WO2016086114A1

WO2016086114A1 - Sports drink formulation

Info

Publication number: WO2016086114A1
Application number: PCT/US2015/062639
Authority: WO
Inventors: Arturo Bravo NUEVO; Demetri MENEGOS
Original assignee: Artdem, Llc
Priority date: 2014-11-25
Filing date: 2015-11-25
Publication date: 2016-06-02

Abstract

The present invention relates to methods and sports drink compositions for treating and/or preventing muscle weakness and/or increasing muscle strength and/or stamina in subjects in need thereof. The sports drink composition includes meglumine or a salt thereof and at least one electrolyte compound, the electrolyte compound including sodium, potassium, phosphorus, magnesium, calcium ions, and combinations thereof. The method includes administering to the subject an effective amount of a sports drink composition comprising meglumine or a salt thereof and at least one electrolyte compound; wherein administration of the sports drink composition reduces and/or prevents muscle weakness and/or lack of stamina in the subject and/or increases muscle strength in the subject.

Description

SPORTS DRINK FORMULATION

CROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 62/084,107 filed November 25, 2014, all of which application is hereby incorporated by reference in its entirety herein.

BACKGROUND

[0002] The present invention provides compositions containing meglumine or a salt thereof and at least one electrolyte compound for treating and/or preventing muscle weakness and/or increasing muscle strength and/or stamina. The present invention further provides methods for treating and/or preventing muscle weakness and/or increasing muscle strength and/or stamina.

[0003] Optimal rehydration is desirable in the athletic population in order to maximize performance as dehydration, defined as a water deficit in excess of 2% body weight, decreases exercise performance (American Dietetic Association, Dietitians of Canada, American College of Sports Medicine. Position Statement on Nutrition and Athletic Performance. Medicine and Science in Sports and Exercise 41 : 709-731). In this context, adequate oral electrolyte replacement is directed at offsetting sweat deficit, which will conversely lead to dehydration and impaired exercise capacity. Exercise performance will be impaired when an individual is dehydrated by as little as 2% of body weight. While an individual dehydrated in excess of 5% of body weight, will experience a decrease in capacity for work by at least 30% and up to 45% (Saltin B, Costill DL. Fluid and electrolyte balance during prolonged exercise. In : Horton ES, Terjung RL, eds. Exercise, nutrition, and metabolism. New York : Macmillan, 1988: 150-8; Nielsen B, Kubica R, Bonnesen A, Rasmussen IB, Stoklosa J, Wilk B. Physical work capacity adter dehydration and hyperthermia. Scand J Sports Sc 1982; 3:2-10).

[0004] Oral electrolyte replacement is aimed towards replacing electrolytes lost in sweat, as well as increasing endurance, so as to maximize athletic performance. The major cation lost in sweat is sodium, while chloride is the major anion. Other major electrolytes present in sweat are potassium, calcium, magnesium (Maughan RJ. Fluid and electrolyte loss and replacement in exercise. In: Harries M, Williams C, StanishWD, Micheli LL, eds. Oxford textbook of sports medicine. Oxford: Oxford University Press, 1994:82-93). As magnesium is required for the absorption of potassium, we can surmise the importance of these electrolytes working in tandem. It is this constellation of electrolytes that should be replaced in any formulation geared towards increasing overall individual performance.

[0005] In formulating an electrolyte rehydration solution that optimizes the characteristics required for maximized performance, consideration is also given to osmolality, flavoring components, as well as other active ingredients. The formulation must be palatable to the individual so as to encourage intake prior, during and after exercise. In addition, the tonicity plays a major role as well, since an isotonic, or slightly hypotonic, solution will allow for better overall absorption and delivery of important electrolytes (Maughan RJ. Fluid and electrolyte loss and replacement in exercise. In: harries M, Williams C, StanishWD, Micheli LL, eds. Oxford textbook of sports medicine. Oxford: Oxford University Press, 1994:82-93).

[0006] While mechanisms of insulin-induced glucose uptake in skeletal muscle are well established, the pathways driving muscle contraction-induced glucose uptake remain largely obscure. Indeed, exercise greatly benefits the management of blood glucose levels, but the reasons for this benefit are unclear. The master metabolic kinase AMPK has been one focus of studies in this area, and the AMPK-related kinase SNARK has been suggested recently as a key mediator of glucose uptake stimulated by muscle contraction (Lefebvre DL, Bai Y, Shahmolky N, Sharma M, Poon R, et al. (2001) Identification and characterization of a novel sucrose-non-fermenting protein kinase/AMP -activated protein kinase-related protein kinase, SNARK. Biochem J 355: 297-305).

