 8.8 (preferably about 8.5) and a temperature of about 40 to about 70° C. (preferably about 65° C.) at an enzyme concentration of about 0.5 to about 2.5 (preferably about 1.0) percent of the protein. Preferably, enzyme treatment is carried out for about 5 to about 120 minutes (preferably 15 minutes) to achieve adequate hydrolysis.
Preferably the whey protein hydrolysate represents a minimum of 50% of the protein content in the formulation. It is preferably the sole protein source but may be combined with intact whey protein or other protein or peptide sources including peptides naturally found in whey or milk such as caseino glycomacropeptide (CGMP). Surprisingly, it has been found that, despite the high proportion of partially hydrolyzed protein, in the composition it is phys
Anantharaman Helen Gillian
Fuchs Eileen C.
Garcia-Rodenas Clara L.
Guigoz Yves
Leathwood Peter
Belly, Boyd & Lloyd LLC
Nestec S.A.
Srivastava Kailash C.
Tate Christopher R.
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