CA2595096A1 - Herbal product comprising cinnamon and chocolate - Google Patents

Abstract

A new herbal product comprising cinnamon (Cinnamomi cassiae: Cinnamonum verum) and chocolate. Each of these ingredients is known to demonstrate therapeutic effects but the combination of the two ingredients demonstrates significant synergism and improved therapeutic effects.

Description

Title HERBAL PRODUCT COMPRISING CINNAMON AND CHOCOLATE
Field of the Invention [0001] This invention relates to a new herbal product and in particular, to a new herbal product comprising cinnamon (Cinnamomi cassiae: Cinnamonum verum) and chocolate. Each of these ingredients is known to demonstrate therapeutic effects but the combination of the two ingredients demonstrates significant synergism and improved therapeutic effects.

Background of the Invention [0002] Diabetes, hyperlipidemis and obesity, besides being detrimental to health by themselves, are all recognized risk factors for cardiovascular disease (CVD), which is still the number one killer in North America. Obesity is reaching epidemic proportions in N. America and Type 2 diabetes, with its close links to obesity, has become a major cause for concern. High blood cholesterol levels have persisted as a key factor in the development of atherosclerosis and CVD, and high triglycerides have also been recognized as an important risk factor, especially for women. The incidence of metabolic syndrome (also known as insulin resistance syndrome, or syndrome X), which presents as a cluster of characteristics and symptoms, including obesity, increased waist circumference, borderline high blood glucose and blood pressure levels, and abnormal blood lipid levels, has been increasing sharply since it was first recognised as a common precursor to both CVD and diabetes.

[0003] While modern pharmaceutical drugs exist for the treatment of hyperlipidemia, diabetes, and CVD, the side effects associated with many of these drugs may have severely detrimental health effects which preclude their use, or these side effects may simply reduces patient compliance. As a result, a majority of the population has been looking elsewhere for the treatment of these diseases and conditions, and complementary therapies have become a popular alternative to the pharmaceutical model for treatment.

[0004] A herbal product which is a likely candidate as a treatment option is cinnamon (Cinnamomi cassiae; Cinnamomum verum).

[0005] Cinnamon has been widely used for centuries, and is a traditional folk herb for diabetes mellitus in Russia, China and Korea. It is also thought to possess anti-fever and antibiotic properties, as well as being as mild analgesic and sedative. Recent research has focused on its ability to lower blood glucose levels. In recent animal studies, its blood-glucose-lowering ability was dose-dependent, with higher doses lowering glucose levels more than lower doses. Insulin levels increased, as did HDL cholesterol levels (the so-called "good" cholesterol).
Total and LDL cholesterol levels and triglyceride levels, on the other hand, were reduced with cinnamon supplementation. An additional benefit of cinnamon supplementation may be its antioxidant capacity, due to its phenolic acids and flavonoids. This antioxidant capacity may not only slow the progression of Type 2 diabetes complications, by quenching the excessive oxygen free radical damage seen in diabetes, it may also protect LDL cholesterol from oxidation, reducing the likelihood of it being scavenged and incorporated into blood vessel wall plaque, the latter being a major part of atherosclerosis, hypertension and CVD.

[0006] Cocoa and chocolate have recently been found to be rich plant-derived sources of antioxidant flavonoids with beneficial cardiovascular properties. These favourable physiological effects include: antioxidant activity, vasodilation and blood pressure reduction, inhibition of platelet activity, and decreased inflammation. Increasing evidence from experimental and clinical studies using cocoa-derived products and chocolate suggest an important role for these high-flavanol-containing foods in heart and vascular protection.

[0007] Accordingly, the present inventors have combined these two basic ingredients into a single therapeutic formulation which demonstrates synergistic results. The inventors have found that the new therapeutic formulation has resulted in the following:
1. Reduction in blood glucose levels and increased glucose tolerance in diabetics and people with metabolic syndrome.
2. Reduction in total and LDL cholesterol and triglycerides, and increase in HDL cholesterol in people with dyslipidemia, including people with metabolic syndrome.
3. Reduction in obesity.
4. Improved antioxidant capacity, with the potential to protect diabetics against free radical damage, and to reduce oxidized LDL cholesterol levels.

[0008] Thus, this new therapeutic formulation may be used to treat diabetes and CVD, and also in the precursor syndrome, where almost all of the characteristics of this syndrome - high total and LDL cholesterol, high triglyceride, low HDL cholesterol, borderline high blood glucose levels, obesity and high waist circumference - may be improved. Even borderline high blood pressure, which is normally affected by the degree of obesity, may be reduced.
In effect, this therapeutic formulation will reduce the incidence of metabolic syndrome, which, in turn, would reduce the incidence of diabetes, CVD and obesity. This is the first herbal combination with the potential to have more significant effects than pharmaceutical drugs on this triumvirate of conditions which continues to have a major impact on the health of North Americans.

Summary of the Invention [0009] To this end, in one of its aspects, the present invention provides a novel therapeutic formulation which comprises cinnamon and chocolate.

[0010] A further object of the present invention is to provide a new therapeutic formulation which comprises cinnamon and chocolate in a ratio of about 1:5 to about 1:10.
Preferably, the ratio is about 1:8.

[0011] A still further object of the invention is to provide a new therapeutic product which provides between about 250 milligrams to about 12,000 milligrams of cinnamon powder per day admixed in a vehicle of chocolate containing about 40 grams to about 50 grams of chocolate.

[0012] A still further object of the invention is to provide a new therapeutic product which provides between about 3000 milligrams to about 6000 milligrams of cinnamon powder per day admixed in a vehicle of chocolate containing about 40 grams to about 50 grams of chocolate.

[0013] A still yet further object of the present invention is to provide a new therapeutic product which contains between 250 milligrams to about 12,000 milligrams of cinnamon powder mixed in a chocolate bar containing about 40 grams to 50 grams of chocolate.

[0014] A still yet further object of the present invention is to provide a new therapeutic product which contains between about 3000 milligrams to about 6000 milligrams of cinnamon powder mixed in a chocolate bar containing about 40 grams to 50 grams of chocolate.

[0015] A still further object of the present invention is to provide a novel chocolate bar containing 43 grams of chocolate and 5000 milligrams of cinnamon powder for daily ingestion.

Detailed Description of the Invention [0016] The two active ingredients of the new therapeutic formulation are cinnamon and chocolate.

