USOO 8613963B2

(12) United States Patent (10) Patent No.: US 8,613,963 B2 Karl (45) Date of Patent: Dec. 24, 2013

(54) NUTRITIONAL SUPPLEMENT (56) References Cited (75) Inventor: Mitchell Karl, Boca Raton, FL (US) U.S. PATENT DOCUMENTS 6,068,705 A * 5/2000 Tang et al...... 127/32 (73) Assignee: Healthy Drink Discoveries 6,365,176 B1 * 4/2002 Bell et al...... 424/439 Incorporated, Boca Raton, FL (US) 2006/0003947 A1 1/2006 Udell ...... 514, 26 (*) Notice: Subject to any disclaimer, the term of this OTHER PUBLICATIONS patent is extended or adjusted under 35 U.S.C. 154(b) by 219 days. Seki et al., Asia Pac J. Clin Nutr., 2003, vol. 12, No. 3, p. 282-91. Abstract Only.* (21) Appl. No.: 12/861,898 * cited by examiner (22) Filed: Aug. 24, 2010 O O Primary Examiner — Kade Ariani (65) Prior Publication Data (74) Attorney, Agent, or Firm — Johnson & Martin, P.A.: US 2010/0316758 A1 Dec. 16, 2010 James David Johnson Related U.S. Application Data (57) ABSTRACT (63) Continuation-in-part of application No. 12/5 76,035 s A nutritional Supplement specifically designed to lower cho filed O Oct. 8, 2009, now. abandoned, which is a lesterol that addresses multiple mechanisms including continuation-in-part of application No. 12/120,765, hepatic synthesis and release, intestinal absorption of choles filed on May 15, 2008, now abandoned. terol, while, at the same time, including ingredients that miti (60) Provisional application No. 60/942,122, filed on Jun. gate the side effects of the constituents and increase their 5, 2007. efficacy by affecting emotional factors that influence compli ance Such as a sense of well-being and euphoria on the one (51) Int. Cl. hand, or an increased overall metabolism and desire for the A23K L/8 (2006.01) product stemming from its coloration on the other hand. The (52) U.S. Cl. nutritional Supplement can be prepared as a powder that can USPC ...... 426/2: 426/72; 426/419, 426/531; be added to a food item by a human subject, a concentrate that 426/590: 426/656: 426/658: 514/7.4 can be mixed with water or another beverage, or incorporated (58) Field of Classification Search into a baked good for ingestion by the human Subject. None See application file for complete search history. 6 Claims, No Drawings US 8,613,963 B2 1. 2 NUTRITIONAL SUPPLEMENT ingredients that reduce toxicity, increase the rate of metabo lism both on a general and a cellular level and, finally stimu CROSS-REFERENCE TO RELATED late compliance by causing a sense of mild euphoria and APPLICATION well-being, as well as enhancing metabolism. Accordingly, in one aspect, the invention features a nutri This application is a continuation-in-part of U.S. nonpro tional Supplement that includes at least two active ingredients visional patent application Ser. No. 12/576,035 filed on Oct. selected from among the following: niacin, a phytosterol 8, 2009, which is a continuation-in-part application of U.S. component, red yeast rice, coenzyme Q10, L-carnitine, and nonprovisional patent application Ser. No. 12/120,765 filed ascorbic acid. on May 15, 2008, which claims the priority of U.S. provi 10 In another aspect, the invention can feature the nutritional sional patent application Ser. No. 60/942,122 filed on Jun. 5, Supplement further including water, juice, or juice concen 2007. trate. In another aspect, the invention can feature the nutritional FIELD OF THE INVENTION Supplement prepared as a baked good, a concentrate, or a 15 powder. This invention relates to nutritional supplements. More In another aspect, the invention can feature each serving of particularly, the invention relates to compositions and meth the nutritional supplement including about 5 to 100 mg of ods for Supplementing the diet for improving health and pre niacin. venting disease. In another aspect, the invention can feature each serving of the nutritional supplement including about 400 to 3,000 mg of BACKGROUND the phytosterol component. In another aspect, the invention can feature each serving of Chronically elevated blood levels of cholesterol lead to the nutritional supplement including about 300 to 3,000 mg of cardiovascular disease as the