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(12) Patent Application Publication (10) Pub. No.: US 2014/0335123 A1 Pak (43) Pub US 20140335123A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2014/0335123 A1 Pak (43) Pub. Date: Nov. 13, 2014 (54) FOOD COMPOSITION AND USES FOR A61E36/02 (2006.01) DABETES A 6LX36/899 (2006.01) (71) Applicant: Kyoungsik Pak, King of Prussia, PA A61E36/82 (2006.01) (US) (52) U.S. Cl. CPC ............... A2.3L 1/168 (2013.01); A61K 36/899 (72) Inventor: Kyoungsik Pak, King of Prussia, PA (2013.01); A61E36/82 (2013.01); A6 IK36/02 (US) (2013.01); A61K 45/06 (2013.01) (21) Appl. No.: 14/260,494 USPC ........................... 424/195.17:426/619; 426/2 (22) Filed: Apr. 24, 2014 (57) ABSTRACT Related U.S. Application Data (60) Provisional application No. 61/815,794, filed on Apr. The present invention provides a composition to promote 25, 2013. healthy weight and reduce diabetic complications. The com position provides biologically active ingredients that are Publication Classification combined in a food and provide dietary fiber, trace minerals (51) Int. Cl. and phytonutrients, wherein the composition may be used A2.3L. I./68 (2006.01) alone or in combination with other foods in a method for A6 IK 45/06 (2006.01) improving health. Patent Application Publication Nov. 13, 2014 US 2014/0335123 A1 FIGURE 1. 0 Trial 1 Trial 2 Trail 3 Trial 4 -0-Trial 5 Hours US 2014/03351 23 A1 Nov. 13, 2014 FOOD COMPOSITION AND USES FOR vides a food for use by a subject to reduce the complications DABETES of hyperglycemia and improve parameters measurable in the blood Such as the presence of glycated proteins, for example, CROSS REFERENCE TO RELATED hemoglobin Alc. In one embodiment the food comprises an APPLICATIONS oatmeal, a tea, one or more of an edible seaweed and, option 0001. This application is a U.S. provisional application. ally, a cornmeal, whereby the food, when ingested, promotes Satiety and promotes gastric function while providing essen BACKGROUND OF THE INVENTION tial macronutrients and micronutrients. In one aspect the invention is a composition for the preparation of a food foruse 0002 1. Field of the Invention by a subject to promote healthy weight and reduce diabetic 0003. The invention relates to the preparation and use of a complications comprising an oatmeal and green tea is pro food for promoting healthy weight and stable serum glucose vided. In a second aspect, the composition of the invention levels. comprises oatmeal and green tea in a ratio of dry weight from 0004 2. Background and Related Art about 2:1 to about 100:1 and oatmealand a seaweedinaration 0005 Diabetes (Diabetes mellitus, DM) is a metabolic of about 1:25 to about 200:1. disorder characterized by the handling of glucose by the body. 0010. In a third aspect, the present invention provides a Glucose is derived from dietary sources by processes of method of preparing the food for use to reduce the complica digestion and from biochemical processes. Glucose released tions of hyperglycemia and reduce diabetic symptoms or from food enters the blood stream and requires the concomi complications. tant release of insulin to drive cellular uptake and utilization 0011. In a fourth aspect, the present invention provides a by the cells of the body. Glucose is an aldol (aldehyde con method of using the compositions of the invention by a Sub taining Sugar) and reactive with other serum components such ject to promote healthy weight and reduce diabetic compli as hemoglobin, other proteins, cells and tissues that circulate cations by orally administering a food comprising the com or make up tissues such as nerves and blood vessels. In position of the present invention at least one time in a day and particular, uncontrolled elevated blood glucose or hypergly at least once in a given time period. In aspects of the present cemia can cause both microvascular and macrovascular dam invention the food composition is ingested in order to age leading to retinopathy, nephropathy, neuropathy, and car improve a symptom of diabetes selected from a elevated diovascular events. postprandial blood glucose, paresthesia, and angina. 0006. The association between chronic hyperglycemia and increased risk of microvascular complications in patients 0012. In a fifth aspect, a kit comprising packaging mate with type 1 DM was demonstrated in the Diabetes Control rial, a container comprising a composition of the invention, and Complications Trial (DCCT) (The Diabetes Control and and instructions for preparing a food according to the Complications Trial Research Group. NEngl J Med. Sep. 30 embodiments of the invention. In one embodiment, the com 1993: 329(14):977-86). In that trial, intensive therapy position provided is ready to eat. In another embodiment, the designed to maintain normal blood glucose levels greatly composition is used to prepare a food which is a beverage or reduced the development and progression of retinopathy, is baked or cooked to produce a porridge, a cookie, a cake, or microalbuminuria, proteinuria, and neuropathy, as assessed a cracker. In another embodiment, the composition is a semi over 7 years. Several landmark studies have confirmed the sold suitable for spreading or applying to another comestible, effectiveness of glycemic control in the management of type Such as a fruit, vegetable, or cracker. 