US006224871B1 (12) United States Patent (16) Patent N6.= US 6,224,871 B1 Hastings et al. (45) Date of Patent: May 1, 2001

(54) DIETARY SUPPLEMENT FOR (56) References Cited NUTRITIONALLY PROMOTING HEALTHY JOINT FUNCTION U.S. PATENT DOCUMENTS

(75) Inventors: Carl W. HastingS,- Glencoe; David J._ , , * 1;; gogp?a re . . .""""""""""""""""" ...... " girllets.’ widvlgoi’d’ bg?ll °fbMOI£U%)’S 5,494,668 * 2/1996 Parwaedhan .. 424/1951 “5 me ' a ey> O um 1*" ( ) 5,536,506 * 7/1996 Majeed ...... 424/464 5 888514 * 3 1999 W ' ...... 424 195.1 (73) Assignee: Reliv International, Inc., Chester?eld, ’ ’ / elsman / MO (Us) * cited by examiner ( * ) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 Primary Examiner—F. J. MoeZie U.S.C. 154(b) by 0 days. (74) Attorney, Agent, or Firm—Tilton Fallon Lungmus (21) Appl. No.: 09/038,394 (57) ABSTRACT - _ A dietary supplement for nutritionally promoting healthy (22) Flled' Mar‘ 11’ 1998 joint function in human subjects is disclosed. The supple (51) Int. Cl.7 ...... A61K 35/78; A61K 38/01; ment includes as a major ingredient a protein derived from A61K 38/02; A61K 47/46 the enzymatic hydrolysis of collagen in combination With (52) us. c1...... 424/1951; 424/1961; lesser proportions of glucosamine sulfate, ginkgo biloba, 424/825; 424/886; 424/439; 514/2; 514/21 borage oil poWder, turmeric, boswellia serrata, (58) Field of Search ...... 424/439, 440, aShWagandha>PiPer nigmm extracb and a herbal blend 424/441, 195.1, 196.1, 825, 886; 514/886, 2 5 Claims, N0 Drawings US 6,224,871 B1 1 2 DIETARY SUPPLEMENT FOR tion. More speci?cally, the dietary supplement takes the NUTRITIONALLY PROMOTING HEALTHY form of an essentially dry mixture of 78% to 90% protein JOINT FUNCTION derived from the enZymatic hydrolysis of collagen, 2% to 6% glucosamine sulfate, 2% to 5% ginkgo biloba (Salsburia BACKGROUND AND SUMMARY OF THE adiantifolia) , 0.8% to 1.5% borage oil poWder (Borago INVENTION o?icinalis), 0.3% to 0.7% turmeric (Curcuma longa), 0.01% to 0.03% Boswellia serrata, 0.5% to 0.7% ashWagandha Degenerative joint diseases, commonly known as (Withania sominfera), 0.04% to 0.08% Piper nigrum extract, orthroses, are most frequently found in bradytrophic tissue and 5% to 10% herbal blend. In a preferred embodiment, the (tendon, cartilage) Which is knoWn to shoW little or no blood herbal blend includes cat’s claW poWder (Uncaria ?oW and, because of its sloW metabolism, is incapable of 10 tomentosa), sarsaparilla root (Smilax ornata), licorice root responding to external noxious in?uences either With (Glycyrrhiza glabra), kelp (Ascophyllum nodosum), bur in?ammatory and or With regenerative processes. As dock root poWder (Arctium lappa), alfalfa poWder (Medicajo brought out in Koepff et al US. Pat. No. 4,804,745, clinical sativa), barley grass (B. Hordeum vulgare L.), echinacea investigations have noW led to the discovery that peptides root (Echinacea purpurea), yucca extract (Yucca 15 soluble in cold Water, and speci?cally those from a group of schidigera), bilberry extract (Vaccinium myrtillus), devil’s hydrolyZed collagens, are suitable for the treatment of claW poWder Harpagophytum procumens, capsicum poWder orthoses. Particularly suitable is an enZymatically hydro (Capsicum annum linne var. Longum sendt capsuccum) lyZed collagen having an average molecular Weight of from celery seed poWder, and aloe vera extract. 10,000 to 80,000 daltons. Such enZymatically hydrolyZed Once the essentially dry mixture has been blended, the. collagen is almost ?avorless or neutral in ?avor, is soluble 20 composition can be delivered enterally as a beverage. The in cold Water, and, unlike denatured collagen (gelatin) is beverage is prepared by dissolving the proper amount of the incapable of binding signi?cant amounts of Water. essentially dry mixture in Water, juice, milk or any other drinkable liquid. The recommended serving siZe is 7 to 10 g Collagen is a ?ber protein forming the main constituent of of the essentially dry mixture, optimally 8.5 g of that the supporting tissue and