US20050100637A1 - Carbohydrate and electrolyte replacement composition - Google Patents

Carbohydrate and electrolyte replacement composition Download PDF

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Publication number
US20050100637A1
US20050100637A1 US10/706,420 US70642003A US2005100637A1 US 20050100637 A1 US20050100637 A1 US 20050100637A1 US 70642003 A US70642003 A US 70642003A US 2005100637 A1 US2005100637 A1 US 2005100637A1
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United States
Prior art keywords
meq
beverage
sodium
composition
chloride
Prior art date
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Abandoned
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US10/706,420
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English (en)
Inventor
Robert Murray
Craig Horswill
Robert Ferraro
Dennis Passe
John Stofan
Chan Du
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Stokely Van Camp Inc
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Stokely Van Camp Inc
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Priority to US10/706,420 priority Critical patent/US20050100637A1/en
Priority to GT200400233A priority patent/GT200400233A/es
Priority to PE2004001102A priority patent/PE20050650A1/es
Priority to CA002545606A priority patent/CA2545606A1/en
Priority to EP04811040A priority patent/EP1689254A2/en
Priority to BRPI0416505-5A priority patent/BRPI0416505A/pt
Priority to AU2004289359A priority patent/AU2004289359B2/en
Priority to PCT/US2004/038155 priority patent/WO2005046360A2/en
Priority to ARP040104190A priority patent/AR046706A1/es
Priority to RU2006120415/13A priority patent/RU2006120415A/ru
Priority to JP2006539978A priority patent/JP2007510758A/ja
Priority to IT000797A priority patent/ITTO20040797A1/it
Priority to KR1020067011548A priority patent/KR100878133B1/ko
Assigned to STOKELY-VAN CAMP, INC. reassignment STOKELY-VAN CAMP, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DU, CHAN T., HORSWILL, CRAIG A., MURRAY, ROBERT, STOFAN, IV, JOHN R., FERRARO, ROBERT F., PASSE, DENNIS H.
Assigned to STOKELY-VAN CAMP, INC. reassignment STOKELY-VAN CAMP, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DU, CHAN T., HORSWILL, CRAIG A., MURRAY, ROBERT, STOFAN, IV, JOHN R., FERRARO, ROBERT F., PASSE, DENNIS H.
Publication of US20050100637A1 publication Critical patent/US20050100637A1/en
Priority to AU2008212089A priority patent/AU2008212089B2/en
Priority to US12/273,609 priority patent/US7993690B2/en
Priority to US13/177,675 priority patent/US20110262596A1/en
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
    • A23L2/52—Adding ingredients
    • A23L2/68—Acidifying substances
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
    • A23L2/52—Adding ingredients
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
    • A23L2/52—Adding ingredients
    • A23L2/56—Flavouring or bittering agents
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
    • A23L2/52—Adding ingredients
    • A23L2/60—Sweeteners
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
    • A23L2/52—Adding ingredients
    • A23L2/62—Clouding agents; Agents to improve the cloud-stability
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/30—Foods or foodstuffs containing additives; Preparation or treatment thereof containing carbohydrate syrups; containing sugars; containing sugar alcohols, e.g. xylitol; containing starch hydrolysates, e.g. dextrin
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/16—Inorganic salts, minerals or trace elements
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/20—Reducing nutritive value; Dietetic products with reduced nutritive value
    • A23L33/21—Addition of substantially indigestible substances, e.g. dietary fibres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7016—Disaccharides, e.g. lactose, lactulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/02—Nutrients, e.g. vitamins, minerals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/08—Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the present invention relates to an improved rehydration beverage which provides for fluid, carbohydrate, and electrolyte replacement.
  • the beverage comprised of a novel mineral blend enhances rehydration by providing superior voluntary fluid consumption and fluid retention.
  • Non-fluid components of the beverage composition can be provided in forms other than beverages.
  • Rehydration can be accomplished in a number of different ways. In the most basic sense, water replaces some of the fluids lost through sweat and helps maintain body temperature and important cardiovascular functions. Sports drinks have been developed which replace the fluids and electrolytes lost through sweat. This is an improvement over plain water not only because these drinks replace some of the minerals lost in sweat but also because carbohydrates are provided as a source of added energy. However, rehydration would be improved if the beverage also improved fluid retention, reduced urinary fluid loss, stimulated increased voluntary consumption, possessed superior sensory qualities, and supported the physiological response to continue drinking.