[0017] In recent years numerous laboratory and clinical studies have been conducted on cinnamon by biological scientists, pharmacologists and pharmacists at prestigious research centres like Department of Pharmacy at the Kings College of London, University of Califoinia, Santa Barbara, Iowa State University and the U.S. Department of Agriculture.
All of these studies show findings that confirm the therapeutic properties of cinnamon claimed by the traditional medicine and some of the research actually is considered to be break through in the field of natural health products. At USDA, scientists have been able to identify the particular molecule in cinnamon that mimics insulin and is responsible for its hypoglycaemic properties.

[0018] The new therapeutic formulation contains cinnamon and chocolate at a ratio of 1:8 which is the most synergistic combination of the two ingredients for the management of blood sugar levels of type 2 diabetes patients as well as for normalizing the lipid profiles.

[0019] The dietary habits of the developed countries such as Canada and United States have recently been criticized for causing an increase in the incidence of several types of lifestyle-related diseases such as diabetes, obesity and cardiovascular diseases.
Diabetes, a disorder of carbohydrate, fat and protein metabolism attributed to diminished production of insulin or mounting resistance to its action, is the most common metabolic disease presently. It is a major cause of disability and hospitalization resulting in a significant financial burden on the health care system (Rathi et al. 2002 and Virdi et al. 2003), and is estimated to cost Canadians up to $9 billion annually (Public Health Agency of Canada, 2005). It also has a significant impact on the health, quality of life and life expectancy of patients. Diabetes is a potent risk factor for cardiovascular disease as it not only affecting glucose metabolism but also influences lipid metabolism (Jayasooriya et al. 2000). Diabetes is divided into two major categories: type 1 diabetes, previously known as insulin dependent diabetes mellitus (IDDM), and type 2 diabetes, previously known as non-insulin dependent diabetes mellitus (NIDDM). Although the recommended treatments for these two categories are usually somewhat different, insulin for IDDM and lifestyle management for NIDDM, the overall result is improving glucose homeostasis. Lifestyle management such as changes in diet and an exercise regimen continues to be essential and effective but it may be insufficient or difficult for patient compliance rendering conventional drug therapies useful (Dey et al. 2002). The problems with the use of insulin or any other antidiabetic drugs are the presence of adverse effects such as hypoglycemia at higher doses, liver problems, lactic acidosis and diarrhea (Virdi et al.
2003). In recent years, there has been a growing interest in herbal medicines specifically herbal extracts as a popular alternative in healthcare due to people's perception of it being a`natural' product and therefore a minimal chance of having any side effects. The current popularity is also due to the many botanicals reported for the management of diabetes in other alternative systems of medicine such as Ayurveda and Traditional Chinese Medicine, the interest in these herbal plants has been piqued.

[0020] The following is a brief description of the two ingredients and their therapeutic properties.

[0021] Cinnamomum aromaticum (sp. Cassia) is from the family Lauraceae. It is a medium-sized evergreen tree native to China and Vietnam. It contains volatile oils composed of cinnamaldehyde, phenolic compounds, flavonoid derivates, methylhydroxychalcone polymer, mucilage, calcium oxalate, resins, sugars, and coumarins. Cassia, the species name for Cinnamomum aromaticum comes from the Greek work "kassia" meaning "to strip off the bark".
Cinnamon bark has been used medicinally in China since 2700 B.C.E and is said to supplement vital energy and blood, tone the kidney and spleen and acts as an antioxidant (Blumenthal et al.
1998). Cinnamomum aromaticum has also been used in Korea, China and Russia as a traditional folk herb with hypoglycemic properties for the treatment of diabetes mellitus (Kim et al. 2005).

[0022] The increasing prevalence of diabetes and cardiovascular disease is evident worldwide with an estimated 1700 new cases diagnosed daily (Jarvill-Taylor et al. 2001).
Additionally, several million people worldwide are suffering from `pre-diabetes' caused by high glucose levels with a resistance to insulin (Khan et al. 2003). The primary function of insulin is to maintain low blood glucose, lipid and cholesterol levels to maintain a sense of well-being.
Environmental factors such as diet, exercise, and stress also attribute to decreasing insulin sensitivity and increasing glucose and low-density lipoprotein (LDL) cholesterol levels, increasing the risk of cardiovascular diseases, obesity, dyslipidemias, diabetes mellitus and premature aging. The increase in disease is partly due to the augmented intake of calories and refined carbohydrates, lesser consumption of fibers and a more sedentary lifestyle. Controlling dietary intake and exercise could prevent disease but the majority of individuals require an extra aid to maintain normal health (Talpur et al., 2005). There is a growing interest in herbal remedies due to the side effects associated with therapeutic hypoglycemic agents and insulin (Kim et al. 2005). Botanical products with a long history of safety are widely used to lower glucose, lipid and cholesterol levels and for the prevention and treatment of diabetes.

[0023] Cinnamomum aromaticum has been used as a hypoglycemic agent in ancient medicines (Kim et al. 2005). The modem therapeutic properties of cinnamon are supportable based on thousands of years of use in well established systems of traditional medicines, as well as some modem clinical studies (Blumenthal et al. 1998). A number of well proven in vivo animal studies on Cinnamomum aromaticum demonstrate that activation of the insulin receptor increases autophosphorylation resulting in an increase in glucose uptake and glycogen synthesis.
However, there is a limited amount of published data on the effects of cinnamon consumption on blood glucose in humans. In vivo, in vitro and human studies have established that cinnamon extract regulates insulin activity and reduces serum glucose and cholesterol levels (Khan et al.
2003 and Kim et al. 2005).

[0024] In a study by Khan et al. in 2003, 60 men and women with type 2 diabetes ingested daily doses of cinnamon or placebo capsules for 40 days followed by a 20-day washout period.
Cinnamon capsules contained 1, 3 or 6 g of Cinnamomum aromaticum. After 20 days, only the 6 g cinnamon group showed significantly lower glucose levels. However, after 40 days, serum glucose (18-29%), triglycerides (23-30%) and total cholesterol (12-26%) concentrations were significantly lower in all cinnamon groups. Total cholesterol was lower in all groups at 40 days but low-density lipoprotein (LDL) concentrations were only significantly lower in the 3 g and 6 g cinnamon groups (10% and 24%, respectively). For the 1 g cinnamon group, LDL
concentrations continued to decline during the washout period and were significant at 60 days (P<0.05). The decreased concentration of glucose was maintained by the 1 g cinnamon group while triglyceride and total cholesterol levels were maintained in all cinnamon groups throughout the 20-day washout period.