connective tissue in animals 25 mixture, in a selected beverage. The recommended serving (including humans) and, more particularly, is found in the should be consumed once each day. skin, tendons and bones. Therefore, hydrolyZed collagen, and speci?cally enZymatically hydrolyZed collagen, may be DETAILED DESCRIPTION OF PREFERRED produced from animal skin, animal bones, and other suf? EMBODIMENT ciently puri?ed connective tissue. Such enZymatically 30 A major ingredient of the dietary supplement of this hydrolyZed collagens have previously been used in the invention is hydrolyZed collagen, particularly enZymatically pharmaceutical industry as tabletting aids, encasing agents hydrolyZed collagen. Such material consists of a series of 19 and ?llers. US. Pat. No. 4,804,745 describes that clinical amino acids joined in chains by peptide bonds. These are the investigations and double blind studies have noW estab same amino acids that comprise the frameWork of human lished that these enZymatically hydrolyZed collagens, taken 35 cartilage, and are required for its generation. EnZymatically in an amount of from 5 to 12 g per day, have alleviating hydrolyZed collagen may be prepared by cutting, Washing, effects on orthoses and also produce an analgesic effect and enZymatically hydrolyZing fresh or connective tissue in Which tends to reduce the need for administering other a tank ?tted With a stir, folloWed by inactivation of the analgesics. enZyme, separation, ?ltration, re-concentration, steriliZation, Recent studies have also shoWn the bene?cial effects of 40 and spray drying. The product is a Whitish to yelloW poWder glucosamine sulfate and its relationship With the symptoms that is soluble in cold Water, neutral in ?avor, and of particle of osteoarthritis, the most common form of arthritis. Glu siZes less than about 0.5 mm. The average molecular Weight cosamine sulfate, Which is naturally found in high concen falls generally Within the range of about 10,000 to trations in joint structures, is a stable, tasteless and Water 80,000daltons. Higher molecular Weight preparations are soluble nutrient. It is readily absorbed from the intestines, 45 not suf?ciently or as readily soluble in cold Water, and loWer stays in the blood for several hours, and very little is molecular Weight preparations are more difficult to bring excreted. Glucosamine sulfate, taken as a dietary into acceptable forms for application. Such enZymatically supplement, has been shoWn to exert a protective effect hydrolyZed collagen is commercially available under the against joint destruction and is selectively used by joint designation “Arthred” from Traco Labs, Champaign, Ill. tissues, exerting a dramatic positive effect in reducing 50 Further information concerning such enZymatically hydro arthritic symptoms and promoting healthy joint function. In lyZed collagen is set forth in Koepff et al US. Pat. No. particular, glucosamine stimulates the body’s manufacture 4,804,745, the disclosure of Which is incorporated herein by of collagen, the protein portion of the ?brous substance that reference. The patent discloses some of the double blind holds joints together. Collagen is the main component of the studies conducted With such enZymatically hydrolyZed shock-absorbing cushion called articular cartilage, and glu 55 collagen, the comparative clinical investigations revealing cosamine is therefore a necessary nutrient in the production good compatability and intakeability With particularly good of cartilage and synovial ?uid. HoWever, the body’s pro ef?ciency against orthroses being observed. duction of glucosamine decreases as a person ages, thereby Glucosamine is an amino sugar normally found in humans inhibiting the neW groWth of cartilage destroyed through and derived from glucose. It is considered the starting point Wear and tear. 60 for the synthesis of macro-molecules such as glycoproteins, The composition of this invention is a dietary supplement glycolipids, and glyco-aminoglycans or mucopolysaccha containing both glucosamine