cholesterol finds its way into the red yeast rice. walls of blood vessels and damages them. This ultimately 25 In another aspect, the invention can feature each serving of results in symptoms of chronic arterial insufficiency Such as the nutritional supplement including about 50 to 250 mg of angina and claudication on the one hand, and acute vascular L-carnitine. insufficiency, such as heart attack and stroke on the other. In another aspect, the invention can feature each serving of Over S120 billion dollars is spent on direct and indirect the nutritional supplement including about 300 to 1,200 mg of costs associated with cardiovascular disease annually in the 30 ascorbic acid. United States alone. Cardiovascular disease incidence In another aspect, the invention can feature each serving of increases with serum LDL cholesterol in a log linear fashion the nutritional supplement including about 10 to 200 mg of and more importantly declines with treatment-induced reduc coenzyme Q10. tion of serum LDL cholesterol. In another aspect, the invention can feature each serving of Conventional therapy for elevated blood cholesterol levels 35 the nutritional Supplement including less than about 50 mg of takes the form of four classes of FDA approved medications: niacin. statins, bioresins, fibrates, and niacin. In another aspect, the invention can feature the phytosterol Of these, statins are the most widely used with greater than component including at least one phytosterol ester. S20 billion in annual sales; however, all the classes, including In another aspect, the invention can feature the nutritional statins, have side effects and at higher doses, that are neces 40 Supplement including at least three active ingredients selected sary to achieve targets, result in side effects that limit their from among the following: niacin, a phytosterol component, utility. This is especially so of niacin and statins. red yeast rice, coenzyme Q10, L-carnitine, and ascorbic acid. Recently, it has been appreciated that in attempting to In another aspect, the invention can feature the nutritional lower cholesterol, two or more drugs with different mecha Supplement including at least four active ingredients selected nisms of action can lower toxicity and produce synergy in the 45 from among the following: niacin, a phytosterol component, cholesterol lowering effect. Vytorin, a recently introduced red yeast rice, coenzyme Q10, L-carnitine, and ascorbic acid. combination of Zetia and Simvastatin, has been shown to In another aspect, the invention can feature the nutritional decrease cholesterol absorption and synthesis and reduce Supplement including at least five active ingredients selected cholesterol better than the sum of the expected reduction of from among the following: niacin, a phytosterol component, either drug alone. This is explained by a phenomenon I refer 50 red yeast rice, coenzyme Q10, L-carnitine, and ascorbic acid. to as “escape homeostasis.” When one pathway to cholesterol In another aspect, the invention can feature the nutritional elevation is blocked, an alternative pathway is often enhanced Supplement including niacin, a phytosterol component, red by the body, so that the overall cholesterol levels are main yeast rice, coenzyme Q10, L-carnitine, and ascorbic acid. tained. There is, thus, a built-in or automatic drug resistance In another aspect, the invention features the nutritional that can only be overcome with multiple active agents work 55 Supplement including maltodextrin. ing simultaneous at different sites. It is noteworthy that evi In another aspect, the invention can feature the nutritional dence exists that even homeopathic, previously felt sub-thera Supplement including two daily servings. Each serving can peutic amounts of biologically active cholesterol lowering include as ingredients water or juice, about 5 to 50 mg of compounds can exert powerful efficacy with minimal side niacin, about 500 to 1,500 mg of at least one phytosterol ester, effects when combined with other agents that work by alter 60 about 300 to 1,500 mg of red yeast rice, about 10 to 200 mg of native