Abstract:
A method of lowering blood cholesterol in a non-diabetic patient by at least 30% is described. The method involves orally administering for 30 consecutive days a fenugreek seed extract composition. Various methods of preparation and various formulations are described. Physiologically effective pharmaceutical compositions and beverages containing fenugreek seed extracts and other active components are also disclosed.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims benefit under 35 U.S.C. §119(e) of U.S. provisional patent application No. 60/535,731, filed Jan. 10, 2004, the disclosure of which is herein incorporated by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention is directed to relatively stable, convenient and patient-friendly compositions of fenugreek seed extract, including pharmaceutically acceptable compositions thereof. The invention further provides a method for preparing such compositions. The compositions of this invention are advantageously used in methods for treating a non-diabetic individual having a disorder associated with high cholesterol. Specifically, the present invention includes employing fenugreek seed extract, or compositions or formulations comprising them, to lower cholesterol in a non-diabetic to a greater degree compared to conventional preparations. Fenugreek seed extracts, or compositions or formulations comprising them, have several advantages, including: the capability of daily oral dosing, ease of use in suspension form, safety, efficacy, purity, relative stability, and resuspendability over a short period of time. 
     The invention relates to an extraction process that uses fenugreek, fenugreek extracts or grinds (herein referred to as “juice” or “extract”). The instant compositions also encompass carbonated or non-carbonated beverages and formulations containing the aforementioned fenugreek extract which may further contain minerals, vitamins, nutrients, standard excipients, carriers, physiologically active agents, etc. The formulation may be in a ready-to-drink form in a container, a concentrate, or as a powder mix to be reconstituted with water or other ingestible liquids. Moreover, it may be compounded in the form of a pill, capsule, granules, microparticles, nanoparticles or liposomes. 
     The instant inventors have discovered that treating non-diabetic patients suffering from high cholesterol levels with the above-mentioned composition(s) significantly lowers the patient&#39;s cholesterol levels. While it may be anticipated that any soluble fiber may achieve a decrease in the blood cholesterol level (U.S. Pat. Nos. 4,834,990, 5,009,819, 5,558,897 and 5,851,578, incorporated herein by reference), the instant process yields the following unexpected result. While the prior art generally discloses a reduction of several points using “juices” such as those of fenugreek often in the range of 5-15 points (which is in the general range of 2-10%), the inventors compositions(s) derived via the specific extraction process yields invariably reductions in the range of 30% or higher (Table 1). For instance, consuming little amounts of fenugreek “juice” over thirty days of consecutive usage provides dramatic results enumerated herein. This data is unprecedented in the literature. In fact, such a result is neither disclosed in the prior art nor would it be obvious to one of ordinary skill in the art. 
     As stated above, the present invention also provides a ready-to-drink beverage or a concentrate in a solid (e.g., powder mix) or a liquid form for reconstitution into a beverage. Furthermore, such beverages may be supplemented with soluble minerals (e.g., calcium), vitamins, soluble fibers, flavors, colors, adjuvants, taste-masking agents, conventional solvents and carriers. 
     Commercially marketed fiber-containing products are not often well received by patients with respect to taste and appearance of the final product at the time of consumption. The present invention alleviates these problems. 
     The present invention also has the advantage of simplicity of extraction. The present inventors have discovered that simply boiling fenugreek seeds in water results in an extraction (the “juice” or “extract”) that can be directly employed in the claimed compositions to lower cholesterol to the specified degree. 
     Furthermore, the instant inventors have also noted the following benefits of using fenugreek “juice” (without any observed side effects):
     1) alleviation of a woman&#39;s birth pains;   2) aiding women suffering from a lack of estrogen;   3) regulating menstrual period;   4) assisting in milk production in nursing women;   5) treating rheumatism;   6) treating cough and sore throat pain; and   7) acting as a sexual stimulant in women.   

