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Patent application title: INGESTIBLES CONTAINING SUGAR AND CINNAMON OR GINSENG

Inventors:  David Solomon (Toronto, CA)  Hector J. Gomez (Jupiter, FL, US)
Assignees:  ALLEGIANCE EQUITY CORPORATION
IPC8 Class: AA61K36258FI
USPC Class: 424728
Class name: Drug, bio-affecting and body treating compositions plant material or plant extract of undetermined constitution as active ingredient (e.g., herbal remedy, herbal extract, powder, oil, etc.) containing or obtained from panax or acanthopanax (e.g., ginseng, etc.)
Publication date: 2011-09-01
Patent application number: 20110212192



Abstract:

A composition of ingestible ingredients containing a first ingestible ingredient which has an undesired effect on the human body when ingested, wherein preferably the ingredient is sugar and the undesired effect is blood sugar fluctuations which can lead to diabetes, and at least one other ingestible ingredient which reduces the impact or the undesired effect of the first ingestible ingredient, wherein the other ingredient is either cinnamon or polyphenols from cinnamon, or ginseng or ginsenosides from ginseng. The composition may be in a package, a bulk mix or a product.

Claims:

1-25. (canceled)

26. A package of ingestible ingredients, each package containing a first ingestible ingredient having an undesired effect when ingested, and at least a second ingestible ingredient in an effective non-toxic amount which reduces the impact of the undesired effect of the first ingestible ingredient when the contents of the package are ingested.

27. A bulk mix containing a first ingestible ingredient having an undesired effect, when ingested and at least a second ingestible ingredient which reduces the impact of the undesired effect of the first ingestible ingredient when ingested.

28. A package containing table sugar and at least one ingestible beneficial ingredient in an effective non-toxic amount for reducing the impact of the undesired effect of the ingestion of the table sugar on the human body.

29. A bulk mix containing table sugar and at least one ingestible beneficial ingredient for reducing the impact of the undesired effect of the ingestion of the table sugar on the human body.

30. The package of claim 28 wherein the at least one beneficial ingredient is selected from an effective amount of cinnamon (or polyphenols found therein), an effective amount of ginseng (or ginsenosides found therein) or combinations thereof.

31. The mix of claim 29 wherein the at least one beneficial ingredient is selected from an effective amount of cinnamon (or polyphenols found therein), an effective amount of ginseng (or ginsenosides found therein) or combinations thereof.

32. A packet comprised of a first ingestible ingredient having an undesired effect on the human body when ingested and at least one ingestible ingredient in an effective non-toxic amount which reduces the impact of the undesired effect of the first ingestible ingredient when the contents of the package are ingested wherein the at least one ingestible ingredient comprises at least two ingestible ingredients (in effective non-toxic amounts) which reduce the impact of the effect of the first ingestible ingredient when the contents of the package are ingested.

33. A mix containing a first ingestible ingredient having an undesired effect on the human body when ingested and at least one ingestible ingredient in an effective non-toxic amount which reduces the impact of the undesired effect of the first ingestible ingredient ingested wherein the at least one ingestible ingredient comprises at least two ingestible ingredients (in effective non-toxic amounts) which reduce the impact of the effect of the first ingestible ingredient when ingested.

34. A paper package containing table sugar and at least one ingestible ingredient selected from an effective amount of cinnamon (or polyphenols found in cinnamon), ginseng (or ginsenosides found in ginseng, and combinations thereof, for reducing the effect of the ingestion of the table sugar on the human body when all are ingested.

35. A bulk mix containing table sugar and at least one ingestible ingredient selected from an effective amount of cinnamon (or polyphenols found in cinnamon), ginseng (or ginsenosides found in ginseng, and combinations thereof, for reducing the effect of the ingestion of the table sugar on the human body when all are ingested.

36. A comestible product suitable for ingestion by a human comprising a combination of Products A and B packaged together, Product A being an ingestible product which has an undesired effect(s) on the human when ingested by the human and Product B reduces the impact of the effects of the ingestion of Product A on the human body.

37. The product of claim 36 wherein Product A is table sugar and Product B comprises cinnamon or ginseng or combinations thereof, each in effective non-toxic amounts.

38. The product of claim 37 wherein when Product B is cinnamon, the amount of cinnamon present comprises an effective non-toxic amount to impact the undesirable effect of table sugar.

39. The product of claim 38 wherein the effective amount of cinnamon comprises polyphenols or polyphenol polymers present in the cinnamon in the effective non-toxic amount of at least about 12% (w/w) polyphenols.

40. The product of claim 38 wherein when Product B is ginseng, the effective amount of ginseng present is in the form of ginseng extract standardized 1.5 to 7% of ginsenosides.

41. The package of claim 30 wherein the at least one ingestible ingredient comprises effective amounts of cinnamon and ginseng and the amounts may be from cinnamon extract and ginseng extract mixed with the table sugar.

