Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form
Reexamination Certificate
1998-12-18
2001-04-03
Pak, John (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
C514S557000, C514S568000, C514S569000, C514S570000, C514S576000, C514S577000, C514S579000, C514S613000, C514S773000, C514S777000, C514S778000, C514S781000, C514S783000, C514S786000, C514S824000, C514S904000, C514S948000
Reexamination Certificate
active
06210686
ABSTRACT:
BACKGROUND OF THE INVENTION
Ischemic heart disease is a major health problem in the United States. One and half million new cases of heart disease are diagnosed annually; 700,000 of these are diagnosed at the occurrence of an acute myocardial infarction. Nine hundred thousand people die annually of heart disease (http://www.amhrt.org).
The relative risk of mortality from heart disease increases four-fold as the serum cholesterol concentration of the individual goes from 4.32 mmol/L (167 mg/dL) to ≧6.83 mmol/L (264 mg/dL). (Schaefer, E. J., et al., “Individual Variability in Lipoprotein Cholesterol Response to the National Cholesterol Education Program Step 2 Diet,”
Am J. Clin. Nutr.
65:823-830 (1997)). At least 25% of the U.S. population has serum cholesterol levels outside the desirable range. (Sempos, C., et al., “The prevalence of High Blood Cholesterol Levels Among Adults in the United States,”
JAAM,
262:45-52 (1988)). However, a 1% reduction in serum cholesterol concentrations could reduce heart disease by 2%. (Lipid Research Clinics Programs. The Lipid Research Clinics Coronary Primary Prevention Trial Results I: Reduction in Incidence of Coronary Heart Disease,
JAMA,
251:351-364 (1984); Lipid Research Clinics Programs. The Lipid Research Clinics Coronary Primary Prevention Trial Results II: The Relationship of Reduction in Incidence of Coronary Heart Disease to Cholesterol Lowering,
JAAM,
251:365-374 (1984).
It is known that changing the fat intake in the diet can significantly alter levels of cholesterol, LDLs and HDLs. The National Cholesterol Education Program (NCEP) limits intakes of total fat (<30% of total energy), saturated fat (<10% of total energy), and cholesterol (<300 mg) (Schaefer, E. J., et al., “Individual Variability in Lipoprotein Cholesterol Response to the National Cholesterol Education Program Step 2 Diet,”
Am J. Clin. Nutr.
65:823-830 (1997)). Patients can expect to experience a reduction in LDL-C (cholesterol in low density lipoproteins, or so-called “bad cholesterol”) of 16% to 19%; HDL-C (cholesterol in high density lipoproteins, or so-called “good cholesterol”) also declined, 11% for women and 17% for men.
The effects of some different types of soluble fibers on cholesterol levels have been tested. Oat &bgr;-glucan can be expected to reduce total serum cholesterol by 2% to 19%. Most studies reported a reduction in LDL-C by 5% to 10%. (Ripsin, C. M. et al., “Oat Products and Lipid Lowering,”
JAMA
267:3317-3325 (1992)). The HDL-C level did not change in this study. The FDA allows a claim to be made on 3 g of oat &bgr;-glucan (as three 0.75 g portions) for its cholesterol-lowering effect. Psyllium containing products are also allowed a claim for 1.7 g of soluble fiber portions on four eating occasions for a total of 7 g per day (Davidson, M. H. et al., Long-term Effects of Consuming Foods Containing Psyllium Seed Husk on Serum Lipids in Subjects with Hypercholesterolemia,”
Am. J. Clin. Nutr.
67:367-376 (1998)).
However, food products containing high amounts of fiber from such sources as oats and psyllium suffer from the disadvantage that large amounts must be eaten to achieve the cholesterol-lowering effect, adding unwanted extra caloric intake in the diet. These foods frequently suffer from low palatability and undesirable gastrointestinal effects. A more concentrated and palatable nutritional supplement could provide an alternative to ingestion of oats or psyllium, and to drug therapy for hypercholesterolemia.
