Glucose tolerance testing gel

Abstract

A shelf-stable gel formulation for glucose tolerance testing is provided that may replace existing glucose drinks used for such testing. Unlike existing glucose drinks for glucose tolerance testing, the inventive gel formulations are more palatable and exhibit a sensory profile more alluring to patients. The gel formulations generally contain dextrose and a synergetic combination of gelling agents, which provide a formulation exhibiting superior texture, stability, and mouthfeel.

Description

GLUCOSE TOLERANCE TESTING GELRELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 635,245 entitled “GLUCOSE TOLERANCE TESTING GEL,” filed April 17, 2024, the entire disclosure of which is incorporated herein by reference.BACKGROUND1. Field of the Invention

[0002] The present disclosure is generally directed to a shelf-stable gel formulation for use in glucose tolerance testing. More particularly, the present disclosure is generally directed to a gel formulation for use in glucose tolerance testing that contains a dosage amount of dextrose and exhibits superior sensory characteristics.2. Description of the Related Art

[0003] The glucose tolerance test, also known as the oral glucose tolerance test, measures a patient’s response to glucose. This glucose tolerance test is typically applied while the patient is fasting or after the patient consumes a meal. The glucose tolerance test can be used to screen for Type 2 Diabetes, insulin resistance, and / or gestational diabetes, which is a type of diabetes that develops during pregnancy. The glucose tolerance test is designed to identify abnormalities in how the human body handles glucose during fasting or after a meal.

[0004] Generally, prior to the glucose tolerance test, patients consume a liquid glucose tolerance test drink (e.g., Glucola) with a specific dosage of glucose for the test. However, these drinks are often unpalatable to the patients, particularly to children. The children may struggle to consume the test drink in the required amount of time (five minutes). In many cases, the patients struggle to consume these poor-tasting drinks in the required amount of time (five minutes) prior to glucose tolerance testing.

[0005] Accordingly, there is a need for a superior test preparation formulation for glucose tolerance testing that exhibits superior palatable and sensory characteristics.SUMMARY

[0006] One or more embodiments of the present disclosure generally relate to a method for testing glucose tolerance in a test subject. Generally, the method comprises: (a) providing a glucose tolerance gel composition having a pH of less than 4.0; (b) administering the glucose tolerance gel composition to the test subject; and (c) determining a glucose tolerance level of the test subject at one or more predetermined intervals.

[0007] One or more embodiments of the present disclosure generally relate to a glucose tolerance test kit. Generally, the test kit comprises: (a) at least one container containing a glucose tolerance gel composition having a pH of less than 4.0; and (b) a set of instructions with dosage instructions of the glucose tolerance gel composition for a test subject.

[0008] One or more embodiments of the present disclosure generally relate to a glucose tolerance gel composition for glucose tolerance testing. Generally, the glucose tolerance gel composition comprises a dextrose dosage configured for glucose tolerance testing. Moreover, the glucose tolerance gel composition has a pH of less than 4.0.DETAILED DESCRIPTION

[0009] The present disclosure is generally directed to a shelf-stable gel composition to be used for the glucose tolerance test. More particularly, the gel compositions described herein are designed to replace the unpalatable drinks currently used for glucose tolerance tests. The gel compositions described herein exhibit superior sensory characteristics that make them more palatable and easier to consume for patients undergoing glucose tolerance testing. Moreover, the gel formulations of the present disclosure can also be vegan and, therefore, be devoid of any animal components or byproducts.The Gel Formulations

[0010] As discussed below in greater detail, the gel formulations of the present disclosure may comprise, consist essentially of, or consist of:(i) at least one glucose source (e.g., dextrose);(ii) a first gelling agent (e.g., locust bean gun);(iii) a second gelling agent (e.g., carrageenan);(iv) water;(v) a pH adjustment agent (e.g., citric acid);(vi) at least one flavorant; and(vii) at least one colorant.

[0011] As used herein, the terms “gel formulation,” “gel composition,” “glucose tolerance gel formulation,” and “glucose tolerance gel composition” may all be used interchangeably and refer to the inventive gel formulation of the present disclosure.

[0012] Generally, the gel formulations comprise at least one carbohydrate, such as a simple sugar. Preferably, in certain embodiments, the simple sugar is glucose and / or dextrose. In one or more embodiments, the gel formulations comprise at least 1, 5, 10, 15, 20, 21, 22, 23, 24, 25, 26, 27, or 28 weight percent of at least one carbohydrate, based on the total weight of the glucose tolerance gel composition. Additionally, or in the alternative, the gel formulations may comprise less than 60, 55, 50, 45, 40, 35, 30, or 29 weight percent of at least one carbohydrate, based on the total weight of the glucose tolerance gel composition.