2 DM. Improved glycemic control using injected insulin or 0013. In another embodiment of the invention, is provided the use of other agents has been shown to reduce the risk of a composition in a package with instructions for the prepara major cardiovascular events, but may increase the risk of tion and method using of the food prepared from the packaged severe hypoglycemia. ingredients to promote healthy weight and reduce the Symp 0007 People with diabetes also have an increased risk of toms and complications of diabetes. having high serum cholesterol and a tendency toward obesity. Elevated cholesterol is believed to lead to cardiovascular DESCRIPTION OF THE DRAWING damage by attaching to or contributing to the formation of aterial plaques. 0014 FIG. 1 is a graph showing the change in blood glu 0008 Thus, there is a need for a convenient and safe prod cose of a human Subject after consuming a meal from a fast ucts that limit or attenuate intervals of elevated blood sugar food restaurant (Trial 1), or consuming a meal comprising one (hyperglycemia) and control blood Sugar and blood choles embodiment of the present composition as described and terol in individuals prone to exhibiting high blood glucose prepared herein (Trials 2-5) as detailed in Example 1. levels after eating and who may also have high blood lipid levels. DETAILED DESCRIPTION OF THE INVENTION 0015. In order that the present invention may be more SUMMARY OF THE INVENTION readily understood, certain abbreviations and terms are first 0009. The present invention provides embodiments defined. Additional definitions are set forth throughout the intended for use by subjects to promote healthy body weight detailed description. Abbreviations used, include: and for the improvement or prevention of symptoms and ECGC-epigallocatechin-3-O-gallate: mcg microgram; complications of diabetes comprising dietary fiber, phytonu mg milligram; gm gram(s): kcal kilocalories: BMI body trients and trace minerals; wherein the composition com mass index. prises an oatmeal and ground tea, one or more of a kelp and a 0016 All publications, including but not limited to patents seaweed, and optionally, comprises a cornmeal, and, option and patent applications, cited in this specification are herein ally, cinnamon. In the first aspect, the present invention pro incorporated by reference as though fully set forth. US 2014/03351 23 A1 Nov. 13, 2014 DEFINITIONS 0025. Digestible fiber is comprised of predominantly alpha-1,4 and alpha-1,6 glycosidic linkages that are cleavable 0017. By “promote healthy weight’ is meant that the con by enzymes of humans and other higher animals. Beta-D- Sumption of excess food energy (e.g. as measured by kcal) is glucans, usually referred to as beta-glucans, comprise a class reduced in order to assist the Subject in maintaining a body of non-digestible polysaccharides widely found in nature in weight which has been shown by actuarial information com Sources such as grains, barley, yeast, bacteria, algae and paring height and weight of individuals to morbidity and mushrooms. In oats, barley and other cereal grains, they are mortality data to reduce disease and extent lifespan. Healthy located primarily in the endosperm cell wall. Beta D-glucans weight is also sometimes reported as “ideal body weight' by nature comprise a beta-D-glycosidic linkage between the based on such tables or a healthy BMI. saccharides (Sugar units) of the polymer which are not cleav 0018. By “reduces postprandial blood sugar levels” or able by the enzymes of the animal digestive system, although “improves the postprandial excursions of blood glucose' is though within the digestive tract, they may be attached by the meant that the excursions (increase from preprandial level) of flora (microbes) inhabiting the gut. Inulin, for example, is a serum glucose following ingestion of a meal are attenuated. non-absorbable, nondigestible polysaccharide found in 0019. By “food” is meant any comestible. dahlia tubers, Jerusalem artichoke, or chicory root. Inulin was 0020. As used herein, the term “subject' includes any historically used by physicians to regulate blood Sugar levels human, nonhuman primate, or nonhuman animal, a tissue of in diabetic patients at a dosage of between 25 and 50 grams an animal, e.g. a mammal, including a human. Non human per day. animals Subject to treatment include, for example, without 0026. Medical and nutritional studies show that fiber is limitation, a simian; a murine animal, a canine; livestock; essential to good health. Insoluble fiber provides a health sport animals (e.g.
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