42. The package of claim 41 wherein the cinnamon extract includes cinnamon aqueous extract TC112 which has at least about 12% (w/w) polyphenols.

43. The package of claim 42 wherein the ginseng extract includes ginseng extract standardized at 1.5 to 7% of ginsenosides.

44. The package of claim 41, 42 or 43 wherein the ratio of cinnamon extract to ginseng extract is 1 to 1 by weight.

45. The mix of claim 31 wherein the at least one beneficial ingredient comprises effective non-toxic amounts of cinnamon and ginseng and the amounts may be from cinnamon extract and ginseng extract mixed with the table sugar.

46. The mix of claim 45 wherein the cinnamon extract includes cinnamon aqueous extract TC112 which has at least about 12% (w/w) polyphenols.

47. The mix of claim 45 or 46 wherein the ginseng extract includes ginseng extract standardized at 1.5 to 7% of ginsenosides.

48. The mix of claim 45 or 46 wherein the ratio of cinnamon extract to ginseng extract is 1 to 1 by weight.

49. The product of claim 38, 39, 40, 41 or 42 wherein the polyphenols contain at least about 1% polyphenol Type A polymers.

50. The mix of claim 45 or 46 wherein the polyphenols contain at least about 1% polyphenol Type A polymers.

51. The mix of claim 47 wherein the polyphenols contain at least about 1% polyphenol Type A polymers.

Description:

FIELD OF INVENTION

[0001] This invention relates to packages for example recyclable paper packets or sachets of ingestible ingredients, each package containing a first ingestible ingredient having an undesired effect on the human body and at least one ingestible ingredient which reduces the impact of the undesired effect(s) of the first ingestible ingredient when the contents of the package are ingested. This invention also relates to the bulk mix of a first ingestible ingredient having an undesired effect on the human body and at least one ingestible ingredient which reduces the impact of the undesired effect(s) of the first ingestible ingredient when ingested.

BACKGROUND OF INVENTION

[0002] Coffee is one of the most popular hot beverage drinks in the world. Table sugar and milk and/or cream are popular additions to the hot beverage. For take out of cups of coffee from restaurants and coffee shops, the proprietors provide the customers usually with packets or sachets of sweetener, including table sugar in the packets or sachets set near the coffee pot for the user to help herself/himself when the coffee is poured into the disposable drinking cup. Each such sachet or packet usually contains about 3 grams (1 teaspoon) of table sugar. Some proprietors use sugar bowls of table sugar.

[0003] Sugars affect the human body in many ways. Some of these ways are good, some are bad and some are worse.

[0004] Energy created for the human from ingested sugars is the good since humans need the energy to function. The best sugars are those having a low glycemic index rating. These sugars are released by the body into the blood stream at a slower, more healthy absorption rate.

[0005] The bad and worse news associated with sugars is that many are processed into all kinds of foods humans ingest. These sugars often carry a high glycemic index rating (such as table sugar) thereby being more quickly released into the bloodstream. This faster release and subsequent absorption causes the pancreas (the organ which controls sugar levels) to release insulin which drops the blood-sugar levels in the body. Fluctuation in blood-sugar levels by the human ingesting these sugars not only stresses the human body, but over time can lead to diabetes.

[0006] Three types of sugars that are processed into everyday foods include sucrose (known most often in its white crystalline form, as "table sugar"), fructose or high-fructose (corn syrup) and dextrose, a sugar derived from corn. Almost all processed foods have one or more of these processed sugars. Common foods such as bread, peanut butter, sauces, jams, syrups and condiments (for example ketchup) have table sugar processed into them, often to keep them fresh or to preserve them and to enhance their flavours.

[0007] The white crystalline substance, table sugar, is an unnatural substance produced by industrial processes (mostly from sugar cane or sugar beets) by "refining", for example the sugar cane or sugar beets, down to pure sucrose, after stripping away all the vitamins, minerals, proteins, enzymes and other beneficial nutrients.

[0008] What is left is a concentrated "unnatural" substance which the human body is not able to process comfortably, at least not in anywhere near the quantities that are now ingested in today's accepted lifestyle. The average American (man, woman and child) now consumes approximately 115 pounds of sugar per year.

[0009] Table sugar does so much damage when ingested because it is considered and marketed as a "food", and is ingested in huge quantities starting early in life yet is pure chemical and through refining has been stripped of all the natural food nutrition that it originally had in the plant itself. For example, from the day a baby is born and nursed by his/her mother, if the mother eats table sugar (usually the case), the baby ingests the table sugar. If the baby is given formula, table sugar is in the formula.

