Food or edible material: processes – compositions – and products – Products per se – or processes of preparing or treating... – Beverage or beverage concentrate
Reexamination Certificate
2002-03-26
2003-09-23
Paden, Carolyn (Department: 1761)
Food or edible material: processes, compositions, and products
Products per se, or processes of preparing or treating...
Beverage or beverage concentrate
C426S601000, C426S611000, C426S599000
Reexamination Certificate
active
06623780
ABSTRACT:
FIELD OF INVENTION
The present invention relates to a novel composition for delivery of sterols for use in food and dietary supplement applications.
BACKGROUND OF THE INVENTION
Coronary heart disease (CHD) is a common and serious form of cardiovascular disease that causes more deaths in the U.S. every year than any other disease. High serum cholesterol, and especially high levels of low density lipoprotein (LDL) cholesterol, are risk factors associated with CHD. Research has shown that consumption of plant sterols may lower total and LDL cholesterol and thereby reduce the risk of CHD.
One way that individuals can get more sterols into their diet is by consuming fortified or “functional” foods. A primary drawback to the use of plant sterols is their poor water solubility due to their hydrophobic nature. There have been numerous efforts to overcome this shortcoming such as esterifying sterols with fatty acids to render a product suitable for fat-based uses. The FDA has recently authorized labeling sterol fortified foods with a health claims about the role of plant sterol esters in reducing the risk of CHD. Producers may advertise that foods containing at least 0.65 g of plant sterol esters per serving, eaten twice a day with meals for a daily total intake of at least 1.3 g (or 1.7 g of stanol esters twice a day for a total of 3.4 g), as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. Because sterol esters are fat soluble hydrophobic ingredients they have been typically incorporated in fat based foods such as margarine, spread, salad dressing, and mayonnaise. While this approach is a technical solution to formulating the ingredient, it is contradictory and confusing to cholesterol-conscious consumers who are trying to reduce the amount of fat in their diets.
The incorporation of free sterols into aqueous systems has been a challenge due to the hydrophobic nature of free sterols. The literature describes various methods of incorporating sterols into water by either chemical modification or mixing with various emulsifiers. Numerous practitioners have proposed solutions for aqueous formulation, however, many of these solutions have inherent problems of their own including: the cost of chemical modification, the ineffectiveness of the products, the cost and/or food safety concerns of mixing through the use of organic solvents, poor stability, subsequent flocculation, and poor textural or flavor properties. The present invention is directed toward a novel formulation of plant sterols which provides for their use in aqueous systems and overcomes many of the problems with alternative aqueous formulations. The present invention does not require any solvents or drying steps, uses only readily available food materials, and uses methods and equipment common to the food and beverage application industry.
SUMMARY OF THE INVENTION
The present invention has the advantage of producing a sterol product which is easily dispersed into water, can be produced using traditional and inexpensive processing techniques, and uses readily available and inexpensive emulsifiers. The process does not involve the use of organic solvents or water and therefore does not involve expensive solvent removal or drying operations. In addition, in comparison to other products made using a solvent free process, the current invention provides a much lower particle size. This product is easier to disperse in aqueous systems, results in the sterols being more stable, and has minimal impact on the sensory characteristics of the end formulation. The specific emulsifiers and/or amounts of these emulsifiers used are less expensive, readily available, food compatible, and may be more effective than demonstrated in the prior art.
The present invention entails a composition comprising: a sterol, a monoglyceride, and a polysorbate wherein the sterol, monoglyceride, and polysorbate are present in a weight ratio of
i) one part sterol, to
ii) about 1.14 to about 1.5 parts monoglyceride, to
iii) about 0.04 to about 0.20 parts polysorbate;
and wherein upon distribution in water the composition yield particles, and wherein greater than 90% of the particles are smaller than one micron.
The present invention further describes a process of preparing an aqueous beverage comprising the steps of:
a) forming a homogeneous melt solution of sterols with a monoglyceride by heating to yield a mixture;
b) rapidly cooling the mixture such that no or minimal separation of the sterols from the emulsifier mix occurs to yield a powder;
c) mixing the powder with water or an aqueous food application;
d) Heating the water or aqueous food application to above the melting temperature of the mixture to yield an aqueous matrix; and
e) Mixing the aqueous matrix under high shear at a temperature above the melting point of the mixture.
DETAILED DESCRIPTION OF THE INVENTION
The term “sterol” as used herein means both specific sterols such as: sitosterol, campesterol, stigmasterol, brassicasterol, avenasterols, and diosgenin, or mixtures of specific sterols. The specific sterols or mixtures of sterols or sterol derivatives may be isolated from the following sources: oilseeds such as soybeans, canola seed, corn, sunflower, cottonseed, palm kernel, corn fiber, soy germ, sheanut, or peanut; tree sources such as tall oil, tall oil soap or tall oil pitch; other plant sources such as Mexican yam, olives, or sugar cane. Also included within the definition of sterols are hydrogenated forms of the above mentioned sterols (known in the art as stanols) including but not limited to sitostanol and campestanol. Further included within this definition are sterol ester derivatives such as: steryl or stanol fatty acid esters, ferulate esters, or succinate esters. Also included within this definition are sterol based pharmaceuticals and pharmaceutical intermediates such as estron, estrogen, progesterone, testosterol, androstenedione, androstene-diene-dione. Mixtures of all of various sterols are also within the scope of the current invention.
The term “monoglyceride” as used herein means single fatty acid esters of glycerol. The fatty acid portion of the monoglyceride may come from any source and be of varied length and degree of saturation. Common sources include natural oils such as soybean, canola, sunflower, palm, and the like. The fatty acid portion may often be a mixture of various lengths and degrees of saturation. The monoglyceride may unavoidably contain a fraction of diglycerides or triglycerides as impurities. Preferably the monoglyceride is distilled to lower the impurity level. Most preferred monoglycerides for the present invention are those having a melting point above 15° C. more preferably above 35° C. or above 50° C. Most preferably the monoglyceride is comprised of substantially fully saturated C18 fatty acids.
The term “polysorbate” as used herein means polyoxyethylene sorbitan esters. Polysorbates preferred in the present invention are polysorbate 60, polysorbate 65, and polysorbate 80. Most preferred is polysorbate 60 (polyoxyethylene(20)sorbitan monosterate).
The primary difficulty in formulating sterols is their high melting point. Commercially available food grade sterols typically have a melting point range of 120° C.-140° C. This makes their dispersion in water very difficult because the sterols cannot be dispersed in water as liquid sterols without resorting to high temperatures and associated high pressures. The result of mixing solid sterols with water is that the particle size of the sterols remains substantially the same as the particle size of the input sterols. Even finely ground sterols would have a particle size significantly greater than what is obtained by the present invention.
The current invention overcomes this problem by mixing the sterols with monoglycerides or other medium polarity emulsifiers. Monoglycerides are surprisingly effective at dissolving sterols at reasonable temperatures. A mixture of 1 part sterols and 1.25 parts monoglycerides which is melt mixed and spray prilled results in a powd
Schmelzer Wade Nolan
Stevens Luke Alan
Cargill Inc.
Paden Carolyn
Skelton Jeff
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