  • the mineral content of sports drinks varies widely. For instance some beverages can contain 5 mEq/L of sodium while others can contain over four times that amount. Similarly, there are wide differences in the content and amounts of other minerals, such as potassium, magnesium and chloride.
  • Fluid replacement after significant dehydration is driven by various physiological changes.
  • the two major physiological drivers that encourage voluntary drinking are plasma osmolality and plasma volume.
  • plasma osmolality and plasma volume During exercise, the loss of fluid through sweat causes plasma volume to drop and plasma osmolality to increase. These physiological changes cause a thirst response which drives voluntary fluid consumption.
  • Scientific studies have shown that sodium also plays an important role in regulating plasma volume and osmolality. Ingesting beverages containing sodium helps increase the rate at which plasma volume and osmolality return to normal. However, ingesting too high a level of sodium causes rapid restoration of plasma volume, which reduces the drinking response and prevents adequate rehydration.
  • the sensory properties of a beverage containing too high a level of sodium are unfavorable, and would further reduce the drive to drink.
  • electrolytes and minerals play an important role in rehydration by possibly affecting fluid replacement and fluid retention.
  • water is distributed between fluid compartments so that both the extracellular and intracellular compartments share the water deficit.
  • Sodium, potassium, magnesium, calcium and chloride are some of the more important electrolytes/minerals involved in filling these body fluid compartments, particularly sodium, chloride, potassium and magnesium. Beverages providing sodium and chloride encourage the filling of the extracellular compartment, while beverages providing potassium, magnesium, and calcium favor the filling of the intracellular compartment. Properly balancing the sodium, potassium, magnesium, calcium and chloride levels will further improve the rehydration properties of the beverage.
  • electrolyte ions assist in filling these body fluid compartments more rapidly and help to retain the fluid instead of it being excreted as urine. Since both sodium and chloride ions favor the filling of the extracellular compartments, substitution of one with the other may not affect the overall result. The same may be true for potassium and magnesium in regards to intracellular hydration.
  • U.S. Pat. No. 4,981,687 issued to Fregly et al., incorporated herein, discloses a beverage comprising water, sugar, and electrolytes, an improvement wherein said beverage further comprises glycerol, pyruvate and/or caffeine.
  • the sugar contained in the beverage claimed in this patent can be glucose, sucrose or other appropriate sugar compound, with glucose at a concentration of from about 2% to about 8% being specifically disclosed and glucose at a concentration of about 4% being preferred.
  • Examples of electrolytes disclosed in this patent include 15-30 mEq/L sodium, 1-5 mEq/L potassium, 2-8 mEq/L phosphate, bicarbonate, sulfate, chloride, calcium, and magnesium.
  • the beverages as disclosed above are said to ameliorate the adverse physiological effects which can result from physical exertion and heat exposure.
  • the present invention also seeks to address the adverse physiological effects of physical exertion, but without including stimulants or other chemical compounds which may have known acute effects (e.g. glycerol and pyruvate promoting gastrointestinal distress) and unknown long-term effects.
  • the present invention fulfills these needs.
  • the beverages of the present invention enhance rehydration, supply necessary electrolytes and energy sources, exhibit organoleptic properties at least substantially equivalent to other sports drinks, improve fluid retention and voluntary fluid consumption.
  • the method of the present invention also addresses the above concerns through the administration of the composition of the present invention.
  • the composition may be administered orally.
  • the composition can take many forms including but not limited to, liquid, gel, dry powder, tablet or capsule. Concentrated forms of the composition such as a powder can be can be added to water and/or other liquids which can include electrolytes and/or carbohydrates, including even sports drinks such as Gatorade® in order to provide beverages of the present invention.
  • Example 2 Dehydration is reduced and fluid retention is improved by abating urinary loss when one embodiment of the present invention is taken during exercise, as illustrated in Example 2 hereof.