[0010] The ingestion of this "alien" chemical, table sugar, in such quantities that humans ingest, damages the body over the years including the pancreas, adrenal glands and throws the whole endocrine system out of kilter causing diabetes, hyperglycemia and hypoglycemia. Sugar thus has an extremely harmful effect in unbalancing the endocrine system and injuring its component glands such as the adrenal glands, pancreas and liver, fluctuating the blood sugar level widely. Table sugar when ingested as discussed is processed by insulin, the hormone produced by the pancreas that helps the body control the level of the sugar in the blood. If the body makes little or no insulin or the body cannot use it readily, the person has diabetes.

[0011] Diabetes is a lifelong condition where either the human body (pancreas) does not produce enough insulin, or the body cannot use the insulin it produces. The human body needs the insulin to change the "table sugar" from food into energy.

[0012] When the body cannot do so, it has one of three types of diabetes: [0013] Type 1, where the body makes little or no insulin; [0014] Type 2, where the body (pancreas) makes either not enough insulin but cannot use it properly; and [0015] Gestational Diabetes, where the body is not able to properly use insulin during pregnancy. This type of diabetes usually goes away after the baby is born.

[0016] Nine out of ten people with diabetes have Type 2 diabetes.

[0017] Thus people having Type 2 diabetes (in which the pancreas does not produce enough insulin, or the body does not properly use the insulin it makes) build up glucose in the blood instead of the glucose being used for energy--a dangerous condition.

[0018] Diabetics having Type 2 diabetes (including those marginally diabetic) who drink coffee picked up for take out, in many instances sweeten their coffee, not by artificial sweeteners which have their own undesirable effects, but by emptying the contents of at least one packet or sachet of table sugar into the hot coffee (or tea). Some coffee (tea) drinkers do it automatically without thought.

SUMMARY OF INVENTION AND DETAILED DISCUSSION OF EMBODIMENTS THEREOF

[0019] It is, therefore, an object of this invention to provide packages for example recyclable paper packets or sachets, of ingestible ingredients, each package containing a first ingestible ingredient having an undesired effect on the human body and at least one ingestible ingredient in an effective non-toxic amount which reduces the impact of the undesired effect of the first ingestible ingredient when the contents of the package are ingested.

[0020] It is a further object of this invention to provide a bulk mix containing a first ingestible ingredient having an undesired effect on the human body and at least one ingestible ingredient (in an effective non-toxic amount) which reduces the impact of the undesired effect of the first ingestible ingredient when ingested.

[0021] It is a further object of this invention to provide in one embodiment, a package (packet or sachet) and a mix containing table sugar and at least one ingestible ingredient (for example an effective amount of cinnamon (or polyphenols for example found therein) or ginseng (or ginsenosides for example found therein) or combinations thereof) for reducing the impact of the undesired effect of the ingestion of the table sugar on the human body.

[0022] Thus according to one aspect of the invention there are provided packages (for example recyclable or disposable paper packets or sachets) containing a first ingestible ingredient having an undesired effect on the human body when ingested and at least one ingestible ingredient in an effective non-toxic amount which reduces the impact of the undesired effect of the first ingestible ingredient when the contents of the package are ingested.

[0023] The at least one ingestible ingredient may comprise for example at least two ingestible ingredients (in effective non-toxic amounts) which reduce the impact of the effect of the first ingestible ingredient when the contents of the package are ingested.

[0024] According to another aspect of the invention there is provided a mix, and a paper package (or sachet), containing table sugar (as the first ingredient)and at least one ingestible ingredient (for example an effective amount of cinnamon (or polyphenols, for example found in cinnamon) or ginseng (or ginsenosides for example found in ginseng or combinations thereof) for reducing the effect of the ingestion of the table sugar on the human body when all are ingested.

[0025] According to another aspect of the invention, a comestible product suitable for ingestion by a human is provided comprising a combination of Products A and B together (for example packaged together), Product A being an ingestible product which has (an) undesired effect(s) on the human when ingested by the human (for example such as table sugar) and Product B reduces the impact of the effects of the ingestion of Product A on the human body.

[0026] According to another aspect of the invention Product B is a product (preferably a Natural Product") with medicinal benefits. A "Natural Product" includes both cinnamon and ginseng.

[0027] According to another aspect of the invention the packaging may comprise disposable/recyclable paper packets or sachets.

[0028] According to still another aspect of the invention Product A is table sugar and Product B comprises cinnamon or ginseng or combinations thereof, each in effective amounts.

[0029] Where the ingredient or Product B is cinnamon, the amount of cinnamon present comprises an effective amount to impact (for example reduce) the undesirable effect of for example, table sugar. Preferably the effective amount of cinnamon comprises polyphenols (water soluble polyphenol polymers present in the cinnamon) in the effective non-toxic amount of at least about 12% (w/w) polyphenols (preferably containing at least about 1% doubly-linked polyphenol Type A polymers). Thus preferably the effective amount of the cinnamon present is in the form of a cinnamon extract, such as cinnamon extract TC112 prepared by Finzelberg (Andernach, Germany). 112 mg of aqueous cinnamon extract TC112 corresponds to 1 gm of cinnamon with respect to equivalent amounts of polyphenols. The extract contains at least about 12% (w/w) of polyphenols. Preferably the extract contains at least about 1% polyphenol Type A polymers.

