Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2001-08-10
2004-09-07
Carlson, Karen Cochrane (Department: 1653)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
Reexamination Certificate
active
06787151
ABSTRACT:
BACKGROUND OF THE INVENTION
The following abbreviations are used in the course of the present application:
LDL
Low density lipoproteins
TC
Total cholesterol (including free cholesterol and
cholesteryl ester)
TG
Triglycerides
VLDL
Very low density lipoproteins
CHD
Coronary Heart Disease
MUFA
Mono-unsaturated fatty acid moieties
PUFA
Poly-unsaturated fatty acid moieties
Despite considerable research efforts over the years, coronary heart disease (CHD) remains a formidable threat to the health of people in many countries throughout the world. Among factors considered to be of predictive value concerning the risk of CHD, an important traditional one has been blood total cholesterol (TC) levels, while in recent years the relative amounts of HDL cholesterol and LDL cholesterol have been linked to risk of CHD. High ratios of HDL to LDL are now generally considered as an indicator of salutary cardiac status.
Phytosterols, i.e., plant sterols, are well documented to have a hypocholesterolemic effect. Phytosterols inhibit intestinal cholesterol absorption, thereby lowering blood total and low-density lipoprotein (LDL) cholesterol concentrations. In human studies, phytosterols have been shown to reduce blood cholesterol concentration by an average of 10%. Moghadasian M H, Frohlich J J, “Effects of dietary phytosterols on cholesterol metabolism and atherosclerosis: clinical and experimental evidence.” Am J Med 1999;107:588-594.
Soy protein is among a number of other food ingredients which have been well documented to have a hypocholesterolemic effect. Dietary intake of soy protein has been associated with reduced blood cholesterol concentrations and a lower incidence of coronary heart disease based on a number of the reports obtained from animal, (Potter S M. “Overview of proposed mechanisms for the hypocholesterolemic effect of soy.” J Nutr 1995;125:606S-611S), human (Cassidy A, Bingham S, Setchell K D. “Biological effects of a diet of soy protein rich in isoflavones on the menstrual cycle of premenopausal women,” Am J Clin Nutr 1994;60:333-340; Teixeira S R, Potter S M, Weigel R, Hannum S, Erdman J W J, Hasler C M. “Effects of feeding 4 levels of soy protein for 3 and 6 wk on blood lipids and apolipoproteins in moderately hypercholesterolemic men,” Am J Clin Nutr 2000;71:1077-1084,) and epidemiological (Hollman P C, Katan M B. “Dietary flavonoids: intake, health effects and bioavailability,” Food Chem Toxicol 1999;37:937-942) studies.
The mechanisms by which soy protein exerts its hypocholesterolemic effect may be different from that of phytosterols. It is generally assumed that the cholesterol lowering effects of soy protein are mediated through an increased plasma cholesterol clearance and/or an increased bile acid formation and excretion (Cassidy A, Bingham S, Setchell K D, “Biological effects of a diet of soy protein rich in isoflavones on the menstrual cycle of premenopausal women,” Am J Clin Nutr 1994;60:333-340; Lichtenstein A H. “Soy protein, isoflavones and cardiovascular disease risk,” J Nutr 1998;128:1589-1592; Baum J A, Teng H, Erdman J W J, et al. “Long-term intake of soy protein improves blood lipid profiles and increases mononuclear cell low-density-lipoprotein receptor messenger RNA in hypercholesterolemic, postmenopausal women,” Am J Clin Nutr 1998;68:545-551).