sulfate and protein derived rides. Glycosamine sulfate is one of the biological chemicals from the enZymatic hydrolysis of collagen in combination involved in the formation of cushioning ingredients for joint With certain antioxidants, anti-in?ammatory agents, thermo ?uids and surrounding tissues and contributes to make nutrients for increasing absorption and utiliZation of other 65 synovial ?uid thick and elastic in joints and vertebrae. nutrients, and an herbal blend composed of ingredients that Numerous studies have shoWn the bene?cial effects of coact With other components to promote healthy joint func glucosamine sulfate and its relationship With the symptoms US 6,224,871 B1 3 4 of osteoarthritis, the most common form of arthritis. Such ginkgo biloba plant and boswellia serrata is from an ethanol double blind studies reveal that the oral administration of extract of boswellia serrata roots. Turmeric consists of glucosamine sulfate is effective in reducing articular pain, curcuminoids from an ethanol extract of cucuma longa joint tenderness and swelling, and the restrictions on active plant. Piper nigrum extract may be produced by the method and passive movements, and tends to rebuild damaged of isolation of piperine disclosed in Us. Pat. No. 5,536,506, cartilage, thereby restoring articular function in arthrosic and the compound obtained in such manner is commercially patients. available as “Bioperine” from Sabinsa Corporation. The herbal components of the dietary supplement of this The dietary supplement is an essentially dry mixture of invention include ginkgo biloba and turmeric, both knoWn 78% to 90% protein derived from the enZymatic hydrolysis for their properties as antioxidants and, in the case of 10 of collagen, 2% to 6% glucosamine sulfate, 2% to 5% turmeric, its anti-in?ammatory properties. Turmeric is a rich ginkgo biloba, 0.8% to 1.5% borage oil poWder, 0.3% to source of curcuminoids, particularly curcumin, 0.7% turmeric, 0.01% to 0.03% boswellia serrata, 0.5% to demethoxycurcumin, and bisdemethoxycurcumin. Continu 0.7% ashWagandha, 0.04% to 0.08% piper nigrum extract, ing laboratory and clinical research indicate that turmeric and 5% to 10% herbal blend. Optionally included in the and its phenolics have unique antioxidant and anti 15 supplement are up to 3% natural and arti?cial ?avoring in?ammatory properties. Sharma, O. P., “Antioxidant Activ agents and up to 5% lecithin, the latter being included to ity of Curcumin and Related Compounds,” Biochem. Phar facilitate processing of the blend during manufacture. macol. 25:1811 (1976); Scrimal, R. C., et al, “Pharmacology The herbal blend, Which constitutes 5% to 10%, may itself of Diferuloyl Methane (Curcumin), A Non-Steroidal Anti contain up to 20% (preferably 8% to 15%) of each of the In?ammatory Agent,” J. Pharm. Pharmacol. 25 :447 (1973). 20 folloWing ingredients: cat’s claW poWder, also knoWn as Such herbs are Widely available in poWder form, as is borage processed cat’s claW bark (Uncaria tormentosa), sarsaparilla oil poWder, also knoWn as an anti-in?ammatory agent as root, licorice root, kelp, burdock root poWder, alfalfa Well as a supplier of fatty acids. poWder, barley grass, and echinocea root. Additionally, the Other anti-in?ammatory compounds in this dietary herbal blend may also include up to 7% of each of the supplement are boswellia serrata and ashWagandha. 25 folloWing: yucca extract, bilberry extract, devil’s claW Boswellia serrata, With bosWellic acids as the active poWder, also knoWn as processed cat’s claW bark (Uncaria principle, are reported effective in various forms of arthritis, tormentosa), capsicum poWder, celery seed poWder, and aloe having been found to improve blood supply to the joints and vera extract. prevent breakdoWn of tissues affected by arthritis. Clinical While the ingredients identi?ed above are knoWn and 30 trials have revealed its effectiveness in reducing pain and commercially available, the folloWing sources are identi?ed morning stiffness as Well as improving grip strength and for further reference: glucosamine sulfate, SeltZer physical performance. It is regarded as a non-steroidal Chemicals, Carlsbad, Calif.; ginkgo biloba and kelp, Chart anti-in?ammatory compound Without the side effects caused Corp., Patterson, N.J.; borage oil poWder, Traco Labs, by non-steroidal analgesics such as aspirin. 