[0030] This cinnamon product is discussed in "effects of a cinnamon extract on plasma glucose, HbA1c, and serum lipids in diabetes mellitus type 2", European Journal of Clinical Investigation 36, 340-344, 2006 by B. Mang et al., where it was disclosed that cinnamon extract seemed to have a moderate effect in reducing fasting plasma glucose concentrations in diabetic patients with poor glycaemic control. A cinnamon capsule was used which contained 112 mg of the aqueous cinnamon extract TC112 prepared by Finzelberg (Andernach, Germany) corresponding to 1 g of cinnamon.

[0031] The use of purified aqueous cinnamon extract for 4 months resulted in a 10.3% decrease in fasting blood sugar compared to 3.3% in the placebo group. TC112 capsules 112 mg of aqueous cinnamon extract corresponding to 1 g of cinnamon.

TABLE-US-00001 TABLE 2 Variables of glucose and lipid metabolism at baseline and after the intervention period Cinnamon Placebo Variable group (n = 33) group (n = 32) Fasting plasma glucose 9.26 ± 2.26.sup. 8.66 ± 1.47 at baseline (mmol L-1) Fasting plasma glucose 8.15 ± 1.65.sup.† 8.31 ± 1.62 postintervention (mmol L-1) Differences.sup..dagger-dbl. of fasting 1.11 ± 1.59.sup.§ 0.35 ± 1.29 glucose (mmol L-1) Mang et al. Effects of a cinnamon extract on plasma glucose, HhA1c, serum lipids in diabetes mellitus type 2. Eur J Clin Investig 36: 340-344, 2006

[0032] The beneficial effects of cinnamon extract are the Polyphenols found in its water-soluble fractions. The major active component of the cinnamon extract appears to be doubly linked procyanidin type-A polymers (Anderson et al., 2004). CE has been reported to have anti-oxidant effects in rats (Lee et al., 2003; Lin et al., 2003; Anderson et al., 2004) and humans, insulin-potentiating effects in rats (Qin et al., 2003; 2004), mice (Kim et al., 2006) and humans (Khan et al., 2003; Ziegenfuss et al., 2006; Wang et al., 2007). Cinnamon extract also prevents insulin resistance induced by a high-fructose diet in rats (Qin et al., 2004). In addition, cinnamon decreases levels of glucose, triglycerides, and LDL cholesterol in people with type-2 diabetes (Khan et al., 2003).

[0033] Water-soluble polyphenol polymers are believed to be the key components responsible for its beneficial metabolic effects (Anderson et al., J. Agric. Food Chem. 2004, 52, 65-70); they enhance the activity of insulin and are antioxidants. The polyphenol type-A polymers from cinnamon upregulate genes involved in blood sugar control (Imparl-Radosevich et al., Horm res 50(3):177-182, 1998). These polymers are composed of monomeric units with a molecular mass of 288. Two trimers with a molecular mass of 864 and a tetramer with a mass of 1152. Their protonated molecular masses indicated that they are A type doubly linked procyanidin oligomers of the catechins and/or epicatechins. (J. Agric. Food Chem. 2004, 52, 65-70).

[0034] In "Cinnamon improves glucose and lipids of people with type 2 diabetes.", Diabetes Care 26:3215-3218, 2003 by A. Khan et al., a human study was conducted involving subjects with type 2 diabetes consuming cinnamon. Subjects consumed 1, 3, or 6 g of cinnamon per day for 40 days with 3 placebo groups corresponding to the three groups that consumed different numbers of capsules containing cinnamon. Decreases in fasting serum glucose (18-29%), triglycerides (23-30%), total cholesterol (12-26%), and LDL cholesterol (7-27%) were found after 40 days. Benefits in insulin sensitivity were also likely to lead to decreased incidence of cardiovascular diseases, which is more than double in people with diabetes.

[0035] The following Table 1 from Khan, et al., illustrates the effects of cinnamon on glucose levels in people with type 2 diabetes

TABLE-US-00002 Fasting serum glucose level (mmol/l).sup.† Before After Doses of cinnamon cinnamon cinnamon intake During cinnamon intake intake Group* (g/day) Day 0 Day 20 Day 40 Day 60 1 1 11.6 ± 1.7a .sup. 10.5 ± 1.8ab 8.7 ± 1.6c .sup. 9.7 ± 1.4bc 2 3 11.4 ± 1.2a .sup. 9.9 ± 1.1ab 9.4 ± 1.1b .sup. 9.9 ± 1.6ab 3 6 13.0 ± 1.4a .sup. 10.2 ± 1.3bc 9.2 ± 1.5c .sup. 11.4 ± 1.8ab 4 Placebo 1 12.2 ± 1.0a 12.7 ± 0.8a 12.4 ± 1.1a 12.6 ± 1.0a 5 Placebo 2 12.4 ± 1.0a 11.8 ± 0.9a 12.7 ± 1.0a 12.6 ± 1.3a 6 Placebo 3 16.7 ± 1.4a 16.7 ± 1.6a 16.8 ± 1.7a 17.0 ± 1.3a Data are means ± SD. *Ten individuals in each group; .sup.†means followed by different superscript letters in the same row are significantly different at P < 0.05.