pathways. coenzyme Q10, about 50 to 250 mg of L-carnitine, and about 300 to 1,200 mg of ascorbic acid. SUMMARY In another aspect, the invention can feature two servings of the nutritional Supplement being packaged in a container. The invention is based on the development of a cholesterol 65 The invention also features a method that includes the step lowering nutritional Supplement that utilizes multiple mecha of administering to a Subject for at least 7 days a nutritional nisms and sites of action to reduce cholesterol and also has Supplement comprising at least two active ingredients US 8,613,963 B2 3 4 selected from among the following: niacin, a phytosterol todextrin. Servings of the beverage can be consumed twice component, red yeast rice, coenzyme Q10, L-carnitine, and daily, for example, one serving in the morning and one serv ascorbic acid. ing at night. In another aspect, the method can also feature the step of In another embodiment, the beverage can include 8.2 g of administering the nutritional Supplement to the Subject twice a composition in an 8-ounce container. The beverage can be daily. packaged in a bottle or other container that contains two In another aspect, the method can also feature the step of servings, e.g., two 4-ounce servings in an 8-ounce container. preparing the nutritional Supplement in a form selected from The composition can include the following ingredients in among a baked good, a concentrate, or a powder. each 4-ounce serving: about 600 mg of red yeast rice powder, Unless otherwise defined, all technical terms used herein 10 have the same meaning as commonly understood by one of about 12.5 mg of niacin (niacinamide), about 500 mg of ordinary skill in the art to which this invention belongs. vitamin C (ascorbic acid), about 150 mg of L-carnitine Although methods and materials similar or equivalent to (L-carnitine-L-tartrate), about 25 mg of coenzyme Q10. those described herein can be used in the practice or testing of about 660 mg of phytosterol esters, and q.S. maltodextrin. the present invention, Suitable methods and materials are 15 Servings of the beverage can be consumed twice daily, for described below. All publications, patent applications, pat example, one serving in the morning and one serving at night. ents and other references mentioned herein are incorporated Although 4-ounce servings and 8-ounce containers are by reference in their entirety. In the case of conflict, the described herein, the serving size and container size can be present specification, including definitions will control. different as long as the amounts of each ingredient remain consistent. For example, each serving can be 3.5, 4.5, 5, 6, 7, DETAILED DESCRIPTION 7.5, 8.5, 9, 10, 12, 13, 14, or 16 ounces. Each serving of the composition can include niacin in the The invention provides an aqueous composition of ingre amounts of about 4.5, 5, 6, 6.1, 6.5, 6.6, 6.9, 7, 7.5, 8, 9, 9.9, dients and dietary Supplements to yield a cholesterollowering 10, 10.1, 10.5, 11, 11.5, 11.9, 12, 12.1, 12.5, 12.6, 12.9, 13, drink. The composition is typically contained within a two 25 15, 19, 20, 25, 30, 40, 50, 60, 70, 75, 80, 90,99, 100, 101, or serving container Such as a can or bottle and includes water 110 mg or more. In exemplary embodiments, each serving of and a combination of at least two of niacin, a phytosterol the composition can contain less than about 50 mg of niacin. component, red yeast rice, coenzyme Q10, L-carnitine, and In one exemplary embodiment, each serving of the composi ascorbic acid in amount effective to reduce serum cholesterol tion can contain about 12.5 mg of niacin. levels in a Subject who drinks the composition on a regular 30 Each serving of the composition can include phytosterol basis (e.g., once a day, twice a day, every two days, or every esters in the amounts of about 300, 400, 500, 550, 600, 625, three days). 