Although the cholesterol lowering effect of soy protein is well documented, the component(s) responsible for this effect in soy protein are still not identified. Soy protein is a rich source of isoflavones. While several studies appear to have demonstrated that the isoflavones in the soy protein may be the cause of the cholesterol lowering effect, (Merz-Demlow B E, Duncan A M, Wangen K E, et al. “Soy isoflavones improve plasma lipids in normocholesterolemic, premenopausal women,” Am J Clin Nutr 2000;71:1462-1469; Anthony M S, Clarkson T B, Williams J K, “Effects of soy isoflavones on atherosclerosis: potential mechanisms, Am J Clin Nutr 1998;68:1390S-1393S; Ni W, Yoshida S, Tsuda Y, Nagao K, Sato M, Imaizumi K., “Ethanol-extracted soy protein isolate results in elevation of serum cholesterol in exogenously hypercholesterolemic rats,” Lipids 1999;34:713-716; Crouse J R, Morgan T, Terry J G, Ellis J, Vitolins M, Burke G L, “A randomized trial comparing the effect of casein with that of soy protein containing varying amounts of isoflavones on plasma concentrations of lipids and lipoproteins,” Arch Intern Med 1999;159:2070-2076), other studies appear to have shown that the soy protein itself (including soy amino-acids or peptides) or the protein-associated substances other than isoflavones exhibited a cholesterol lowering activity (Greaves K A, Wilson M D, Rudel L L, Williams J K, Wagner J D. “Consumption of soy protein reduces cholesterol absorption compared to casein protein alone or supplemented with an isoflavone extract or conjugated equine estrogen in ovariectomized cynomolgus monkeys,” J Nutr 2000;130:820-826).
A hypotriglyceridemic effect of soy protein in human subjects was noted in a meta-analysis by Anderson J W, Johnstone B M, Cook-Newell M E in “Meta-analysis of the effects of soy protein intake on serum lipids,” N.Engl.J Med 1995;333:276-282.
Other ingestable materials which have been suggested in scientific literature or the press as causing improvement in cholesterol status or potential cholesterol improvement effects include: statins, niacin, inositol hexaniacinate, Vitamin E, tocotrienols, vitamin C, pantethine, quercetin, chromium, calcium, magnesium, L-carnitine, soy, chondroitin sulfate, lecithin, chitosan, royal jelly and copper. Despite the many agents which have been mentioned thus far in the scientific and popular literature as having potential cholesterol improving benefits in animals and humans, there is still a serious need for many individuals to improve further their cholesterol status, preferably without resorting to pharmaceuticals.
The problem of elevated cholesterol levels has received considerable attention in the patent literature, as well.
Potter et al., U.S. Pat. No. 5,855,892 discloses that daidzein and its metabolites, o-desmethylangolensin and dihydrodaidzein are useful for altering the concentration of cholesterol constituents in the blood of a human by increasing the concentration of high density lipoprotein cholesterol and decreasing the concentration of low density lipoprotein cholesterol. Potter et al. also report that vegetable protein materials, particularly soy protein materials, are known to reduce total cholesterol and LDL-cholesterol levels in the blood of animals.
Phytoestrogens in the soy protein are said to be recognized as a potentially significant factor in the hypocholesteremic effects of soy protein, and estrogen itself is said to be determined to be a significant cardio protective factor. In their background discussion, Potter et al. report that recent studies have determined that isoflavones lower blood concentrations of total cholesterol and LDL cholesterol in animals and thereby inhibit or slow the development of atherosclerosis, but that the effect of these isoflavones on blood cholesterol level in humans has been less clear.
The Potter et al. invention is directed to a method of altering the concentration of the cholesterol constituents in the blood of a human to reduce the risk of atheroschlerosis and vascular disease by administering a material containing daidzein to a human in an amount effective to increase the concentration of HDL cholesterol and to decrease the concentration of LDL cholesterol in the blood of a human. In one embodiment, daidzein is administered in a human in a soy protein material dietary supplement. Dietary supplements incorporating daidzein can be prepared by adding daidzein to a food which is said to include almost all foods, such as beverages, including nutritional beverages, frozen desserts such as ice cream, ice milk, low fat frozen desserts and non-dairy frozen desserts, soups, salad dressings and dips and spreads such as mayonnaise and chip dips. Acceptable and effective daily doses are said to be from about 10 to about 1
Franke William Conrad
Meijer Geert Willem
Reddy Podutoori Ravinder
Carlson Karen Cochrane
Lipton division of Conopco, Inc.
McGowan, Jr. Gerard J.
Snedden Sheridan
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