Nutrient composition to normalize blood sugar and related health complications

Abstract

A composition comprising an extract of Trigonella foenum Graecum, Fenugreek and Cinnamon administered in high doses is capable of arresting the formation Glocotoxicity and Lipotoxicity which lead to Insulin Resistance (IR), the hall mark of Type 2 Diabetes (T2DM). Natural ingredients with similar properties to Fenugreek and Cinnamon are used in the composition to function in synergy with the Fenugreek and Cinnamon to control IR and to minimize any undesirable side effects of using the high doses of Fenugreek and Cinnamon. Use of the composition results in a significant reduction of IR with a remarkable improvement in health in subjects suffering either from pre-diabetes and/or from T2DM.

Claims

1. A tableted composition in an oral dosage form comprising: A) 30-1800 mg of a Cinnamon product selected from cinnamon oil, cinnamon extract, ground cinnamon and combinations thereof, B) 20-1000 mg of an extract from the Fabaceae family selected from Goat's Rue extracts, Fenugreek oil extracts and combinations thereof, C) 5-850 mg of an extract of gymnema, or Momordica charantia, and D) 5-700 mg of an extract of Abelmoschus esculentus or Opuntia ficus-indica.

2. The tableted composition of claim 1 wherein the extract of gymnema is selected as component C and an extract of Opuntia ficus-indica is selected as component D, said tableted composition additionally comprising: E) 10-1000 mg of an extract of Momordica charantia, and F) 25-2000 mg of an extract of Abelmoschus esculentus.

3. The tableted composition of claim 2 which comprises 50-500 mg of the Cinnamon product, 50-500 mg of the extract from the Fabaceae family, 50-500 mg of an extract of gymnema, 50-500 mg of an extract of Opuntia ficus-indica, 50-500 mg of an extract of Momordica charantia, and 50-500 mg of an extract of Abelmoschus esculentus.

4. The tableted composition of claim 3 wherein the cinnamon product is provided in a range of 50 mg and 300 mg.

5. The tableted composition of claim 3 wherein the extract from the Fabaceae family is provided in a range from 50 mg to 300 mg.

6. The tableted composition of claim 3 wherein the extract of gymnema is provided in a range from 50 mg to 300 mg.

7. The tableted composition of claim 3 wherein the extract of Opuntia ficus-indica is provided in a range from 50 mg to 300 mg.

8. The tableted composition of claim 3 wherein the extract of Momordica charantia is provided in a range from 50 mg to 300 mg.

9. The tableted composition of claim 3 wherein the extract of Abelmoschus esculentus is provided in a range from 50 mg to 300 mg.

10. The tableted composition of claim 2 wherein the cinnamon product is cinnamon extract, the extract from the Fabaceae family is Goat's Rue extract.

11. The tableted composition of claim 1 wherein the extracts are alcohol extracts.

12. A tableted composition in an oral dosage form comprising: A) About 225 mg of a cinnamon extract, B) About 150 mg of Goat's Rue extract, C) About 100 mg of gymnema extract, D) About 100 mg of an extract of Abelmoschus esculentus, E) About 100 mg of an extract of Momordica charantia, and F) About 300 mg of an extract of Opuntia ficus-indica wherein “about” is variation of from 0% to 5% of the value indicated.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 shows the observed results of observations on Pre-diabetes.

1. ANECDOTAL OBSERVATIONS ON PRE-DIABETICS

(2) A small group of pre-diabetic patients (n=10, F=4) was recruited in order to investigate initially if this Nutrient Composition of Table 3 is capable of controlling the IR, which is mainly responsible for initiating T2DM. This was done by supplementing 2 tablets of this new Nutrient Composition, twice a day with main meals, breakfast and dinner, to these pre-diabetic volunteers, for one month only. Three of these pre-diabetics were found to be obese, whose body mass index (BMI) was above 30 kg/m.sup.2 and continue taking this supplement for another month. The base-line fasting blood sugar of these volunteers ranges between 100 and 126 mg/dL with higher level of insulin (hyperinsulinemia), which usually is indicative of IR in T2DM. The observed results are summarized in FIG. 1:

(3) It could be observed in this FIGURE that after supplementing the Nutrient Composition for a month only, the fasting blood sugar level was lowered from 112±10 to 105±6 mg/dL. However, the insulin level was highly significantly (p<0.001) reduced from 23±5 (hyperinsulinemia) to the normal level of 11±4 mU/L. This is an extremely important observation suggesting strongly that this new nutrient Composition is indeed capable of controlling IR. Additionally, it was also observed as in FIG. 1 that those 3 obese volunteers showed a significant trend of loss of body weight. Thus this new Nutrient Composition is expected to be highly capable of not only preventing an onset of diabetes in pre-diabetics, but also perhaps as an anti-obese treatment, if taken for a longer period of time.