640, 649, 651, 660, 675, 700, 800, 900, 1,000, 1,250, 1,320, The active ingredients are preferably included at a concen 1,500, 1,800, 1,900, 1950, 1999, 2,000, 2001, 2,050, or tration effective to reduce a subject’s serum cholesterol by at 2,100 mg or more. In exemplary embodiments, each serving least 10% (e.g., at least 20, 30, 40, or 50%) when included in 35 of the composition can contain about 660 mg of phytosterol combination with each other and administered to the subject esterS. on a regular basis (e.g., twice a day or once a day for at least Each serving of the composition can include coenzyme Q 2, 3, 4, 5, 6, 12, or 24 weeks). In an exemplary embodiment, in the amounts of about 8, 9, 10, 13, 15, 17, 19, 20, 22.5, 24, the composition can be administered twice daily to the sub 24.5, 24.9, 25, 25.1, 25.5, 26, 27, 27.5, 28, 29, 30, 35, 40, 45, ject in the form of and as part of a beverage, e.g., as a nutri 40 50, 55, 75, 90, 100, 150, 200, 250, or 300 mg or more. In tional drink. exemplary embodiments, each serving of the composition Niacin lowers cholesterol by inhibiting lipoprotein forma can contain about 25 mg of coenzyme Q. tion or release in the liver. Phytosterols lower cholesterol by Each serving of the composition can include L-carnitine in competing for absorption in the intestines. Red Yeast Rice is the amounts of about 90, 95, 100, 110, 115, 125, 135, 140, a dietary Supplement and coloring agent that has been used in 45 145, 149, 149.1, 149.9, 150, 150.1, 150.5, 151,153,155, 160, Chinese food and medicines for centuries. It decreases Syn 170, 175, 180, 190, 200,250,300,400, or 500 mg or more. In thesis and absorption of cholesterol, produces red coloration exemplary embodiments, each serving of the composition which stimulates appetite, compliance, and metabolism. On a can contain about 75-150 mg of L-carnitine. In one exem cellular level, L-carnitine and coenzyme Q10 enhance trans plary embodiment, each serving of the composition can con port of fatty acids to the mitochondria and enhance the burn 50 tain about 150 mg of L-carnitine. ing of fatty acids respectively. L-carnitine can also cause a Each serving of the composition can include ascorbic acid mild sense of euphoria, a beneficial effect that may result in in the amounts of about 50, 100, 200, 250, 300, 400, 450, 475, greater compliances with the preparation containing it. 490,499, 499.1, 500, 500. 1,500.5, 501, 510,520, 535, 550, Ascorbic acid changes the constitution of bile to decrease 600, 625, 640, 649, 651, 660, 675, 700, 800, 900, 1,000, cholesterol absorption and inhibit the HMG-CoA reductase 55 1,500, or 2,000 mg or more. In exemplary embodiments, each pathway, the rate-limiting step in cholesterol biosynthesis. serving of the composition can contain about 500 mg of In an exemplary embodiment, the phytosterol component ascorbic acid. can include one or more phytosterol esters. Each serving of the composition can include red yeast rice In one embodiment, the beverage can include 6.9 g of a in the amounts of about 300, 400, 500, 550, 575, 590, 595, composition in a 8-ounce container. The beverage can be 60 599,599.1,599.9, 600, 600.1, 600.5, 601, 610, 620,625, 640, packaged in a bottle or other container that contains two 650, 660, 675, 700, 800, 900, 1,000, 1,250, 1,500, 1,800, servings, e.g., two 4-ounce servings in an 8-ounce container. 1,900, 1950, 1999, 2,000, 2,001, 2,050, 2,100, or 2,400 mg The composition can include the following ingredients in or more. In exemplary embodiments, each serving of the each 4-ounce serving: about 12.5 mg of niacin (niacinamide), composition can contain about 600 mg of red yeast rice. about 500 mg of vitamin C (ascorbic acid), about 150 mg of 65 The composition can also feature maltodextrin making up L-carnitine (L-carnitine-L-tartrate), about 25 mg of coen the remainder of any 6.9 g, 8.2 g, or other amount of the Zyme Q10, about 660 mg of phytosterol esters, and q.S. mal composition premixture before the addition of water to create US 8,613,963 B2 5 6 the beverage. The beverage may also contain artificial or ment, the composition can be administered twice daily to the natural flavorings and colorings. subject in the form of and as part of a powder that can be added to food items, incorporated into a baked good (e.g., as EXAMPLE1 a snack bar, a cookie or a brownie), or as a concentrate mixed with water