35 Champaign, Ill.; turmeric, boswellia serrata, and Bioperine, AshWagandha, also knoWn as Indian ginseng, is a root Sabinsa Corp., PiscataWay, N.J.; cat’s claW poWder, sarsa extract described in the literature as an adaptogen or vitaliZer parilla root, yucca extract, bilberry extract, and celery seed and is used as a restorative or rejuvenative, particularly in poWder, Stryka Botanicals, Somerville, N.J.; ashWagandha, the management of chronic diseases. It has anti Fabrichem, Fair?eld, Conn.; licorice root, burdock root in?ammatory and analgesic properties, it loWers blood 40 poWder, alfalfa poWder, echinocea root, devil’s claW pressure, protects the liver from toxins, and protects an poWder, and capsicum poWder, Botanicals International, organism from the results of physical stress. It has been Long Beach, Calif.; barley grass, Vitarich Foods Inc., found to increase the state of NSIR (non-speci?cally Naples, Fla; aloe vera extract, Aloe Corp., Broom?eld, increased resistance) of the human body by offering protec Colo. tion against the deleterious effects of stress. 45 The folloWing examples are not intended to be limiting in Piper nigrum extract has been knoWn for its medicinal use any Way, but demonstrate some of the preferred embodi dating back to the seventh century BC. and experimental ments of the present invention. evidence shoWs it to be a thermonutrient capable of enhanc ing the bioavailability of other drugs and essential nutrients. EXAMPLE 1 As noted in Majeed et al US. Pat. No. 5,536,506, the 50 A herbal blend suitable for use in the dietary supplement disclosure of Which is incorporated herein by reference, the of this invention contains the folloWing herbs in the per metabolic pathWays for a nutrient and a drug are different in centages indicated: cat’s claW poWder 10.75%, sarsaparilla that a nutrient sustains basic metabolism and physiological root 10.75%, licorice root 10.75%, kelp 10.75%, burdock functions of an organism While a drug is utiliZed as an root poWder 10.75%, alfalfa poWder 10.75%, barley grass adjunct to basic metabolism to restore homeostasis to the 55 10.75%, echinacea root 10.75%, yucca extract 5.38%, cap physiological functions. In the context of this invention, sicum poWder 1.08%, celery seed poWder 1.08%, aloe vera piper nigrum extract is considered to increase the absorption extract 1.08%, bilberry extract 2.69%, devil’s claW poWder of nutrients and to increase their metabolic utiliZation. Its 2.69%. inclusion in this nutritional supplement is intended to The ingredients, all available commercially in dry form, enhance the crossing-over of nutrients and botanical com 60 are blended together using a standard ploW blender pounds through biological barriers such as, but not limited (American Process CPB-45) in a continuous mixing opera to, the gastrointestinal epithelium. tion in Which such ingredients are added in the folloWing The nutrients and nutritional supplements included in the sequence: cat’s claW poWder, sarsaparilla root, licorice root, composition of the present invention are available commer kelp, burdock root poWder, alfalfa poWder, barley grass, cially. The herbal compounds are generally available in 65 echinacea root, yucca extract, capsicum poWder together poWder form as a dried ethanol extract of a particular plant. With celery seed poWder and aloe vera poWder, and bilberry For example, ginkgo biloba is from an ethanol extract of the extract together With devil’s claW poWder. Activation of the US 6,224,871 B1 5 6 choppers of the blender for approximately 2 minutes results What is claimed is: in a substantially homogenous blend of herbal components. 