[0007] Sorbitol is a slowly absorbed sugar alcohol found in certain fruits (Adcock LH, Gray CH (1957) The metabolism of sorbitol in the human subject. Biochem J 65:554-560) that stimulates SNARK activity and increases glucose uptake by muscle cells (Koh HJ, Toyoda T, Fujii N, Jung MM, Rathod A, et al. (2010) Sucrose nonfermenting AMPK-related kinase (SNARK) mediates contraction-stimulated glucose transport in mouse skeletal muscle. Proc Natl Acad Sci U S A 107: 15541-15546). Sorbitol has been explored as a supplement to increase glucose uptake in diabetic individuals, but its clinical use is impractical because its oral administration causes acute gastrointestinal distress and diarrhea (Ravry MJ (1980) Dietetic food diarrhea. JAMA 244: 270; Wang YM, van Eys J (1981) Nutritional significance of fructose and sugar alcohols. Annu Rev Nutr 1: 437-475). Moreover, under diabetic conditions, sorbitol accumulation in some tissues, where it is slowly cleared by the polyol pathway, may promote diabetic complications including atherosclerosis, cataracts, nerve damage and retinopathy (Ramasamy R, Goldberg I J (2010) Aldose reductase and cardiovascular diseases, creating human-like diabetic complications in an experimental model. Circ Res 106: 1449-1458). Thus, alternatives to sorbitol for clinical use have been desired and sought.

[0008] Meglumine, N-Methyl-D-glucamine, is an amino sugar that is often used in pharmaceutical formulations as an excipient. Meglumine is able to form adducts with organic acids, markedly increasing their aqueous solubility. This property has been exploited by the pharmaceutical industry in making certain drug substances more soluble in water when taken in the form of an adduct with meglumine, without affecting the original activity of the drug. Examples of such increased solubility are meglumine antimonate (for human use) and flunixin meglumine (for animal use) (Roberts WL, McMurray WJ, Rainey PM (1998) Characterization of the antimonial antileishmanial agent meglumine antimonate (glucantime). Antimicrob Agents Chemother 42: 1076-1082; Kopcha M, Ahl AS (1989) Experimental uses of flunixin meglumine and phenylbutazone in food-producing animals. J Am Vet Med Assoc 194: 45-49). Meglumine is also used in the manufacturing of contrast media in combination with iodine- containing compounds (Bleicher AG, Kanal E (2008) Assessment of adverse reaction rates to a newly approved MRI contrast agent: review of 23,553 administrations of gadobenate dimeglumine. AJR Am J Roentgenol 191 : W307-311). Meglumine is also a useful agent of protein stabilizers in pharmaceutical compositions comprising antibody molecules (Igawa T, Kameoka D (2006) Stabilizer for protein preparation comprising meglumine and use thereof In: Application EP, editor). In addition, meglumine has been found useful to treat or prevent certain conditions associated with weight gain, high blood glucose, high triglyceride levels, high LDL levels, high cholesterol levels, diabetes, muscle weakness, and certain skin conditions (See, e.g., United States Patent No. 2014/0045947; Arturo B-N, Alice M, Minzhou H, Frank K, Jennifer M, et al. (2014) Meglumine Exerts Protective Effects Against Metabolic Syndrome and Type II Diabetes. PLOS ONE 9(2): e90031).

SUMMARY

[0009] The present invention provides a well-balanced electrolyte drinkable composition in conjunction with meglumine as a sports drink formulation that optimizes muscle development and strength by reducing exhaustion and optimizing athletes' work outs. The present invention is directed to a sports rehydration solution, utilizing a combination of meglumine with an optimized electrolyte replacement solution that provides superior performance to placebo in professional athletes. This combination of meglumine with optimized electrolytes provides rehydration with the additional significant benefit of a rapid, significant increase in muscle strength. [0010] During vigorous exercise, dehydration results from the body's attempts to balance endogenous heat production with exogenous heat accumulation through heat dissipation. The major mechanism by which the exercising individual is able to promote heat loss is through evaporation via sweat. This leads to the loss of the aforementioned major electrolytes found in sweat, mainly sodium and chloride.

[0011] As heat levels increase and place strain on the exercising individual, evaporation through sweat, may account for up to 98% of cooling by the exercising body. Progressive and profound dehydration will subsequently occur with improper electrolyte replacement. This will lead to the altered cardiovascular and thermoregulatory responses associated with dehydration. At the muscular level this can signal a possible increase in the rate of glycogen degradation, which can lead to decreased overall performance, decreased muscle strength and decreased muscular stamina. The present invention is directed to an electrolyte solution that not only addresses hydration status, but also looks to improve overall performance, the effect at the muscular level cannot be understated.