[0025] Vanschoonbeek et al. 2006 performed a 6 week standardized placebo-controlled study to investigate the proposed benefits of Cinnamomum cassia on 25 postmenopausal women diagnosed with type 2 diabetes. Patients were divided into two groups and supplemented with 1.5 g/day of Cinnamomum or placebo to assess the effects on glucose tolerance and whole-body insulin sensitivity. At 0, 2 and 6 weeks oral glucose tolerance tests and blood lipid profiles were performed resulting in no time x treatment interaction observed for fasting glucose, insulin concentration, insulin resistance, (oral glucose) insulin sensitivity or fasting blood lipid concentrations. This study shows cinnamon supplementation does not have a health benefit in patients with type 2 diabetes contradicting the results found by Khan et al.
2003. Differences between the two studies could be attributed to the selection of patients and the combination of medications taken. In the current study, only postmenopausal female patients were included and continued using commonly prescribed combinations of oral blood glucose-lowering agents, which was not a factor in the study by Khan et al. 2003, explaining the low baseline values found in the patients used in the current study. Although the authors concluded cinnamon supplementation in combination with oral blood glucose-lowering agents may not be beneficial to overweight, postmenopausal women, this is a small concentrated study not factoring in the use of other medications and patient characteristics.

[0026] In a study by Talpur et al. in 2005, Zucker fatty rats (ZFRs) and spontaneously hyper-tensive rats (SHRs) were fed water or essential oils in acute or chronic doses to assess the effect of essential oil combinations on insulin sensitivity. The essential oil treatment consisted of 8 essential oils including cinnamon. Insulin sensitivity was determined by systolic blood pressure (SBP) and a glucose tolerance test. In the acute study, ZFRs and SHRs with essential oil treatments showed significant decreases in SBP at 4, 10 and 20 hours and at 4 hours, respectively. However, SBP levels were equal to the control group at 30 hours in ZFRs and at 10, 20 and 30 hours in SHRs. In the chronic study, ZFRs and SHRs consuming the essential oils showed significantly lower SBP at 8, 17 and 25 days in comparison to the control group.
Decreases in SBP levels ranged from 11 to 20 mmHg. During the oral glucose test, ZFRs consuming the essential oil combination showed consistently lower levels of circulating insulin, however these results were not significant. SHRs did not produce any effect on insulin levels and were equal to the controls, paralleling previous studies where effects were only produced when rats were challenged in stress-free environments (Verspohl et al. 2005).
The decreases in SBP and circulating glucose levels, produced by both species of rats, enhance insulin sensitivity and parallels the idea that fluctuating SBP is the most sensitive index of insulin sensitivity.
Cinnamon has been shown to have insulin-like actions and affect insulin signaling (Broadhurst et al. 2000), and as an ingredient in the essential oil combination it may have a role in the reduction of SBP.

[0027] In another study, Kim et al. 2006, administered db/db mice Cinnamomum cassia dosages of 50, 100, 150 or 200 mg/kg for 6 weeks to determine its effect on blood glucose. The control group showed high blood glucose levels at 2, 4, and 6 weeks. The cinnamon extract-treated group showed significantly lower blood glucose levels at each time period (P<0.05, <0.01 and <0.001). Significant decreases in triglyceride and total cholesterol levels were noted in the cinnamon extract group. Similar to Khan et al. 2003 these results parallel the hypoglycemic effects in the cinnamon extract-treated group as reduced levels are maintained for a long period of time.

[0028] In a similar study by Verspohl et al. in 2005, blood glucose and plasma insulin levels were evaluated in Wistar rats given extracts of Cinnamomum bark, cassia or zeylanicum. During the glucose tolerance test, plasma insulin levels increased significantly after the administration of Cinnamomum extracts with cassia showing the most pronounced effect. The saline placebo group showed no effect on plasma insulin. In all extract-treated groups, blood glucose levels did not decrease unless the rat was challenged by a glucose tolerance test in a stress-free environment. Cinnamomum cassia produced a direct insulin stimulatory effect showing superior effects compared to zeylanicum.

[0029] The increase in fructose consumption has risen worldwide in the past two decades as a significant proportion of energy intake in the diet. Qin et al. 2004 fed 18 male Wistar rats a high-fructose diet and 6 a control diet for 3 weeks to determine the effects of glucose utilization and insulin sensitivity. 12 of the rats consuming a high-fructose diet had Cinnamomum cassia extracts (300 mg/kg/day) added to their diet. During the euglycemic clamp procedure to measure glucose infusion rates (GIR), the 6 rats consuming only a high-fructose diet showed significant decreases (p<0.0001) in glucose infusion rates while cinnamon treated rats produced significant increases, similar to the controls. The consumption of a high-fructose diet, an environmental factor contributing to diabetes, is common in the western society; the addition of Cinnamomum cassia extract to the diet shows a preventative effect, through an increase in glucose utilization and insulin sensitivity.

[0030] In another study, the effect of cinnamon extract on insulin action was evaluated in Wister rats. Qin et al. 2003 randomly assigned 18 rats into three groups:
saline, 30mg/kg and 300mg/kg cinnamon extract. Cinnamon treatment for 3 weeks did not have an effect on plasma free fatty acids and fasting blood glucose concentrations. Although these levels were not affected in the cinnamon treated group, a difference was prevalent in glucose uptake compared to the placebo group. A dose-dependent manner was noticed with glucose utilization as 300mg/kg enhanced glucose utilization to a greater degree than the 30mg/kg or control groups.

[0031] Methylhydroxychalcone polymer (MHCP), a bioactive compound of cinnamon extract, is hypothesized to trigger an insulin-like response. In a study by Jarvill-Taylor et al.
2001, 3T3-L1 adipocytes were assessed with MHCP to determine its function as an insulin mimetic. Within the first 10 minutes of incubation, the insulin treated adipocytes showed a 2.5 fold increase in glucose transport while the MHCP treated group did not show any increase.
However, gradually over the one-hour period, glucose uptake increased in the MHCP treated group and at 60 minutes, a significant increase was noted. As noted in other studies, the effect of cinnamon did not diminish immediately after stopping treatment. As MHCP is administered, the kinase receptor is activated resulting in phosphorylation of the insulin receptor, a similar effect is seen throughout the insulin signaling pathway.