  • Examples 3 through 7 further show that the present invention reduces the effects of dehydration, improves fluid retention, reduces urinary fluid loss, and possess superior sensory properties which should improve voluntary fluid consumption when taken after activity-induced fluid loss. It is further believed that similar results should be obtained when the beverage of the present invention is taken before activity-induced fluid loss.
  • the present invention relates to a beverage composition for oral consumption comprising: from about 4% to about 10% by weight of carbohydrates; at least about 30 mEq/L of beverage of sodium; at least about 7 mEq/L of beverage of potassium; from about 10 to about 20 mEq/L of beverage of chloride; from about 0% to about 0.4% of a flavoring agent, when present; from about 0 to about 100 parts per million (ppm) of a clouding agent, when present; from about 0.24% to about 0.38% by weight citric acid, when present; and typically balance water.
  • the extracellular-favoring ions may be present in combination at levels of from about 40 to about 78 mEq/L of beverage.
  • the complete beverage can be fully formulated as noted above, or it can be made up by providing portions or all of a component or components by added liquids, whether the liquid is water or water already containing components adequate to prepare the final beverage.
  • the formulation added to the liquid has components so as to make up the finally prepared beverage when the formulation and the liquid are combined to form the complete beverage.
  • the osmolality of the beverage is in the range of from about 250 to about 350 mOsm/Kg.
  • the beverage also may include from about 1 to about 6 mEq/L of calcium; and when present, from about 1 to about 6 mEq/L of magnesium.
  • the present invention also relates to a beverage concentrate which is formulated to provide the beverage already described herein upon preparation by the consumer.
  • the concentrate can take many forms including, but not limited to, gel, dry powder, tablet, capsule and liquid concentrates.
  • the concentrates may be added to water and/or other liquids including water and carbohydrates and/or electrolytes, such as Gatorade®.
  • Administration can be oral, intravenously, or by other suitable means.
  • FIG. 1 shows the hedonic scores of various formulations with regard to overall acceptance and liking of saltiness when consumed during exercise.
  • FIG. 2 illustrates the experimental procedure employed to determine ad-libitum drinking characteristics, sensory aspects, hydration characteristics, and voluntary fluid intake of various formulations.
  • FIG. 3 shows the total fluid consumed for each of various formulations.
  • FIG. 4 shows the trend in urine loss by graphing the urine volume for each formulation.
  • FIG. 5 shows dehydration in terms of initial body weight of individuals to whom each formulation was administered.
  • FIG. 6 illustrates the ratings of saltiness intensity during exercise and sedentary conditions and further shows the ideal perceived saltiness.
  • FIG. 7 shows hedonic scores in terms of overall acceptance and liking of saltiness for the various formulations during exercise and sedentary conditions.
  • FIG. 8 illustrates the experimental protocol used to determine how much fluid is retained up to three hours after exercise-induced dehydration that is followed by replacement of total sweat loss.
  • FIG. 9 shows cumulative urine loss over time during the recovery period for the various formulations.
  • FIG. 10 shows fluid retention as a percentage of the volume ingested during recovery time for the various formulations.
  • FIG. 11 illustrates the experimental protocol used to determine how much fluid is retained up to three hours after exercise-induced dehydration that is followed by replacement of total sweat loss.
  • FIG. 12 shows cumulative urine loss over time during the recovery period for various formulations.
  • FIG. 13 shows fluid retention as a percentage of the volume ingested during recovery time for various formulations.
  • FIG. 14 shows the plasma volume changes over time for various formulations.
  • FIG. 15 shows fluid retention as a percentage of the volume ingested during recovery time for various formulations.
  • FIG. 16 shows urine production over time during a recovery period for various formulations.
  • FIG. 17 shows the urine osmolality over time-before exercise and during recovery-for various formulations.
  • FIG. 18 shows urine sodium losses over time for various formulations.
  • FIG. 19 shows urine potassium losses over time for various formulations.
  • FIG. 20 shows urine specific gravity over time for various formulations.
  • FIG. 21 illustrates the experimental protocol used to determine how much fluid is retained up to three hours after exercise-induced dehydration that is followed by replacement of total sweat loss.
