Triglyceride reducing agent

Details Triglyceride reducing agent Triglyceride reducing agent

2001-11-29

2003-07-29

Page, Thurman K. (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Food or edible as carrier for pharmaceutical

C424S400000, C424S451000, C424S456000, C424S464000, C424S465000, C424S489000

Reexamination Certificate

active

06599522

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to triglyceride reducing agents for use in the human body, and, more particularly, a flavour compound for prevention and treatment of hyperlipidemia (hypertriglyceridemia).
2. Description of Related Art
The consumption of foods with high content of fat and sugar is on the rise. This leads to an increasing number of cases suffering from hyperlipidemia, a major pathologic metabolic change accompanying several disorders such as obesity, diabetes, and cardiac disturbances. Particularly, it affects children of the growing age. A dietary formulation or dietary supplement or a specific hypolipidemic agent which is easy to use, with no side effects and absolutely non-toxic over a wide range would be the ideal goal.
Recent scientific reports indicate that in some of the pungent spices the main active components possess the desirable hypolipidemic and/or hypocholesterolimic activities. Many of these spices find wide use as medicinal components in the native countries. India is foremost among the countries which consume spices, particularly of the hot, pungent type. Some, such as pepper, ginger, and turmeric are native to the country. Chillies or capsicums have been imported from Mexico, but adopted into its dietaries and has become native to India.
Extensive nutritional studies have indicated that the pungent spices as well as the milder turmeric and their principal active constituents have no adverse toxic effects as judged by the effects on growth, internal organs, nitrogen balance and blood chemistry. Some of these spices seem to have special nutritional virtues like beneficial effects of reducing the cholesterol and lipid levels in the blood and some of the special internal organs such as the liver, the kidney, and the heart. They are now slowly getting adopted into special therapeutic preparations or nutritional formulae for the treatment of diseases which seem to originate from specific disturbances in lipid metabolisms, such as diabetes, cardiovascular diseases and obesity. Adequate intakes of some of these spices in normal human dietaries may also provide good protection against these types of diseases.
The main pharmacological property of turmeric, which it owes to curcumin, is hypocholesterolemia, which involves the stimulation and formation of bile. Curcumin, through this function of excreting bile, helps prevent the formation of bilestones. More recently, the anti-carcinogenic activity of curcumin has been demonstrated in several experimental and clinical studies. For this purpose, a specially concentrated combination of the three active curcumins has been developed. Clinical studies are in progress at several research centers. There has also been a revival of interest in the antioxidant and anti-inflammatory properties of the active component of turmeric.
Extensive nutritional studies on capsaicin have exhibited the hypolipidemic property of the spice component, alone, or with other spice combination, on the lipid metabolism at different dietary levels of the spice. These studies serve to firmly establish it's fat mobilizing (lipotropic) action on the liver and also stimulation of fat utilization in peripheral tissues through activation of lipoprotein lipase. Also, in some of the studies on liver lipid mobilization, simultaneous mobilization of cholesterol was noticed somewhat similar to the reported activity of turmeric, curcumin, and ginger.
Nutritional evaluation of whole chilli and extracts (capsaicinoids) at low to maximum use levels and even five to ten times the maximum did not adversely affect the growth, nitrogen metabolism, lipid or amino acid absorption. On the contrary, some beneficial effects on lipid metabolism with high fat or high carbohydrate food intake were shown at the higher levels. Hypocholesterolimic effect with a high fat diet, significant in lowering of liver and serum triglycerides and serum lipoprotein triglycerides, has been observed.
Toxicological tests with chillies, chilli extracts and capsaicin and dihdrocapsaicin have established that they are non-mutagenic and non-carcinogenic. Examination of the tissues of the experimental animals fed fairly high levels of the spices have also demonstrated that they are non-carcinogenic.
One of the main physiological responses to capsaicin, even at extremely low doses, is pain production through interaction with nociceptive neurons which give rise to heat production. This involves specifically the capsaicin receptor recently identified as a heat activated ion channel in the pain pathway. Capsaicin and similar molecules have been employed for the relief of pain through heat generation. The thermogenic reaction of capsaicin requires the acid-amide group to be incorporated into the basic vanillin structure which does not have any such heat generating property.
In the first paper published by the inventor on red pepper and capsaicin in 1978, it is suggested that the hypocholesterolimic and hypolipidemic activity which is exhibited by turmeric and curcumin, and also ginger (gingerol), known as the vanilloid spices, implicate the vanillyl moiety as the most probable active component which all these structures seem to share. In other investigations on dihydro-capsaicin, vanillin and vanillin derivative were detected in the urine of the experimental rats, which led to the first experiment on the influence of vanillin on the liver and blood lipids in rats. This comparative study(0.15 mg % vanillin and 0.3 mg % capsaicin) showed a 24% and 13% reduction in serum triglycerides, respectively. These experimental findings, along with all the other experimental data reported on capsaicin and its metabolic effect, stimulated interest in pursuing the hypolipidemic studies on vanillin with planned clinical investigations for determining its therapeutic efficacy as a hypolipidemic agent in diabetes, obesity, and atherosclerotic conditions.
U.S. Pat. No. 5,674,498, issued Oct. 7, 1997, to Inoue et al. describes a blood lipid depressant with an extract from the senna species and vanilla (see Example 11 in column 7).
U.S. Pat. No. 5,034,215, issued on Jul. 23, 1991, to Santa-Coloma Roth describes a nail conditioning composition with vanilla extract.
U.S. Pat. No. 4,287,368, issued on Sep. 1, 1981, to Johnson et al. describes a method for preparing vanillin.
Chinese Patent document 1167581, published Dec. 17, 1997, to Zhang describes a beverage composition comprising sugar, maltose, corn flour, rice flour, starch, table salt, de-fatted milk powder, vanillin, biologic calcium carbonate, high-quality oats flour, and highland barley flour. The Ahang beverage serves to make bones stronger, decrease blood fat and cholesterol, and nourishes the blood.
None of the above inventions and patents, taken either singly or in combination, is seen to describe the instant invention as claimed.
SUMMARY OF THE INVENTION
The present invention provides for vanillin, extracted naturally from vanilla pods, or derived from synthetic derivatives, mixed with other food additives and nutritional and processing agents as a fat reducing agent. This material is then processed into readily usable additive agents or used in the production of food. The vanillin helps reduce the blood fat levels in adults or children. The use of the vanillin additives in fat or sugar rich, foods promotes the utilization of lipids and prevents their diversion into irregular metabolic routes, resulting in pathological toxins, such as cholesterol.
Accordingly, it is a principal object of the invention to provide food additives to affect the reversal of hyperglyceridemia in humans to normal with consequent relief of pathologic clinical symptoms.
It is another object of the invention to provide a combination of effective treatment procedures as above for adoption as needed.
It is a further object of the invention to use the above-mentioned additives and treatment procedures for growing children, and adults having a tendency to adiposity, by adding adequate quantities to milk and manufactured mil

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