[0032] A similar study by Broadhurst et al. in 2000 reported an increase in insulin action demonstrated by cinnamon extract in vitro. Rat epididymal adipocytes were given either insulin or cinnamon extract after incubation to determine glucose metabolism. At all dilutions (1:2, 1:10, 1:50) cells exposed to cinnamon extract showed a significant increase in insulin-dependent activity and the effect was maintained at the high dilution (1:50). As adipocytes were treated with cinnamon extract the insulin receptor kinase became activated, a necessary requirement to increase insulin sensitivity. The activation of kinase mimics insulin activity in adipocytes.
Afterwards, active cinnamon extract was incubated with soluble polyvinylpyrrolidone (PVP) to determine if activity was associated with tannins or polyphenols. Cinnamon readily bound to PVP giving it a polyphenolic characterization. With an increase in glucose metabolism, 98% of activity is attributed to PVP indicating the use of phenolics to destroy free radicals that inhibit the activation of insulin-receptor kinase. Cinnamon extract mimics the same mechanism as insulin in adipocytes, increasing insulin sensitivity and glucose metabolism.

[0033] Cinnamomum aromaticum (cinnamon) has convincingly been shown to prevent and control elevated glucose and blood lipid concentrations in both in vitro and in vivo studies and can be maintained for a long period after use. The insulin kinase receptor is activated with cinnamon extract demonstrating insulin-mimetic activity. Elevated glucose and blood lipid concentrations increase the incidence of diabetes and/or cardiovascular health. The use of cinnamon extract can prevent these diseases by regulating the insulin receptor to increase glucose uptake and metabolism.

[0034] To date there have been no formal pharmacokinetic studies done on this plant in animals or humans. The only information derived from literature was a study conducted by Khan et al. in 2003 that found Cinnamomum aromaticum (extract) has a prolonged effect on the human body for 20 days during the washout period. Several animal studies have also shown prolonged effects after consumption of cinnamon extract.

[0035] The exact mechanism of action of Cinnamomum aromaticum (extract) is thought to be that it acts as an insulin-mimetic by activating the kinase receptor and increasing insulin sensitivity. The interaction within the intracellular kinase domain triggers an insulin-like response and stimulates glucose oxidation. Cinnamon also regulates enzymes inside the insulin receptor kinase domain and inhibits both phosphotyrosine-specific protein phosphatase (PTP-1) in vitro and glycogen synthase kinase-3 ^(GSK-3 ^) in vivo. The inhibition of PTP-1 keeps the insulin receptor in an activated state and inhibition of GSK-3 ^ stimulates glycogen production.
Cinnamon acts independently from insulin but similar levels of activity were observed proposing that it may activate the same cascade as the insulin signaling pathways (Jarvill-Taylor et al.
2001).

[0036] Cinnamon significantly helps people with type 2 diabetes improve their ability to respond to insulin, thus normalizing their blood sugar levels. Both test tube and animal studies have shown that compounds in cinnamon not only stimulate insulin receptors, but also inhibit an enzyme that inactivates them, thus significantly increasing cells' ability to use glucose. Studies to confirm cinnamon's beneficial actions in humans are currently underway with the most recent report coming from researchers from the US Agricultural Research Service, who have shown that less than half a teaspoon per day of cinnamon reduces blood sugar levels in persons with type 2 diabetes. Their study included 60 Pakistani volunteers with type 2 diabetes who were not taking insulin. Subjects were divided into six groups. For 40 days, groups 1, 2 and 3 were given 1, 3, or 6 grams per day of cinnamon while groups 4, 5 and 6 received placebo capsules. Even the lowest amount of cinnamon, 1 gram per day (approximately'/4 to V2 teaspoon), produced an approximately 20% drop in blood sugar; cholesterol and triglycerides were lowered as well.
When daily cinnamon was stopped, blood sugar levels began to increase.

[0037] Test tube, animal and human studies have all recently investigated cinnamon's ability to improve insulin activity, and thus our cells' ability to absorb and use glucose from the blood.

[0038] Ongoing in vitro or test tube research conducted by Richard Anderson and his colleagues at the USDA Human Nutrition Research Center is providing new understanding of the mechanisms through which cinnamon enhances insulin activity. In their latest paper, published in the Journal ofAgricultural and Food Chemistry, Anderson et al.
characterize the insulin-enhancing complexes in cinnamon-a collection of catechin/epicatechin oligomers that increase the body's insulin-dependent ability to use glucose roughly 20-fold..
Some scientists had been concerned about potentially toxic effects of regularly consuming cinnamon. This new research shows that the potentially toxic compounds in cinnamon bark are found primarily in the lipid (fat) soluble fractions and are present only at very low levels in water soluble cinnamon extracts, which are the ones with the insulin-enhancing compounds.