[0013] In many cases, the carbohydrate is dextrose. In one or more embodiments, the gel formulations comprise at least 1, 5, 10, 15, 20, 21, 22, 23, 24, 25, 26, 27, or 28 weight percent of dextrose, based on the total weight of the glucose tolerance gel composition. Additionally, or in the alternative, the gel formulations may comprise less than 60, 55, 50, 45, 40, 35, 30, or 29 weight percent of dextrose, based on the total weight of the glucose tolerance gel composition.

[0014] The gel formulations of the present disclosure may also comprise one or more gelling agents. In one or more embodiments, the gel formulations comprise at least 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, or 1.7 weight percent of at least two or more gelling agents, based on the total weight of the glucose tolerance gel composition. Additionally, or in the alternative, the gel formulations may comprise less than 10.0, 9.0, 8.0, 7.0, 6.0, 5.0, 4.5, 4.0, 3.5, 3.0, 2.5, 2.0, 1.9, or 1.8 weight percent of at least two or more gelling agents, based on the total weight of the glucose tolerance gel composition. Exemplary gelling agents include locust bean gum, agar, pectin, carrageenan, alginate, guar gum, gellan gum, xanthan gum, or any combination thereof.

[0015] Generally, the gel formulations of the present disclosure may comprise a first gelling agent and a second gelling agent.

[0016] In one or more embodiments, the gel formulations comprise at least 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, or 0.7 weight percent of a first gelling agent, based on the total weight of theglucose tolerance gel composition. Additionally, or in the alternative, the gel formulations may comprise less than 10.0, 9.0, 8.0, 7.0, 6.0, 5.0, 4.5, 4.0, 3.5, 3.0, 2.5, 2.0, 1.5, 1.4, 1.3, 1.2, 1.1, 1.0, 0.9, 0.8, 0.7, or 0.6 weight percent of a first gelling agent, based on the total weight of the glucose tolerance gel composition. In various embodiments, the first gelling agent may comprise locust bean gum, agar, or a combination thereof. In certain embodiments, the first gelling agent is locust bean gum.

[0017] In one or more embodiments, the gel formulations comprise at least 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, or 1.0 weight percent of a second gelling agent, based on the total weight of the glucose tolerance gel composition. Additionally, or in the alternative, the gel formulations may comprise less than 10.0, 9.0, 8.0, 7.0, 6.0, 5.0, 4.5, 4.0, 3.5, 3.0, 2.5, 2.0, 1.5, 1.4, 1.3, 1.2, 1.1, 1.0, 0.9, or 0.8 weight percent of a second gelling agent, based on the total weight of the glucose tolerance gel composition. In various embodiments, the second gelling agent may comprise carrageenan, pectin, or a combination thereof. In certain embodiments, the second gelling agent is carrageenan, such as iota-carrageenan.

[0018] While not wishing to be bound by theory, it has been observed that the combination of locust bean gum and iota-carrageenan exhibits a synergy that results in a gel composition with superior texture, stability, and mouthfeel.

[0019] Furthermore, as noted above, the gel formulations of the present disclosure may comprise water, which can be used to dissolve certain ingredients and facilitate the formation of the gel. In one or more embodiments, the gel formulations comprise at least 1, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 66, 67, 68, or 69 weight percent of water, based on the total weight of the glucose tolerance gel composition. Additionally, or in the alternative, the gel formulations may comprise less than 99, 98, 95, 90, 85, 80, 75, 71, 70, or 69 weight percent of water, based on the total weight of the glucose tolerance gel composition. In certain embodiments, the water may be distilled water.

[0020] Moreover, the gel formulations of the present disclosure may contain a pH adjustment agent. In one or more embodiments, the gel formulations comprise at least 0.01, 0.05, 0.1, 0.12, or 0.15 weight percent of at least one pH adjustment agent, based on the total weight of the glucose tolerance gel composition. Additionally, or in the alternative, the gel formulations may comprise less than 1.0, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, or 0.2 weight percent of at least one pH adjustment agent, based on the total weight of the glucose tolerance gelcomposition. The pH adjustment agent may be an organic acid, such as citric acid. Besides adjusting the pH of the gel, the pH adjustment agent may also increase the tartness of the formulation. The pH is measured with a pH meter, such as Five Easy Plus FP 20 (Mettler- Toledo, China).

