Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Cyclopentanohydrophenanthrene ring system doai
Reexamination Certificate
2001-05-16
2002-04-23
Clardy, S. Mark (Department: 1616)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Cyclopentanohydrophenanthrene ring system doai
C426S601000, C426S602000, C426S604000, C426S611000
Reexamination Certificate
active
06376482
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to low-fat, fat-free and triglyceride-free food products which incorporate plant sterols, plant stanols, plant sterol esters, and plant stanol esters as cholesterol-reducing agents in low-fat, fat-free and triglyceride-free foods. These cholesterol-reducing agents are incorporated into mouthfeel-enhancing, texture-building, emulsion-stabilizing and dispersion-stabilizing compositions which are mesophase-stabilized compositions for use in low-fat, fat-free and triglyceride-free food products.
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. 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. Plant stanols are the hydrogenated form of plant sterols. See, e.g., “Reduction of Serum Cholesterol With Sitostanol-ester Margarine in a Mildly Hypercholesterolemic Population”,
New England Journal of Medicine
, Nov. 16, 1995 pp. 1308-1312.
For purposes of this invention, “plant sterols” is intended to include both plant sterols and plant stanols; the term “sterols” alone is intended to include only the plant sterols; and the term “stanols” alone is intended to include only the plant stanols. Likewise, for purposes of this invention, “plant sterol esters” is intended to include both plant sterol esters and plant stanol esters; the term “sterol esters” alone is intended to include only the plant sterol esters; and the term “stanol esters” alone is intended to include only the plant stanol esters. For purposes of this disclosure, a “cholesterol-reducing-compound” is defined as either a plant sterol or a plant sterol ester as defined herein.
For purposes of this invention, “emulsifier mixture” is intended to include one of three different possible emulsifier mixtures: (1) a mixture of emulsifier A which has an HLB ranging from about 6 to about 9, emulsifier B which has an HLB ranging from about 2 to about 6, and emulsifier C which has an HLB ranging from about 9 to about 22; (2) a mixture of emulsifier A which has an HLB ranging from about 6 to about 9 and emulsifier C which has an HLB ranging from about 9 to about 22; and (3) a mixture of emulsifier B which has an HLB ranging from about 2 to about 6 and emulsifier C which has an HLB ranging from about 9 to about 22.
The use of plant sterols in food products is considered safe, since plant sterols are natural components of vegetable fats and oils. 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 value 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. The mechanism by which plant sterols achieve this effect has not been fully elucidated.
In recent years, many efforts have been made to reduce the fat content of various foods, such as salad dressing, sour cream and frozen desserts. When the fat level is reduced in conventional food products, however, the organoleptic properties are generally adversely affected because of the oiliness (lubricity) and slipperiness imparted by the fat particles suspended in the food product are effectively lost.
Other mouthfeel and textural properties such as richness and creaminess may also be adversely affected by removal or reduction of fat. Polysaccharide and protein ingredients commonly known as fat mimetics have been used to restore some of the textural properties contributed by emulsified fats and oils, such as viscosity and gel strength. They have been used less successfully to restore more subtle mouthfeel factors. In addition, many of these ingredients have negative impact on flavor, another key aspect of product quality. The FDA Standards of Identity recognize “reduced-fat” foods as foods that have 25% less fat than the market standard of a full-fat counterpart of that food type. “Light” products retain 50% less fat than the market standard of a full-fat serving of that food type. “Low-fat” foods are defined as having less than 3 grams of fat per serving, and “fat-free” foods have less than ½ gram fat per serving.
For purposes of this invention, the term “low-fat” includes “reduced-fat,” “light,” “low-fat,” and “fat-free” as defined by the FDA Standards of Identity. In addition, for purposes of this invention, “low-fat” also encompasses triglyceride-free products although they are not included in the FDA Standards of Identity. However, the term “fat-free” is intended to include only “fat-free” as defined by the FDA Standards of Identity. In addition, the terms “low-fat” and “fat-free” are intended to include low-fat and fat-free food products that do not fall into the categories defined by the FDA Standards of Identity (as of the time of this disclosure) but deliver to the consumer reduced levels of fat per serving. Furthermore, through the use of higher levels of plant sterol esters, even if no oil is added in a formulation of the described compositions, while such a composition may not be termed “fat-free”, the term “triglyceride-free” is an accurate description of such formulations utilized in this disclosure.
Low-fat and fat-free food products have been developed which duplicate the viscosity and other textural attributes of the missing fat by means of suitable food polymers, such as gums (xanthan or alginate), cellulose and its derivatives, starches and various microparticulated polymeric complexes. Unfortunately, such additives generally cannot provide the desired organoleptic characteristics normally associated with full-fat products, namely flavor, mouthfeel and thermal factors.
Many of these desired attributes associated with full-fat products are due to the presence of two distinct phases—an aqueous phase and an oil phase. The oil phase provides a reservoir of solvent for the flavor chemicals to dissolve in. By altering the proportions of the two phases, the partitioning of the flavor chemicals between the two phases is changed, affecting the character of the flavor and the way it is released in the mouth. In the extreme example of a fat-free product, the product consists of a single phase, and the flavor chemicals are dispersed in the aqueous phase. Free oil typically contributes to the mouthfeel of full-fat products. In the mouth, some free oil separates from the bulk of the product, coats the mouth, and provides oily lubricity. Fats and oils also contribute thermal sensations in the mouth. These effects can be either mouthwarming as a result of the coating of the free oil, or mouthcooling due to melting of any crystalline fat.
The cholesterol-reducing-compound-containing mesophase-stabilized compositions which are provided by the present disclosure significantly improve the quality of low-fat and fat-free food products by providing some of the aforementioned missing attributes. They do this by providing a separate pha
Akashe Ahmad
Miller Miranda
Clardy S. Mark
Kraft Foods Inc.
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