or another beverage. A beverage for administration twice daily to a human Sub In an exemplary embodiment, the phytosterol component ject can include two servings stored in a container Such as, for can include one or more phytosterol esters. example, a bottle. Each serving of the beverage can include In one embodiment, the nutritional Supplement can include water (100-500 ml) and 6.9 g of the composition. The com 6.9 g of a composition in an 8-ounce container. The nutri position can include as ingredients phytosterol esters (about 10 tional Supplement can be packaged in a container that con 660 mg), niacin (less than about 50 mg), coenzyme Q10 tains two servings, e.g., two 4-ounce servings in an 8-ounce (about 25 mg), ascorbic acid (about 500 mg), L-carnitine container. The composition of this embodiment of the nutri (about 75-150 mg), and maltodextrin (q.s.). tional Supplement can include the following ingredients in each 4-ounce serving: about 12.5 mg of niacin (niacinamide), EXAMPLE 2 15 about 500 mg of vitamin C (ascorbic acid), about 150 mg of L-carnitine (L-carnitine-L-tartrate), about 25 mg of coen A beverage for administration twice daily can include two Zyme Q10, about 660 mg of phytosterol esters, and q.S. mal servings stored in a container Such as, for example, a bottle or todextrin. Servings of the nutritional Supplement can be con can. Each serving of the beverage can include water (about Sumed twice daily, for example, one serving in the morning 100 to 500 ml) and 8.2 g of the composition. As ingredients, and one serving at night. the composition can feature phytosterol esters (about 660 In another embodiment, the nutritional Supplement can mg), niacin (less than about 50 mg), red yeast rice (about 600 include 8.2 g of a composition in an 8-ounce container. The mg), coenzyme Q10 (about 25 mg), ascorbic acid (about 500 beverage can be packaged in a bottle or other container that mg), L-carnitine (about 75-150 mg), and maltodextrin (q.S.). contains two servings, e.g., two 4-ounce servings in an In an exemplary method of the invention, the composition 25 8-ounce container. The composition of this embodiment of can be administered to a human Subject at least twice daily in the nutritional Supplement can include the following ingredi the form of a beverage or nutritional drink. The two daily ents in each 4-ounce serving: about 600 mg of red yeast rice doses of the beverage can be contained within a single con powder, about 12.5 mg of niacin (niacinamide), about 500 mg tainer Such as, for example, a bottle or can. In another embodi of vitamin C (ascorbic acid), about 150 mg of L-carnitine ment, each serving of the beverage can be packaged in a 30 (L-carnitine-L-tartrate), about 25 mg of coenzyme Q10. separate bottle or container. The beverage can be adminis about 660 mg of phytosterol esters, and q.S. maltodextrin. tered twice daily for at least 7 days. The beverage can include Servings of the nutritional supplement can be consumed water and at least two active ingredients selected from among twice daily, for example, one serving in the morning and one the following: niacin, a phytosterol component, red yeast rice, Serving at night. coenzyme Q10, L-carnitine, and ascorbic acid. 35 Although 4-ounce servings and 8-ounce containers are In another method of the invention, the composition may described herein, the serving size and container size can be be administered at an interval different than twice daily, e.g., different as long as the amounts of each ingredient remain once, three times, or four times daily. consistent. For example, each serving can be 3.5, 4.5, 5, 6, 7, In still another method of the invention, the composition 7.5, 8.5, 9, 10, 12, 13, 14, or 16 ounces. can be administered to a human Subject to reduce the Subjects 40 Each serving of the nutritional Supplement can include blood cholesterol levels. niacin in the amounts of about 4.5, 5, 6, 6.1, 6.5, 6.6, 6.9, 7, The invention can also include a nutritional Supplement 7.5, 8, 9, 9.9, 10, 10.1, 10.5, 11, 11.5, 11.9, 12, 12.1, 12.5, that can be created as a powder that can be added to food 12.6, 12.9, 13, 15, 