[0021] The gel formulations may also comprise one or more flavorants to enhance the flavor of the formulations. In one or more embodiments, the gel formulations comprise at least 0.0001, 0.0005, 0.001, 0.005, 0.01, 0.05, 0.1, 0.15, 0.2, or 0.25 weight percent of at least one flavorant, based on the total weight of the glucose tolerance gel composition. Additionally, or in the alternative, the gel formulations may comprise less than 1.0, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, or 0.2 weight percent of at least one flavorant, based on the total weight of the glucose tolerance gel composition. The flavorant may be a liquid flavorant, such as Natural Fruit Punch Flavor WONF 0.2-0.3%, Natural Strawberry Flavor WONF 0.4%, Natural Watermelon Flavor WONF 1-1.2%, and / or Natural Blue Raspberry Flavor WONF 0.3%, all of which are from Flavorchem (Downers Grove, IE).

[0022] The gel formulations may also comprise one or more colorants to enhance the visual characteristics of the formulation. In one or more embodiments, the gel formulations comprise at least 0.01, 0.05, or 0.1, weight percent of at least one colorant, based on the total weight of the glucose tolerance gel composition. Additionally, or in the alternative, the gel formulations may comprise less than 1.0, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, or 0.2 weight percent of at least one colorant, based on the total weight of the glucose tolerance gel composition. The colorant can be a liquid colorant, such as a food grade colorant. Exemplary colorants include brilliant pink, rubescent red, vivid red, or shade blue food colorings by EXBERRY®. Preferably the colorants are natural food colors.

[0023] The gel formulations of the present disclosure may also contain or exclude certain optional additives or ingredients.

[0024] For example, in various embodiments, the gel formulations of the present disclosure may not contain certain types of gelling agents that can negatively affect the sensory characteristics of the formulations. In one or more embodiments, the gel formulations comprise less than 40, 35, 30, 25, 20, 15, 10, 5, 4, 3, 2, 1, 0.5, 0.1, or 0.01 weight percent of gelatin, glycerin, agar-, alginate, pectin, or a combination of any of these gelling agents, based on the totalweight of the glucose tolerance gel composition. In certain embodiments, the gel formulations comprise substantially no gelatin, glycerin, agar, alginate, and / or pectin.

[0025] The gel formulations of the present disclosure may also comprise minimal amounts of additional sugars besides dextrose. In one or more embodiments, the gel formulations comprise less than 40, 35, 30, 25, 20, 15, 10, 5, 4, 3, 2, 1, 0.5, or 0.1 weight percent of additional sugars besides dextrose, such as sucrose, based on the total weight of the glucose tolerance gel composition. In certain embodiments, the gel formulations comprise substantially no sucrose.

[0026] In one or more embodiments, the gel formulations comprise less than 40, 35, 30, 25, 20, 15, 10, 5, 4, 3, 2, 1, 0.5, or 0.1 weight percent of a preservative, such as potassium sorbate or sodium citrate, based on the total weight of the glucose tolerance gel composition. In certain embodiments, the gel formulations comprise substantially no preservatives, such as potassium sorbate or sodium citrate.

[0027] In one or more embodiments, the gel formulations comprise less than 40, 35, 30, 25, 20, 15, 10, 5, 4, 3, 2, 1, 0.5, or 0.1 weight percent of adipic acid and / or hydrochloric acid, based on the total weight of the glucose tolerance gel composition. In certain embodiments, the gel formulations comprise substantially no adipic acid and / or hydrochloric acid.

[0028] As noted above, the gel formulations of the present disclosure may exhibit numerous sensory characteristics that make the formulations highly palatable and desirable for test subjects, such as optimized pH, water activity, Brix measurements, and Bloom values.

[0029] In one or more embodiments, the gel formulations have a pH of at least 1.0, 1.5, 2.0, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, or 3.55. Additionally, or in the alternative, the gel formulations may have a pH of less than 6.0, 5.5, 5.0, 4.5, 4.0, 3.9, 3.8, 3.75, 3.70, or 3.65. In certain embodiments, the gel formulations have a pH in the range of 1.0 to 4.0, 1.0 to 3.9, 1.5 to 3.9, 2.0 to 3.8, or 3.0 to 3.6.

[0030] In one or more embodiments, the gel formulations exhibit a water activity at 24°C of at least 0.70, 0.75, 0.80, 0.85, 0.90, or 0.95 as measured by a water activity measuring device such as an Aqualab Water Activity Meter (e.g., Aqualab 4, Meter Group Inc., Pullman, WA). Additionally, or in the alternative, the gel formulations may exhibit a water activity at 24°C of less than 0.99, 0.98, 0.96, 0.95, 0.85, 0.80, or 0.75 as measured by a water activity measuringdevice such as an Aqualab Water Activity Meter. The water activity measures the free, unbound water present in the gel.

