Food or edible material: processes – compositions – and products – Products per se – or processes of preparing or treating... – Fat or oil is basic ingredient other than butter in emulsion...
Reexamination Certificate
2000-04-06
2002-05-21
Paden, Carolyn (Department: 1761)
Food or edible material: processes, compositions, and products
Products per se, or processes of preparing or treating...
Fat or oil is basic ingredient other than butter in emulsion...
C426S602000, C514S170000, C514S182000, C514S559000, C552S544000, C552S546000, C552S547000
Reexamination Certificate
active
06391370
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to micromilling of free plant sterols and/or plant stanols in the presence of emulsifiers to provide oil or aqueous suspensions or dispersions which can be used directly in food compositions. Such oil or aqueous dispersions of plant sterols and/or plant stanols may be used as cholesterol-reducing agents to generate full fat, low-fat, fat-free, and triglyceride-free food products which deliver relatively high levels of the cholesterol-reducing agents.
BACKGROUND OF THE INVENTION
Cholesterol has been known for many years to be a component of atherosclerotic plaques. Mounting evidence indicates diets high in cholesterol may increase the levels of cholesterol in the blood which, in turn, increase the risk of atherosclerotic disease and its attendant manifestations of heart attack, stroke and other tissue injuries resulting from atherosclerosis. Cholesterol absorbed from dietary sources is thought to increase the risk of atherosclerotic disease.
Other than avoidance or reduced consumption of high cholesterol foods, measures available without prescription to the general public to reduce the absorption of cholesterol from the diet have met with little success. Furthermore, in many cases, high serum cholesterol cannot be reduced by lowering dietary cholesterol. However, high cholesterol levels in serum can be lowered effectively by altering the intestinal metabolism of lipids. In recent years, it has become known that certain plant sterols and plant stanols such as &bgr;-sitosterol (24-ethyl-5-cholestene-3&bgr;-ol) and its hydrogenated form (&bgr;-sitostanol (24-ethyl-5&agr;-cholestane-3&bgr;-ol) can help lower serum cholesterol by inhibiting cholesterol absorption in the digestive system. Plant stanols are the hydrogenated form of plant sterols. See, e.g., “Reduction of Serum Cholesterol With Sito Stanol-Ester Margarine in a Mildly Hypercholesterolemic Population”,
New England Journal of Medicine
, Nov. 16,1995, pp. 1308-1312; “Short- Term Administration of Tall Oil Phytosterols Improves Plasma Lipid Profiles in Subjects with Different Cholesterol Levels,”
Metabolism
, Vol.47, No. 6 (June), 1998, pp.751-756; and “Cholesterol-lowering Efficiency of a Sitostanol-containing Phytosterol Mixture with a Prudent Diet in Hyperlipidemic Men,”
Am. J. Clin. Nutr.
, 1999, 1144-50.
The use of plant sterols, which are natural components of vegetable fats and oils, in food products is considered safe. Plant sterols themselves are not absorbed—or only absorbed in very small amounts—from the intestines. A decreased incidence of coronary disease is clearly associated with a decrease in serum cholesterol and, in particular, a decrease in LDL cholesterol. A high serum cholesterol level is one of the most significant indicators of risk of coronary disease. There are a variety of naturally occurring plant sterols which have been reported to have a cholesterol-reducing effect, although not all have equivalent action.
Although the mechanism by which plant sterols achieve the effect of lowering serum cholesterol has not been fully elucidated and not wishing to be limited by theory, it is believed that plant sterols interfere with cholesterol absorption by competition-type mechanisms. Cholesterol absorption appears to take place primarily in the proximal third of the small intestine. Cholesterol esters must be converted to their free hydroxyl form by the action of cholesterol esterases before they can be absorbed. The free cholesterol requires bile salts for solubilization and absorption. Bile salts form an aqueous dispersion of micelles in which the cholesterol is solubilized along with phospholipids and hydrolysis products of other dietary lipids. Micelles transport the cholesterol across the hydrophilic barrier (the unstirred water layer) to reach the surface of the intestinal mucosa. At the mucosa, it is thought that the cholesterol dissociates from the micelle and is transported into the mucosa cells by a process which has not yet been fully defined but may include passive exchange diffusion or by protein-mediated transport. Plant sterols could interfere with cholesterol absorption by either of, or by both of, the following general mechanisms: (a) competition with cholesterol for absorption into the bile-salt micelles or (b) competition with the transport mechanism into the mucosa cells.
Conventionally, plant sterols have been incorporated into food products by melting a sterol or stanol, incorporating it into an oil phase, and blending the oil phase with other components to result in a plant sterol-containing food product. However, the plant sterols generally have high melting points (i.e., about 130-180° C.) which can result in significant crystallization of the plant sterols within the oil phase of such food products. Such crystallization results in food products with a gritty and unacceptable texture. This gritty texture is especially detectable when the oil/plant sterol phase is incorporated at high levels in the food product. The high melting points and hydrophobic nature of such plant sterols also makes it difficult to blend such plant sterols with an aqueous phase. Furthermore, actual melting of the plant sterol for incorporation into food products is energy intensive. Attempts have been made to solve these problems using, for example, chemical modification of the plant sterols. For example, esterification of plant sterols generally results in lowered melting temperatures. Thus, such plant sterol esters generally may be incorporated into food products more readily due to the lower melting points and can provide food products without significant gritty texture.
More recently, several different approaches have been used to incorporate plant sterols into food products. For example, copending U.S. Application Ser. No. 09/324,702 (filed Jun. 2, 1999) provides plant sterol and/or plant stanol complexes or blends which are generated by co-crystallization of the plant sterols or plant stanols with one or more emulsifiers. More specifically, the plant sterol-emulsifier complexes were prepared by mixing plant sterol and emulsifier in the ratio of about two parts plant sterol to about one part emulsifier to a ratio of about one part plant sterol to about two parts emulsifier, adding about 0 to about 80 percent of a triglyceride oil, heating the mixture until it melts, and co-crystallizing the melted mixture to form the plant sterol-emulsifier complex. Such plant sterol-emulsifier complexes have melting temperatures at least 30° C. below that of the plant sterol and can be incorporated into food products without the grittiness normally associated with plant sterols or plant stanols.
European Patent Application EP 0 896 671 A (published Feb. 24, 1999) provides an aqueous dispersion of phytosterols by melting the phytosterols and emulsifiers to form a molten mixture and then dispersing the molten mixture in water using high shear. It was reported “that the step of melting the high melting phytosterols with surfactant prior to dispersion in water with or without surfactant contributes importantly to the ability to prepare a very fine dispersion with the use of high shear mixing or homogenization of the phytosterol or other melting lipid.” The phytosterols are reported to have particle sizes of less than 15 microns and preferably less than 10 microns in aqueous dispersions. Such phytosterol dispersions could be incorporated into food products without the grittiness normally associated with phytosterols.
It would be desirable, therefore, to provide additional forms of plant sterols which can be incorporated into food products at relatively high levels without adversely affecting texture or other organoleptic properties. It would also be desirable to provide forms of plant sterols which can more easily be incorporated into food products. It would also be desirable to provide forms of plant sterols which can more easily be incorporated into food products without requiring significant modification of existing food production lines or methods. It would also be
Casanovas Johnny
DeWalt John A.
Gaonkar Anilkumar G.
Gwartney Elizabeth
Lis Daniel G.
Fitch Even Tabin & Flannery
Kraft Foods Inc.
Paden Carolyn
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