  • FIG. 22 shows the percentage of fluid retained over time of the various formulations.
  • FIG. 23 shows the cumulative urine loss in grams over time of the various formulations.
  • FIG. 24 indicates the overall acceptance of the various formulations during the rehydration period preceding the measurement of fluid retention.
  • FIG. 25 indicates the tartness scores of the various formulations during the rehydration period preceding the measurement of fluid retention.
  • FIG. 26 indicates the perceived saltiness of the various formulations during the rehydration period preceding the measurement of fluid retention.
  • FIG. 27 shows the percent fluid retained as a percentage of the volume ingested during recovery time for various formulations and historical range of fluid retention.
  • FIG. 28 shows the urine osmolality over time-before exercise and during recovery-for various formulations.
  • FIG. 29 shows the urine sodium concentration during the recovery period for various formulations.
  • FIG. 30 shows the urine specific gravity over time-before and after exercise and during recovery-for various formulations.
  • FIG. 31 shows the percent of total fluid retained at the end of the recovery period for various formulations.
  • FIG. 32 shows the urine osmolality over time-before exercise and during recovery-for various formulations.
  • FIG. 33 shows the urine specific gravity over time-before and after exercise and during recovery-for various formulations.
  • FIG. 34 shows the urine potassium concentration during the recovery period for various formulations.
  • FIG. 35 shows the overall acceptance ratings from the sensory evaluations for various formulations.
  • the beverage of the present invention provides superior rehydration by improving fluid retention and reducing urine fluid loss. Additionally, the beverage enhances rehydration by also improving voluntary fluid intake. Moreover, the organoleptic or sensory properties of the beverage are at least as favorable as other sports drinks.
  • the beverage of the present invention optimizes the level of sodium and typically also chloride and potassium levels so as to maximize rehydration without compromising the sensory properties of the beverage.
  • potassium, magnesium and chloride at especially advantageous levels, the rehydration effects are further improved without changing the palatability of the beverage.
  • the combination of extracellular-favoring ions at a level of between about 40-78 mEq/L, the advantageous rehydration and sensory properties are promoted.
  • the experimental formulation having 30 mEq/L of sodium remained the same. It was compared to different experimental formulations. In addition, blood and urine chemical analyses were conducted. The experimental formulation having 30 mEq/L of sodium had improved rehydration properties; urinary fluid loss was reduced, the percentage of fluid retained increased, and overall body weight change was greater.
  • the second of these experiments compared the 30 mEq/L of sodium formulation with a 25 mEq/L of sodium formulation, but this time the combined levels of sodium and chloride were more closely matched in the two formulations. (See the formulation table in example 7). No differences in fluid retention were found between these formulations. However, the 25 mEq/L of sodium formulation received initial negative sensory ratings versus the formulation having 30 mEq/L of sodium, but less chloride.
  • the beverage of the present invention typically includes from about 4% to about 10%, preferably from about 5.5% to about 6.5%, more preferably about 6% by weight of a carbohydrate source.
  • Carbohydrate sources include but are not limited to, sucrose, maltose, maltodextrin, glucose, galactose, trehalose, fructose, fructo-oligosaccharides, beta-glucan, and trioses such as pyruvate and lactate.
  • a mixture of a minimum of three of these is formed, with the amount of fructose being less than the total amount of glucose from all carbohydrate sources.
  • a preferred composition of carbohydrates comprises from about 1% to about 5% sucrose, from about 1% to about 2.5% glucose and from about 0.8% to about 1.8% fructose to produce a total of 6% carbohydrate, and more preferably from about 2 to about 4% sucrose, from about 1.4 to about 2% glucose, and about 1.1 to about 1.5% fructose, to produce a total of 6% carbohydrates.
  • the sodium content of the beverage of the present invention comprises at least about 30 mEq/L, preferably from about 30 to about 100 mEq/L of beverage, more preferably from about 30 to about 60 mEq/L of beverage, even more preferably from about 33 to about 40 mEq/L.
  • This sodium concentration indicates the total amount of sodium present in the beverage, including sodium contained in the carbohydrate source, flavoring agent (to the extent known), and clouding agent.