[0031] In one or more embodiments, the gel formulations exhibit a Brix measurement of at least 20, 21, 22, 23, 24, 25, 26, 27, or 28 °Brix. Additionally, or in the alternative, the gel formulations may exhibit a Brix measurement of less than 40, 39, 38, 37, 36, 35, 34, 33, 32, 31, 30, or 29 °Brix.

[0032] In one or more embodiments, the gel formulations exhibit a Bloom grade of at least 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, or 300 Bloom. Additionally, or in the alternative, the gel formulations may exhibit a Bloom grade of less than 1,000, 900, 800, 700, 600, 550, 500, 450, 400, 350, 300, 275, or 250 Bloom. The Bloom test is used to measure the strength of a gel or gelatin. The test determines the weight in grams needed by a specified plunger (generally with a diameter of 0.5 inches) to depress the surface of the gel by 4 mm without breaking it at specified temperatures. Typically, the higher a Bloom value, the higher the melting and gelling points of a gel, and the shorter its gelling times. The standard test involves using a 6.66% gel after storage at 10°C for 17 hours.

[0033] The gel formulations of the present disclosure may be shelf-stable and do not require refrigeration, except for sensory aspects. Refrigeration may be used if the test subject prefers cooler foods. The gel compositions may be stored at room temperature conditions.Production of the Gel Formulations

[0034] Generally, the process for forming the gel formulations of the present disclosure involves:(a) Preparing the dry ingredients (e.g., dextrose, at least one first gelling agent, and at least one second gelling agent), the colorants, and the flavorants, which are weighed and blended together. The liquid colorant may be first added to the dry mixture, followed by the liquid flavorant.(b) Preparing and dissolving the pH adjustment agent (e.g., citric acid) by weighing the agent, mixing it with water, and dissolving it in water, thereby forming an acidic solution. The acidic solution may comprise a pH adjustment agent to water ratio of at least 0.1:1, 0.3:1, or 0.5:1 and / or less than 2:1, 1.5:1, or 1:1.(c) Providing water heated to a temperature of at least 100, 125, 150, 175, 180, 185, or190°F and / or less than 300, 275, 250, 225, or 200°F. In certain embodiments, the water has a temperature of about 190°F. While not wishing to be bound by theory, it is believed that the temperature of the water is critical when forming the gel compositions.(d) Once the water has reached the desired temperature, it is mixed with the dry ingredients, colorant, and flavorant under stirring. At least a portion of the acidic solution may then be added to the mixture under continuous stirring. The mixture is then stirred until all clumps are gone.(e) The resulting mixture is then poured into containers or molds with cavities of desired sizes. The sizes of the containers and molds are used to form the gel samples and the size of the containers and molds can dictate the amount of dextrose available in each sample. The containers and molds must also be able to account for loss of moisture during the solidification step.(f) The poured gel composition is allowed to cool and solidify in the container. A lid may be placed on the container to prevent outside contamination. While wishing to not be bound by theory, it has been observed that the order of the production process is important for gelling, the moisture percentage of the resulting gel, and the water activity of the resulting gel.

[0035] The pour weight / container (e.g., a cup) may be based on the desired dextrose dosage. For example, the pour weight / container (e.g., a cup) may be based on the following dosages: (i) for 50 g of dextrose, you need to provide 187.91 g of the gel composition; (ii) for 10 g of dextrose, you need to provide 37.58 g of the gel composition; and (iii) for 5 g of dextrose, you need to provide 18.79 g of the gel composition.

[0036] The gel formulations may be provided in several different containers. The type of containers is versatile and can be chosen to facilitate the environment in which the materials are stored and used. In one or more embodiments, the containers may comprise a plastic pouch, a cup with or without a lid, a bottle, a tube with or without a lid, or any other conventional container known in the art that can hold a gel.The Glucose Tolerance Test

[0037] Generally, the glucose tolerance test involves administering the gel formulations of the present disclosure to a test subject, such as a human patient. The patient can be an adult, teenager, child, or infant. Initially, prior to consuming the gel formulation, a baseline blood sample may be taken from the test subject after fasting overnight. Afterwards, the gel formulation may then be consumed by the test subject. The dosage amount of the gel formulation depends on the weight of the test subject. Typically, a dosage providing 75 g of dextrose is commonly used for adults. Alternatively, for smaller test subjects, 1.75 g of dextrose must be dosed per kilogram of body weight (with a maximum dosage of 75 g of dextrose). After consuming the gel formulation, additional blood samples are taken from the test subject at designated intervals in order to measure and analyze the glucose concentration in the test subject. In many cases, this blood sample is collected two hours after consuming the gel formulation; although, other time intervals may be utilized (e.g., after 1, 2, 3, 4, 5, 6, and / or 7 hours).