[0036] In "Isolation and Characterization of Polyphenol Type-A Polymers from Cinnamon with Insulin-like Biological Activity", J. agric food chem. 52(1):65-70, 2004 by Anderson et al., it was disclosed that water-soluble polyphenol polymers from cinnamon would increase insulin dependent in vitro glucose metabolism roughly 20-fold and display antioxidant activity. Certain studies demonstrated that water-soluble polymeric compounds isolated from cinnamon have insulin-enhancing biological activity in the in vitro assay measuring the insulin dependent effects on glucose metabolism and also function as antioxidants. These same compounds have been shown to inhibit phosphotyrosine phosphatase in the insulin-receptor domain and to activate insulin receptor kinase and function as a mimetic for insulin 3T3-L1 adipocytes.

[0037] There are two types of cinnamon: Ceylon and cassia, both derived from the bark of evergreen trees. Ceylon cinnamon is grown in South America, Southeast Asia, and the West Indies, while cassia cinnamon is grown in Central America, China, and Indonesia. Ceylon cinnamon bark looks like tightly rolled scrolls, while cassia cinnamon is more loosely rolled. Cassia is the variety most commonly sold in the United States.

[0038] Several polyphenolic polymer compounds have been isolated from cinnamon bark. In test tube assays using fat cells, the polyphenolic polymers were found to increase sugar metabolism a whopping 20-fold. Previous studies suggest that compounds from cinnamon exhibit insulin-like activity in cells, intact animals and people with type 2 diabetes.

[0039] To understand the molecular basis of the insulin-like activity and explore additional benefits of cinnamon, the effects of compounds from cinnamon were investigated on the utilization of sugar and control of insulin function. The results showed that factors from cinnamon improve/inhibit factors involved in inflammation. These results suggest that compounds from cinnamon were involved in the use of sugar by cells.

[0040] It has also been shown that cinnamon improves glucose and lipid profiles of people with type 2 diabetes and that a water-soluble cinnamon extract and HPLC-purified cinnamon polyphenols (CP) display insulin-like activity. The objective of the study was to investigate the biochemical basis for the insulin-like effects of cinnamon. Immunoblotting procedure was employed to analyze three proteins, insulin receptor (IR), glucose transporter 4 (GLUT4), and the anti-inflammatory protein tristetraprolin (TTP) involved in insulin signal transduction pathway in mouse 3T3-L1 adipocytes. The results showed that both insulin and CP increased the levels of the three proteins, and recombinant TTP was phosphorylated in vitro by glycogen synthase kinase 3 beta and protein kinases A, B, and C. These results suggest that like insulin, CP increase the amount of the three critically important proteins involved in insulin signaling, glucose transport and inflammatory response. A model of actions was proposed to link CP and TTP in insulin signal transduction pathway. The study provided new biochemical evidence for the beneficial effects of CP in insulin-like action and suggests anti-inflammatory properties of CP.

[0041] Preferably the type of cinnamon extract to be used should contain at least 12% (w/w) of water-soluble polyphenol polymers without volatile oils. The polyphenol polymers should preferably be Type-A polymers doubly linked procyanidin oligomers of the catechins and/or epicatechins

[0042] Cinnamon extract can be used in doses ranging between about 50 to about 1,000 mg/day.

[0043] Cinnamon extract in the amounts of 50 to 1,000 mg/day which contain 12% of polyphenols are approximately equivalent to 0.5 to 6 grams per day of Cinnamon powder. These polyphenol polymers are composed of monomeric units with a molecular mass of 288, two trimers with a molecular mass of 864 and a tetramer with a mass of 1152.

[0044] The major active component of cinnamon extract, it is believed, appears to be the doubly linked procyanidin Type-A polymers.

[0045] The total phenolic content of cinnamon extract and its antioxidant potential are both predictive of the extract's ability to inhibit protein glycation (Dearlove et al., J of Medicinal Food 11(2):275-281. 2008). Glucose and fructose form glycation products linked to serious diseases. For example, postprandial fructose has been linked to retinopathy in diabetics (Kawsaki et al., Metabolism 53: 583-588, 2004) and fructose has been implicated in symptoms of metabolic syndrome (Kawasaki et al., Diabetes Care 25:353-357, 2002).