1. A dietary supplement for nutritionally promoting EXAMPLE 2 healthy joint function comprising an essentially dry mixture The herbal blend of Example 1 may be blended With other of the folloWing ingredients in a daily serving of 7 g to 10 ingredients as folloWs to produce the dietary supplement in g: 78% to 90% protein derived from the enZymatic hydroly the form of a dry poWder: sis of collagen; 2% to 5% glucosamine sulfate; 2% to 3.5% ginkgo biloba (Salsburia adiantifolia); 0.8% to 1.2% borage oil poWder (Borago o?icinalis»; 0.3% to 0.6% turmeric (Curcuma longa); 0.01% to 0.03% Boswellia serrata; 0.5% Herbal blend 6.68% 10 Enzymatically hydrolyzed collagen 82.35% to 0.7% ashWagandha (Withania sominfera); 0.04% to (“Arthred”, Traco Labs, Inc.) 0.06% Piper nigrum extract; and 5% to 10% herbal blend. Glucosamine sulfate 3.18% 2. The dietary supplement of claim 1 in Which said herbal Turmeric 0.46% blend contains up to 20% of each of the folloWing ingredi BosWellia serrata 0.02% Piper nigrum extract (“Bioperine”) 0.06% 15 ents in said herbal blend: cat’s claW poWder (Uncaria Borage oil powder 1.06% tomentosa), sarsaparilla root (Smilax ornata), licorice root AshWagandha 0.59% (Glycyrrhiza glabra), kelp (Ascophyllum nodosum), bur Ginkgo biloba 2.82% Flavoring agent 1.28% dock root poWder (Arctium lappa), alfalfa poWder (Medicajo Lecithin 1.5 % sativa), barley grass (B. Hordeum vulgare L.), and echinocea 20 root (Echinacea purpurea). Using a conventional ploW blender (American Process 3. The dietary supplement of claim 2 in Which said herbal CPB-45) set for continuous mixing, the enZymatically blend also contains 0% to 7% each of the folloWing: yucca hydroliZed collagen in the form of a dry poWder (“Arthred”) extract (Yucca schidigera), bilberry extract (Vaccinium is introduced into the mixing chamber With the blender in myrtillus), devil’s claW poWder (Harpagophytum operation. Lecithin is then added gradually and the choppers 25 procumens), capsicum poWder (Capsicum annum linne), are turned on for approximately 2 minutes, folloWed by the celery seed poWder (Apium gaveolens), and aloe vera poW addition of the other dry ingredients in the folloWing der (Aloe barbaa'enis). sequence: glucosamine sulfate, curcumin 95% (turmeric), 4. The dietary supplement of claim 3 in Which said boswellia serrata, “Bioperine” (piper nigrum extract), ingredients of said herbal blend have the folloWing Weight herbal blend (of Example 1), borage oil poWder, natural 30 percentages of said herbal blend: cat’s claW poWder 10.75%, pineapple ?avoring, ashWagandha, and ginkgo biloba. The sarsaparilla root 10.75%, licorice root 10.75%, kelp 10.75%, choppers are again turned on for a period of an additional 2 burdock root poWder 10.75 %, alfalfa poWder 10.75 %, barley minutes to produce a uniformly-mixed dietary supplement grass 10.75%, echinocea root 10.75%, yucca extract 5.38%, embodying the invention. bilberry extract 2.69%, devil’s claW poWder 2.69%, capsi The dietary supplement prepared in accordance With 35 cum poWder 1.08%, celery seed poWder 1.08%, aloe vera Examples 1 and 2 takes the form of a ?ne dark-yelloW poWder 1.08%. poWder that is consumed enterally as a beverage. 7 g to 10 5. The dietary supplement of claim 1 in Which said g of the essentially dry mixture, optimally 8.5 g of that mixture has the folloWing proportions of ingredients in mixture, is mixed With Water, juice, milk, or any other Weight percentage: 82.35% protein derived from the enyZ suitable beverage. The recommended serving should be 40 matic hydrolysis of collagen, 3.18% glucosamine sulfate, consumed once each day. 2.82% ginkgo biloba, 1.06% borage oil poWder, 0.46% While in the foregoing We have disclosed an embodiment turmeric, 0.02% boswellia serrata, 0.59% ashWagandha, of the invention in considerable detail for purposes of 0.06% piper nigrum extract, 6.68% herbal blend, 1.5% illustration, it Will be understood by those skilled in that art lecithin, and 1.28% ?avoring agents. that many of these details may be varied Without departing 45 from the spirit and scope of the invention.