[0012] The present invention is directed to compositions that include meglumine or a salt thereof and at least one electrolyte compound. The electrolyte compound being chosen from sodium, potassium, phosphorus, magnesium, calcium ions, salts, and/or combinations thereof.

[0013] The present invention is also directed to methods for treating and/or preventing muscle weakness and/or increasing muscle strength and/or stamina in a human subject, the method including administering to the human subject an effective amount of a compositions that include meglumine or a salt thereof and at least one electrolyte compound chosen from sodium, potassium, phosphorus, magnesium, and calcium ions, salts, and/or combinations thereof.

[0014] The features that characterize the present invention are pointed out with particularity in the claims, which are annexed to and form a part of this disclosure. These and other features of the invention, its operating advantages and the specific objects obtained by its use will be more fully understood from the following description in which non-limiting features of the invention are illustrated and described.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIG. 1. Effect of the sports drink formulation (optimized electrolyte-meglumine rehydration solution) including meglumine and electrolytes on muscle strength of professional baseball players. Professional baseball players were treated either with the optimized electrolyte-meglumine rehydration solution or a placebo daily for 4 weeks. Professional baseball players on the optimized electrolyte-meglumine rehydration solution (gray bar) showed a 4.21%increase in grip strength after treatment versus a 0.3% showed by placebo treated players (white bar). N = 6 (optimized electrolyte-meglumine rehydration solution group) and N = 5 for Placebo group. P = 0.04.

[0016] FIG. 2. Effect of the sports drink formulation (optimized electrolyte-meglumine rehydration solution) including meglumine and electrolytes on muscle strength of professional football players. Professional football players were treated either with the optimized electrolyte-meglumine rehydration solution or a placebo daily for 4-6 weeks. Professional football players on the optimized electrolyte-meglumine rehydration solution (gray bar) showed a 4.92%increase in grip strength after treatment versus a 1.61% showed by placebo treated players (white bar). N = 9 (optimized electrolyte-meglumine rehydration solution group) and N = 10 for Placebo group. T test p value P=0.02.

DESCRIPTION

[0017] For purposes of the following detailed description, it is to be understood that the invention may assume various alternative variations and step sequences, except where expressly specified to the contrary. Moreover, other than in any operating examples, or where otherwise indicated, all numbers expressing, for example, quantities of ingredients used in the specification and claims, are to be understood as being modified in all instances by the term "about." Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are approximations that may vary depending upon the desired properties to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

[0018] Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard variation found in their respective testing measurements.

[0019] All documents, such as, but not limited to, issued patents and patent applications, referred to herein, and unless otherwise indicated, are to be considered to be "incorporated by reference" in their entirety. [0020] Unless otherwise indicated, all ranges or ratios disclosed herein are to be understood to encompass any and all sub-ranges or sub-ratios subsumed therein. For example, a stated range or ratio of "1 to 10" should be considered to include any and all subranges between (and inclusive of) the minimum value of 1 and the maximum value of 10; that is, all subranges or subratios beginning with a minimum value of 1 or more and ending with a maximum value of 10 or less, such as but not limited to, 1 to 6.1, 3.5 to 7.8, and 5.5 to 10.

[0021] In this application, the use of the singular includes the plural and plural encompasses singular, unless specifically stated otherwise. In addition, in this application, the use of "or" means "and/or" unless specifically stated otherwise, even though "and/or" may be explicitly used in certain instances. Further, in this application, the use of "a," "an," and "the" include plural referents unless otherwise expressly and unequivocally limited to one referent.

[0022] As used herein, the transitional term "comprising" (and other comparable terms, e.g., "containing," and "including") is "open-ended" and is used in reference to compositions, methods, and respective component(s) thereof, that are essential to the invention, yet open to the inclusion of unspecified matter. The term "consisting essentially of refers to those component(s) required for a given embodiment and permits the presence of component(s) that do not materially affect the properties or functional characteristic(s) of that embodiment. The term "consisting of refers to compositions and methods that are exclusive of any other component not recited in that description of the embodiment.

[0023] As used herein, a "subject" or "individual" may be a human or non-human mammal. Non-human mammals include, for example, livestock and pets, such as ovine, bovine, porcine, canine, feline and murine mammals. Preferably, the subject is human.

[0024] As used herein, a "compound" refers to one or more chemical entities, each of which may independently be isolated from nature or synthesized, ionic or neutral.