[0046] Reference should also be had to Hlebowicz et al., Effect of cinnamon on postprandial blood glucose, gastric emptying, and satiety in healthy subjects. Am J Clin Nutr 85:1552-6, 2007 which teaches the following:

Cinnamon (6 g) reduced postprandial blood glucose AUC by 52% at 45 minutes (from 68.1 to 32.4, table 1) in healthy people.

TABLE-US-00003 TABLE 1 Postprandial blood glucose areas under the curve (AUCs) in healthy subjects after ingestion of meals consisting of rice pudding with or without added cinnamon1 Rice pudding without Rice pudding with Cinnamon cinnamon AUC mmol * min/L 0-15 min 6.8 ± 1.8 .sup. 3.6 ± 1.0 0-30 min 30.7 ± 5.1 13.7 ± 3.42 0-45 min 68.1 ± 8.2 32.4 ± 6.62 0-60 min 97.2 ± 11.0 47.3 ± 9.22 0-90 min 125.0 ± 16.8 63.3 ± 11.72 0-120 min 139.1 ± 19.6 75.0 ± 13.72 1All values are x ± SEM; n = 14. Significant differences in postprandial blood glucose AUCs were evaluated with Wilcoxon's t test. 2Significantly different from rice pudding without cinnamon, P < 0.05.

Cinnamon (6g) was also shown to have reduced fasting blood glucose by 54% (from 2.6 to 1.2 mmol/L, FIG. 1) in healthy people. Ziegenfuss et al., also showed the effect of water-soluble cinnamon extract in pre-diabetic men and women. J Int Soc Sports Nutrition 3(2):45-53, 2006

[0047] Ginseng also reduces plasma glucose concentration in the human. The effective amount of ginseng preferably present, is in the form of ginseng extract standardized at 1.5 to 7% of ginsenosides.

[0048] The term ginseng refers to several species of the genus Panax. For more than two thousand years, the roots of this slow-growing plant have been valued in Chinese medicine. The two most commonly used species are Asian ginseng (Panax ginseng C. A. Meyer), which is mostly extinct in its natural range but is still cultivated, and American ginseng (P. quinquefolius L.), which is both harvested from the wild and cultivated. Panax ginseng should not be confused with Siberian ginseng (Eleutherococcus senticosus). In Russia, Siberian ginseng was promoted as a cheaper alternative to ginseng and was believed to have identical benefits. However, Siberian ginseng does not contain the ginsenosides that are present in the Panax species, which are believed to be active ingredients and have been studied scientifically.

[0049] In "Ginsengs: A Review of Safety and Efficacy", Nutrition in Clinical Care 3(2):90, 2000 by Gail E. Mahady et al., an investigation of ginseng involved a standardized extract of panax ginseng containing 1.5 to 7% of ginsenosides. The recommended dose was 0.5 to 2 g per day of dried root, corresponding to 100 to 300 mg per day of this extract.

[0050] In another example, in Ginsana G2G® (a ginseng supplement) the recommended daily dose is 200 mg of ginseng extract per day.

[0051] According to the U.S. National Institutes of Health website, the daily therapeutic dosage of ginseng root is 0.5-2 g of the dried root, or 100 to 300 mg per day of a standardized extract containing 1.5 to 7% ginsenosides, or other preparations taken correspondingly.

[0052] The German Commission E recommends Panax ginseng at the dosage of 1-2 g of root or equivalent preparations taken daily.

[0053] Standardized extracts are recommended with the dosage of 200-500 mg daily. Capsules of powdered root extracts are recommended with the dosage of 200-500 mg daily or 1-4 g of powdered root per day.

[0054] Tincture is recommended at the dosage of 1-2 ml daily of 1:1 extract (equivalent to 1-2 grams ginseng root).

[0055] Positive clinical trials with Panax ginseng generally involve a dosage of greater than 1 gram per day.

[0056] According to the U.S. National Institutes of Health, exceeding the recommended dose of Asian ginseng may cause adverse reactions such as hypertension, diarrhea, nervousness and insomnia. They also note that while there are no contraindications, Panax ginseng should be used with caution during pregnancy, nursing, and in children under the age of 12 years old, as safety data is currently unavailable.

[0057] Ginsenosides are a group of triterpenoid saponins that can be classified into two groups by the skeleton of their aglycones, namely dammarane- and oleanane-type. Ginsenosides are found nearly exclusively in Panax species (ginseng) and up to now more than 150 naturally occurring ginsenosides have been isolated from roots, leaves/stems, fruits, and/or flower heads of ginseng. Ginsenosides have been the target of a lot of research as they are believed to be the main active principles behind the claims of ginseng's efficacy. The potential health effects of ginsenosides include antidiabetic effects. Ginsenosides can be metabolized in the stomach (acid hydrolysis) and in the gastrointestinal tract (bacterial hydrolysis) or transformed to other ginsenosides by drying.