  • maltodextrin as a carbohydrate source may contain sodium.
  • these sources alone cannot raise the sodium levels of the beverage to the necessary levels, and as such additional sodium must be added from another sodium ion source.
  • any source of sodium known to be useful to those skilled in the art can be used in the present invention.
  • useful sodium sources include, but are not limited to, sodium chloride, sodium citrate, sodium bicarbonate, sodium lactate, sodium pyruvate, sodium acetate and mixtures thereof.
  • a mixture of sodium chloride and sodium citrate being preferred, and a mixture of from about 10 to about 50 mEq/L, preferably from about 10 to about 30 mEq/L, and more preferably from about 10 to about 20 mEq/L of sodium from sodium chloride and from about 10 to about 50 mEq/L, preferably from about 10 to about 30 mEq/L, and more preferably from about 10 to about 20 mEq/L of sodium from sodium citrate.
  • the beverage of the present invention also includes chloride.
  • the chloride ion can come from various sources known to those skilled in the art. Examples of chloride sources include, but are not limited to, sodium chloride, potassium chloride, magnesium chloride and mixtures thereof.
  • the concentration of chloride is at least about 10 mEq/L, preferably from about 10 to about 20 mEq/L, more preferably from about 11 to about 18 mEq/L of chloride from sodium chloride.
  • the beverage of the present invention also preferably includes a combination of extracellular favoring ions, where the sum of these ions is from about 40 to about 78 mEq/L. This range can even be from about 42 to about 70 mEq/L or from about 46 to about 60 mEq/L.
  • Sodium and chloride ions are some of the ions which favor the filling of the extracellular fluid compartment.
  • the beverage of the present invention also includes potassium.
  • the potassium ion source can come from many sources known to those skilled in the art as being useful in the present invention. Examples of potassium sources useful herein include, but are not limited to, potassium monophosphate, potassium diphosphate, potassium chloride, and mixtures thereof, with potassium monophosphate being preferred.
  • the potassium content is at least 8 mEq/L, preferably from about 8 to about 20, and more preferably at from about 10 to about 19 mEq/L.
  • the beverage of the present invention further preferably includes magnesium.
  • the magnesium ion can also come from many sources known to those skilled in the art. Examples of magnesium sources include, but are not limited to, magnesium oxide, magnesium acetate, magnesium chloride, magnesium carbonate, magnesium diphosphate, magnesium triphosphate, magnesium in the form of an amino acid and mixtures thereof, with magnesium oxide being preferred.
  • the concentration of magnesium is at a level of at least 0.1 mEq/L, preferably from about 0.5 to about 6 mEq/L, more preferably from 1 to 3 mEq/L.
  • calcium preferably is present in the beverage of the present invention.
  • the calcium ion may come from a variety of sources known to those skilled in the art. Examples include but are not limited to, calcium lactate, calcium carbonate, calcium chloride, calcium phosphate salts, calcium citrate and mixtures thereof, with calcium lactate being preferred. Calcium is present at a concentration of at least 0.1 mEq/L, preferably from about 0.5 to about 6 mEq/L, more preferably from 1 to 3 mEq/L.
  • a flavoring agent may be used in the beverage of the present invention.
  • the flavoring agent of the beverage of the present invention also impacts the overall acceptance of the beverage. In order to achieve this overall acceptance, the strength of the flavor cannot be too intense.
  • the flavor intensity of the beverage will depend upon the amount and type of the particular flavoring agent used.
  • the same flavor from different suppliers may have differing intensity. Thus, it is difficult to quantify the level of flavoring agent necessary for the present invention.
  • a flavoring agent at a concentration of from about 0% to about 0.400% by weight is useful in the present invention.
  • flavoring agents themselves may contain gum arabic, ester gum, starches such as, dextrins, “modified food starch”, propylene glycol or alcohol. These additional components may acts as carriers or stabilizers.
  • any flavoring agent which satisfies the above criteria and is known to be useful to those skilled in the art can be used in the present invention.
  • particularly useful flavoring agents include but are not limited to, lemon-lime, orange, and fruit punch.
