CROSS-REFERENCE TO RELATED APPLICATIONS

[001] This application claims priority to U.S. provisional application serial number 62/537,876, filed on July 27, 2017.

FIELD OF THE INVENTION

[002] The field of the present invention relates to food and beverage sweeteners. More particularly, the field of the present invention relates to sweetener compositions that may serve as a replacement for traditional sugar, and which deliver a reduced level of carbohydrates to a consumer (relative to currently-available sweeteners).

BACKGROUND OF THE INVENTION

[003] Natural sweeteners, as substitutes for traditional sugar and chemical- based artificial sweeteners, have been growing in popularity for many years. Recently, consumers have been purchasing and demanding natural sweeteners that are considered "low carbohydrate" sweeteners. For many years, "stevia" has been used as a natural sweetener (and as a sugar substitute), which generally consists of an extract from the leaves of the plant species Stevia rebaudiana. However, most stevia sweeteners are coupled to maitodextrin as a carrier, which adds carbohydrate to the sweetener (which is less preferred by those looking to eliminate or reduce carbohydrates from their diet). Attempts have been made to replace maitodextrin with certain digestion-resistant carbohydrates or fibers; however, those substitutes have been shown to often cause gastrointestinal distress. [004] In view of the foregoing, there is a continuing and growing demand for natural sweeteners, which (1 ) exhibit a desirable sweet taste, (2) deliver a reduced level of carbohydrates to a consumer (relative to currently-available sweeteners), and (3) do not cause gastrointestinal distress. Still further, it would be desirable for such sweeteners to facilitate insulin activity, blood sugar clearance, and/or appetite control. As the following will demonstrate, the compositions of the invention and those described herein address such demands (and others) in the marketplace.

SUMMARY OF THE INVENTION

[005] According to certain aspects of the invention, natural sweetener compositions are provided that generally include (1 ) stevioi glycosides extracted from a Stevia rebaudiana plant and (2) an amino acid component consisting of free glycine. In some embodiments, the stevioi glycosides extracted from a Stevia rebaudiana plant may consist of a mixture of stevioside and rebaudioside- A (whereas, in other embodiments, the stevioi glycosides extracted from a Stevia rebaudiana plant may include other stevioi glycosides as well). In addition, such natural sweetener compositions may optionally include a third component, namely, gymnemic acid (such as an extract of a Gymnemic sylvestre herb that includes 25% - 75% gymnemic acid). The invention provides that the natural sweetener compositions may consist essentially of just those two or three components; whereas, in other embodiments, the natural sweetener

compositions may comprise those two or three components along with others.

[006] The invention further encompasses beverages that include the natural sweetener compositions of the present invention. In addition, the invention encompasses a beverage powder that comprises the sweetener compositions of the present invention. Still further, the invention encompasses the natural sweetener compositions of the present invention formulated in an individualized, dry powder form, or formulated as a liquid-based sweetener.

[007] The above-mentioned and additional features of the present invention are further illustrated in the Detailed Description contained herein.

BRIEF DESCRIPTION OF THE FIGURES

[008] FIGURE 1 : a line graph summarizing the impact of a sweetener composition of the present invention (and traditional sucrose) on serum glucose levels in multiple subjects.

[009] FIGURE 2: a bar graph summarizing the impact of a sweetener composition of the present invention, glucose, and glyburide on insulin secretion in Min6 cells.

DETAILED DESCRIPTION OF THE INVENTION

[0010] The following will describe, in detail, several preferred embodiments of the present invention. These embodiments are provided by way of explanation only, and thus, should not unduly restrict the scope of the invention. In fact, those of ordinary skill in the art will appreciate upon reading the present specification and viewing the present drawings that the invention teaches many variations and modifications, and that numerous variations of the invention may be employed, used and made without departing from the scope and spirit of the invention.