2. A RANDOMIZED CASE-CONTROL CLINICAL TRIAL ON T2DM PATIENTS

(4) This randomized case-control clinical trial for the new Nutrient Composition (Supplement) on T2DM patients was conducted at a renowned diabetes treatment clinic. Twenty (n=20, F=10) T2DM, age, sex and duration of this disease matched, non-ambulatory patients were selected for this study. All of these patients were suffering from uncontrolled blood sugars with some health complications due to diabetes and were being treated with a combination of 3 or 4 hypoglycemic drugs, containing particularly Glucophage/Metformin, Glipizide and Pioglitazone. They were randomized to receive either the Supplement or the Placebo (containing methylcellulose), 2 tablets twice a day, at breakfast and dinner, for 3 weeks only. After completion, they were grouped as Placebo (controls) and Supplement (cases) as presented in the Table 4, below, along with their demographic and biochemical findings as analyzed statistically.

(5) TABLE-US-00004 TABLE 4 Demographic and Biochemical Parameters Supplement Placebo Parameters (n = 10) (n = 10) p-value Sex M = 5, F = 5 M = 5, F = 5 — Age (years) 46.6 ± 12.3 46.8 ± 11.8 NS Weight (kg) 58.7 ± 10.6 58.5 ± 9.9  NS Height (cm) 155.9 ± 5.8  156.1 ± 7.6  NS Race Asian Indians Asian Indians — Blood Sugars (mg/dL) Pre-  244 ± 36.4 236.8 ± 30.6  NS Post- 231.8 ± 12.6  243.2 ± 16.2  <0.05  TBARS (μmol/L) Pre- 8.6 ± 1.3 8.7 ± 0.9 NS Post- 6.5 ± 0.7 8.6 ± 0.8 <0.001

(6) It is clear in the table above that the blood glucose level in the Supplement group went down significantly (p<0.05). Because of short duration, 3 weeks only, the sugar level did not reach to the normal level, which possibly could have attained if the duration of treatment was longer. Inflammation in the diabetic patients as expected to be high, is also evident in the table above in terms of TBARS (Thiobarbituric Acid Reacting Substances). TBARS was reduced significantly (p<0.001) in the group taking Supplement, indicating thus a remarkable reduction of inflammation in the diabetic patients. This, therefore, provides strong evidence that the new Nutrient Composition of Table 3 is indeed a highly effective anti-inflammatory product, as expected, and also capable of controlling blood sugars.

(7) The clinical observations, as described in Table 5 (below), clearly show that complications due to the metabolic disorders (hyperglycemia and heart conditions) were relieved and most importantly a tremendous feeling of wellness was observed, as reported by the supplemented patients. These observations validate the efficacies of our new Nutrient Composition in relieving many health complications in T2DM diabetics in addition to blood sugar reduction, and most importantly having no undesirable side-effects, as reported by the patients after taking the Supplement.

(8) TABLE-US-00005 TABLE 5 Clinical Observations Patients Health Complications Clinical Outcomes Female, Uncontrolled blood sugar, Blood sugar started getting age 48 diabetic-nerve pain on foot lower, foot pain diminished years and fatigue and gained a considerable energy. Male, Uncontrolled blood sugar, Blood sugar controlled, age 55 sign of cataract formation energized and an improved years in both eyes and erectile sexual health, a diminished dysfunction. sign of cataract formation Male, Fatigue, diabetic Sugar was under controlled; age 44 neuropathy, skin lesions no sign of neuropathy, skin years and uncontrolled blood lesions were relieved sugar. considerably. Male, Severe weight loss, Sugar was lowered, arrhythmia age 59 numbness and tingling and weight loss were years (neuropathy), arrhythmia controlled, neuropathy relieved, and weakness started feeling of wellness. Female, Neuropathy in terms of A considerable improvement in age 46 burning sensation in the blood circulation, no more years limbs, circulatory burning sensation and cold abnormality and cold sweat sweating. Female, Cardiomyopathy (dilated Blood sugar showed improve- age 54 with about 33% heart ment along with heart years function) and severe function and weakness was weakness reduced remarkably Female, Fatigue, weight loss, early Blood sugar normalized, gained age 45 sign of cataract energy and improved weight years and eye sight Male, Uncontrolled blood sugars, Most of this patient’s health age 47 cold sweat, arrhythmia and conditions improved and his years general weakness quality of life improved. Male, Neurological problems due Blood sugar was lowered age 50 to uncontrolled blood sugar, significantly, although not to years unable to walk without a the normal range. But his old support and had an old wound healed completely and untreatable wound near his he started walking without a right ankle. support, a remarkable case of recovery.