     
       
         
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 1 
               
               
                   
               
               
                   
                   
                   
                   
                 Cholesterol 
                   
                 Cholesterol 
                   
                 Cholesterol 
                   
               
               
                   
                   
                   
                   
                 levels 
                   
                 levels 
                   
                 levels 
               
               
                   
                   
                   
                 Cholesterol 
                 following 
                   
                 following three 
                   
                 following 
               
               
                   
                   
                   
                 levels prior 
                 one month 
                   
                 months of 
                   
                 one year of 
               
               
                   
                   
                   
                 to fenugreek 
                 of fenugreek 
                   
                 fenugreek 
                   
                 fenugreek 
               
               
                   
                   
                   
                 treatment 
                 treatment 
                 % 
                 treatment 
                 % 
                 treatment 
                 % 
               
               
                 Case # 
                 Age 
                 Sex 
                 (mg/100 ml) 
                 (mg/100 ml) 
                 Decrease 
                 (mg/100 ml) 
                 Decrease 
                 (mg/100 ml) 
                 Decrease 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 1 
                 33 
                 M 
                 320 
                 280 
                 12.5 
                 240 
                 25 
                 190 
                 40.6 
               
               
                 2 
                 41 
                 M 
                 280 
                 220 
                 21.4 
                 180 
                 35.7 
                 150 
                 46.4 
               
               
                 3 
                 48 
                 M 
                 330 
                 280 
                 15 
                 240 
                 27 
                 180 
                 45.5 
               
               
                 4 
                 57 
                 M 
                 285 
                 255 
                 10.5 
                 215 
                 24.6 
                 205 
                 28.1 
               
               
                 5 
                 52 
                 M 
                 337 
                 245 
                 27.3 
                 200 
                 40.7 
                 165 
                 51 
               
               
                 6 
                 44 
                 M 
                 295 
                 265 
                 10.2 
                 215 
                 27.1 
                 198 
                 33 
               
               
                 7 
                 48 
                 M 
                 305 
                 285 
                 7 
                 255 
                 16.4 
                 204 
                 33.1 
               
               
                 8 
                 39 
                 M 
                 440 
                 380 
                 13.6 
                 285 
                 35.2 
                 205 
                 53.4 
               
               
                 9 
                 65 
                 M 
                 276 
                 245 
                 11.2 
                 205 
                 25.7 
                 155 
                 43.8 
               
               
                 10 
                 58 
                 M 
                 288 
                 238 
                 17.4 
                 220 
                 23.6 
                 210 
                 27.1 
               
               
                 11 
                 48 
                 M 
                 305 
                 245 
                 19.7 
                 185 
                 39.3 
                 175 
                 42.6 
               
               
                 12 
                 47 
                 M 
                 265 
                 245 
                 7.5 
                 235 
                 11.3 
                 215 
                 18.9 
               
               
                 13 
                 55 
                 M 
                 276 
                 266 
                 3.6 
                 260 
                 5.8 
                 235 
                 14.9 
               
               
                 14 
                 62 
                 M 
                 457 
                 352 
                 23 
                 320 
                 30 
                 265 
                 42 
               
               
                 15 
                 27 
                 M 
                 305 
                 265 
                 13.1 
                 255 
                 16.4 
                 210 
                 31.1 
               
               
                 16 
                 55 
                 M 
                 330 
                 290 
                 12.1 
                 260 
                 21.1 
                 199 
                 39.7 
               
               
                 17 
                 25 
                 M 
                 345 
                 245 
                 29 
                 235 
                 32 
                 225 
                 35 
               
               
                 18 
                 36 
                 M 
                 294 
                 230 
                 22 
                 210 
                 29 
                 189 
                 36 
               
               
                 19 
                 47 
                 M 
                 282 
                 252 
                 11 
                 222 
                 21.3 
                 185 
                 34.4 
               
               
                 20 
                 32 
                 M 
                 288 
                 232 
                 19.4 
                 210 
                 27.1 
                 155 
                 46.2 
               
               
                 21 
                 53 
                 M 
                 270 
                 235 
                 13 
                 215 
                 20.4 
                 195 
                 28 
               
               
                 22 
                 60 
                 M 
                 284 
                 235 
                 17.3 
                 185 
                 35 
                 175 
                 38.4 
               
               
                 23 
                 61 
                 M 
                 295 
                 245 
                 17 
                 215 
                 27.1 
                 200 
                 32.2 
               
               
                 24 
                 33 
                 M 
                 340 
                 240 
                 29.4 
                 200 
                 41.2 
                 192 
                 44 
               