SUMMARY OF THE INVENTION
Described herein are dietary supplements that comprise yeast fiber (also “yeast-derived fiber” herein; e.g., &bgr;-glucan or glucomannan), and further comprise folic acid or a salt thereof, vitamin B
6
, vitamin B
12
, and vitamin E. In one embodiment, the yeast fiber is obtained from
Saccharomyces cerevisiae,
but other yeast species can also be sources of the yeast fiber. The dietary supplements of the invention can further comprise fats, carbohydrates and proteins, for example, other vitamins and minerals, and other ingredients, including those added primarily for non-nutritive purposes to formulate a food product, in various amounts and combinations. The nutritional supplement can be formulated as a food to be ingested by itself, as a food additive to be added to or combined with another food or as a nutritional supplement in the form of a tablet or capsule. In a preferred embodiment, the dietary supplement can be provided as a beverage, a solid or semi-solid, and most preferably as an extruded bar.
One embodiment of the invention is a dietary supplement which supplies, in a recommended daily intake of the dietary supplement, nutrients comprising from about 1 gram to about 50 grams yeast-derived fiber, from about 1 &mgr;g to about 1,000 &mgr;g folic acid, from about 1 mg to about 100 mg vitamin B
6
, from about 1 &mgr;g to about 2,000 &mgr;g vitamin B
12
, and from about 10 I.U. to about 800 I.U. vitamin E. A preferred embodiment of the invention is a dietary supplement which supplies, in a recommended daily intake of the dietary supplement, nutrients comprising from about 5 grams to about 20 grams yeast-derived fiber, from about 180 &mgr;g to about 800 &mgr;g folic acid, from about 1.6 mg to about 4.6 mg vitamin B
6
, from about 1.5 &mgr;g to about 4.0 &mgr;g vitamin B
12
, and from about 135 I.U. to about 150 I.U. vitamin E. Further embodiments of the invention comprise, in addition to those ingredients as shown in Table 1, various amounts of carbohydrate, protein and fat, so that the weight percent of each component of the yeast fiber, carbohydrate, protein and fat can vary within a wide range. For example, a particular embodiment of the invention can comprise, in addition to those ingredients listed in Table 1, from about 0 grams to about 40 grams of protein per daily recommended intake of the supplement as in the third column of Table 1. Another embodiment of the invention can comprise, in addition to the ingredients in Table 1, from about 0 grams to about 60 grams of carbohydrate per daily recommended intake as in the third column of Table 1. A further embodiment can comprise, in addition to the ingredients in Table 1, from about 0 grams to about 50 grams of fat per daily recommended intake of the supplement as shown in Table 1.
The invention also pertains to a method for providing an individual with dietary supplementation that 1.) improves the serum lipid profile, 2.) lowers serum homocysteine, and 3.) provides an anti-oxidant to protect low density lipoproteins from oxidation, by administering to the individual a dietary supplement comprising yeast-derived fiber, folic acid, vitamin B
6
, vitamin B
12
, and vitamin E. The method can be carried out by administering to the individual any of the embodiments of the dietary supplements described herein, in effective doses and for sufficient treatment time.
The invention provides a dietary supplement which is effective in improving the serum lipid profile of an individual who consumes recommended amounts. Elevated levels of homocysteine in the blood are associated with increased risk of heart attack. By including folate and vitamin B
6
, the dietary supplement provides the additional benefit of suppressing the level of homocysteine in the blood. A third benefit is provided by the anti-oxidant properties of vitamin E, particularly the effect of preserving low density lipoproteins from oxidation. The dietary supplement thus provides three mechanisms for improving the cardiovascular health of an individual. The method for improving serum cholesterol, and thereby reducing the risk of cardiovascular disease, can be more appealing to the individual than presently available methods of lowering cholesterol, such as cholesterol-lowering pharmaceuticals or ingestion of large amounts of oat fiber or psyllium.
REFERENCES:
patent: 4810646 (1989-03-01), Jamas et al.
patent: 4962094 (1990-10-01), Jamas et al.
patent: 5811542 (1998-09-01), Jamas et al.
patent: 5817643 (1998-10-01), Jamas et al.
patent: 0 595 005 (1994-05-01), None
patent: WO 97/
Bell Stacey J.
Bistrian Bruce R.
Forse R. Armour
Beth Israel Deaconess Medical Center
Choi Frank
Hamilton Brook Smith & Reynolds P.C.
Pak John
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