[0039] A recent animal study demonstrating cinnamon's beneficial effects on insulin activity appeared in the December 2003 issue of Diabetes Research and Clinical Practice. In this study, when rats were given a daily dose of cinnamon (300 mg per kilogram of body weight) for a 3 week period, their skeletal muscle was able to absorb 17% more blood sugar per minute compared to that of control rats, which had not received cinnamon, an increase researchers attributed to cinnamon's enhancement of the muscle cells' insulin-signaling pathway. In humans with type 2 diabetes, consuming as little as 1 gram of cinnamon per day was found to reduce blood sugar, triglycerides, LDL (bad) cholesterol, and total cholesterol, in a study published in the December 2003 issue of Diabetes Care. The placebo-controlled study evaluated 60 people with type 2 diabetes (30 men and 30 women ranging in age from 44 to 58 years) who were divided into 6 groups. Groups 1, 2, and 3 were given 1, 3, or 6 grams of cinnamon daily, while groups 4, 5, and 6 received 1, 3 or 6 grams of placebo. After 40 days, all three levels of cinnamon reduced blood sugar levels by 18-29%, triglycerides 23-30%, LDL
cholesterol 7-27%, and total cholesterol 12-26%, while no significant changes were seen in those groups receiving placebo. The researchers' conclusion: including cinnamon in the diet of people with type 2 diabetes will reduce risk factors associated with diabetes and cardiovascular diseases.(January 28, 2004) [0040] The latest research on cinnamon shows that by enhancing insulin signaling, cinnamon can prevent insulin resistance even in animals fed a high-fructose diet! A
study published in the February 2004 issue of Hormone Metabolism Research showed that when rats fed a high-fructose diet were also given cinnamon extract, their ability to respond to and utilize glucose (blood sugar) was improved so much that it was the same as that of rats on a normal (control) diet. Cinnamon is so powerful an antioxidant that, when compared to six other antioxidant spices (anise, ginger, licorice, mint, nutmeg and vanilla) and the chemical food preservatives (BHA
(butylated hydroxyanisole), BHT (butylated hydroxytoluene), and propyl gallate), cinnamon prevented oxidation more effectively than all the other spices (except mint) and the chemical antioxidants. (May 6, 2004).
[0041 ] In addition to its unique essential oils, cinnamon is an excellent source of the trace mineral manganese and a very good source of dietary fiber, iron and calcium.
The combination of calcium and fiber in cinnamon is important and can be helpful for the prevention of several different conditions. Both calcium and fiber can bind to bile salts and help remove them from the body. By removing bile, fiber helps to prevent the damage that certain bile salts can cause to colon cells, thereby reducing the risk of colon cancer. In addition, when bile is removed by fiber, the body must break down cholesterol in order to make new bile. This process can help to lower high cholesterol levels, which can be helpful in preventing atherosclerosis and heart disease.
[0042] Cinnamaldehyde (also called cinnamic aldehyde) has been well-researched for its effects on blood platelets. Platelets are constituents of blood that are meant to clump together under emergency circumstances (like physical injury) as a way to stop bleeding, but under normal circumstances, they can make blood flow inadequate if they clump together too much.
The cinnaldehyde in cinnamon helps prevent unwanted clumping of blood platelets. (The way it accomplishes this health-protective act is by inhibiting the release of an inflammatory fatty acid called arachidonic acid from platelet membranes and reducing the formation of an inflammatory messaging molecule called thromboxane A2.) Cinnamon's ability to lower the release of arachidonic acid from cell membranes also puts it in the category of an "anti-inflammatory" food that can be helpful in lessening inflammation.
[0043] Cinnamon's essential oils also qualify it as an "anti-microbial" food, and cinnamon has been studied for its ability to help stop the growth of bacteria as well as fungi, including the commonly problematic yeast Candida. In laboratory tests, growth of yeasts that were resistant to the commonly used anti-fungal medication fluconazole was often (though not always) stopped by cinnamon extracts.
[0044] Cinnamon's antimicrobial properties are so effective that recent research demonstrates this spice can be used as an alternative to traditional food preservatives. In a study, published in the August 2003 issue of the International Journal of Food Microbiology, the addition of just a few drops of cinnamon essential oil to 100 ml (approximately 3 ounces) of carrot broth, which was then refrigerated, inhibited the growth of the food borne pathogenic Bacillus cereus for at least 60 days. When the broth was refrigerated without the addition of cinnamon oil, the pathogenic B. cereus flourished despite the cold temperature. In addition, researchers noted that the addition of cinnamon not only acted as an effective preservative but improved the flavor of the broth.(October 1, 2003).
[0045] In addition to the active components in its essential oils and its nutrient composition, cinnamon has also been valued in energy-based medical systems, such as Traditional Chinese Medicine, for its warming qualities. In these traditions, cinnamon has been used to provide relief when faced with the onset of a cold or flu, especially when mixed in a tea with some fresh ginger.
[0046] In a study published in Nutrition Reviews; Mar 2006; 64, 3; Research Library PG. 109, Engler et al discusses the emerging role of chocolate in the treatment of cardiovascular health and disease. This paper reported that evidence based on epidemiological studies suggests that flavonoid-rich diets high in fruits and/or vegetables reduce the risk of coronary heart disease. Recent studies also report reduced cardiovascular risk and events associated with the consumption of foods rich in flavonoids.. A meta-analysis of seven prospective cohort studies with 105,000 individuals indicates that high dietary intake of flavonoids from a small number of fruits and vegetables, tea, and red wine is inversely associated with coronary heart disease risk.
Dietary flavonoids and their potential role in the prevention of cardiovascular disease have gained recent scientific and medical interest due to their antioxidant properties: their ability to scavenge reactive oxygen species (ROS) and reactive nitrogen species.
[0047] Oxidative stress due to excess production of free radicals or ROS is associated with a number of cardiovascular risk factors such as hypertension, dyslipidemias, diabetes, and smoking. Cellular DNA, proteins, and lipids are susceptible to ROS attack, which can result in damage to cell membranes and organelles. Mitogeniciry and apoptosis of vascular cells is enhanced, and in-creased expression and activation of redox-sensitive genes occurs. Tissue damage and pathophysiological processes, including endothelial dysfunction and atherosclerosis, eventually ensue. Oxidative modification of low-density lipoproteins (LDL) due to oxidative stress is believed to be a major contributing factor in atherosclerosis. The antioxidant properties of flavonoids represent one of many diverse beneficial effects that these poly-phenolic compounds may exert in cardiovascular disease. The direct antioxidant-quenching theory of fla-vonoids is now being supplanted by other physiological theories, including their effects on cellular redox regulation, signal transduction, and modulation of other enzyme and genomic systems.
[0048] Flavonoids, a subclass of polyphenols, are ubiquitous micronutrients derived from plants, primarily fruits and vegetables. There are more than 5000 flavonoids and six major flavonoid categories: flavanols, flavanones, flavones, isoflavones, flavonols, and anthocyanidins.
The various subclasses are listed below and include typical foods or beverages with a substantial content of flavonoids:

= Flavanols (catechin, epicatechin): chocolate, tea, red wine, beans, apricot, cherry, grape, peach, black-berry, apple;

= Flavanones (hesperetin, namgenin, eriodictyol): citrus fruits and juices;
= Flavones: (apigenin, luteolin): parsley, celery;

= Isoflavones: (daidzein, genistein): soy products;