               
                 25 
                 22 
                 M 
                 290 
                 210 
                 27.6 
                 190 
                 34.5 
                 182 
                 37.2 
               
               
                 26 
                 42 
                 M 
                 287 
                 255 
                 11.1 
                 220 
                 23.3 
                 185 
                 35.5 
               
               
                 27 
                 60 
                 M 
                 290 
                 265 
                 8.6 
                 240 
                 17.2 
                 185 
                 36.2 
               
               
                 28 
                 58 
                 M 
                 280 
                 270 
                 3.6 
                 230 
                 17.9 
                 220 
                 21.4 
               
               
                 29 
                 40 
                 M 
                 275 
                 245 
                 10.9 
                 220 
                 20 
                 185 
                 32.7 
               
               
                 30 
                 32 
                 M 
                 455 
                 380 
                 16.5 
                 290 
                 36.3 
                 220 
                 51.6 
               
               
                 31 
                 45 
                 M 
                 295 
                 220 
                 25.4 
                 190 
                 35.6 
                 170 
                 42.4 
               
               
                 32 
                 43 
                 M 
                 270 
                 245 
                 9.3 
                 210 
                 22.2 
                 200 
                 26 
               
               
                 33 
                 24 
                 M 
                 290 
                 265 
                 8.6 
                 210 
                 27.6 
                 195 
                 32.8 
               
               
                 34 
                 47 
                 M 
                 290 
                 245 
                 15.5 
                 205 
                 29.3 
                 175 
                 39.7 
               
               
                 35 
                 45 
                 M 
                 297 
                 265 
                 10.8 
                 220 
                 26 
                 200 
                 32.7 
               
               
                 36 
                 51 
                 M 
                 330 
                 285 
                 13.6 
                 245 
                 25.8 
                 199 
                 40 
               
               
                 37 
                 47 
                 M 
                 280 
                 210 
                 25 
                 200 
                 28.6 
                 185 
                 40 
               
               
                 38 
                 78 
                 M 
                 295 
                 235 
                 20.3 
                 215 
                 27.1 
                 193 
                 34.6 
               
               
                 39 
                 41 
                 M 
                 260 
                 210 
                 19.2 
                 200 
                 23.1 
                 185 
                 29 
               
               
                 40 
                 29 
                 M 
                 299 
                 236 
                 21.1 
                 205 
                 31.5 
                 198 
                 33.8 
               
               
                 41 
                 16 
                 M 
                 335 
                 285 
                 19.8 
                 220 
                 38 
                 195 
                 45.1 
               
               
                 42 
                 46 
                 M 
                 298 
                 256 
                 14.1 
                 225 
                 24.5 
                 205 
                 31.2 
               
               
                 43 
                 24 
                 M 
                 270 
                 225 
                 16.7 
                 205 
                 24 
                 200 
                 26 
               
               
                 44 
                 45 
                 M 
                 260 
                 215 
                 17.3 
                 195 
                 25 
                 180 
                 30.8 
               
               
                 45 
                 41 
                 M 
                 250 
                 210 
                 16 
                 200 
                 20 
                 190 
                 24 
               
               
                 46 
                 55 
                 M 
                 270 
                 245 
                 9.3 
                 215 
                 20.4 
                 195 
                 27.8 
               
               
                 47 
                 28 
                 M 
                 280 
                 250 
                 10.7 
                 210 
                 25 
                 200 
                 28.6 
               
               
                 48 
                 22 
                 M 
                 310 
                 290 
                 6.5 
                 245 
                 20.9 
                 198 
                 36.1 
               
               
                 49 
                 35 
                 M 
                 295 
                 290 
                 0 
                 310 
                 0 
                 295 
                 0 
               
               
                 50 
                 48 
                 M 
                 345 
                 355 
                 0 
                 340 
                 0 
                 348 
                 0 
               
               
                 51 
                 55 
                 M 
                 295 
                 298 
                 0 
                 290 
                 0 
                 310 
                 0 
               
               
                 52 
                 45 
                 M 
                 280 
                 280 
                 0 
                 275 
                 0 
                 285 
                 0 
               
               
                 53 
                 38 
                 F 
                 390 
                 320 
                 18 
                 260 
                 33.3 
                 230 
                 41 
               