[0038] The dosing for the glucose tolerance tests is measured by weight of the test subject. Generally, the maximum dextrose dosage is 75 g. Thus, the gel compositions may be provided in at least three different sizes that can be mixed and matched to provide accurate dosing for a test subject. For example, the gel compositions may be provided in separate sizes that provide 5 g, 10 g, and 50 g of dextrose. Thus, an adult patient needing 75 g of dextrose could consume one 50 g cup, two 10 g cups, and one 5 g cup. In addition, it is important that the dosage is consumed within a short time frame of less than 10 minutes. More preferably, the time frame for consumption is less than 9, 8, 7, 6, or 5 minutes.

[0039] In various embodiments, test kits can be prepared with prepared samples of the gel compositions of the present disclosure. These kits can contain: (i) prepackaged containers (e.g., cups with lids) containing the gel compositions and (ii) instructions for using the gel compositions for glucose tolerance testing. These instructions can include dosage information and may be available via printed instructions or digitally via a QR code. The kit may be packaged in a box or another receptacle capable of holding the containers and instructions. The kits may contain multiple containers of the gel compositions and provide a combination of containers that, when combined, may provide the max dextrose dosage (i.e., 75 grams of dextrose).

[0040] This invention can be further illustrated by the following examples of embodiments thereof, although it will be understood that these examples are included merely forthe purposes of illustration and are not intended to limit the scope of the invention unless otherwise specifically indicated.EXAMPLESExample 1

[0041] Gel formulations according to the formulas depicted in TABLE 1, below, were produced in 500 g and 1,000 g batches.TABLE 1

[0042] First, the dry ingredients (i.e., the dextrose, locust bean gum, and iota- carrageenan) were weighed out and then mixed together. Afterwards, the colorants and flavorants were added to the dry ingredients and blended therein. Meanwhile, the citric acid solution was prepared by dissolving citric acid in water and the distilled water was separately heated in a saucepan to 190°F.

[0043] The heated water was then poured into a container with the blended dry ingredients and subjected to stirring. The citric acid solution was then added and the mixture was subjected to constant stirring (without creating a vortex) until the clumps were gone.

[0044] The resulting clump-free mixture was then poured into the final containers (cups with lids) depending on the desired dextrose dosage desired for each container. For a 50 g dextrose dose, 187.91 g of the gel composition was poured into the container; for a 10 g dextrose dose, 37.58 g of the gel composition was poured into the container; and for a 5 g dextrose dose, 18.79 g of the gel composition was poured into the container.

[0045] Separate batches of 500 g and 1,000 g were produced for each of the following flavorant / colorant combination:(i) Nat Strawberry Flavor WONF 0.4% by EXBERRY® and Shade Brilliant Pink;(ii) Nat Watermelon Flavor WONF 1 - 1 .2% by EXBERRY® and Shade Rubescent Red;(iii) Nat Fruit Punch Flavor WONF 0.2-0.3% by EXBERRY® and Shade Vivid Red; and(iv) Nat Blue Raspberry Flavor Type 0.3% by EXBERRY® and Shade Blue.Example 2

[0046] Gel formulations according to the formulas depicted in TABLE 2, below, were produced in 500 g and 1,000 g batches. These formulations were similar to Example 1, except higher concentrations of flavorants and colorants were utilized.TABLE 2

[0047] First, the dry ingredients (i.e., the dextrose, locust bean gum, and iota- carrageenan) were weighed out and then mixed together. Afterwards, the colorants and flavorants were added to the dry ingredients and blended therein. Meanwhile, the citric acid solution was prepared by dissolving citric acid in water and the distilled water was separately heated in a saucepan to 190°F.

[0048] The heated water was then poured into a container with the blended dry ingredients and subjected to stirring. The citric acid solution was then added and the mixture was subjected to constant stirring (without creating a vortex) until the clumps were gone.

[0049] The resulting clump-free mixture was then poured into the final containers (cups with lids) depending on the desired dextrose dosage desired for each container. For a 50 g dextrose dose, 187.91 g of the gel composition was poured into the container; for a 10 g dextrose dose, 37.58 g of the gel composition was poured into the container; and for a 5 g dextrose dose, 18.79 g of the gel composition was poured into the container.

