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Overview
In the US, 10.3 million people have been diagnosed with diabetes and an estimated additional 5.4 million have undiagnosed diabetes. Approximately 90% have type 2 diabetes and the remainder have type 1 diabetes. The morbidity and mortality associated with diabetes are related to the hypoglycemia and hyperglycemia, increased risk of infections, microvascular complications (ie, retinopathy, nephropathy), neuropathic complications, and macrovascular disease. Diabetes is the major cause of blindness in adults aged 20-74 years, as well as the leading cause of nontraumatic lower- extremity amputation and end-stage renal disease (ESRD). Type 2 diabetes mellitus is more prevalent among Hispanics (10.6%), Native Americans (12-50%, depending on the tribe), African Americans (10.8%), and Asians/Pacific Islanders than in whites. Incidence is essentially equal in females and males in all populations. Type 2 diabetes is becoming increasingly common because more people are living longer (diabetes prevalence increases with age). It is also being seen more frequently in younger people in association with the rising prevalence of childhood obesity. Although type 2 diabetes still occurs most commonly in adults aged 40 years and older, the incidence of disease is increasing more rapidly in adolescents and young adults than in other age With this state of the art in mind there is now provided according to the present invention a pharmaceutical composition for alleviating excess levels of sugar in the blood of type 2 diabetic patients comprising a source of at least one cyanogenic glucoside as active ingredient therein. In preferred embodiments of the present invention said source is a In especially preferred embodiments of the present invention said natural source of at least one cyanogenic glucoside is from kernels of bitter In further preferred embodiments of the present invention said natural source of at least one cyanogenic glucoside is from kernels from fruits of the In especially preferred embodiments of the present invention said natural source of at least one cyanogenic glucoside is from a powder formed from a dried lemon component selected from the group consisting of lemon pulp, peel, and seeds and combinations thereof. In a most preferred embodiment of the present invention there is provided a pharmaceutical composition for alleviating excess levels of sugar in the blood of type 2 diabetic patients comprising a powder formed from a mixture of dry bitter almond kernels and from a dried lemon component selected from the group consisting of lemon pulp, peel, and seeds and In these preferred embodiments said powder preferably comprises between about 70% and 90% dried and ground bitter almond kernels, and between about 30% and 10% of a dried lemon component selected from the group consisting of lemon pulp, peel, and seeds and combinations thereof. In further embodiments of the present invention, there is provided a method for alleviating excess levels of sugar in the blood of type 2 diabetic patients comprising providing a pharmaceutical composition containing a source of at least one cyanogenic glucoside as active ingredient therein. In yet further embodiments the present invention is directed to the use of a source of at least one cyanogenic glucoside for the manufacture of a pharmaceutical composition for alleviating excess levels of sugar in the blood of type 2 diabetic patients substantially as described herein. As stated in its most preferred embodiment the present invention is directed to pharmaceutical compositions containing as active ingredients therein compounds found in bitter almonds kernels and or leaves and in lemon pulp, peel or seeds. Both components are dried up by a hot air stream and mixed in a ratio of 1:4 (lemon/almonds respectively). The daily dose for an adult type 2 diabetic patient is preferably about 15,000 mg. although other doses can also be utilized. The dry powder is administered orally 3 times a day. Each of the components is capable of lowering blood sugar in diabetic patients but the combined formulation is more effective than each individually. The powder may be orally administered as a powder or as a suspension in water or other non-sugared liquids. The daily dose ranges according to age, body weight and degree of illness. Nevertheless a 15,000 mg per day per adult person is the recommended dose. The formulation may be administered It is most effective in patients that can synthesis approximately 70% or higher of the medically considered normal levels of insulin. It is highly effective in overweight patients that synthesize normal or The fact that both the kernels of bitter almonds and the lemon tissues contain cyanogenic glucosides along with other circumstantial results suggests that CN-glucoside is an effective compound for lowering blood sugar levels in diabetic patients. Kernels of other Prunus species contain cyanogenic glucosides and consequently were found effective as well to lower blood sugar and are therefore included within the scope of the present It is to be noted that amygdalin otherwise known as d-Mandelonitrile glucoside or as amygdaloside is recognized as a major glucoside from bitter almonds and was used in some of the examples herein. While in preferred embodiments of the present invention and in the following examples, a natural source of at least one cyanogenic glucoside was used and tested, the invention is also directed to the utilization of Furthermore, in other preferred embodiments of the present invention, other components as set forth in tables 1 and 2 hereinafter, can be included in the pharmaceutical composition to act in a complimentary or other function While the invention will now be described in connection with certain preferred embodiments in the following examples and with reference to the accompanying figures so that aspects thereof may be more fully understood and appreciated, it is not intended to limit the invention to these particular embodiments. On the contrary, it is intended to cover all alternatives, modifications and equivalents as may be included within the scope of the invention as defined by the appended claims. Thus, the following examples which include preferred embodiments will serve to illustrate the practice of this invention, it being understood that the particulars shown are by way of example and for purposes of illustrative discussion of preferred embodiments of the present invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of formulation procedures as well as of the principles and conceptual aspects of In the drawings: Figure 1 is a graphical representation of the mean distribution of glucose levels in blood as a function of time after the administration of a composition according to the present invention and administration of a placebo (sweet Figure 2A is a graphical representation of an HPLC analysis of amygdalin in. Figure 2B is a graphical representation of an HPLC analysis of amygdalin in Figure 2C is is a graphical representation of an HPLC analysis of a standard