               
                 54 
                 41 
                 F 
                 355 
                 280 
                 21.1 
                 220 
                 38 
                 185 
                 47.9 
               
               
                 55 
                 42 
                 F 
                 450 
                 350 
                 22.2 
                 320 
                 28.9 
                 230 
                 48.9 
               
               
                 56 
                 47 
                 F 
                 290 
                 270 
                 6.9 
                 220 
                 24.1 
                 175 
                 39.7 
               
               
                 57 
                 55 
                 F 
                 425 
                 375 
                 11.8 
                 325 
                 23.5 
                 240 
                 43.5 
               
               
                 58 
                 45 
                 F 
                 335 
                 285 
                 14.9 
                 265 
                 20.9 
                 185 
                 44.8 
               
               
                 59 
                 43 
                 F 
                 296 
                 221 
                 25.3 
                 185 
                 37.5 
                 155 
                 47.6 
               
               
                 60 
                 35 
                 F 
                 270 
                 245 
                 9.2 
                 205 
                 24.1 
                 145 
                 46.3 
               
               
                 61 
                 32 
                 F 
                 265 
                 205 
                 22.7 
                 165 
                 37.7 
                 110 
                 58.5 
               
               
                 62 
                 31 
                 F 
                 260 
                 195 
                 25 
                 175 
                 32.7 
                 135 
                 48.1 
               
               
                 63 
                 37 
                 F 
                 245 
                 195 
                 20.4 
                 155 
                 36.7 
                 125 
                 49 
               
               
                 64 
                 35 
                 F 
                 280 
                 240 
                 14.3 
                 192 
                 31.4 
                 180 
                 35.7 
               
               
                 65 
                 49 
                 F 
                 285 
                 220 
                 22.8 
                 210 
                 26.3 
                 205 
                 28.1 
               
               
                 66 
                 56 
                 F 
                 295 
                 215 
                 27.1 
                 205 
                 30.5 
                 185 
                 37.3 
               
               
                 67 
                 41 
                 F 
                 268 
                 210 
                 21.6 
                 196 
                 26.9 
                 145 
                 45.9 
               
               
                 68 
                 46 
                 F 
                 295 
                 255 
                 13.6 
                 195 
                 33.9 
                 190 
                 35.6 
               
               
                 69 
                 59 
                 F 
                 278 
                 244 
                 12.2 
                 215 
                 22.7 
                 202 
                 27.3 
               
               
                 70 
                 55 
                 F 
                 245 
                 185 
                 24.5 
                 155 
                 36.7 
                 135 
                 44.9 
               
               
                 71 
                 50 
                 F 
                 560 
                 495 
                 11.6 
                 432 
                 22.9 
                 298 
                 46.8 
               
               
                 72 
                 66 
                 F 
                 332 
                 285 
                 14.2 
                 234 
                 29.5 
                 200 
                 39.8 
               
               
                 73 
                 44 
                 F 
                 260 
                 220 
                 15.4 
                 195 
                 25 
                 165 
                 36.5 
               
               
                 74 
                 59 
                 F 
                 290 
                 240 
                 17.2 
                 195 
                 32.8 
                 165 
                 43.1 
               
               
                 75 
                 37 
                 F 
                 305 
                 205 
                 32.8 
                 175 
                 42.6 
                 155 
                 49.2 
               
               
                 76 
                 69 
                 F 
                 295 
                 265 
                 10.2 
                 210 
                 28.8 
                 200 
                 32.2 
               
               
                 77 
                 55 
                 F 
                 275 
                 255 
                 7.3 
                 215 
                 21.8 
                 195 
                 29.1 
               
               
                 78 
                 24 
                 F 
                 290 
                 230 
                 20.7 
                 198 
                 31.7 
                 170 
                 41.4 
               
               
                 79 
                 47 
                 F 
                 310 
                 265 
                 14.5 
                 245 
                 21 
                 200 
                 35.5 
               
               
                 80 
                 48 
                 F 
                 270 
                 210 
                 22.2 
                 190 
                 29.6 
                 180 
                 33.3 
               
               
                 81 
                 38 
                 F 
                 310 
                 255 
                 17.7 
                 220 
                 29 
                 185 
                 40.3 
               