[0058] Where the at least one ingestible ingredient comprises effective amounts of cinnamon and/or ginseng, the amounts may be from cinnamon extract and ginseng extract mixed with the table sugar. Thus, the cinnamon extract may include cinnamon aqueous extract TC112 which has at least about 12% (w/w) polyphenols (preferably containing at least about 1% doubly-linked polyphenol Type A polymers). The ginseng extract may include ginseng extract from panax ginseng standardized at 1.5 to 7% of ginsenosides. In one embodiment, the ratio of cinnamon extract to ginseng extract is 1 to 1 by weight.

[0059] With respect to daily dosages of the cinnamon extract which is 120 mg of cinnamon aqueous extract having at least about 12% (w/w) polyphenols and the ginseng extract is equivalent of 120 mg of ginseng standardized at 1.5 to 7% of ginsenosides.

[0060] Thus in one embodiment the packets or sachets of, for example table sugar, preferably contain an effective amount of a form cinnamon (and/or polyphenols) or an effective amount of a form of ginseng (and/or gensenosides) or an effective amount of a combination of the two for the maintenance or lowering of blood-sugar levels (for consumption for example by diabetics, those marginally diabetic or those who are diabetic but do not know they are).

[0061] Because the average person consumes 31/2 cups of coffee (or tea) a day, each packet or sachet may for example contain 2/7 of the suggested daily dosage of the beneficial ingredient(s). such as cinnamon (or the polyphenols) or ginseng (or the ginsenosides) or combinations thereof. Therefore the user in 31/2 cups of coffee (or tea) would have his/her daily dose of the beneficial ingredients. This is assuming the amount of table sugar in each packet is 1 teaspoon. Where the packets contain larger amounts, for example containing two teaspoons of table sugar, the packets contents of the beneficial ingredient would be adjusted for example by increasing the amounts of their contents.

[0062] There are no concerns of overdoses with cinnamon given in moderation. The same is expected with respect to ginseng which is relatively safe even in relatively large amounts. Thus over the long run the coffee user (or tea user) is helped to deal with health issues related to diabetes and excess table sugar.

[0063] Preparation of packages and/or sachets of the ingredients may be by combining the ingredients to be put in each package by mixing them together in a mixer (where the ingredients are solids) or by spray drying the liquid(s) (for example where one ingredient is a liquid for example cinnamon extract) onto the table sugar during mixing, drying the material and then granulating to form the mix or before packaging in the packets and/or sachets as would be understood by persons skilled in the art. The mixed material may instead of being packaged in the packages or sachets, may be bulk packaged. The bulk material may then be used to fill for example sugar bowls.

[0064] Thus, in another embodiment, where cinnamon extract is used instead of raw cinnamon, the extract would have for example a polyphenol content at least equivalent to or slightly greater than the polyphenol content of the raw cinnamon used. This is because cinnamon extracts are more concentrated than raw cinnamon. Thus cinnamon extracts used would have equivalent polyphenol content as for example between about 0.01 grams of raw cinnamon to about 0.4 grams of raw cinnamon per gram of sugar.

[0065] Thus a packet of sugar (3 grams of sugar or one teaspoon) may have for example between about 0.03 grams of raw cinnamon or equivalent to about 1.2 grams of raw cinnamon or equivalent.

[0066] Further where ginseng extract is used instead of raw ginseng, the extract would have for example a ginsenoside content at least equivalent to or slightly greater than the ginsenoside content of the raw ginseng used. This is because ginseng extract is more concentrated than raw ginseng. Thus ginseng extracts used would have equivalent ginsenoside content as for example between about 0.14 grams of raw ginseng to about 0.6 grams of raw ginseng per gram of sugar.

[0067] Thus a packet of sugar (3 grams or one teaspoon) may have for example between about 0.14 grams of raw ginseng or equivalent and about 0.6 grams of raw ginseng or equivalent.

[0068] These amounts of cinnamon and ginseng can be adjusted up or down as desired. As may be the equivalent amount of extract of each or the amount of polyphenols or ginsenosides.

[0069] The ginseng and cinnamon may be combined with the sugar as discussed above.

[0070] A Certificate of Analysis for Batch No. CC/08007 from Natural Remedies Private Limited yielded the following test results in respect of suitable cinnamomum cassia extract suitable for use herein.