[0011] According to certain preferred embodiments of the present invention, natural sweetener compositions are provided that generally include (1 ) Stevia rebaudiana plant extract (including steviol glycosides extracted from such plant species) and (2) an amino acid component consisting of free glycine. In addition, the natural sweetener compositions of the present invention may, optionally, include gymnemic acid (including an extract of a Gymnemic sylvestre herb that includes 25% - 75% gymnemic acid). The invention provides that the natural sweetener compositions may consist essentially of just those two or three components (i.e., primarily Stevia rebaudiana plant extract, free glycine, and optionally gymnemic acid); whereas, in other embodiments, the natural sweetener compositions may comprise those two or three components along with others. The following will describe each of those components of the present invention in further detail.

[0012] Stevia.

[0013] The term "stevia" generally refers to a composition - used as a sweetener and sugar substitute - which is extracted from the leaves of the plant species Stevia rebaudiana. Such extract includes certain steviol glycosides that are primarily responsible for delivering a sweet taste upon consumption - and such glycosides primarily consist of stevioside and rebaudioside-A. Steviol is the chemical scaffold on which the steviol glycosides are based (the structure of which is represented below).

[0014] As mentioned above, the steviol glycosides that are primarily responsible for delivering a sweet taste consist of stevioside and rebaudioside-A. The lUPAC name of rebaudioside-A is 19-0-beta-glucopyranosyl-13-0-(beta- glucopyranosyl(1 -2)-beta-glucopyranosyl(1 -3))-beta-glucopyranosyl-13- xhydroxykaur-16-en-19-oic acid); whereas, the lUPAC name of stevioside is 13- [(2-0-beta-D-Glucopyranosyl-alpha-D-glucopyranosyl)oxy]kaur- 6-en-18-oic acid beta-D-glucopyranosyl ester.

[0015] The methods by which such steviol glycosides may be extracted from Stevia rebaudiana plants are well known. Such methods generally entail drying the leaves of Stevia rebaudiana plants and subsequently performing a water extraction process (to generate a crude extract of the steviol glycosides, e.g., stevioside and rebaudioside-A). The crude extract of the steviol glycosides may then be further separated and purified via crystallization techniques, e.g., using ethanol or methanol as a solvent.

[0016] Glycine.

[0017] Glycine is an amino acid that has a single hydrogen atom as its side chain (i.e., as its R-group). The chemical formula of glycine is NH2-CH2-COOH, and is further represented by the structure below.

[0018] The invention provides that the glycine component of the present invention will serve multiple functions and benefits. First, the free glycine (i.e., glycine residues that are substantially unbound from each other) will serve as a carrier for the stevia component. In certain embodiments, the invention provides that about 4 grams of glycine is preferred (in the sweetener compositions of the invention) to deliver about 50 milligrams of stevia in the same sweetener composition, i.e., a 4 grams of glycine per 50 milligrams of stevia ratio (50 milligrams of stevia is typically required to sweeten a 300 ml_ - 500 mi- beverage). Second, glycine itself often confers a natural sweet taste upon consumption, thereby enhancing the sweetness of the composition. Third, replacing maltodextrin and/or digestion-resistant carbohydrates with free glycine substantially reduces (or, in some cases, may substantially eliminate) the amount of carbohydrates present in the sweetener, which is a highly desirable trait for many consumers today. In addition, by replacing maltodextrin and/or digestion-resistant carbohydrates (which are included in many currently-available sweeteners), the compositions of the present invention also mitigate the gastrointestinal distress that otherwise accompanies maltodextrin and/or digestion-resistant carbohydrates.

Fourth, the inventors have found that when glycine is used to carry stevia in a sweetener composition, less stevia is required to deliver the same (or substantially the same) sweet taste. Finally, including glycine in the sweetener composition introduces a glucagon-inducing protein-like composition, which has been shown to oppose serum glucose elevation, improve insulin activity, and enhance appetite control.

[0019] Gymnemic Acid.