[0050] Separate batches of 500 g and 1,000 g were produced for each of the following flavorant / colorant combination:(i) Nat Strawberry Flavor WONF 0.4% by EXBERRY® and Shade Brilliant Pink;(ii) Nat Watermelon Flavor WONF 1-1.2% by EXBERRY® and Shade Rubcsccnt Red;(iii) Nat Fruit Punch Flavor WONF 0.2-03% by EXBERRY® and Shade Vivid Red; and(iv) Nat Blue Raspberry Flavor Type 0.3% by EXBERRY® and Shade Blue.Example 3

[0051] Gel formulations according to the formulas depicted in TABLES 3 and 4, below, were produced in 500 g and 1,000 g batches. The production processes described in Examples 1 and 2 were utilized to also produce these samples.TABLE 3 - 500 g BatchTABLE 4 - 1,000 g Batch

[0052] Separate batches of 500 g and 1,000 g of TABLES 3 and 4 were produced for each of the following flavorant / colorant combination:(i) Nat Strawberry Flavor WONF 0.4% by EXBERRY® and Shade Brilliant Pink;(ii) Nat Watermelon Flavor WONF 1-1.2% by EXBERRY® and Shade Rubescent Red;(iii) Nat Fruit Punch Flavor WONF 0.2-0.3% by EXBERRY® and Shade Vivid Red; and(iv) Nat Blue Raspberry Flavor Type 0.3% by EXBERRY® and Shade Blue.Example 4

[0053] Consumer acceptability testing of the gel formulations described herein was conducted on human children subjects from two afterschool programs. At each testing location, there were three researchers conducting the test. Children waited in a room separate from the testing room. Staff of the afterschool program would bring three children into the room at a time. Each child would sit with one researcher, facing away from the other children, so that they could not see the other children’s faces.

[0054] Researchers would then ask the child which two flavors they would like to try (out of the options of watermelon, blue raspberry, and strawberry). The researcher would offer the child a small spoonful of the first requested flavor, then ask them to point to the face on the 7 -point hedonic face scale that represents how much they liked the color, the taste, and the entire thing. The researcher would circle the faces the child pointed to on the ballot. The process would then be repeated for the second selected flavor. Once the child had completed their test, they would wait until the other children in that group were done before being offered a piece of candy and returning to the other room. The next set of three children would then be brought in and the process was repeated.

[0055] During both data collection periods, researchers attempted to guide children to not answer the ballot questions out loud or to otherwise make comments about the samples that could be overheard by the other participants in the room.

[0056] A total of 27 males and 46 females (ages 5+) participated in the study. Thirty children aged 7+ chose to try strawberry, 40 tried blue raspberry, and 32 tried watermelon. For all flavors (strawberry, blue raspberry, and watermelon), 90% or more children liked the color and entire formulation to some degree, and 86% or more liked the taste to some degree. More specifically, 50% or more of children who tried the strawberry flavor liked the taste, color and entire thing very much. Fifty percent or more of children who tried the blue raspberry flavor liked the color and entire thing very much. Of children who tried the blue raspberry flavor, 40% liked the taste very much. For all flavors, 0% of children disliked the entire thing slightly, moderately or very much. Other attributes similarly had low percentages for any level of dislikefor any flavor. The watermelon was the least popular flavor but still had 40% or more children like the taste and color moderately, and 37.5% like the entire thing moderately.

[0057] The results for children ages 5 and 6 were separated from the age 7+ responses due to the use of a 7-point hedonic scale. Children 6 and under can struggle to be decisive enough for a 7-point scale and a 5-point scale was more suited to them. However, these positive results were included. For flavor selection, 13 chose watermelon, 17 chose strawberry, and 16 chose blue raspberry. More than 80% of children (5-6) liked all aspects (taste, color, and entire thing) of all flavors to some degree. Over 50% of children (5-6) liked all aspects of all flavors very much, except for the entire thing for the watermelon flavor which 38.5% of children liked very much.

[0058] The goal of this study was to develop a product that was fun, easy to consume, and easy for children to understand and use. Spontaneous data collection occurred at one of the afterschool programs after the planned testing ended. Children asked for remaining samples. To observe how children would consume more samples, we decided to give them the remaining samples. Many of them easily ate entire sample cups by themselves. Some of them even ate multiple cups and continued to ask for more. This shows that they enjoyed the samples, and that they would be capable of eating larger quantities of them, which are important characteristics for a product used to conduct glucose testing. Overall, the children sensory evaluation indicates that the flavors strawberry and blue raspberry were preferred with watermelon still being liked by those sampling the product. The high likeability percentages for the taste, color, and entire thing in addition to the spontaneous testing results demonstrates the ability for the glucose testing gel formulation to provide children with a more positive glucose testing experience.DEFINITIONS

[0059] It should be understood that the following is not intended to be an exclusive list of defined terms. Other definitions may be provided in the foregoing description, such as, for example, when accompanying the use of a defined term in context.