19, 20, 25, 30, 40, 50, 60, 70, 75,80, 90,99, items, as a baked good (e.g., as cookies and brownies), and as 100, 101, or 110 mg or more. In exemplary embodiments, a concentrate. The concentrate can be added to water or 45 each serving of the nutritional Supplement can contain less another ingestible liquid to create a nutritional beverage. than about 50 mg of niacin. In one exemplary embodiment, Thus, the nutritional Supplement can be provided in an ingest each serving of the nutritional Supplement can contain about ible form that can lower cholesterol in human subjects. The 12.5 mg of niacin. nutritional Supplement is typically contained within a two Each serving of the nutritional Supplement can include serving container Such as a package, box, carton, wrapper, 50 phytosterolesters in the amounts of about 300, 400, 500, 550, bottle or can. Where the nutritional supplement is prepared in 600, 625, 640, 649, 651, 660, 675, 700, 800, 900, 1,000, the form of a concentrate that can be added to and mixed with 1,250, 1,320, 1,500, 1,800, 1900, 1,950, 1999, 2,000, 2001, a beverage, a bottle or can be used for packaging the concen 2,050, or 2,100 mg or more. In exemplary embodiments, each trate. The nutritional Supplement can include a combination serving of the nutritional Supplement can contain about 660 of at least two of niacin, a phytosterol component, red yeast 55 mg of phytosterol esters. rice, coenzyme Q10, L-carnitine, and ascorbic acid in Each serving of the nutritional Supplement can include amounts effective to reduce serum cholesterol levels in a coenzyme Q in the amounts of about 8, 9, 10, 13, 15, 17, 19. Subject who ingest the composition on a regular basis (e.g., 20, 22.5, 24, 24.5, 24.9, 25, 25.1, 25.5, 26, 27, 27.5, 28, 29, 30, once a day, twice a day, every two days, or every three days). 35, 40, 45, 50, 55, 75,90, 100, 150, 200, 250, or 300 mg or The nutritional Supplement can also include water. 60 more. In exemplary embodiments, each serving of the nutri As with the nutritional beverage, the active ingredients of tional Supplement can contain about 25 mg of coenzyme Q. the nutritional Supplement are preferably included at a con Each serving of the nutritional Supplement can include centration effective to reduce a subjects serum cholesterol by L-carnitine in the amounts of about 90, 95, 100, 110, 115, at least 10% (e.g., at least 20, 30, 40, or 50%) when included 125, 135, 140,145, 149, 149.1, 149.9, 150, 150.1, 150.5, 151, in combination with each other and administered to the sub 65 153,155, 160, 170, 175, 180, 190, 200,250, 300, 400, or 500 ject on a regular basis (e.g., twice a day or once a day for at mg or more. In exemplary embodiments, each serving of the least 2, 3, 4, 5, 6, 12, or 24 weeks). In an exemplary embodi nutritional Supplement can contain about 75-150 mg of L-car US 8,613,963 B2 7 8 nitine. In one exemplary embodiment, each serving of the In still another method of the invention, the composition nutritional supplement can contain about 150 mg of L-car can be administered to a human subject in the nutritional nitine. supplement to reduce the subject’s blood cholesterol levels. Each serving of the nutritional supplement can include ascorbic acid in the amounts of about 50, 100, 200, 250, 300, Other Embodiments 400, 450, 475, 490,499, 499.1, 500, 500.1, 500.5, 501, 510, 520, 535, 550, 600, 625, 640, 649, 651, 660, 675, 700, 800, It is to be understood that while the invention has been 900, 1,000, 1,500, or 2,000 mg or more. In exemplary described in conjunction with the detailed description embodiments, each serving of the nutritional supplement can thereof, the foregoing description is intended to illustrate and contain about 500 mg of ascorbic acid. 10 not limit the scope of the invention, which is defined by the Each serving of the nutritional supplement can include red Scope of the appended claims. Other aspects, advantages, and yeast rice in the amounts of about 300, 400, 500, 550, 575, 590,595,599,599.1,599.9, 600, 600. 1,600.5, 601, 610,620, modifications are within the scope of the following claims. 