[0020] Gymnemic acids represent a class of chemical compounds isolated from the leaves of Gymnema sylvestre (Asclepiadaceae). Such acids generally confer an anti-sweet effect to beverages and foods. Gymnemic acids are triterpenoid glycosides, with aglycone gymnemagenin (C30H50O6) serving as the base structure. The aglycone gymnemagenin may be decorated with certain sugars, such as glucoronic acid, and with various ester groups. Such derivatives represent different gymnemic acids. Gymnemic acids are generally represented by the chemical structure reproduced below.

[0021] Gymnemic acids may be chemically synthesized or, alternatively, extracted from a Gymnemic sylvestre herb. When extracted from a Gymnemic sylvestre herb, such extract typically comprises about 25% - 75% gymnemic acid. As such, when included in the compositions of the present invention, synthetic gymnemic acids may be used - - or gymnemic acids present within Gymnemic sylvestre herb extract may be used. The invention provides that the gymnemic acid, when present in the compositions of the present invention, will serve to mask the undesirable aftertaste that sometimes accompanies stevia consumption. In addition, the invention provides that the gymnemic acid will serve to improve insulin activity and serum glucose clearance (particularly in insulin-resistant consumers). The invention provides that when a serving of the sweetener composition of the present invention includes about 3 - 6 grams of glycine and 45 - 65 milligrams of stevia, it is preferred that the composition include about 25 milligrams of gymnemic acid. However, the invention further provides that the ratios of glycine, stevia, and gymnemic acid may be varied to achieve the desired level of sweet taste.

[0022] Formulations.

[0023] According to certain preferred embodiments of the present invention, the components of the sweetener compositions described herein are preferably formulated according to certain parameters. For example, in certain

embodiments, for an average adult serving of the sweetener composition, the invention provides that the composition will preferably comprise (a) 10 mg - 120 mg of steviol glycosides extracted from a Stevia rebaudiana plant; (b) 1000 mg - 10,000 mg of free glycine; and, optionally, (c) 0.1 mg - 200 mg of gymnemic acid. In the case of gymnemic acid, such component may consist of an extract of a Gymnemic sylvestre herb, which includes about 25% - 75% gymnemic acid. The invention provides that the sweetener compositions may be formulated as standalone sweeteners, such as individualized packets of sweeteners in dry powder form or as liquid-based sweeteners. Alternatively, the sweetener compositions may be formulated into a beverage, beverage powder (i.e., a dry powder that, when reconstituted with water, converts into a drinkable beverage), or food product. Still further, the sweetener compositions of the present invention may be formulated as individual capsules and tablets (which, in the case of tablets, further include standard binders that are known in the art).

[0024] According to certain specific and preferred embodiments, the present invention further encompasses the following formulations:

Formula-1

Glycine (Free Form) 3000

Gymnemic sylvestre Extract

0

(75% Gymnemic Acid)

Formula-3

Component Amount (milligrams)

Stevia 30.0

Glycine (Free Form) 5500

Gymnemic sylvestre Extract

15.0

(75% Gymnemic Acid)

Formula-4

Component Amount (milligrams)

Stevia 50.0

Glycine (Free Form) 5000

Gymnemic sylvestre Extract

22.0

(75% Gymnemic Acid)

Formula-5

Component Amount (milligrams)

Stevia 80.0

Glycine (Free Form) 6000

Gymnemic sylvestre Extract

0

(75% Gymnemic Acid)

EXAMPLES EXAMPLE 1 : The following Example summarizes the impact of the above-listed formulas on serum glucose levels within three different subjects. Specifically, 6.0 grams of a blend of Formula-1 through Formula-5 (above) were stirred vigorously into one shot of regular caffeinated expresso coffee that was topped to 350 milliliters of warm water. The coffee was then completely consumed by each subject within 5 minutes, following a time=0 measurement of each subject's serum glucose levels. Each subject's serum glucose levels were subsequently measured at 15 minute intervals, up to 100 minutes following the time=0 measurement. The impact of traditional sucrose on each of the subject's serum glucose levels was also measured, so that the impact of the test sweetener composition on serum glucose levels could be measured relative to such impact by traditional sucrose. The following Tables summarize the serum glucose level measurements observed with each subject (Table- 1 , Table-2, and Table-3), along with the average across each of the three subjects (Table-4)(the data represent mmol / L serum glucose).