= Flavonols: (quercetin, kaempferol, myricetin): on-ions, kale, broccoli, tomato, blueberry, apples, tea, red wine; and = Anthocyanidins (cyanidin, pelargonidin, peonidin, delphinidin, malvidin):
blueberry, black grape, cherry, blackberry, black currant, rhubarb, straw-berry, red wine, plum, red cabbage.
[0049] The antioxidant properties of flavonoids are related to their structure, two aromatic rings (an A-ring and a B-ring) on the ends bound by an oxygenated heterocycle in the middle (C-ring), which promote free radical scavenging. Specifically, the presence of the catechol or dihydroxylated B-ring allows rapid donation of hydrogen (electron) for stabilization of radical species. This is considered the most important structural feature defining the "classical" antioxidant nature of flavonoids.13 Structure-activity studies also show that flavonoids inhibit key enzymes such as NAD(P)H-oxidase (a major source of endogenous free radicals), tyrosine kinase, and protein kinase based on varied hydroxylation/methylation pat-terns.
[0050] The number of hydroxyl groups on the B-ring and the oxo group at the 4 position of the C-ring are also important in the suppression of cyclooxygenase-2 (COX-2), an inducible enzyme that is upregulated during inflammation and certain tumor formations.
Due to this structural feature, flavanols have been found to have more suppressive activity on COX-2 than flavonols. It is apparent that some functions of flavonoids are dependent on structure. While the antioxidant properties require two hydroxyl groups on the B-ring (with no carbonyl group at C4 or unsaturation of the C-ring), the anti-proliferative effects of flavonoids in many cancer studies require the additional presence of a carbonyl group at C4 and unsaturation of the C-ring.
Catechins and epicatechins, based on their catechol or dihydroxylated B-ring, appear to have a relatively restricted diversity in physiological activity. Flavonoids, depending on their structure, may also affect pathways in a cell- or tissue-specific manner depending on their structure.
[0051] Recent reviews also suggest that flavonoids exert non-antioxidant mechanisms that may confer protection such as binding to receptors, modulation of cellular signaling (i.e., protein and lipid kinase pathways), and gene expression. For example, flavonoids of the catechin family, major constituents of red wine, have been found to mediate the inhibitory effects of red wine on (3-platelet-derived growth factor (PDGF) receptor signaling, PDGF-dependent proliferation, and migration of vascular smooth muscle cells. PDGF is a potent mitogenic and chemotacric factor and one of many inflammatory components that contribute to atherogenesis.
Interestingly, the findings of this study are believed to provide a molecular explanation for the "French paradox" in that the French have a high consumption of red wine and one of the lowest incidences of coronary heart disease despite a diet with a high fat content.
[0052] Cocoa and chocolate contain both a high quantity and quality of antioxidant flavonoids, even exceeding black and green tea and red wine. Cocoa and chocolate, especially dark chocolate, have only recently been identified as rich sources of flavonoids due to advances in technology and analytical methods used in the detection of complex flavonoids. The high antioxidant capacity of cocoa and chocolate are attributed to their significant amount of procyanidins, the oligomeric form of the flavanol monomeric units, (-)-epicatechin and (+)-catechin. These monomers, mainly (-)-epicatechin, provide most of the total procyanidin content in chocolate; however, dimers (two monomer units) and up to 10 monomer units are also present. The amount of flavonoids in chocolate is not only dependent on the cacao bean, but also on the processing steps involved in chocolate's manufacture. For example, excess heat and alkalization ("Dutch" processing) can significantly reduce the amount of flavonoids. Typically, dark chocolate contains two to three times as many cocoa flavonoids as milk chocolate.

[0053] The antioxidant capacities of foods and beverages measured by current methodology, i.e., oxygen radical absorbance capacity (OR.AC-) assay with fluorescein, Trolox equivalent antioxidant capacity (TEAC), total radical-trapping antioxidant parameter (TRAP), ferric-reducing ability of plasma (FRAP), may not reflect in vivo antioxidant effects. The measurement of antioxidant capacity, which reflects the concentrated polyphenolic content of the food or beverage, is also not comparable among the different methods. Measurement of both the lipophilic and hydrophilic fractions in a given sample are needed to obtain an accurate total ORACFL (total antioxidant capacity) value.

[0054] Other factors such as processing, plant genetics, season, and growing conditions may also alter the phenolic content and, thus, the antioxidant capacity of foods.
Therefore, the content of flavonoids in various foods and beverages and their respective antioxidant properties may be dependent on a number of factors. Careful evaluation of these factors and the methodology used for measurements are important. With these considerations, flavonoids, specifically, the flavanols catechin and epicatechin, may be beneficial in cardiovascular health and disease based on their antioxidant properties, anti-proliferative effects, and other emerging physiolog-ically relevant mechanisms.
10055] Engler reported that the decreased susceptibility of LDL oxidation has recently been ascribed to the cocoa flavonoids and discusses the literature references.
[0056] Endothelial dysfunction is recognized as an early event in the development of atherosclerosis, and is associated with decreased bioavailability of the vasodilator nitric oxide. Current evidence suggests that the consumption of cocoa and chocolate, rich in flavonoids, may provide protective vascular effects. In isolated rabbit aortic rings, cocoa extracts were shown to induce endothelium-dependent relaxation and to activate endothelial nitric oxide synthase. Oligomeric forms of the monomeric units (-)-epicatechin and (+)-catechin, such as tetramers and higher, were associated with these effects.
Additionally, a favorable balance in eicosanoid synthesis has been reported in cultured human aortic endothelial cells exposed to cocoa flavanols and in human plasma samples from subjects 2 hours following the consumption of high-flavanol chocolate (37 g). A decrease in the plasma leukotriene-prostacyclin ratio was also found, which would result in more vasodilation, less platelet aggregation, and an anti-inflammatory profile. A significant rise in plasma epicatechin was also noted at the 2-hour time point following chocolate consumption.
[0057] Studies have shown in healthy subjects following 4 days to 2 weeks of daily consumption of a cocoa beverage or flavonoid-rich dark chocolate bar, increased vasodilation or improvement in endothelial function.
[0058] The cardioprotective mechanisms may be related to increases in plasma epicatechin or catechin concentrations that signal release of vasoactive substances from the endothelium, including nitric oxide and prostacyclin.
[0059] Studies also provide evidence for increased nitric oxide synthesis and beneficial changes in the eicosanoid ratio. Epicatechin in particular has been recently found to protect the integrity of endothelial cells by scavenging free radicals and by maintaining endothelial nitric oxide synthase. Moreover, several of the studies measured endothelium-dependent, flow-mediated dilation, which reflects an increase in flow and shear stress after reactive hyperemia, and is mediated by endothelium-derived nitric oxide and possibly prostanoids derived from the endothelium. When considered together with the increased expression and/or activity of endothelial nitric oxide synthase seen with long-term exposure to epicatechin and related polyphenols, this research provides a molecular basis for the cardioprotective effects of high epicatechin/catechin-containing foods and drinks.
[0060] In healthy subjects, the effects of cocoa and chocolate on blood pressure have been negative, with the exception of two recent studies. Two randomized, crossover trials in untreated hypertensives have also shown a blood pressure lowering effect following 14 to 15 days of consumption of 100 g of dark chocolate. A recent report suggests that cocoa flavanols may lower blood pressure by acting as an angiotensin I converting enzyme inhibitor, which also has antioxidant properties and can modulate nitric oxide production.