[0025] As used herein, the term "treatment" or "treating" is defined as the application or administration of a composition useful within the invention (alone or in combination with another agent), to a subject, or application or administration of a composition useful within the invention to an isolated tissue or cell line from a subject (for example, for diagnosis or ex vivo applications), who has an unhealthy physiological condition contemplated herein, a symptom of or the potential to develop an unhealthy physiological condition contemplated herein, with the purpose to prevent, cure, heal, alleviate, relieve, alter, remedy, ameliorate, improve or affect an unhealthy physiological condition contemplated herein, the symptoms of or the potential to develop an unhealthy physiological condition contemplated herein. Similar considerations apply to improving the physiological functions or parameters contemplated within the invention. Such treatments may be specifically tailored or modified, based on knowledge obtained from the field of pharmacogenomics.

[0026] As used herein, the term "prevent" or "prevention" means no condition development if none had occurred, or no further condition development if there had already been development of the condition. Also considered is the ability of one to prevent some or all of the symptoms associated with the condition.

[0027] As used herein, the term "treat" means reducing the frequency with which symptoms are or may be experienced by a patient or subject or administering a compound to reduce the severity with which symptoms are or may be experienced. An appropriate amount of the compound in any individual case may be determined by one of ordinary skill in the art using routine experimentation.

[0028] As used herein, the term "effective amount" of a compound or composition refers to the amount of the compound or composition that is sufficient to provide a beneficial effect to the subject to which the compound or composition is administered.

[0029] As used herein, the term "acceptable" refers to a material, such as a salt or diluent, which does not abrogate the biological activity or properties of the compound or composition, and is relatively non-toxic, i.e., the material may be administered to an individual without causing undesirable biological effects or interacting in a deleterious manner with any of the components of the composition in which it is contained.

[0030] As used herein, the language "acceptable salt" refers to a salt of the administered compounds prepared from acceptable non-toxic acids, including inorganic acids, organic acids, solvates, hydrates, or clathrates thereof.

[0031] As used herein, the term "composition" refers to a mixture of at least one compound useful within the invention with other chemical components, such as carriers, stabilizers, diluents, dispersing agents, suspending agents, thickening agents, and/or excipients. The composition facilitates administration of the compound to an organism. Multiple techniques of administering a compound exist in the art including, but not limited to: intravenous, oral, aerosol, parenteral, ophthalmic, pulmonary and topical administration. In one embodiment, the composition is non-toxic.

[0032] It has been unexpectedly found that meglumine in combination with electrolytes provides a novel supplement that safely enhances strength, stamina or energy, improves muscle function, and combats muscle fatigue in healthy or disease settings. [0033] Fluid and electrolyte replacement in exercising individuals or athletes prevent the physiologic changes associated with dehydration. Mild dehydration results in decreased athletic performance, with a decrease in urinary output with associated symptoms of dry mouth, flushing, nausea, and lethargy. With accumulating fluid losses, the athlete may develop additional symptoms including tachypnea, tachycardia, decreased concentration, dizziness, weakness and finally an alteration in mental status.

[0034] Meglumine may form salts with acids. Non-limiting examples of such salts are acceptable non-toxic salts. The term "salts" embraces addition salts of free acids useful within the methods of the invention. The term "acceptable salt" refers to salts that possess toxicity profiles within a range that affords utility in in vivo applications. Unacceptable salts may nonetheless possess properties such as high crystallinity, which have utility in the practice of the present invention, such as for example utility in process of synthesis, purification or formulation of compounds useful within the methods of the invention.

[0035] Non-limiting examples of acceptable acid addition salts may be prepared from an inorganic acid or from an organic acid. Examples of inorganic acids include sulfate, hydrogen sulfate, hydrochloric, hydrobromic, hydriodic, nitric, carbonic, sulfuric, hydroxide, chloride and phosphoric acids (including hydrogen phosphate and dihydrogen phosphate). Appropriate organic acids may be selected from aliphatic, cycloaliphatic, aromatic, araliphatic, heterocyclic, carboxylic and sulfonic classes of organic acids, examples of which include formic, acetic, propionic, succinic, glycolic, gluconic, lactic, malic, tartaric, citric, ascorbic, glucuronic, maleic, fumaric, pyruvic, aspartic, glutamic, benzoic, anthranilic, 4- hydroxybenzoic, phenylacetic, mandelic, embonic (pamoic), methanesulfonic, ethanesulfonic, benzenesulfonic, pantothenic, trifluoromethanesulfonic, 2-hydroxyethanesulfonic, p- toluenesulfonic, sulfanilic, cyclohexylaminosulfonic, stearic, alginic, β-hydroxybutyric, salicylic, galactaric and galacturonic acid.

[0036] Meglumine may also form salts with bases. Non-limiting examples of acceptable base addition salts of compounds useful within the invention include, for example, metallic salts including alkali metal, alkaline earth metal and transition metal salts such as, for example, calcium, magnesium, potassium, sodium and zinc salts. Acceptable base addition salts also include organic salts made from basic amines such as, for example, N,N'-dibenzylethylene- diamine, chloroprocaine, choline, diethanolamine, ethylenediamine, and procaine. All of these salts may be prepared from the corresponding compound by reacting, for example, the appropriate acid or base with the compound. Meglumine of salts thereof are preferably present in the sports drink formulation of the present invention in an amount in the range of from about 1 mg/L to about 10,000 mg/L of the sports drink formulation.