Table-1 (Subject 1 )

Test Sucrose

T=0 5.20 5.20

T=15 5.40 6.20

T=30 5.30 7.60

T=45 5.50 7.60

T=60 5.20 7.00

T=75 5.30 6.20

T=100 5.40 6.00

Table-2 (Subject 2)

Test Sucrose

T=0 5.00 5.10

T=15 5.00 6.00

T=30 5.40 7.50 T=45 5.40 7.40

T=60 5.60 7.00

Τ=75 5.40 6.00

Τ=100 5.40 5.60

Table-3 (Subject 3)

Test Sucrose

τ=ο 4.90 5.20

Τ=15 5.30 5.60

Τ=30 5.30 7.70

Τ=45 5.30 7.80

Τ=60 5.20 7.40

Τ=75 5.30 6.40

Τ=100 5.20 6.20

Table-4 (Average)

Test Sucrose

Τ=0 5.03 5.17

Τ=15 5.23 5.93

Τ=30 5.33 7.60

Τ=45 5.40 7.60

Τ=60 5.33 7.13

Τ=75 5.33 6.20

Τ-100 5.33 5.93

[0026] As shown in the Tables above, and as further illustrated in Figure 1 , the sweetener (test) composition of the present invention did not cause serum glucose levels to elevate to the same extent as traditional sucrose. In fact, the sweetener (test) composition was much more effective at maintaining stable serum glucose levels in each subject, relative to traditional sucrose. [0027] EXAMPLE 2: The following Example summarizes the impact of certain formulas and compositions included in the present invention on glucose metabolism at systemic and cellular levels - - and, furthermore, demonstrates that formulas and compositions included in the present invention can induce insulinogenic activity (insulin secretion) from pancreatic beta cells. The impact of glucose and Glyburide were also tested for insulinogenic activity (insulin secretion), to serve as a baseline for assessing the activity of the compositions of the present invention (listed as Glyvia in Figure 2). The "Glyvia" compositions that were tested in this Example included the following: (1 ) Glyvia HD (High Density): 22.5 mg stevioside complex and 1 ,600 mg L-glycine; and (2) Glyvia 1 :1 : one unit of sucrose to one unit of Glyvia (which consisted of 22.5 mg stevioside complex and 4,500 mg L-glycine).

[0028] More particularly, the foregoing compositions of the present invention (and, separately, glucose and Glyburide) were administered to mouse pancreatic beta cells (Min6 cell line) to assess the effect of such compositions on insulin secretion. The Min6 cells were plated on a 96-well plate, at a concentration of 10,000 cells per well. The cells were then cultured overnight with high glucose containing DMEM media. The next day, the media was replaced with fresh DMEM with low glucose, along with the test compositions of the present invention. Next, an ELISA assay (provided by Abeam) was used to quantify the insulin secreted into the media by the cells following the manufacturer's instructions. As mentioned above, the insulinogenic activity was also compared between control, glucose-treated, test-composition treated, and Glyburide-treated (a commercially-available drug for type II diabetes) cells. For each experimental cohort, three biological repeats were conducted. An ANOVA was performed to calculate the statistical significance. [0029] As shown and summarized in Figure 2, the ability of the compositions of the present invention (referred to as Glyvia) to induce insulin secretion exceeds the activity observed for Glyburide (a commercially-available drug for type II diabetes, which is administered for the same purpose). Such data show that the compositions of the present invention exhibit favorable insulinogenic activity.

[0030] The many aspects and benefits of the invention are apparent from the detailed description, and thus, it is intended for the following claims to cover all such aspects and benefits of the invention that fall within the scope and spirit of the invention. In addition, because numerous modifications and variations will be obvious and readily occur to those skilled in the art, the claims should not be construed to limit the invention to the exact construction and operation illustrated and described herein. Accordingly, all suitable modifications and equivalents should be understood to fall within the scope of the invention as claimed herein.