3. EFFECTS ON PERIPHERAL NEUROPATHY

(9) As observed in the clinical findings in Table 5 above, a couple of patients indicated a greater relief of their diabetic nerve pain. Since this diabetic nerve pain, a peripheral neuropathy, has been reported (http://www.painmed.org/library/research/neuropathic) to pose a greater threat to the quality of life of many T2DM patients, we tested the efficacy of our new Nutrient Composition on some severely affected T2DM patients with diabetic nerve pain being treated by an experience neurologist as illustrated below.

(10) Case #1. 76-year-old Asian Origin American female has a history of diabetes for many years, taking Metformin, she also has hypertension, knee pain and knee replacement. She complains of having tingling and numbness in her legs and feet and in drawing and twisting of legs for more than a year. Sometimes she gets in drawing and cramps and spasm of leg muscles at night. She had to cry and literally her grandchild had to sit on her feet to keep it straight. Patient was started taking the Supplement, which is a complementary support for blood sugar. She started taking 2 tablets twice a day as recommended. In one week, she started feeling good. After 2 weeks she had dramatic improvement in her leg cramps, she did not have any further leg cramps and had only one episode in a month and her tingling sensations had also improved. Since we did not monitor her for a longtime, we didn't check for HgA1c. Her regular blood sugar levels also seem to be controlled. She was on Metformin for a long time. We feel at this time that the Supplement contributed to her better blood sugar control. Diabetes itself can cause neuropathy with symptoms of muscle cramps; and treatment with Metformin has also shown to cause neuropathy itself. It is suggested that this Supplement, which helped control her blood sugar with beneficial effects on neuropathy, should be taken along with Metformin to achieve the treatment goals.

(11) Case #2. 82-year-old Caucasian American female has a long-standing history of diabetes, hypertension, and anxiety disorder. She presented with complaints of having burning sensation in her legs and also to her hands for a while. She could not sleep well because of this burning sensation and she had been anxious because of the discomfort for a while. She was prescribed the Supplement, which she took 2 tablets twice a day as recommended. At the end of 2 weeks she started feeling much comfortable, her burning and tingling sensations had moderately improved. She had been sleeping well and she was less anxious. She has been taking Alprazolam for longtime because of the anxiety from the feeling of discomfort in her legs and feet and she could not sleep. As reported by her and her husband, she had been sleeping well, doing better since she started the Supplement. Her blood sugar had been fluctuating since she was not compliant on her Metformin and sometimes she had to take Insulin. It is the Supplement that has contributed for her better control of blood sugar, which was encouraging and easier for her to take the pills and it also helped her relieve some of her symptoms of neuropathy.

(12) Case #3. 65-year-old Caucasian female came to the clinic with her husband. She has a history of hypertension, diabetes, and depression for a longtime. She presented with complaints of having pain and cramps in her legs and feet for more than a year and she could not sleep well. She was prescribed the Supplement, which she took for a few days. However, she says she started having diarrhea-like symptoms and she discontinued the Supplement. It is not sure if the Supplement caused this diarrhea-like symptom or she had it because of other reasons. So, in this case we could not draw any conclusion on the efficacy of the Supplement.

(13) Case #4. 58-year-old African American male came to the clinic alone. He has a history of diabetes, hypercholesterolemia for a few years. He had complained of burning sensation in both his feet and legs for 6 months and he had been taking oral hypoglycemic agents, Metformin, for more than a year. He also continued to have night cramps. He was prescribed the Supplement and he reported a moderate improvement of his symptoms of neuropathy and leg cramps in 3 weeks. He didn't have any side effects from the Supplement.

(14) Case #5. 66-year-old African American female has a history of hypertension, diabetes, hypercholesterolemia, and depression. She says she controls her blood sugar with hypoglycemic agents, she did not need Insulin. She presented with complaints of difficulty sleeping at night because of feeling of restlessness in her legs. She also complained of burning and tingling sensation and cramps in her legs, which interfered with sleeping at night and she felt tired during the daytime. She was prescribed the Supplement and within 3-4 weeks, she reported moderate benefit of her symptoms of leg cramps and burning sensation in her feet. Her blood sugar by finger stick was also well-controlled on taking this Supplement.

(15) By monitoring and reviewing the symptoms of these patients for about two months, it could be concluded that the new Nutrient Composition has indeed many beneficial effects in controlling at least some peripheral neuropathy and leg cramps.