[0037] The electrolytes needed for an oral rehydration solution containing meglumine include ions chosen from sodium, potassium, chloride, calcium, magnesium, and combination thereof. In particular, sodium may provide additional benefits when considering the functional goal of a rehydration solution, as it has been shown to enhance fluid absorption in the small intestine, while also promoting maintenance of plasma osmolality and maintenance of thirst. For example, in clinical application, decreased sodium levels have been a cause of mortality in endurance athletes and long distance runners. In addition, maintenance of potassium, magnesium and calcium levels are vital in promoting long term health and longevity.

[0038] The electrolytes of the present invention are ionic components obtainable from their corresponding water-soluble and non-toxic salts. Unless otherwise defined, the amount of electrolytes or ionic components in the sports drink formulation is based on those present in the final sports drink formulation. Some of the less soluble electrolyte salts are dissolved in water, or in aqueous solution having an acidic or a basic pH.

[0039] The sodium ions can be provided by any acceptable salt such as sodium salt, such as sodium chloride, sodium carbonate, sodium bicarbonate, sodium citrate, sodium phosphate, sodium hydrogen phosphate, sodium tartrate, sodium benzoate and the like, or a combination thereof. The sodium ions are preferably present in the sports drink formulation of the present invention in an amount in the range of from about 0.5 mg/L to about 5,000 mg/L of the sports drink formulation.

[0040] The potassium ions can be provided by any acceptable salt such as potassium chloride, potassium bicarbonate, potassium citrate, potassium phosphate, potassium hydrogen phosphate, potassium tartrate, potassium sorbate and the like, or a combination thereof. The potassium ions are preferably present in the sports drink formulation of the present invention in an amount in the range of from about 0.5 mg/L to about 5,000 mg/L of the sports drink formulation.

[0041] The chloride ions can be provided by any salt such as sodium chloride or potassium chloride. The chloride ions are preferably present in the sports drink formulation of the present invention in an amount in the range of from about 0.5 mg/L to about 2,000 mg/L of the sports drink formulation.

[0042] The calcium ions used in the present invention can be provided by any acceptable salt such as calcium carbonate, calcium phosphate, calcium hydrogen phosphate, calcium dihydrogen phosphate, calcium hydroxide, calcium chloride dehydrate, calcium sulfate, calcium citrate, calcium malate, calcium ascorbate, or calcium orotate, and the like, or a combination thereof. The calcium ions are preferably present in the sports drink formulation of the present invention in an amount in the range of from about 0.5 mg/L to about 1,000 mg/L of the sports drink formulation.

[0043] The magnesium ions used in the present invention can be provided by any acceptable salt or oxide such as magnesium hydroxide, oxide, magnesium aspartate, magnesium chloride, or magnesium sulfate. The magnesium ions are preferably present in the sports drink formulation of the present invention in an amount in the range of from about 0.5 mg/L to about 2,000 mg/L of the sports drink formulation.

[0044] The sports drink formulation of the present invention includes a diluent such as water or any acceptable potable solution. The sports drink formulation of the present invention can include any acceptable additive including caffeine, natural and/or synthetic flavoring compounds or compositions, coloring agents, preservatives, and the like.

[0045] The sports drink formulation of the present invention may be prepared by mixing together all of the ingredients and dissolving the resulting mixture in water or any acceptable potable solution by blending or mixing such mixture. It may be necessary for the solution to be heated to a temperature between about 25°C to about 100°C to get all the ingredients dissolved.

[0046] The sports drink formulation of the present invention can be administered to a subject as frequently as several times daily, or it may be administered less frequently, such as once a day, once a week, once every two weeks, once a month, or even less frequently, such as once every several months or even once a year or less. The amount of compounds, including meglumine or a salt thereof and at least one electrolyte compound chosen from sodium, potassium, phosphorus, magnesium, and calcium ions, may be administered, in non-limiting examples, every day, every other day, every 2 days, every 3 days, every 4 days, or every 5 days. For example, a daily dose of sports drink may contain 2000 mg of meglumine, 250 mg of sodium ion, 250 mg of potassium ion, 25 mg of phosphorus-containing ion, 5 mg of magnesium ion, and 25 mg of calcium ion. The frequency and amount of the administration of the sports drink is readily apparent to the skilled artisan and depends upon any number of factors, such as, but not limited to, the type and severity of the condition being treated, and the type, age, gender, overall health, and physical activity of the subject.

