Phytosterol and phytostanol compositions

Details Phytosterol and phytostanol compositions Phytosterol and phytostanol compositions

1999-11-24

2004-01-13

Clardy, S. Mark (Department: 1616)

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Cyclopentanohydrophenanthrene ring system doai

C424S439000, C424S489000, C424S499000, C426S590000, C426S654000, C426S656000, C426S657000, C426S662000, C514S002600, C514S169000, C514S170000, C514S171000, C514S773000, C514S775000, C514S785000, C514S786000, C514S788000, C514S975000

Reexamination Certificate

active

06677327

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to an edible phytosterol or phytostanol composition useful in the food industry and a method of preparing such an edible composition. The invention also relates to edible products containing such a composition and to methods for the production of the edible products.
2. Related Art
Phytosterols are plant sterols structurally similar to cholesterol that have been known for many years to reduce cholesterol absorption and serum cholesterol levels while not being absorbed themselves. Chemically, natural sterols are C
26
-C
30
steroid alcohols which have an aliphatic side chain at the C
17
position. The differences between a cholesterol molecule and a phytosterol molecule are primarily found in the structure of the side chain of the basic frame. Plant sterols may also be hydrogenated to produce plant stanols, i.e., phytostanols.
Since phytosterols are natural components of vegetable fats and oils which are non-toxic and inexpensive byproducts of food processing, they may be important in the treatment of individuals with mildly-increased serum cholesterol, or for the general population in food products or dietary supplements. However, the use of phytosterols has not been very extensive primarily due to their poor solubility; they are poorly soluble in fats and insoluble in water. Therefore, the production of edible products containing phytosterols is technically difficult, and the final products are often not organoleptically pleasing in structure and mouth-feel.
Several investigators have proposed ways to increase the solubility or bioavailability of phytosterols in order to make them more useful. For example, attempts have been made to increase the solubility of phytosterols by producing fat-soluble forms, such as fatty acid esters, by dissolving or emulsifying the phytosterols or their derivatives in a fat or fat component or by other esterification procedures. Methods of preparing fat-soluble phytosterol esters are disclosed, for example, in U.S. Pat. No. 5,502,045.
In addition, solubilized sterol compositions are disclosed, for example, in EP 839 458 and in U.S. Pat. No. 5,244,887. EP 839 458 describes oilsolubilized solutions consisting of sitosterol-containing phytosterols, vitamin E and emulsifiers which can be added to foods. U.S. Pat. No. 5,244,887 describes the use of stanols, phytosterol derivatives in which all carbon-carbon bonds in the rings are saturated, as food additives to reduce cholesterol absorption from foods and beverages which contain cholesterol. The disclosed method comprises the step of dissolving a stanol selected from the group consisting of clionastanol, 22,23 dihydrobrassicastanol, campestanol, sitostanol and mixtures thereof, with an edible solubilizing agent such as triglyceride, an effective amount of a suitable antioxidant such as tocopherol and an effective amount of a suitable dispersant such as lecithin.
Phytosterol compositions which do not contain triglycerides or oils have also been disclosed. International Publication No. WO 98/58554 describes a premix useful in the food industry, particularly in bakery products. The disclosed premix contains a pulverized plant sterol and/or stanol and a conventional foodstuff raw material that is selected from a group comprising cereal, leguminous plants, milk powder, fruits, vegetables and/or berries, fish, meat, bone, feather and rind, and has a mean particle size of less than about 600 &mgr;m.
U.S. Pat. No. 5,932,562 describes compositions and methods useful for reducing cholesterol absorption from the intestine. The disclosed phytosterol composition is in solid, but water soluble form, and comprises an aqueous homogeneous micellar mix of a plant sterol and lecithin which has been dried to a finely divided water soluble powder, wherein the mole ratio of said plant sterol to lecithin is within the range of 1:1 to 1:10.
Currently, physical mixtures of phytosterols and food products and/or ingredients do not produce a smooth product without chemical modification of the phytosterols. As such, there is a need in the art for edible products containing phytosterols and/or phytostanols which do not require the use of triglycerides or oils as a carrier, can be effectively incorporated into a variety of edible consumer products regardless of cholesterol or fat content and remain homogeneously dispersed, are convenient and cost-effective to produce, are stable in storage, and contain a smooth and pleasing mouthfeel.
SUMMARY OF THE INVENTION
It is therefore an object of the present invention to provide an edible phytosterol or phytostanol composition which can be utilized as such as a functional food or incorporated in aqueous or powder form into foods and beverages with improved stability and without chemical modification, and which imparts a smooth and pleasing mouthfeel. Other objects, features and advantages of the present invention will be set forth in the detailed description of preferred embodiments that follows, and in part will be apparent from the description or can be learned by practice of the invention. These objects and advantages of the invention will be realized and attained by the compositions and methods particularly pointed out in the written description and claims hereof.
These and other objects are accomplished by the compositions and methods of the present invention, which, in a first embodiment, are broadly directed to an aqueous edible composition comprising a phytosterol or phytostanol and an isolated water soluble protein, wherein the weight ratio of the protein to the phytosterol or phytostanol is from about 0.2:1 to about 10:1. Other aspects and embodiments of the present invention will be described in more detail below.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are intended to provide further explanation of the invention as claimed.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
In one aspect of the invention there is provided a non-soluble, water dispersible aqueous edible composition comprising a phytosterol and an isolated water soluble protein, wherein the weight ratio of the protein to the phytosterol or phytostanol is from about 0.2:1 to about 10:1.
As used herein, the term “phytosterol” includes all phytosterols, for example, sitosterol, campesterol, stigmasterol, taraxasterol, and any derivatives or reduction products of the foregoing. The term “phytostanol” as used herein means a hydrogenated form of a phytosterol. Hence, it will be appreciated that hydrogenation modifications, as well as modifications of phytosterol compounds to include, for example, small side chains, are also well within the scope of the present invention.
Any phytosterol or phytostanol which can be incorporated into an edible aqueous mixture and imparts a smooth and pleasing mouth-feel can be utilized in the present invention. In a preferred embodiment, the phytosterol or phytostanol is selected from the group consisting of sitosterol, sitostanol, campesterol, campestanol, taraxasterol, stigmasterol, clionastanol, brassicastanol and brassicasterol, or mixtures thereof. Commercially available phytosterols are often mixtures of phytosterols that are also appropriate for use according to the present invention.
The phytosterols which are used in the present invention can be procured from a variety of natural sources. Phytosterols can be obtained from vegetable oils, vegetable oil sludge, vegetable oil distillates, and other plant oil sources such as tall oils by relatively simple and inexpensive means. For example, a preparation of sterols from vegetable oil sludge by using solvents such as methanol is taught in U.S. Pat. No. 4,420,427. Further, sitosterol can be obtained from cold pressed wheat germ oil, soy extract, or rice extract. (It will be appreciated that natural sitosterol contains about 40% alpha-sitosterol and about 60% beta-sitosterol. Both the alpha and beta forms of sitosterol can be used to form the edible

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