Food or edible material: processes – compositions – and products – Products per se – or processes of preparing or treating... – Beverage or beverage concentrate
Reexamination Certificate
2000-11-14
2003-06-10
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, C426S602000, C426S611000, C424S439000
Reexamination Certificate
active
06576285
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
A beverage or pre-beverage emulsion and method for producing the beverage or pre-beverage emulsion formulated with sterol or stanol esters.
2. Description of the Prior Art
Plant sterols or phytosterols and stanols are naturally occurring constituents of edible vegetable oils and as such are present in the human diet. The function of plant sterols and stanols in plants is similar to that of cholesterol in mammals; that is, the plant sterols and stanols are involved in membrane structure.
Beneficial effect of plant sterols in cholesterol-lowering was published as early as 1953 (Pollak, 1953). Numerous subsequent studies have confirmed the cholesterol-lowering effect. Moreover, the minimum required daily dosage for the desired result has since been determined.
In order to have a significant cholesterol-lowering effect, approximately one (1) gram per day of plant sterols should be consumed (Hendriks et al.,1999).
It is a well established demographic fact that coronary heart disease (CHD) is one of the major diseases for which the United States population is at significant risk. It is also widely recognized that serum cholesterol levels are linked to the risk of CHD in individuals. In an Interim Final Rule, 21 CFR Part 101, published on Sep. 8, 2000, the Food and Drug Administration (FDA) recognizes the cholesterol-lowering benefit of sterol/stanol esters, and allows certain health claims associated with the minimum dietary intake of sterol esters of 1.3 grams per day, taken twice per day at a level of 0.65 grams each time with meals or stanol esters of 3.4 grams per day, taken twice per day at a minimum level of 1.7 grams each time with meals.
It has been shown that the site of action for plant sterols and plant stanols is in the intestinal lumen where plant sterols/stanols, which closely resemble cholesterol in structure, act to interfere with the absorption of cholesterol across the intestinal mucosa. Specifically, the phytosterols block the absorption of cholesterol. Moreover, little of the plant sterol compounds are absorbed through the intestines, but are instead passed through the stool. Although people consume some plant sterols and stanols every day in their normal diet, most people do not consume enough sterols/stanols to achieve a significant cholesterol-lowering benefit.
It has been shown that plant sterols and stanols when ingested in the free or pure crystalline form have limited solubility in fats or water. Esterification of plant sterols and stanols with fatty acids produces a more fat soluble and useful form called sterol and stanol esters. Stanol esters are made by hydrogenating the sterol forms. These esterified forms of sterol/stanol are much more oil soluble and can more easily be included in fatty food applications. It has been claimed that phytosterols should be consumed in an emulsified and/or solubilized form to be effective when when delivered to the intestinal wall.
Applicant has found that with these esterified forms of phytosterols/stanols, a successful emulsion can be created, which can then be consumed in a typically low-fat beverage application, and yet would be delivering the phytosterols/stanols esterified into the preferred form.
U.S. Pat. Nos. 5,502,045 and 5,958,913 describe a process for making saturated &bgr;-sitostanol fatty acid esters for subsequent inclusion in the fatty portion of several foods that have a significant fat or oil content, such as rapeseed oil, other vegetable oils, mayonnaise, and margarine. However, the application possibilities for the saturated &bgr;-sitostanol esters in these patents focuses on those foods containing a significant fat percentage.
U.S. Pat. No. 5,892,068 relates to the production of discrete stanol/sterol esters using a food grade acid catalyst. This patent focuses on a synthetic route which can be transferred to large-scale production. The implication of this process is to provide tighter control over specific stanol/sterol esters including the specific fatty acid fractions they are joined to for a pharmaceutical application. The final dietary uses of the sterol/stanol esters through specific foods or beverages are not discussed.
U.S. Pat. No. 6,031,118 teaches a method for the production of hydrogenated stanol fatty acid esters and subsequent use in food products focusing on their use in foods with a significant fat content, with examples being 70% and 40% fat spreads, and high fat dressing. Once again, low fat beverages as a possible mode of dietary delivery of the sterol/stanol esters are not discussed.
U.S. Pat. No. 6,025,348 discloses fat compositions obtained by dissolving a phytosterol with polyhydric alcohol/fatty acid esters, each having a degree of esterification of 2 or higher, and containing at least one hydroxyl group remaining unesterified. The oil composition can then be used in foods with particular application in fat-processed foods. However, the phytosterol content in the example oils created is rather low due to the large amount of non-phytosterol oil used. The maximum amount of phytosterols present in all of the example oil mixtures is less than 5% phytosterol. This low level of phytosterol does not lend itself to low fat beverage delivery systems. Furthermore, the examples illustrate ingesting 10 grams of the mixtures as cooking oil, 10 grams of the oil mixtures as brioche (rolls), and 12 grams of the oil mixtures through french fries.
U.S. Pat. No. 6,113,972 shows to a phytosterol protein complex comprising phytosterols, an amount of protein (preferably defatted whole egg protein), and an amount of edible oil. The phytosterol constituent is esterified with triglycerides or other fatty acids. The complex includes other oils and a protein moiety to successfully emulsify a more pure form of the phytosterol. The dosage delivered is set at a minimum of 0.1 gram of phytosterol and more preferably 0.3 grams of phytosterol per serving of food product, which is well below the recommendation of the FDA. This phytosterol/oil/protein complex may be used in various foods. However, it is known that proteins of the type utilized are not soluble in acidified beverages and therefore limit the use to neutral pH beverages. This is because this type of protein coagulates in the lower pH range (below 4.5).
The emulsion system of Applicant's invention differs from U.S. Pat. No. 6,113,972 by using esterified phytosterols/stanols and not using a protein as a part of the emulsion matrix. Thus, the use is not restricted because of possible compatibility problems with the protein. This permits the use of the pre-beverage emulsion of Applicant's invention in all types of beverage pH ranges without special stabilization including the acid pH range lower than about 4.5, where almost all of the fruit flavored and juice containing beverages fall.
U.S. Pat. No. 6,087,353 relates to a process of condensing an aliphatic acid with one or more phytosterols to form a phytosterol ester and hydrogenating the phytosterol ester to form a hydrogenated phytosterol ester. The hydrogenated phytosterol esters may be used in a myriad of products including beverages by several possible delivery systems, including emulsions. The focus is specifically on delivering hydrogenated phytosterols because of the inherent improved stability to oxidation. However, it is not clear how an emulsion as a delivery vehicle would be constructed without examples of such. Further, no specific minimum dose of hydrogenated phytosterols is suggested.
SUMMARY OF THE INVENTION
The present invention relates to a beverage and pre-beverage emulsion comprising sterol/stanol esters for use in beverages. The invention also includes a method of producing the beverage or pre-beverage emulsion.
Currently no commercially available beverage has been enriched to provide an effective cholesterol-lowering beverage when regularly consumed. The present invention has been formulated to provide the minimum effective daily dose of sterol esters of 0.65 grams per serving twice daily for 1.3 grams per day or 1
Bader Primo
Fowler Stephen P.
Lijana Robert C.
Fisher III Arthur W.
Paden Carolyn
Sunpure Ltd.
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