(16) As elaborated above, diabetes is responsible for many life threatening complications to human health. Although the incidence of Type 1 diabetes (T1D), also known as insulin dependent diabetes mellitus (IDDM), is much less, about 5 to 10% of the total of T1D and T2DM, the number of T2DM also known as non-insulin dependent diabetes (NIDDM) patients is steadily increasing worldwide. The number of pre-diabetics is almost 3 times more than diabetics. For example, number of diabetics currently is about 30 million, whereas the number of pre-diabetics is around 100 million in the USA; in China there are about 120 million diabetics and more than 350 million pre-diabetics and in the Indian subcontinent the number of diabetics is over 150 million, with almost 1 in 3 as pre-diabetics (Forouhi N G and Wareham N J. Medicine 2014; 42:698). The number of pre-diabetics is, however, increasing in an alarming rate, which may be reaching to a billion marks worldwide sooner than later.

(17) It has been observed in this disclosure that after supplementing the new Nutrient Composition of Table 3, for a month only, that the fasting blood sugar level was lowered from a total average of 6.2 mmol/L (112 mg/dL) to 5.8 mmol/L (104 mg/dL), while the insulin level was statistically significantly (p<0.001) reduced from 22 (hyperinsulinemia) to the normal level of 8.9 mU/L, thus indicating that this Nutrient Composition is indeed capable of controlling insulin resistance (IR), a hallmark of a person becoming diabetic sooner or later. This is an extremely important observation, since this Composition is very likely be capable of preventing onset of diabetes in pre-diabetics. Another important observation could be noted in the present findings, as stated above, that the body weight of obese patients was found to be reduced, indicating another use of this Composition to control obesity.

(18) Inflammation, as mentioned earlier, has been found to be associated with many human health complications, particularly diabetes and cardiovascular diseases (CVD). Postprandial inflammation, provoked soon after ingesting a meal, is transient in duration, but with dreadful consequences on human health over a period of time depending on the compositions of a meal. However, many populations, particularly obese people, are in a constant postprandial state, which is likely to initiate insulin resistance (IR) resulting in T2DM and CVD. Postprandial inflammation is dependent on the food quality and quantity, mostly in terms of its energy/calorie content and its nutritional value. Micronutrients, such as minerals and vitamins, constitute the nutritional value of a food, while macronutrients, such as carbohydrate, protein and fat/lipid, are basically the sources of its energy/calorie content. The inventor, Khaled M A, and coworkers have previously revealed that postprandial inflammation occurs 2 hours after consuming a meal, either high in carbohydrates or high in fat/lipid (http://www.gscience.com/doi/pdf/10.5339/qfarf.2012.BMP69). It has also been cited earlier that glucotoxicity is induced by consuming carbohydrates, while fat/lipid is primarily responsible for lipotoxicity. Our new Nutrient Composition, as designed to prevent these gluco- and lipotoxicities to control the occurrence of IR, has been shown to be successful in this respect in a randomized case-control study on T2DM patients, as presented above. Patients in this study were suffering from an uncontrolled sugar level even after taking several hypoglycemic prescription drugs and also having various sugar related health complications. Inspection of Table 4 clearly shows that the sugar level was statistically significantly (p=<0.05) lower in the supplemented group compared to the control group. Inflammation, in terms of TBARS, was also highly significantly (p=<0.001) lower (see Table 4) after taking the Composition just for 3 weeks only. This suggest that a desirable benefit by using this Composition may be expected if taken for an extended period of time. Clinical outcomes after consuming this Composition indicate a greater relief from many of their health complications as listed in Table 5. While metabolic syndromes, in terms of T2DM and CVD, were much improved, peripheral neuropathy due to uncontrolled blood sugars in a couple of these patients was also noticed. A separate anecdotal observation was, therefore, performed to verify the efficacy of this new Nutrient Composition on 5 patients suffering from various diseases, mostly from diabetic nerve disorders. Except one patients, all 4 completed this study, conducted for 2 months. A tremendous beneficial effects due to this Composition were reported back to us by these patients, as described above.

(19) The above mentioned results, although conducted on a small number of T2DM patients all together, suggested strongly that the new Nutrient Composition could potentially improve metabolism in both the pre-diabetes and T2DM patients, through its effects to reduce/reverse the insulin resistance (IR). These small studies and anecdotal experiences, and the rational construction of the Composition itself, may extend its further use for patients with Type 1 diabetes, for people suffering from peripheral neuropathy, for people with heart diseases and perhaps most importantly for obese people to improve insulin sensitivity and glucose homeostasis, concomitantly losing some body weight.