  • the lemon-lime flavoring agent can be at a concentration in the range of from about 0.050% to about 0.200%, preferably from about 0.080 to about 0.150%, and more preferably from about 0.090 to about 0.120% by weight.
  • the beverage of the present invention is formulated to have an osmolality, when initially formulated, in the range of from about 220 to about 350 mOsm/Kg of beverage, and is preferably in the range of from about 250 to about 330, more preferably from about 260 to about 320 mOsm/Kg of beverage.
  • the beverage of the present invention are isotonic.
  • the scientific and strict definition of the term isotonic is a solution that has the same or nearly the same osmotic pressure as another solution, typically human blood.
  • the beverages of the present invention can be isotonic when prepared, even with regards to the strict scientific meaning of the term, the term isotonic as presently used is not meant to be so narrowly defined. With respect to the present specification, isotonic is meant to refer to the fact that the beverages of the present invention are sports type beverages which contain a certain amount of carbohydrates and electrolytes.
  • the beverage of the present invention may also include a clouding agent at a concentration range of from about 0 to about 100 ppm of clouding agent.
  • clouding agents include, but are not limited to, ester gum, SAIB, starch components and mixtures thereof, with ester gum as the preferred clouding agent at a concentration range of from about 10 to about 50 ppm and more preferably from about 15 to about 35 ppm.
  • the beverage of the present invention may further include citric acid at a concentration range of from about 0.24% to about 0.45% by weight.
  • Citric acid lowers the pH in order to insure it is a high acid beverage which may be pasteurized under conditions less harsh than required for low acid beverages.
  • Beverages of the present invention preferably have a pH of from about 2.5 to about 4.5, preferably from about 2.75 to about 4.25, more preferably from about 2.9 to about 4.0.
  • citric acid adds tartness to the beverage.
  • the present invention also relates to a beverage concentrate used to prepare the beverage already described herein.
  • beverage concentrate refers to a concentrate that is either in liquid or gel form or in essentially dry mixture form.
  • the essentially dry mixture is typically in the form of a powder, although it may also be in the form of a single-serving tablet, or any other convenient form.
  • the concentrate is formulated to provide a final and complete beverage as already described herein when constituted or diluted with water or other liquid.
  • a preferred beverage concentrate of the present invention capable of producing the preferred beverage below when constituted or diluted with water comprises:
  • a formulation designated as G30 was evaluated for sensory properties against four other formulations containing the typical ingredients found in commercial sports drinks.
  • the G30 formulation consisted of a 6% carbohydrate solution in water, 30 mEq/L of sodium, 3 mEq/L potassium, about 10 mEq/L of chloride, 25 ppm of a clouding agent and 0.103% by weight of a flavoring agent.
  • the carbohydrate solution was prepared using a mixture 3% sucrose, 1.7% glucose, and 1.3% fructose.
  • both sodium chloride and sodium citrate were used to provide the sodium ions.
  • the comparison formulations contained the exact ingredients except that the sodium levels of these beverages were modified so that the first formulation, designated as G0, contained 0 mEq/L of sodium, the second formulation, designated as G18, contained 18 mEq/L of sodium, the third formulation, designated as G40, contained 40 mEq/L of sodium, and the fourth formulation, designated as G60, contained 60 mEq/L of sodium.
  • Post-exercise urine volumes indicated an inverse association between sodium level and urine volume produced, which is indicated in FIG. 4 .
  • Urine volumes were directionally less as sodium level increased from 0 to 60 mEq/L and was least for G60 at 15 minutes post-exercise compared to other beverages. Analysis of the trend in the data (e.g. slope) for post-exercise urine excretion was significantly different from 0. That is, there is 95% confidence that the downward trend in the data was not due to chance alone. Overall, exercise urine volumes and total urine volumes were similar among beverages.
  • Subjects were fed a standard diet for dinner (the evening prior to testing), breakfast, and lunch.
  • the total caloric intake was 2440 calories and 2592 mg of sodium.
  • Meals were accompanied with 500 ml of water.
  • the average total urine losses were 0.546, 0.430, 0.322 and 0.287 liters for 0, 18, 30, 60 mEq/l beverages, respectively as shown in FIG. 9 .