[0061] A suppressive effect on platelet reactivity and platelet-related primary hemostasis has been demonstrated in many studies even after a single chocolate dose. The anti-platelet effects of cocoa and chocolate may be due to increased production of nitric oxide, which not only causes vasodilation, as previously discussed, but also inhibits platelet aggregation.
Increased plasma epicatechin concentrations were reported in the studies by Pearson et al. and Murphy et al., and may signal increased nitric oxide synthesis in both the endothelial cells and platelets. Increased production of prostacyclin, an inhibitor of platelet aggregation, has also been proposed as a possible mechanism.These platelet inhibitory effects by cocoa and chocolate may be beneficial due to the pathophysiological role of platelets in artherosclerosis and thrombotic events.
[0062] It is now widely accepted that atherosclerosis is a chronic inflammatory disease.
Inflammation and in-creased oxidative stress promote endothelial dysfunction and atherogenesis. Nitric oxide normally inhibits nu-clear transcription factor (NFKB), which binds to the promoter regions of genes coding for pro-inflammatory proteins such as cytokines and adhesion molecules. In endothelial dysfunction, which is manifested by de-creased bioavailabilty of nitric oxide, this inhibition is loss. Excess intracellular ROS in oxidative stress also activates NFKB Cocoa flavonoids may prevent activation of NFKB and subsequent cytokine transcription by diminishing intracellular ROS.
[0063] In experimental studies, the expression of the pro-inflammatory cytokines interleukin(3(IL-1(3) and interleukin-2 (IL-2) is modulated by cocoa flavonoids. Specifically, IL-expression in phytohemagglutininstimulated peripheral blood mononuclear cells is reduced by purified monomer to tetramer cocoa flavonoids and IL-2 mRNA expression of and secretion by T-cells have also been shown to be inhibited with cocoa treatment. Cocoa flavonoids (epicatechin, catechin, dimeric procyanidins) are also incorporated into Jurkat T-cells with pretreatment, which inhibits phorbol miristate acetate (PMA)-induced NFKB
activation. This finding suggests that the immune response can be regulated by cocoa flavonoids, in part by modulating the oxidant-responsive transcription factor NFKB.
[0064] Cocoa-derived dimers have recently been found to protect Jurkat T-cells from oxidation and to increase plasma membrane fluidity. They also maintain the membrane integrity by preventing leakage of small molecules from vesicles. The increase in membrane fluidity may be linked with functional changes in membrane-associated receptors and enzymes as well as ion transport. Mathur et al.recently reported that cocoa products have no effect on markers of inflammation (whole-blood cytokines, IL-10, IL -6, TNF-a, high-sensitivity C-reactive proteins, and P-selectin). The healthy subjects in this study consumed the cocoa and chocolate supplementation (651 mg of cocoa flavonoids) for 6 weeks. Epicatechin was not detected in the subjects' plasma, and the lack of effect on inflammatory markers was attributed to the short half-life of cocoa flavonoids. It is known that epicatechin As in the plasma at 2 hours after cocoa or chocolate consumption and is cleared approximately 8 hours later.
[0065] The present inventors have shown that the new therapeutic formulation comprising cinnamon and chocolate demonstrates synergist activity and inter alia:
(a) healthy glucose level for people with type 2 diabetes;
(b) optimum level of cholesterol and triglycertides for people of all ages and thus reduces the risk of cardiovascular disease.
[0066] The new therapeutic formulation has also been proven as a powerful antioxidant and effective in helping to prevent cancer, heart disease, and stroke.
[0067] Another major benefit of the new therapeutic formulation is that it can prevent insulin resistance, a major and common complication that develops in people with type II diabetes in later years.
[0068] The two main ingredients of the new therapeutic formulation come from cinnamon and chocolate. Both the ingredients have been successfully used as effective remedies for many medical conditions in Indian, Chinese and South American Traditional Medicine.
[0069] Chocolate has been observed in clinical trials to improve cardiovascular health by improving endothelial cell functions.

[0070] The chocolate used is dark chocolate and must be rich in flavonoids. It is thought that the chocolate contains procyanidins flavanol, (-)-epicatechin and (+)-catechin. The anti-inflammatory action is thought to have been caused by the prevention of the activation of NF kB
and subsequent cytokine transcription by diminishing intracellular free radicals. In experimental studies, the express of the pro-inflammatory cytokines interleukin-b (IL-lb) and interleukin-2 (IL-2) is modulated by cocoa flavonoids. It is also thought that the flavanol modulate NO status, potentially increasing NOS or inhibiting the NO conversion to peroxynitrite.
It is thought that this is done by the B (NF-k regulation of nuclear transcription factor-kB) which controlsl the expression of many enzymes including inducible nitric oxide synthase (iNOS) and cyclooxygenase-2 (COX-2). INOS induces NO in response to pro-inflammation agents. COX-2 is also induced by pro-inflammatory agents. Thus it is thought that the anti-inflammatory action is caused by the inhibition of the enzyme xanthine oxidase which is part of the pathway when the body creates uric acid. The body's respone to a buildup of uric acid is similar to that of inflammation.
[0071] With respect to the reduction of blood sugar, insulin sensitivity is partly dependent on insulin-mediated NO release. Thus, the antioxidants may decrease insulin resistance by ameliorating NO bioavailability.
[0072] Chocolate contains linoleic and oleic acid which are two fatty acids that are known to modulate cholesterol metabolism. Although it has been demonstrated in clinical trials, the mechanism of action is not understood as yet. The cardiovascular health is improved by improving flow-mediated dilation which improves endothelial functions. The endothelial cells are involved in many aspects of vascular biology including the control of blood pressure, blood clotting, atherosclerosis, the formation of new blood vessels, inflammation and swelling and controlling the passage of materials and the transit of white blood cells.
[0073] The chocolate may be sourced from any well known product such as chocolate itself, chocolate milk, chocolate pudding or chocolate yogurt.
[0074] In this regard, a product formulation has been invented which incorporates the novel herbal product into a vehicle comprised substantially of chocolate. Although the product may be incorporated into any suitable chocolate vehicle, a particularly useful process and product is hereinafter described.
[0075] It has been found that certain chocolate form better vehicles than others. In particular, it is desired to use a sugar free chocolate formulation to avoid additional sugar in the final product.
[0076] The inventors have found the following four particularly useful formulations for the chocolate vehicle. Each of the following formulations do not contain any added sugar and are commercially available.
[0077] The first formulation is a dark chocolate which comprises forty-three percent (43%) maltitol, cocoa butter and cocoa powder processed with an alkali. A chocolate liquor and cocoa powder along with milk fat and soya lecithin which is used as the emulsifier, and natural flavours.
[0078] A second formulation relates to a milk chocolate which contains maltitol in the amount of fifty-five percent (55%), cocoa butter and a chocolate liquor.
Calcium carbonate and milk fat are added as well as calcium caseinate and soya lecithin as the emulsifier with vanilla extract for taste.
[0079] A third useful formulation is a high protein sucrose free milk chocolate which includes maltitol, fractionated modified palm kernel oil, milk protein concentrate and cocoa powder. Calcium caseinate, soya lecithin as the emulsifier and vanilla extract are used.
[0080] The fourth formulation is a dark sugar free coating which is comprised of a chocolate liquor processed with an alkali, maltitol, cocoa butter, butter oil, soya lecithin as the emulsifier and vanilla extract.
[0081] The inventors have found the following process to be particularly useful.
[0082] The chocolate is first melted to a minimum temperature of ninety-five degrees Fahrenheit (95 F) to a maximum of one hundred and twenty degrees Fahrenheit (120 F).
Preferably, the chocolate is placed within a water jacketed kettle which has an agitator. After melting of the chocolate, the jacket is cooled to a temperature of sixty degrees Fahrenheit (60 F) to a maximum of ninety degrees Fahrenheit (90 F). The chocolate is allowed to cool to a minimum of sixty-eight degrees Fahrenheit (68 F) to a maximum of eight-nine degrees Fahrenheit (89 F) with the agitator running. The agitator continues to run until the chocolate starts to thicken.
[0083] After the chocolate has thickened, the jacket is gradually warmed to a temperature of a minimum of eighty degrees Fahrenheit (80 F) with the agitator running. The chocolate is warmed to a temperature between eight-five degrees Fahrenheit (85 F) to ninety-five degrees Fahrenheit (95 F) with the agitator running and the cinnamon is then added to this warmed chocolate in slow measures with the agitator running. The product is thoroughly mixed and when the mixing is completed, the jacket temperature is reduced. The chocolate is then poured into molds and cooled in a cooling tunnel.
[0084] It is preferred that the molds in which the chocolate is poured are kept at a temperature between seventy-eight degrees Fahrenheit (78 F) and eighty-two degrees Fahrenheit (82 F). The cooling tunnel subjects the chocolate in the mold to an initial cooling at a temperature between sixty-five degrees Fahrenheit (65 F) and seventy degrees Fahrenheit (70 F), to a main cooling stage between forty-five degrees Fahrenheit (45 F) to fifty degrees Fahrenheit (50 F) and to a final cooling stage of between sixty-five degrees Fahrenheit (65 F) to seventy degrees Fahrenheit (70 F).