625, 640, 650, 660, 675, 700, 800, 900, 1,000, 1,250, 1,500, What is claimed is: 1,800, 1,900, 1,950, 1999, 2,000, 2001, 2,050, 2,100, or 15 2.400 mg or more. In exemplary embodiments, each serving 1. A cholesterol-lowering nutritional supplement compris of the nutritional supplement can contain about 600mg of red ing niacin, a phytosterol component comprising at least one yeast rice. phytosterol ester, red yeast rice, coenzyme Q10, L-carnitine, The nutritional supplement can also feature maltodextrin maltodextrin, and ascorbic acid; making up the remainder of any 6.9 g, 8.2g, or other amount wherein the nutritional supplement comprises two daily of the nutritional supplement premixture before the addition servings, each serving comprising water or juice, about of water orother food ingredients. The nutritional supplement 5 to 50 mg of niacin, about 600 to 1,500 mg of at least may also contain artificial or natural flavorings and colorings. one phytosterolester, about 300 to 1,500 mg of red yeast The invention can also include a method in which the rice, about 10 to 200 mg of coenzyme Q10, about 50 to composition can be administered to a human subject at least 25 150 mg of L-carnitine, and about 450 to 1,200 mg of twice daily in the form of a nutritional supplement. The nutri ascorbic acid. tional Supplement can be created as a solid such as, for 2. The nutritional supplement of claim 1, wherein the nutri example, a powder that can be added to food items or as a tional supplement further comprises water, juice, or juice baked good (e.g., as cookies and brownies). The method can COncentrate. also include the nutritional supplement being a concentrate 30 3. The nutritional supplement of claim 1, wherein the nutri that can be added to water or another ingestible liquid to tional supplement is produced in a form selected from the create a nutritional beverage. The two daily doses of the group consisting of: a baked good, a concentrate, and a pow nutritional supplement can be contained within a single con der. tainer Such as, for example, a package, box, carton, wrapper, 4. A method for lowering cholesterol comprising the step bottle or can. In another embodiment, each serving of the 35 of administering to a subject for at least 7 days a nutritional nutritional supplement can be packaged in a separate bottle or Supplement, the nutritional supplement comprising niacin, a container. The nutritional supplement can be administered phytosterol component comprising at least one phytosterol twice daily for at least 7 days. The nutritional supplement can ester, red yeast rice, coenzyme Q10, L-carnitine, maltodex include at least two active ingredients selected from among trin, and ascorbic acid; the following: niacin, a phytosterol component, red yeast rice, 40 wherein the nutritional supplement comprises two daily coenzyme Q10, L-carnitine, and ascorbic acid. servings, each serving comprising water or juice, about In another method of the invention, the nutritional supple 5 to 50 mg of niacin, about 600 to 1,500 mg of at least ment composition may be administered at an interval differ one phytosterolester, about 300 to 1,500 mg of red yeast ent than twice daily, e.g., once, three times, or four times rice, about 10 to 200 mg of coenzyme Q10, about 50 to daily. For example, the nutritional supplement can be 45 150 mg of L-carnitine, and about 450 to 1,200 mg of ingested by the human subject in the form of a cookie, ascorbic acid. brownie, or snack bar. In another example, the nutritional 5. The method of claim 4, wherein the nutritional supple supplement can be provided in the form of a powder, which ment is administered to the subject twice daily. can be mixed in or sprinkled onto other food items and 6. The method of claim 4, wherein the method further ingested by the human subject. In still another example, the 50 comprises the step of preparing the nutritional supplement in nutritional supplement can be provided in the form of a con a form selected from the group consisting of: a baked good, a centrate that can be mixed with a beverage selected by the concentrate, and a powder. human subject and then imbibed by the human subject.