               
                 82 
                 57 
                 F 
                 277 
                 210 
                 24.2 
                 185 
                 33.2 
                 155 
                 44 
               
               
                 82 
                 33 
                 F 
                 288 
                 245 
                 14.9 
                 198 
                 31.3 
                 185 
                 35.8 
               
               
                 84 
                 68 
                 F 
                 280 
                 200 
                 28.6 
                 192 
                 31.4 
                 165 
                 41.1 
               
               
                 85 
                 44 
                 F 
                 285 
                 255 
                 10.5 
                 210 
                 26.3 
                 195 
                 31.6 
               
               
                 86 
                 37 
                 F 
                 275 
                 225 
                 18.2 
                 205 
                 25.5 
                 173 
                 37.1 
               
               
                 87 
                 82 
                 F 
                 310 
                 255 
                 17.7 
                 225 
                 27.4 
                 196 
                 36.8 
               
               
                 88 
                 75 
                 F 
                 286 
                 255 
                 10.8 
                 210 
                 26.6 
                 200 
                 30.1 
               
               
                 89 
                 53 
                 F 
                 265 
                 210 
                 20.8 
                 195 
                 26.4 
                 190 
                 28.3 
               
               
                 90 
                 42 
                 F 
                 280 
                 255 
                 8.9 
                 220 
                 21.4 
                 200 
                 28.6 
               
               
                 91 
                 47 
                 F 
                 291 
                 240 
                 17.5 
                 210 
                 27.8 
                 195 
                 33 
               
               
                 92 
                 77 
                 F 
                 295 
                 265 
                 10.2 
                 225 
                 23.7 
                 195 
                 33.9 
               
               
                 93 
                 44 
                 F 
                 288 
                 265 
                 8 
                 235 
                 18.4 
                 215 
                 25.3 
               
               
                 94 
                 48 
                 F 
                 350 
                 285 
                 18.6 
                 235 
                 32.9 
                 200 
                 42.9 
               
               
                 95 
                 52 
                 F 
                 285 
                 235 
                 17.5 
                 200 
                 29.8 
                 175 
                 38.6 
               
               
                 96 
                 39 
                 F 
                 275 
                 245 
                 10.9 
                 215 
                 21.8 
                 200 
                 27.3 
               
               
                 97 
                 57 
                 F 
                 265 
                 210 
                 20.8 
                 200 
                 24.5 
                 180 
                 30.1 
               
               
                 98 
                 28 
                 F 
                 285 
                 285 
                 0 
                 275 
                 0 
                 290 
                 0 
               
               
                 99 
                 62 
                 F 
                 315 
                 310 
                 0 
                 320 
                 0 
                 305 
                 0 
               
               
                   
               
             
          
         