[0085] It is preferred that for every forty (40) grams of chocolate, the product will contain between one hundred and fifty (150) milligrams to a maximum of one thousand (1000) milligrams of the cinnamon.
[0086] This produces an excellent product which finds wide acceptance with the consumer in view of the chocolate extract.
[0087] It has been found that the efficacy of the cinnamon is enhanced when about 3000 milligrams to about 6000 milligrams of cinnamon powder is ingested per day.
Cinnamon extract is extracted from cinnamon powder in a ratio of about 1:10 so that either 3000 to 6000 milligrams of cinnamon powder or 300 to 600 milligrams of cinnamon extract will achieve the same result.
[0088] A standard conventional chocolate bar contains 43 grams of chocolate.
In the preferred embodiment, the chocolate incorporates 500 milligrams of cinnamon extract (which is equivalent to 5000 milligrams of cinnamon powder) in a 43 gram chocolate bar.
The synergistic results are achieved by ingesting one chocolate bar per day which will deliver an optimum amount of cinnamon powder per day to the individual.
[0089] Although the disclosure describes a preferred embodiment, the invention is not so limited. For a definition of the invention, reference is made to the claims.

Claims (20)

1. A new therapeutic formulation which comprises cinnamon and chocolate.

2. A new therapeutic formulation which comprises cinnamon and chocolate in a ratio of between 1:5 to 1:10.

3. A new therapeutic formulation which comprises cinnamon and chocolate in a ratio of 1:8.

4. A new therapeutic formulation which contains 250 milligrams to 12,000 milligrams of cinnamon powder per day admixed in a vehicle of chocolate containing 40 grams to 50 grams of chocolate.

5. A new therapeutic formulation which contains 3000 to 6000 milligrams of cinnamon powder per day admixed in a vehicle of chocolate containing 40 grams to 50 grams of chocolate.

6. A new therapeutic formulation which containains between 250 milligrams to 12,000 milligrams of cinnamon powder mixed in a chocolate bar containing 40 grams to 50 grams of chocolate.

7. A new therapeutic product which contains between 3000 milligrams to 6000 milligrams of cinnamon powder mixed in a chocolate bar containing 40 grams to 50 grams of chocolate.

8. A new therapeutic formulation which comprises 43 grams of chocolate and 500 milligrams of cinnamon extract.

9. A new therapeutic formulation which comprises 43 grams of chocolate and milligrams of cinnamon powder.

10. A new therapeutic formulation as claimed in claim 1 which comprises:
Cinnamon (Cinnamomi cassiae: Cinnamonum verum) 280 mg Chocolate 20 g Diluent 151 mg Lubricant 3 mg

11. A new therapeutic formulation as claimed in claim 5 wherein the diluent is microcrystalline cellulose and dicalcium phosphate dihydrate.

12. A new therapeutic formulation as claimed in claim 5 wherein said microcrystalline cellulose is present in the amount of 150 milligrams and dicalcium phosphate dihydrate is present in the amount of one (1) milligram.

13. A new therapeutic formulation as claimed in claim 5 wherein the lubricant is magnesium stearate.

14. A new therapeutic formulation as claimed in claim 1 wherein said chocolate comprises a dark chocolate which comprises a mixture of forty-three percent (43%) maltitol, cocoa butter, cocoa powder processed with an alkali, a chocolate liquor, cocoa powder, milk fat, soya lecithin and natural flavours.

15. A new therapeutic formulation as claimed in claim 1 wherein said chocolate comprises a milk chocolate which contains maltitol in the amount of fifty-five percent (55%), cocoa butter, a chocolate liquor, calcium carbonate, milk fat, calcium caseinate, soya lecithin and vanilla extract.

16. A new therapeutic formulation as claimed in claim 1 wherein said chocolate comprises a high protein sucrose free milk chocolate which includes maltitol, fractionated modified palm kernel oil, milk protein concentrate, cocoa powder, calcium caseinate, soya lecithin and vanilla extract.

17. A new therapeutic formulation as claimed in claim 1 wherein said chocolate comprises a dark sugar free coating which is comprised of a chocolate liquor processed with an alkali, maltitol, cocoa butter, butter oil, soya lecithin and vanilla extract.

18. A new therapeutic formulation as claimed in claim 1 wherein said chocolate is chocolate milk.

19. A new therapeutic formulation as claimed in claim 1 wherein said chocolate is chocolate pudding.

20. A new therapeutic formulation as claimed in claim 1 wherein said chocolate is chocolate yogurt.