Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2000-02-28
2001-10-23
Witz, Jean C. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C424S757000, C426S002000, C426S656000, C514S002600
Reexamination Certificate
active
06306442
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to a pet food product and process for its use in improving clinical signs in animals suffering from renal disease.
Renal failure is one of the most common causes of death in dogs. In animals which suffer from renal disease, several blood indices are used to determine the severity of the disease. These indices include blood urea nitrogen (BUN) and creatinine. BUN and creatinine levels in the bloodstream increase during the course of renal failure because damage to the kidney of the animal makes the kidney inadequate to filter waste products. Because inadequate filtration of waste products is the fundamental basis of renal disease, BUN and creatinine are considered the primary indicators of renal disease.
Other clinical parameters which are important to the animal suffering from renal disease are phosphorus, carbon dioxide, and triglyceride levels. Hyperphosphatemia (abnormally high blood levels of phosphorus) often manifests itself during renal disease. Previous scientific research has indicated that lowering dietary intake of phosphorus is beneficial to lessening the progression of renal disease. However, prior commercial pet food formulations have been unable to provide low levels of dietary phosphorus and still meet all of the amino acid requirements of the canine because the phosphorus component of such diets is primarily derived from ingredients high in protein. Thus, lowering the phosphorus content of the diet required a lowering of the protein components in the diet to levels which are insufficient to supply the amino acid requirements of the animal.
Carbon dioxide levels are an indicator of the level of metabolic buffering (acid-base balance) that occurs in an animal. Metabolic acidosis becomes a problem for an animal suffering from renal disease, and high carbon dioxide levels are indicators of a lack of buffering. Another parameter which is important in animals suffering from renal disease is the blood triglyceride level. It is important in the animal suffering from renal disease as the triglyceride level is often greater than in normal animals. It would be desirable to be able to control these additional parameters in the renal patient through diet.
Current dietary therapies to reduce measured BUN, creatinine, and phosphorus levels include decreasing the amount of dietary protein to levels where amino acids are present in insufficient quantities. Decreasing the level of dietary protein decreases BUN since urea is ultimately derived from protein. However, such diets may result in other problems developing for the animal as the animal's protein needs are unmet. Accordingly, there remains a need in this art for a pet food dietary composition which will result in the lowering of BUN, creatinine, and phosphorus levels in the animal without lowering dietary protein to insufficient levels. There also remains a need in this art for a pet food dietary composition which provides improved metabolic buffering and which lowers triglyceride levels in the renal patient.
SUMMARY OF THE INVENTION
The present invention meets those needs by providing a pet food composition which improves several important clinical indicators in the renal patient and includes adequate protein, has low phosphorus levels, improves metabolic buffering, and lowers blood triglyceride levels in the animal. In accordance with one aspect of the invention, a process for improving clinical signs in an animal with renal disease is provided and includes the steps of feeding the animal a composition comprising from about 10 to about 32 wt % crude protein, from about 8 to about 20 wt % fat, from about 3 to about 25 wt % total dietary fiber, and fermentable fibers which have an organic matter disappearance of 15 to 60 percent when fermented by fecal bacteria for a 24 hour period, the fibers being present in amounts from about 1 to 11 weight percent of supplemental total dietary fiber. The animal is maintained on the diet for a sufficient period of time to reduce BUN and creatinine levels in the animal. Preferably, the composition contains from about 15 to about 25% crude protein, and most preferably, from about 17 to about 22% crude protein. Preferably the composition contains from about 10 to about 16% fat, and most preferably from about 13 to about 15% fat. Preferably the composition contains from about 5 to about 15% total dietary fiber, and most preferably from about 7 to about 12% total dietary fiber.
In a preferred embodiment of the invention, the composition contains from 2 to 9 weight percent of supplemental total dietary fiber of the fermentable fibers, more preferably from 3 to 7 weight percent, and most preferably from 4 to 7 weight percent of supplemental total dietary fiber of the fermentable fibers. It is preferred that the fermentable fibers have an organic matter disappearance of 20 to 50 percent, and more preferably 30 to 40 percent.
The fermentable fibers are selected from the group consisting of beet pulp, gum arabic, gum talha, psyllium, rice bran, carob bean gum, citrus pulp, pectin, fructooligosaccharides, mannanoligosaccharides and mixtures thereof. In a preferred embodiment, the fermentable fibers are selected from the group consisting of beet pulp, gum arabic, gum talha, citrus pulp, and fructooligosaccharides. Most preferably, the fermentable fibers are beet pulp or a blend of beet pulp, gum talha or gum arabic, and fructooligosaccharides.
Optionally, the composition may also have a phosphorus content of less than about 0.50%, and preferably less than about 0.25%, by weight to prevent hyperphosphatemia. The composition may also optionally contain potassium citrate as a metabolic buffering agent. Inclusion of potassium citrate has been found to ameliorate metabolic acidosis in animals with renal disease.
In another embodiment of the invention, a low-phosphorus pet food composition is provided and comprises from about 10 to about 32% crude protein, from about 8 to about 20% fat, and from about 3 to about 25% total dietary fiber, with the percentage of phosphorus being less than about 0.50%, and preferably less than about 0.25%, all percentages by weight. Preferably, the composition contains from about 15 to about 25% crude protein, and most preferably, from about 17 to about 22% crude protein. Preferably the composition contains from about 10 to about 16% fat, and most preferably from about 13 to about 15% fat. Preferably the composition contains from about 5 to about 15% total dietary fiber, and most preferably from about 7 to about 12% total dietary fiber. In order to maintain this low phosphorus content while still providing an adequate amount of amino acids, a combination of low phosphorus-containing protein sources are utilized. Preferred low phosphorus sources of protein for the composition include soy protein isolate and corn gluten meal. Optionally, the composition further includes L-lysine and L-tryptophan as amino acid supplements.
Preferred percentages (by weight) of the protein and amino acid components of the composition are: from about 5 to about 15% soy protein isolate, from about 0.5 to about 2.5% corn gluten meal, from about 0.01 to about 0.22% L-lysine, and from about 0.01 to about 0.22% L-tryptophan. A preferred weight ratio of soy protein isolate to corn gluten meal to L-tryptophan to L-lysine is 420:46.5:5:1.
In yet another embodiment of the invention, a process for lowering blood serum triglycerides in an animal with renal disease is provided and includes the steps of feeding the animal a diet comprising from about 10 to about 32% by weight crude protein, from about 8 to about 20% by weight fat, and fermentable fibers which have an organic matter disappearance of 15 to 60 percent when fermented by fecal bacteria for a 24 hour period, the fibers being present in amounts from about 1 to 11 weight percent of supplemental total dietary fiber, and in which the ratio of calories from protein in the diet to calories from fat in the diet is greater than about 0.40:1. Preferably, the composition contains from about 15 to abou
Reinhart Gregory A.
Sunvold Gregory D.
Tetrick Mark A.
Killworth, Gottman Hagan & Schaeff, L.L.P.
The Iams Company
Witz Jean C.
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