       
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Unless otherwise defined herein, scientific and technical terms used in connection with the present invention shall have the meanings that are commonly understood by those of ordinary skill in the art. Furthermore, unless otherwise required by context, singular terms shall include pluralities and plural terms shall include the singular. Generally, nomenclatures used in connection with, and standard techniques described herein are those well known and commonly used in the art. 
     For millennia, fenugreek ( Trigonella foenum graecum ) has been used both as a medicine and as a food spice in India and the Middle East. Fenugreek seeds have been used for centuries by practitioners of Indian Ayurvedic medicine as well as traditional Chinese Medicine. The fenugreek plant is native to the Mediterranean areas of Europe and to India. Fenugreek is generally regarded as safe and non-toxic. In India its leaves are cooked as a vegetable and also used as animal feed. Fresh seeds are often used as flavoring or sprouted and eaten as a salad green. Fenugreek seeds have a slight maple taste and are often used in production of imitation maple flavorings. The fenugreek plant produces small white flowers in late summer and after the flowers die, large pods that contain 10-20 irregularly-shaped yellow seeds develop. In some parts of the world, dried fenugreek seeds are ground for a curry spice. However, they may also be boiled to produce a yellow dye, roasted as a coffee substitute, or used to flavor foods and tobacco. After the seeds are collected from the plants, the plants may be chopped and used as fertilizer. 
     Recent interest in fenugreek focuses on its potential benefits to lower blood sugar in diabetics. In some individuals dietary intake of soluble fiber can slow absorption and subsequent digestion of food that results in a slower rise in blood sugar levels. Some clinical studies have demonstrated that fenugreek seeds reduce blood glucose levels and decrease insulin resistance in mild type-2 diabetic patients. Fenugreek contains the amino acid, 4-hydroxyisoleucine, which appears to increase the body&#39;s production of insulin when blood sugar levels are elevated. 
     Studies have also shown that fenugreek may lower levels of triglycerides and serum cholesterol levels in diabetics. In terms of weight control, the soluble fiber in fenugreek seeds can reduce dietary fat absorption by binding to fatty acids as well as create a sensation of “fullness,” thereby reducing appetite. Finally, because fenugreek seeds contain estrogen-like saponins, blood levels of total cholesterol, LDL and triglycerides can be reduced (with no change in HDL). Although it is by no means the only major risk factor, elevated serum cholesterol is associated with a greater risk of heart disease. Cholesterol levels under 200 mg/dl are considered optimal. However a low cholesterol level is not any guarantee of good heart health, since some people with low cholesterol levels do suffer heart attacks. Evaluation of changes in cholesterol requires consultation with a healthcare professional and should include measurement of total serum cholesterol, as well as HDL and LDL cholesterol. The present inventors observed no side effects or poisoning as a result of consuming the fenugreek “juice,” even in large quantities. In fact, it was observed that doping or consuming mega-dose has no effect versus dosing in light quantity. The inventors found that amounts as little as two ounces per day for 30 days provided the therapeutic effect. Other patients consumed as much as about five cups a day to derive the identical beneficial effect. 
     Fenugreek seed extracts may also have other medical uses. It may reduce the amounts of calcium oxalate in the kidneys, often a contributing factor in kidney stones. In animal studies, fenugreek also appeared to lessen the chance of developing colon cancer by blocking the action of certain enzymes. Topically, the gelatinous texture of fenugreek seed may have some benefit for soothing skin that is irritated by eczema or other conditions. It has also been applied as a warm poultice to relieve muscle aches and gout pain. To be applied topically, fenugreek seeds can be ground into a powder, and then soaked in hot water to form a thick gel. Fenugreek is a mild but effective laxative. 
     The instant fenugreek extract or “juice” can be combined with any pharmaceutically acceptable excipient. According to this invention, a “pharmaceutically acceptable excipient” is an excipient that acts as filler or a combination of fillers used in pharmaceutical compositions. Preferred excipients included in this category are: 1) amino acids, such as glycine, arginine, aspartic acid, glutamic acid, lysine, asparagine, glutamine, proline; 2) carbohydrates, e.g., monosaccharides such as glucose, fructose, galactose, mannose, arabinose, xylose, ribose; 3) disaccharides, such as lactose, trehalose, maltose, sucrose; 4) polysaccharides, such as maltodextrins, dextrans, starch, glycogen; 5) alditols, such as mannitol, xylitol, lactitol, sorbitol; 6) glucuronic acid, galacturonic acid; 7) cyclodextrins, such as methyl cyclodextrin, hydroxypropyl-β-cyclodextrin and alike; 8) inorganic molecules, such as sodium chloride, potassium chloride, magnesium chloride, phosphates of sodium and potassium, boric acid, ammonium carbonate and ammonium phosphate; 9) organic molecules, such as acetates, citrate, ascorbate, lactate; 10) emulsifying or solubilizing/stabilizing agents like acacia, diethanolamine, glyceryl monostearate, lecithin, monoethanolamine, oleic acid, oleyl alcohol, poloxamer, polysorbates, sodium lauryl sulfate, stearic acid, sorbitan monolaurate, sorbitan monostearate, and other sorbitan derivatives, polyoxyl derivatives, wax, polyoxyethylene derivatives, sorbitan derivatives; and 11) viscosity increasing reagents like, agar, alginic acid and its salts, guar gum, pectin, polyvinyl alcohol, polyethylene oxide, cellulose and its derivatives propylene carbonate, polyethylene glycol, hexylene glycol, tyloxapol. Salts of such compounds may also be used. A further preferred group of excipients includes sucrose, trehalose, lactose, sorbitol, lactitol, mannitol, inositol, salts of sodium and potassium, such as acetate, phosphates, citrates and borate, glycine, arginine, polyethylene oxide, polyvinyl alcohol, polyethylene glycol, hexylene glycol, methoxy polyethylene glycol, gelatin, hydroxypropyl-β-cyclodextrin, polylysine and polyarginine. 
     The fenugreek extract or “juice” according to this invention can also be combined with a carrier or excipient, a substance that, when added to a therapeutic, speeds or improves its action. Examples of carriers or excipients include, for example, buffer substances, such as phosphates, glycine, sorbic acid, potassium sorbate, partial glyceride mixtures of saturated vegetable fatty acids, waters, salts or electrolytes, such as Protamine sulfate, disodium hydrogen phosphate, sodium chloride, zinc slats, colloidal silica, magnesium, trisilicate, cellulose-based substances and polyethylene glycol. 
     This invention advantageously permits consumption of the instant fenugreek extract or “juice” by a human. In one embodiment, the compositions according to this invention are administered about once a day. In another embodiment, the compositions according to this invention are administered about once a day for a month. In yet another embodiment, the compositions according to this invention are administered for a period longer than a month. It will be appreciated by those of skill in the art that the specific treatment regimen will depend upon factors such as the cholesterol level in the patient, the age and weight of the patient to be treated, general physical condition of the patient and the judgment of the treating physician. 
     In order that this invention may be better understood, the following examples are set forth. These examples are for the purpose of illustration only and are not to be construed as limiting the scope of the invention in any manner. Numerous other variations of the present invention will be appreciated by those skilled in the art, in view of the disclosure herein. The exact compositions, methods of preparation and embodiments shown are not limiting of the invention, and any obvious modifications will be apparent to one skilled in the art. 
     EXAMPLE 1 
     Extraction may be carried out in one of the following three ways: 
     