[0060] As used herein, the terms “a,” “an,” and “the” mean one or more.

[0061] As used herein, the term “and / or,” when used in a list of two or more items, means that any one of the listed items can be employed by itself or any combination of two or more of the listed items can be employed. For example, if a composition is described ascontaining components A, B, and / or C, the composition can contain A alone; B alone; C alone; A and B in combination; A and C in combination, B and C in combination; or A, B, and C in combination.

[0062] As used herein, the terms “comprising,” “comprises,” and “comprise” are open- ended transition terms used to transition from a subject recited before the term to one or more elements recited after the term, where the element or elements listed after the transition term are not necessarily the only elements that make up the subject.

[0063] As used herein, the terms “having,” “has,” and “have” have the same open-ended meaning as “comprising,” “comprises,” and “comprise” provided above.

[0064] As used herein, the terms “including,” “include,” and “included” have the same open-ended meaning as “comprising,” “comprises,” and “comprise” provided above.

[0065] As used herein, the term “substantially no” means that the recited component is present in an amount of less than 0.01 weight percent within the described formulation.NUMERICAL RANGES

[0066] The present description uses numerical ranges to quantify certain parameters relating to the invention. It should be understood that when numerical ranges are provided, such ranges are to be construed as providing literal support for claim limitations that only recite the lower value of the range as well as claim limitations that only recite the upper value of the range. For example, a disclosed numerical range of 10 to 100 provides literal support for a claim reciting “greater than 10” (with no upper bounds) and a claim reciting “less than 100” (with no lower bounds). The inverse is also true, for example, in that “at least 0.1 and less than 10” provides support for a range of 0.1 to 10.

[0067] When a numerical sequence is indicated, it is to be understood that each number is modified the same as the first number or last number in the numerical sequence or in the sentence, e.g., each number is “at least,” or “less than” as the case may be; and each number is in an “or” relationship. For example, “at least 10, 20, 30, 40 weight percent” means the same as “at least 10 weight percent, or at least 20 weight percent, or at least 30 weight percent, or at least 40 weight percent”; and “at least 5, 10, 15, 20 and / or not more than 99, 95, 90 weight percent” means the same as “at least 5 weight percent, or at least 10 weight percent, or at least 15 weightpercent, or at least 20 weight percent and / or not more than 99 weight percent, or not more than 95 weight percent, or not more than 90 weight percent..CLAIMS NOT LIMITED TO DISCLOSED EMBODIMENTS

[0068] The preferred forms of the invention described above are to be used as illustration only, and should not be used in a limiting sense to interpret the scope of the present invention. Modifications to the exemplary embodiments, set forth above, could be readily made by those skilled in the ail without departing from the spirit of the present invention.

[0069] The inventors hereby state their intent to rely on the Doctrine of Equivalents to determine and assess the reasonably fair scope of the present invention as it pertains to any apparatus not materially departing from but outside the literal scope of the invention as set forth in the following claims.

Claims

What is claimed is:

1. A method for testing glucose tolerance in a test subject, the method comprising:(a) providing a glucose tolerance gel composition having a pH of less than 4.0;(b) administering the glucose tolerance gel composition to the test subject; and(c) determining a glucose tolerance level of the test subject at one or more predetermined intervals subsequent to the administering.

2. The method according to claim 1, wherein the glucose tolerance gel composition has a pH of 1.0 to 3.9.

3. The method according to claim 2, wherein the glucose tolerance gel composition comprises 1 to 60 weight percent of dextrose, based on the total weight of the glucose tolerance gel composition.

4. The method according to claim 3, wherein the glucose tolerance gel composition comprises 0.1 to 10.0 weight percent of a first gelling agent, based on the total weight of the glucose tolerance gel composition.

5. The method according to claim 4, wherein the first gelling agent comprises locust bean gum, agar, or a combination thereof.

6. The method according to claim 5, wherein the glucose tolerance gel composition comprises 0.1 to 10.0 weight percent of a second gelling agent, based on the total weight of the glucose tolerance gel composition.

7. The method according to claim 6, wherein the second gelling agent comprises carrageenan, pectin, or a combination thereof.