[0047] The amount of meglumine or salt thereof in a daily dosage of the sports drink formulation of the invention may be in the range of from about 1 mg to about 10,000 mg, about 20 mg to about 7,500 mg, about 50 mg to about 6,000 mg, about 100 mg to about 5,000 mg, about 300 mg to about 3,500 mg, about 500 mg to about 3,000 mg, about 1,000 mg to about 2,500 mg, and any and all whole or partial increments therebetween.

[0048] In some features, the amount of an electrolyte compound of the invention is from about 0.5 mg and about 5,000 mg, about 1 mg to about 4,500 mg, about 5 mg to about 4,000 mg, about 10 mg to about 3,500 mg, about 25 mg to about 3,000 mg, about 100 mg to about 2,000 mg, about 200 mg to about 1,000 mg, about 250 mg to about 500 mg, and any and all whole or partial increments therebetween.

[0049] The following examples are presented to demonstrate the general principles of the invention. The invention should not be considered as limited to the specific examples presented. All parts and percentages in the examples are by weight unless otherwise indicated.

EXAMPLES

EXAMPLE 1 AND COMPARATIVE EXAMPLE 2

Materials and Methods

Participants

[0050] The head athletic trainer, manager, coaches were contacted and players were recruited for participation from a professional baseball club in New Jersey, USA. All participants were injury free at the time of initial testing. Ultimately, 18 players participated in the study, on a volunteer basis. Eleven players were used in the final data analysis. Participants were excluded over the course of the study due to injury which prevented their participation in scheduled matches. Consent for study participation was obtained and participants were randomized into two groups, the treatment group and the placebo group.

Testing Procedure

[0051] Participants were initially tested at the onset of the study utilizing a JAMAR Dynamometer (Model 1, ASIMOW Engineering Company) after a night of rest and prior to game play. The testing protocol consisted of dynamometer testing of all athletes, taking measurements bilaterally. Testing was completed at positions 1, 3 and 5 by a double blinded, certified athletic trainer. Dynamometer testing was repeated at the completion of the study after a night of rest and prior to the final game of the season. Testing was again completed at positions 1, 3 and 5 by a double blinded, certified athletic trainer. The dynamometer was factory calibrated prior to initiation of the study. Hand grip strength testing utilizing a hydraulic JAMAR Dynamometer was done according to the testing protocol set forth by the American Society of Hand Therapists.

Study Treatment

[0052] This randomized, single-center, double-blind, placebo-controlled, 2-arm parallel group study, with a study duration of 30 days, compared daily administration of an optimized electrolyte-meglumine rehydration solution and a placebo. Table 1 shows the compositions per daily dose of Example 1 (optimized electrolyte-meglumine rehydration solution) and Comparative Example 2 (Placebo).

Table 1

Statistical analysis

[0053] Values shown in Figures 1 and 2 are means ± standard error of the means (SE). The significance of the differences between the two groups was analyzed by a student's t test. P values of 0.05 or less were defined as statistically significant.

Results

[0054] There was no significant difference in athropometrics between the two study groups. The study groups represented a homogeneous population of professional baseball players that followed a rigid daily routine during the professional baseball season. Participants followed very strict diet and exercise regimens as part of their daily routine. Players that suffered significant injury during the study, that impeded their participation in competitive matches, were excluded from final analysis.

[0055] In analyzing the test results, as shown in Figure 1, there was a nearly 4.5% increase in muscle strength in the optimized electrolyte-meglumine rehydration solution treated baseball player group when compared to placebo (p=0.04), as measured via bilateral dynamometer testing. Testing was completed both pre and post-trial by a double blinded, certified athletic trainer utilizing standardized dynamometer testing protocol with a JAMAR dynamometer (Model 1, ASIMOW Engineering Company). These results confirm that the electrolyte solution in combination with meglumine increases muscle strength.

[0056] The main objective of our study was to establish the validity of utilizing an optimized electrolyte-meglumine rehydration solution in professional athletes, with the primary purpose of rapidly increasing muscle strength and therefore, improving overall athletic performance. As such, an optimized rehydration solution with the addition of meglumine provides superior performance in professional athletes when compared to a placebo. The effectiveness of this electrolyte-meglumine rehydration solution, was measured in terms of its effect on muscle strength following four weeks of daily administration. This effect was measured pre and post study with a JAMAR hydraulic dynamometer. This provided us with the most effective way of testing hand grip strength, providing our research team with an objective biomechanical measurement. When considering the three prevalent types of handgrip dynamometers for use in the study, it was decided that a hydraulic compression dynamometer would provide the most effective and accurate tool, to measure the force that is produced by handgrip strength.