Example 1

A 58 year old female patient who suffers from diabetes type II (N.I.D.D.M.) since the age of three and who was treated previously with glucophage tablets 1 x 3 per day for a few months stopped taking said tablets and instead took 1 teaspoon three times a day of a powder according to the present invention containing 85% ground dry bitter almond kernels and 15% ground dried lemon pulp, peel and seeds. The last blood test of this patient was carried out six months before treatment and all were in the normal range, with the exception of the blood sugar of this patient which was ranging between 280 mg% and 300 mg% prior to treatment. After treatment with the powder of the present invention for two months the average level of blood sugar dropped to 120 mg% on fasting and Example 2
A 64 year old male patient who suffers from diabetes type II (N.I.D.D.M.) since the age of five and who was treated previously with glucophage tablets once a day and glucomine once a day, was found to have no other diseases and no signs of diabetic complications. His last blood tests were done in April 2004 and were all in the normal range, with the exception of average blood sugar which was found to be in the range of 170-200 mg%. He began taking 1 teaspoon three times a day of a powder according to the present invention containing 85% ground dry bitter almond kernels and 15% ground dried lemon pulp, peel and seeds, in combination with one tablet a day of the glucophage tablet and one tablet a day of the glucomine for one month and then continued taking 1 teaspoon three times a day of the powder according to the present invention and only half a tablet a day of the glucophage tablet and half a tablet a day of the glucomine and continued this regimen for an additional three months. At the end of this four month period the average blood sugar of this patient was down to 140-150 mg% Example 3
A 62 year old male patient who suffers from diabetes type II (N.I.D.D.M.) for the last 14 years and who was treated previously with one glucophage tablet three times a day stopped taking said tablets and began taking one teaspoon three times a day of a powder according to the present invention containing 85% ground dry bitter almond kernels and 15% ground This patient suffers from hypertension – treated with normiten, angina pectoris – not active and not treated, hypercholesterolemia and hypertrigliceridemia treated with simovil and asthma which is not active. Before treatment the average blood sugar was 285 mg% and following the treatment the level of blood sugar dropped to 110 – 140 mg%. As will be noted with each of the three patients there was a reduction of blood sugar levels attributable to treatment with a composition according to the present invention, despite the reduction or complete cessation of the Example 4 The metabolic effect of bitter almonds-based mixture in
patients with Type 2 diabetes
A clinical experiment was carried out at the Diabetes Unit of the Hadassah Medical Organization at Hadassah Hospital Ein Kerem Jerusalem, in order to determine whether a mixture, based mainly on ground bitter almonds mixed in a cup of water (the “Mixture”), had any glucose lowering effect, at meal-time, in subjects with Type-2 diabetes, maintained on Metformin and diet, or diet alone. It was assumed that these natural ingredients can be used safely and will improve post-prandial blood glucose Study Design: Type 2 diabetic subjects (7 males and 3 females) with HgA1c
between 6.5-8.5%, BMI < 32, generally healthy individuals, volunteered for this study. After the initial screening visit, subjects attended the Diabetes Unit twice. In each visit they received the same standard breakfast. Blood samples for glucose evaluation, were withdrawn at timed intervals (every 10 minutes for the first two hr. and every 30 min for the following 2 hr.), up to 4 hours following the ingestion of the meal with the Mixture, given at the end of the meal. On 1st visit the volunteers received the active Mixture, the "placebo" of other natural ingredients (based on sweet almonds), was administered on the Results: A significant decrease in post-prandial blood glucose levels, was
demonstrated following the ingestion of the Mixture compared to the placebo. In six subjects the response rate was much more pronounced while in four individuals the response was less impressive. Fig 1 is a graphical representation of the mean distribution of glucose levels in blood as a function of time after the administration of a composition according to the present invention and administration of a placebo and depicts the Conclusions: In Type 2 diabetic patients, the administration of a mixture
(based on natural ingredients containing ground bitter almonds) was effective in attenuating post-prandial blood glucose levels. Example 5: Metabolic profile of bitter and sweet almonds
In order to determine the active components in bitter almonds the volatile and non-volatile compounds were compared by GC-MS (Gas chromatography – Mass spectrum) and HPLC (High performance liquid chromatography). Figures 2A and 2B respectively show the HPLC chromatograms comparing bitter and sweet almonds, and Figure 2C shows the HLPC chromatogram of a standard commercial amydalin. Determination of amygdalin content in bitter and sweet almonds
0.5g of crushed almonds were overnight extracted with 10ml methanol. Isocratic mobile phase was 85% ACN and 15% water, flow of 0.7ml/min. Amygdalin content was calculated using standard curve of authentic standard Results:
A nearly 9 folds higher amygdalin peak was detected in the bitter compared to sweet almond seeds. (Fig 2A, Fig 2B).

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