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
1999-10-04
2001-08-21
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...
C426S611000, C424S439000, C514S170000, C552S544000
Reexamination Certificate
active
06277431
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to an edible oil that is useful in improving blood lipid levels in a human patient, and to methods for making and using the oil.
BACKGROUND OF THE INVENTION
More than 750,000 people in the United States die from coronary heart disease and strokes every year. About 1.25 million people have heart attacks every year, half of which occur without warning. Coronary heart disease is the most frequent killer of men and women in the United States. Despite a century of drug development, ten times as many Americans die of heart attacks as at the turn of the century.
According to the American Heart Association, cholesterol levels are the major predictors of cardiovascular disease. Cholesterol, a soft, waxy substance found among the lipids in the blood stream, is an important part of a healthy body because it is used to form cell membranes, some hormones and other needed tissues. However, a high level of cholesterol in the blood (hypercholesterolemia) is a major risk factor for coronary heart disease, which leads to heart attack.
Cholesterol is insoluble in the blood, and must be transported to and from the cells by a special carrier of lipids and proteins called lipoproteins. There are several kinds of lipoproteins, the most important of which are low-density lipoprotein (LDL) and high-density lipoprotein (HDL).
Low-density lipoprotein is the major cholesterol carrier in the blood. Excess LDL cholesterol circulating in the blood can slowly build up within the walls of the arteries feeding the heart and brain. Together with other substances it can form plaque, a thick, hard deposit that can clog those arteries. This condition is known as atherosclerosis. The formation of a clot (or thrombus) in the region of this plaque can block the flow of blood to part of the heart muscle and cause a heart attack. If a clot blocks the flow of blood to part of the brain, the result is a stroke. A high level of LDL cholesterol reflects an increased risk of heart disease. Thus, LDL cholesterol is often called “bad cholesterol.”
High density lipoprotein (“HDL”) carries about one-third to one-fourth of blood cholesterol. It is believed that HDL carries cholesterol away from the arteries and back to the liver, from which it is ultimately passed from the body. Some experts believe HDL removes excess cholesterol from atherosclerotic plaques and thus slows their growth. HDL is known as “good cholesterol” because a high level of HDL seems to protect against heart attack. The opposite is also true: a low HDL level indicates a greater risk.
Cholesterol comes from two sources. It is produced in the body, mostly in the liver (about 1,000 milligrams a day), and is also found in foods that come from animals, such as meat, poultry, fish, seafood and dairy products. Foods from plants (fruits, vegetables, grains, nuts and seeds) do not contain cholesterol.
Saturated fatty acids are the chief culprit in raising blood cholesterol, which increases the risk of heart disease. But dietary cholesterol also plays a part. The average American man consumes about 360 milligrams of cholesterol a day; the average American woman, between 220 and 260 milligrams.
One hundred (100) million adults have blood cholesterol levels of 200 milligrams per deciliter (mg/dl) or higher, and nearly 40 million Americans have levels of 240 mg/dl or above. It is estimated that there are 53 million Americans with LDL levels that require treatment, but that less than one-third of those in need are receiving the necessary treatment. Furthermore, most patients who are treated fail to attain treatment goals. The yearly cost of treatment is estimated at more than $100 billion, yet coronary heart disease still remains the No. 1 killer of Americans.
Thus, the risk of having a heart attack or stroke is strongly predicted by the amounts of low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides in the blood.
Cholesterol and triglyceride levels can be reduced through medical intervention and/or dietary modification, such as reduction of the dietary intake of cholesterol and saturated fats. However, some dietary modifications have given rise to new problems. For example, in recent years the substitution of margarine for butter has been promoted. Butter is high in cholesterol and saturated fats. Stick margarine, on the other hand, has a semi-solid consistency based on their content of hydrogenated oils. The hydrogenation process, however, forms trans fats. Clinical studies have demonstrated that trans fats are atherogenic, causing two to three times the cardiovascular risk of the naturally saturated fats which give butter its stability. The health advantage of margarine over butter is now suspect in that margarine, particularly stick margarine, can contain 20% to 30% of trans fats. The American Heart Association now recommends soft margarine. Such margarine, so called trans-free margarine, which is formulated from either completely hydrogenated palm oil or palm oil fractions, has been introduced recently. This margarine, while free of trans fats, contain increased levels of saturated fats, the second most dangerous component of margarine.
Other compounds have been reported to reduce cholesterol levels in humans. For example, plant sterols, particularly beta-sitosterol, have been reported to have anticholesterolemic effects, and are believed to inhibit cholesterol absorption in the small intestine. Plant sterols are thought to displace cholesterol in bile salt micelles. Approximately half of the dietary cholesterol ingested is absorbed whereas less than 5% of beta-sitosterol is absorbed. When the plant sterols displace cholesterol of the bile salt micelles, the cholesterol is fecally excreted.
Plant sterols exist naturally in saturated and unsaturated forms, as free alcohols and as esters. The unsaturated forms dominate. It is known that natural sitosterols may be converted to sitostanols by hydrogenation, and it has been reported that stanols are more effective per unit weight than sterols in blocking cholesterol absorption and that stanols are not absorbed. Further, the amount of beta-sitosterol absorbed appears to be relatively constant even when doses administered vary by an order of magnitude. Both sterols and stanols have been used as relative markers of cholesterol absorption because of their unabsorbability. However, it seems clear that while sitostanol is completely unabsorbed, some sitosterol is.
Further, the addition of sitostanol to the diet reduces not only cholesterol absorption but also sitosterol and vitamin absorption. Some have characterized this as an advantage, but the fact that sitostanols block the normal absorption of micronutrients may be problematic.
The Lancet 1995; 345: 1529-1532, reported on the use of beta-sitosterol (20 milligrams per day) for the treatment of benign prostatic hyperplasia (BPH). This condition is a slow enlargement of the fibromuscular and epithelial structures within the prostate gland, eventually leading to obstructive urinary symptoms which are experienced to some extent by most men over the age of 50 years. Using sitostanols alone as an anti-cholesterolemic thus may increase the risk of BPH.
Other compounds that have been studied in connection with the treatment and prevention of diseases including arteriosclerosis and high cholesterol levels include tocotrienols, which are natural forms of vitamin E found in wheat germ, rice bran, oats and palm.
In vitro, the concentration-dependent impact of tocotrienols on cholesterol can be demonstrated to involve post-transcriptional down regulation of 3-hydoxy-3-methyl-glutaryl coenzyme A reductase (HMGCoA reductase) activity. This is the enzyme targeted by statins, the anti-cholesterolemic drug with annual sales of eight (8) billion dollars in the U.S. alone. Statins act directly, blocking HMGCoA reductase. However, statins also sometimes cause liver dysfunction.
Unfortunately, many patients taking statins or tocotrienols respond to the decreased rate of cholesterol synthesis by a compensatory incre
Berry Christopher J.
Bierenbaum Marvin L.
Berman, Esq. Rod S.
Jeffer Mangels Butler & Marmaro LLP
Paden Carolyn
Redeem, Inc.
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