[0057] Testing handgrip strength in professional baseball players provided an effective biomechanical measurement to support the use of the optimized electrolyte-meglumine rehydration solution described above in competitive, professional athletes. The skills specific to professional baseball, require extensive and intricate use of the flexor muscles of the upper extremities. It's the strength and intricate control of these muscles that allows professional baseball players to perform at such competitively high levels for over 200 days a year. The flexor muscles of the upper extremity are responsible for this production of forces responsible for hand grip strength, the antagonist extensor muscles acting as the stabilizers during production of this force. Providing a rehydration solution that would increase handgrip muscle strength in professional baseball players allows for more effective dynamic control of the powerful hand and forearm musculature, so important in the sport specific activities of professional baseball players.

[0058] The choice of setting for the clinical research study was very important in terms of providing a homogeneous group of study participants, without significant variations in terms of anthropometric measurements, diet, exercise, workout routines or even sleep patterns. Anthropometric measurements such as height, weight and hand dimensions can have a significant impact on maximal handgrip strength. The variations that could be expected in the above dimensions in the general population were minimized with the group of professional baseball players that were recruited to partake in the study. In addition, due to the daily schedule of baseball games during the professional baseball season, there was very little room for variation in daily routine among the involved participants. This provided a study environment variables significantly, therefore maximizing the accurate assessment of the use of the optimized electrolyte-meglumine rehydration solution described above over a period of four weeks, during the course of the season.

[0059] The increase in muscle strength, as measured through handgrip testing, in professional baseball players over a period of four weeks, can therefore, be more accurately attributed to the administration of the optimized electrolyte-meglumine rehydration solution described above in the treated group, when compared to the placebo group. The increase of nearly 4.5% in a limited frame during the professional baseball season, can be seen as a very significant increase that could increase players' overall level of performance over an extended period of time. In conjunction with the increase in muscle strength in this group of athletes, the associated athlete's rehydration may account for improved energy levels, as well as overall improved health. In addition, the optimized electrolyte-meglumine rehydration solution described above is devoid of unwanted side effects. In particular, diarrhea is a side effect correlated with the use of sorbitol and a significant drawback to its clinical use with athletes in particular and in the context of dehydration.

[0060] A similar study was completed for football players. The corresponding results show in increase in muscle strength of 4.92% whereas the placebo-treated football players showed an increase of only 1.6% (p = 0.02). Figure 2 shows the effect of the optimized electrolyte- meglumine rehydration solution on muscle strength of professional football players. Professional football players were treated either with the optimized electrolyte-meglumine rehydration solution or a placebo daily for 4-6 weeks. Professional football players on the optimized electrolyte-meglumine rehydration solution (gray bar) showed a 4.92%increase in grip strength after treatment versus a 1.61% showed by placebo treated players (white bar). N = 9 (optimized electrolyte-meglumine rehydration solution group) and N = 10 for Placebo group. T test p value P=0.02.

[0061] The optimized electrolyte-meglumine rehydration solution described above is a non- hormonal and non-steroidal sports drink formulation, which provides a formulation that meets all criteria for use in professional athletics.

[0062] The present invention is also directed to the following clauses.

[0063] Clause 1 : A sports drink composition comprising meglumine or a salt thereof and at least one electrolyte compound. [0064] Clause 2: The sports drink composition of clause 1, wherein the at least one electrolyte compound is chosen from sodium, potassium, phosphorus, magnesium, and calcium ions, salts, and/or combinations thereof.

[0065] Clause 3 : The sports drink composition of clause 2, wherein the amount of sodium in a daily dosage of the sports drink formulation of the invention is in a range of from about 0.5 mg and about 5,000 mg.

[0066] Clause 4: The sports drink composition of any of clauses 2-3, wherein the amount of potassium in a daily dosage of the sports drink formulation of the invention is in a range of from about 0.5 mg and about 5,000 mg.

[0067] Clause 5: The sports drink composition of any of clauses 2-4, wherein the amount of phosphorus in a daily dosage of the sports drink formulation of the invention is in a range of from about 0.5 mg and about 5,000 mg.

[0068] Clause 6: The sports drink composition of any of clauses 2-5, wherein the amount of magnesium in a daily dosage of the sports drink formulation of the invention is in a range of from about 0.5 mg and about 2,500 mg.

[0069] Clause 7: The sports drink composition of any of clauses 2-6, wherein the amount of calcium in a daily dosage of the sports drink formulation of the invention is in a range of from about 0.5 mg and about 3,500 mg.

[0070] Clause 8: The sports drink composition of any of clauses 1-7, wherein the amount of meglumine or salt thereof in a daily dosage of the sports drink formulation of the invention is in a range of from about 1 mg to about 10,000 mg.