TABLE-US-00004 ≧12% total polyphenols Botanical name Cinnamomum cassia Part used bark Extract ratio 20:1 Solvent used Water, Methanol Excipients Collodal silicon dioxide (0-2% approx.) SL. NO. TESTS SPECIFICATION RESULT TEST PROTOCOL 1. Description Reddish brown to Brown -- Dark brown powder powder 2. HPLC Fingerprint To pass the test Compiles By HPLC [NR/QCD/APM04 WI(49)] 3. Moisture (% w/w) <8.0 4.3 As per USP <921> Method II 4. pH (5% w/v solution) 4.0-7.0 5.1 As per USP <791> 5. Total ash content (% w/w) <15.0 6.4 As per USP <561> 6. Acid insoluble Ash (% w/w) <5.0 0.2 As per USP <561> 7. Bulk density (g/cc) 0.15-0.60 0.42 As per USP <616> 8. Tapped bolk density (g/cc) 0.20-0.80 0.64 Method -I 9. Total soluble solids (% w/w) >90.0 90.8 As per USP <561> 10. Material passing >99.0 100 As per USP <786> through 30# Particle size BS/35 ASTM (% w/w) distribution 11. Heavy Metals AAS/ICP-ES Lead <5.0 ppm <0.1 Arsenic <2.0 ppm <0.1 Cadmium <0.2 ppm <0.1 Mercury <0.1 ppm <0.1 12. Microbiology Test As per Total viable aerobic count <103 cfu g-1 200 WHO/PHARM/92.559/ Total fungal count <103 fs g-1 No growth Rev. 1, Pg. 49 Total enterbacteriaceae <103 org g-1 <100 E. coli Absent Complies Salmonella species Absent Complies S. aureus Absent Complies 13. Courmarin content (ppm) <100.0 Complies By HPLC 14. Bio-assay [NR/BSY/SOP/004/01] α-amylase <100.0 Complies Inhibition IC50 (mcg/ml) 15. Phytochemical Analysis ≧12.0 12.5 By Spectrophotometry Total polyphenols (% w/w) [NR/QCD/APM06 WI(18)]

[0071] A Certificate of Analysis for Ginseng Dry Extract 108, Analysis Certificate N. 68297/1 in respect of Panax ginseng C. A. Meyer suitable for use herein gave the following test results in respect of the extract.

TABLE-US-00005 Determination Results Specification U.M. Extract/Drug ratio 1:4 1:3-5 HPLC Contents 11.8 ≧7.0 % Of total ginsengosides and malonyl ginsenosides, with reference to the dried substance Ginsenoside Rg1 0.99 0.9-1.4 % With reference to the dried substance Ginsenoside Rb1 1.94 1.7-3.0 % With reference to the dried substance Ratio Number Rg1/Rb1 51.0 ≧45.0 % Characters Complies Complies % Brown-yellow amorphous powder HPLC Identification Complies Complies pH 5.6 4.0-6.0 (c = 5, ethanol (30% v/v)) Loss on Drying 3.5 ≦7.0 % (T = 105° C., in vacumm, t = 3 h) Residue on Ignition 5.5 ≦9.0 % USP Lead <0.8 ≦5.0 ppm Cadmium <0.1 ≦0.2 ppm Mercury <0.05 ≦0.1 ppm Total residual Organic Solvents 0.14 ≦0.5 % Ethanol 0.14 ≦0.25 % Hexane <3.0 ≦50.0 ppm Sum of other solvents <11.0 ≦50.0 ppm Microbiological Control According to USP Bacteria <3000.0 ≦3000.0 cfu/g TM/0251 Molds and Yeasts <100.0 ≦100.0 cfu/g TM/0252 Escherichia Coli Absent Absent /g TM/0253 Salmonella Absent Absent /10 g TM/0254 Staphylococcus Aureus Absent Absent /g TM/0255 Pseudomonas Aeruginosa Absent Absent /g TM/0256 Pesticide Determination Complies Complies Acc. To specification Eur. Ph. Methods P-PRO-15 and P-PRO-16 Pesticide Determination Method P-FA-253 Pesticide <0.01 ≦0.01 ppm of Pentachlorobenzene Pesticide <0.01 ≦0.01 ppm of Technazene Pesticide <0.01 ≦0.01 ppm of 2,3,5,6-Tetrachloroaniline Pesticide <0.01 ≦0.01 ppm of Hexachlorobenzene Pesticide <0.01 ≦0.01 ppm of α-Hexachlorocyclohexane Pesticide <0.01 ≦0.01 ppm of Pentachlorocyclobenzene Pesticide <0.01 ≦0.01 ppm of γ-Hexachlorocyclohexane Pesticide <0.01 ≦0.01 ppm of β-Hexachlorocyclohexane Pesticide <0.01 ≦0.01 ppm of Pentachloroaniline Pesticide <0.01 ≦0.01 ppm of δ-Hexachlorocyclohexane Pesticide <0.01 ≦0.01 ppm of Pentachlorothioanisole Aflatoxin Determination According to method P-PRO-20 Aflatoxins <0.7 ≦4.0 ppb as a sum of B1, B2, G1 and G2 Aflatoxin <0.1 ≦2.0 ppb B1

[0072] As many changes can be made to the embodiments of the invention without departing from the scope of the invention, it is intended that all material herein be interpreted as illustration of the invention and no in a limiting sense.


Patent applications in class Containing or obtained from Panax or Acanthopanax (e.g., ginseng, etc.)

Patent applications in all subclasses Containing or obtained from Panax or Acanthopanax (e.g., ginseng, etc.)


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