         
         Simple Extraction: Soak about ⅓ cup of fenugreek seeds in about 15 cups of water for 8-10 hours. Bring the mixture to a boil for about 5-7 minutes. Cool, strain and refrigerate the extracted “juice.” 
         Quick Extraction: Combine about ⅓ cup fenugreek seeds in about 15 cups of water and bring to a boil for about 10 minutes. Cool, strain and refrigerate the extracted “juice.” 
         Preferred Extraction: Grind about ⅓ cup of fenugreek seed to a powder. Combine the resulting powder with about 15 cups of water and bring to a boil for 10 minutes. Cool, strain and refrigerate the extracted “juice.”
 
Note: The noted boiling times above are only preferred embodiments and may be considerably shorter or longer. Similarly, the proportion of seed to water employed may be scaled appropriately. The simple extraction method described above produces a slightly more opaque product. The best way to store fenugreek is to keep the seed in a cool and dry place. This allows for it to be kept for several months without loss in activity. Once the seed is ground or powdered, it does not keep well and must be used promptly. As soon as the “juice” is extracted, whether from the seed or the grind, it is preferred that it be kept refrigerated.
 
       
    
     EXAMPLE 2 
     Reconstitution of the extracted “Juice” may be accomplished by the following method: 
     As stated earlier, while the exact composition of the final beverage may be in the form of the extracted “juice,” tea or carbonated beverage, a small quantity taken each day for 30 consecutive days provides a reduction in blood cholesterol of 30% or more. An individual serving of tea may be prepared by boiling a teaspoon of fresh powdered/ground fenugreek seed in a cup of water for ten minutes. Appropriate flavors, conventional carriers, excipients or additives may be additionally incorporated into the extracted “juice.” Examples include sweeteners (e.g., honey, sugar, aspartame, etc.) or flavors (e.g., lemon, anise, mint, etc.). Additionally, these beverages may be supplemented with various nutrients, vitamins, minerals, pharmaceutically active agents, fibers, liposomes and herbal extracts. 
     It is understood that the invention is not limited to the disclosed compositions, methods of preparation and embodiments shown, including any embodiments that may be apparent to one of ordinary skill in the art. Although the foregoing invention has been described in some detail by way of illustration and examples for purposes of clarity of understanding, it will be readily apparent to those of ordinary skill in the art in light of the teachings of this invention that certain variations and modifications may be made thereto without departing from the spirit or scope of the disclosure herein, including the specific embodiments.