[0071] Clause 9: The sports drink composition of any of clauses 1-8, wherein the amount of electrolyte compound in a daily dosage of the sports drink formulation of the invention is in a range of from about 1 mg to about 10,000 mg.

[0072] Clause 10: A method for treating and/or preventing muscle weakness and/or increasing muscle strength and/or stamina in a subject in need thereof, the method comprising administering to the subject an effective amount of a sports drink composition comprising meglumine or a salt thereof and at least one electrolyte compound; wherein administration of the sports drink composition reduces and/or prevents muscle weakness and/or lack of stamina in the subject and/or increases muscle strength in the subject.

[0073] Clause 11 : The method of clause 10, wherein the at least one electrolyte compound is chosen from sodium, potassium, phosphorus, magnesium, and calcium ions, salts, and/or combinations thereof. [0074] Clause 12: The method of any of clauses 10-11, wherein the composition is administered to the subject at a frequency selected from the group consisting of once a day, twice a day, three times a day, four times a day, once a week, twice a week, three times a week, four times a week, once a month, twice a month, and any combinations thereof.

[0075] Clause 13: The method of any of clauses 10-12, wherein the subject is human.

[0076] Clause 14: The use of composition comprising meglumine or a salt thereof and at least one electrolyte compound in a sports drink formulation for treating and/or preventing muscle weakness and/or increasing muscle strength and/or stamina in a subject in need thereof.

[0077] Clause 15: The use of a composition according to clause 14, wherein the at least one electrolyte compound is chosen from sodium, potassium, phosphorus, magnesium, and calcium ions, salts, and/or combinations thereof f.

[0078] Whereas particular features of this invention have been described above for purposes of illustration, it will be evident to those skilled in the art that numerous variations of the details of the present invention may be made without departing from the invention as defined in the appended claims.

Claims

THE INVENTION CLAIMED IS

1. A sports drink composition comprising meglumine or a salt thereof and at least one electrolyte compound.

2. The sports drink composition of claim 1, wherein the at least one electrolyte compound is chosen from sodium, potassium, phosphorus, magnesium, and calcium ions, salts, and/or combinations thereof.

3. The sports drink composition of claim 2, wherein the amount of sodium in a daily dosage of the sports drink formulation of the invention is in a range of from about 0.5 mg and about 5,000 mg.

4. The sports drink composition of claim 2, wherein the amount of potassium in a daily dosage of the sports drink formulation of the invention is in a range of from about 0.5 mg and about 5,000 mg.

5. The sports drink composition of claim 2, wherein the amount of phosphorus in a daily dosage of the sports drink formulation of the invention is in a range of from about 0.5 mg and about 3,500 mg.

6. The sports drink composition of claim 2, wherein the amount of magnesium in a daily dosage of the sports drink formulation of the invention is in a range of from about 0.5 mg and about 2,500 mg.

7. The sports drink composition of claim 2, wherein the amount of calcium in a daily dosage of the sports drink formulation of the invention is in a range of from about 0.5 mg and about 3,500 mg.

8. The sports drink composition of claim 1, wherein the amount of meglumine or salt thereof in a daily dosage of the sports drink formulation of the invention is in a range of from about 1 mg to about 10,000 mg.

9. The sports drink composition of claim 1, wherein the amount of electrolyte compound in a daily dosage of the sports drink formulation of the invention is in a range of from about 1 mg to about 10,000 mg.

10. A method for treating and/or preventing muscle weakness and/or increasing muscle strength and/or stamina in a subject in need thereof, the method comprising administering to the subject an effective amount of a sports drink composition comprising meglumine or a salt thereof and at least one electrolyte compound; wherein administration of the sports drink composition reduces and/or prevents muscle weakness and/or lack of stamina in the subject and/or increases muscle strength in the subject.

11. The method of claim 10, wherein the at least one electrolyte compound is chosen from sodium, potassium, phosphorus, magnesium, and calcium ions, salts, and/or combinations thereof.

12. The method of claim 10, wherein the composition is administered to the subject at a frequency selected from the group consisting of once a day, twice a day, three times a day, four times a day, once a week, twice a week, three times a week, four times a week, once a month, twice a month, and any combinations thereof.

13. The method of claim 10, wherein the subject is human.

14. The use of a composition comprising meglumine or a salt thereof and at least one electrolyte compound in a sports drink formulation for treating and/or preventing muscle weakness and/or increasing muscle strength and/or stamina in a subject in need thereof.

15. The use of a composition according to claim 14, wherein the at least one electrolyte compound is chosen from sodium, potassium, phosphorus, magnesium, and calcium ions, salts, and/or combinations thereof.