8. The method according to claim 7, wherein the glucose tolerance gel composition comprises 1 to 99 weight percent of water, based on the total weight of the glucose tolerance gel composition.

9. The method according to claim 8, wherein the glucose tolerance gel composition comprises 0.01 to 1.0 weight percent of at least one pH adjustment agent, based on the total weight of the glucose tolerance gel composition.

10. The method according to claim 8, wherein the glucose tolerance gel composition exhibits a Brix measurement of 20 to 40 °Brix.

11. The method according to claim 8, wherein the glucose tolerance gel composition exhibits a water activity at 24°C of 0.70 to 0.99.

12. A glucose tolerance test kit comprising:(a) at least one container containing a glucose tolerance gel composition having a pH of less than 4.0; and(b) a set of instructions with dosage instructions of the glucose tolerance gel composition for a test subject.

13. The glucose tolerance test kit according to claim 12, wherein the glucose tolerance gel composition has a pH of 1.0 to 3.9.

14. The glucose tolerance test kit according to claim 13, wherein the glucose tolerance gel composition comprises 1 to 60 weight percent of dextrose, based on the total weight of the glucose tolerance gel composition.

15. The glucose tolerance test kit according to claim 14, wherein the glucose tolerance gel composition comprises 0.1 to 10.0 weight percent of a first gelling agent, based on the total weight of the glucose tolerance gel composition.

16. The glucose tolerance test kit according to claim 15, wherein the first gelling agent comprises locust bean gum, agar, or a combination thereof.

17. The glucose tolerance test kit according to claim 16, wherein the glucose tolerance gel composition comprises 0.1 to 10.0 weight percent of a second gelling agent, based on the total weight of the glucose tolerance gel composition.

18. The glucose tolerance test kit according to claim 17, wherein the second gelling agent comprises carrageenan, pectin, or a combination thereof.

19. The glucose tolerance test kit according to claim 18, wherein the glucose tolerance gel composition comprises 1 to 99 weight percent of water, based on the total weight of the glucose tolerance gel composition.

20. The glucose tolerance test kit according to claim 19, wherein the glucose tolerance gel composition comprises 0.01 to 1.0 weight percent of at least one pH adjustment agent, based on the total weight of the glucose tolerance gel composition.

21. The glucose tolerance test kit according to claim 19, wherein the glucose tolerance gel composition exhibits a Brix measurement of 20 to 40 °Brix.

22. The glucose tolerance test kit according to claim 19, wherein the glucose tolerance gel composition exhibits a water activity at 24°C of 0.70 to 0.99.

23. A glucose tolerance gel composition for glucose tolerance testing, the glucose tolerance gel composition comprising a dextrose dosage configured for the glucose tolerance testing, wherein the glucose tolerance gel composition has a pH of less than 4.0.

24. The glucose tolerance gel composition according to claim 23, wherein the glucose tolerance gel composition has a pH of 1.0 to 3.9.

25. The glucose tolerance gel composition according to claim 24, wherein the glucose tolerance gel composition comprises 1 to 60 weight percent of dextrose, based on the total weight of the glucose tolerance gel composition.

26. The glucose tolerance gel composition according to claim 25, wherein the glucose tolerance gel composition comprises 0.1 to 10.0 weight percent of a first gelling agent, based on the total weight of the glucose tolerance gel composition.

27. The glucose tolerance gel composition according to claim 26, wherein the first gelling agent comprises locust bean gum, agar, or a combination thereof.

28. The glucose tolerance gel composition according to claim 27, wherein the glucose tolerance gel composition comprises 0.1 to 10.0 weight percent of a second gelling agent, based on the total weight of the glucose tolerance gel composition.

29. The glucose tolerance gel composition according to claim 28, wherein the second gelling agent comprises carrageenan, pectin, or a combination thereof.

30. The glucose tolerance gel composition according to claim 29, wherein the glucose tolerance gel composition comprises 1 to 99 weight percent of water, based on the total weight of the glucose tolerance gel composition.31 . The glucose tolerance gel composition according to claim 30, wherein the glucose tolerance gel composition comprises 0.01 to 1.0 weight percent of at least one pH adjustment agent, based on the total weight of the glucose tolerance gel composition.

32. The glucose tolerance gel composition according to claim 30, wherein the glucose tolerance gel composition exhibits a Brix measurement of 20 to 40 °Brix.

33. The glucose tolerance gel composition according to claim 30, wherein the glucose tolerance gel composition exhibits a water activity at 24°C of 0.70 to 0.99.

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