  • Both 0 and 18 were significantly (p ⁇ 0.05) different from 30 and 60.
  • the 30 and 60 beverages did not differ from each other. Differences in urine loss did not become apparent until 1 hour after the end of the drinking period.
  • By 2 hours after the drinking ended (3.5 hrs post-exercise), differences among 0, 18, and the other beverages were greatest.
  • Average fluid intakes ranged from 1.8 to 1.95 liters, but were not different across formulations. Two hours after rehydration with a volume equivalent to 100% of total sweat lost, the total percent of fluid retained was 69%, 75%, 82%, and 83% for 0, 18, 30, and 60 mEq/L, respectively as shown in FIG. 10 .
  • the G30 beverage scored directionally higher than all other beverages. Sensory evaluation indicated that the 30 mEq/L was liked equally well as G18, but was directionally favored over all other beverages for characteristics of sweetness, flavor, tartness, saltiness, and overall acceptance. For the G18 and G30 beverages, ratings of perceived saltiness were very close to ideal ratings of saltiness throughout the drinking period. In general, hedonic scores declined with increasing time (30 to 90 min) during the rehydration period.
  • the G30 formulation performed directionally better than G18 for a number of hedonic ratings and provided a greater fluid retention response during rehydration than other beverages.
  • the highest sodium level in the G60 formulation provided no further benefit beyond the G30 formulation in terms of attenuating fluid loss in the form of urine.
  • G30 provides the following advantages over G0, G18, G60: (1) directionally higher hedonic ratings in athletes undergoing exercise in the heat and (2) attenuated urinary fluid losses after rehydration with a volume equivalent to 100% of sweat loss.
  • Example 3 The same formulations as Example 3 were used except that a G5 formulation was included and the G0 and G60 formulations were eliminated.
  • the G5 formulation was identical to the other formulations except that the sodium level was adjusted to 5 mEq/L.
  • This testing compared the formulations to determine how rapidly fluid is lost and how much is retained up to three hours after exercise-induced dehydration that is followed by replacement of total sweat loss.
  • Certain biochemical parameters were measured to determine physiology related changes. The parameters measured were blood related changes in [Na+], [K+], [Ca++], osmolality, Hb, Hct, ⁇ PV, glucose, pH, and urine related changes in volume, osmolality, [Na+], [K+], SEC, FWC, creatinine, and GFR. This was also conducted in a double-blind experimental design with formulations counterbalanced among the study group.
  • each subject was required to ingest fluid adequate to establish euhydration. This included a minimum intake of 500-ml of water the evening prior to the test as well as 1-liter of water the day of the test. Pre-experiment hydration was further assured by checking the conductivity of the pre-experiment urine sample prior to the experiment. Subjects whose first experimental urine sample had a conductivity that exceeded 21 mS-cm were dismissed from the experiment and required to reschedule. An indwelling venous catheter was inserted into a forearm vein for repeated blood sampling throughout the experiment.
  • a previously determined workload was used to set an exercise intensity equivalent to 70-75% of maximal heart rate as determined by earlier maximal treadmill tests.
  • Heart rate was monitored every 10 minutes using a telemetered HR monitor (Polar) and to assure sufficient intensity of exercise.
  • a whole blood clinical analyzer (Instrumentation Laboratories, Synthesis IL1735) was used to measure changes in blood sodium, potassium, ionized calcium, glucose, hematocrit, hemoglobin, and pH value. Approximately 1-ml of whole venous blood was collected in a 3-ml heparinized arterial blood-gas syringe (Marquest, GASLYTE) and was used specifically for the clinical analyzer. The arterial blood gas syringe was chosen to avoid sample clotting and to ease presentation of the sample to the clinical analyzer.
  • Plasma volume changes were estimated from a published equation (Dill/Costill) relating hematocrit and hemoglobin changes. Plasma osmolality was measured by freezing point depression method on a FISKE 2400 multiple sample osmometer.
  • Urine volume was determined by weight, and urine conductivity was immediately determined using a conductivity meter (WTW LF 340, model 19706-20). Urine was then aliquoted and stored at ⁇ 20° F. until later analysis for [Na+], [K+], osmolality and creatinine. Urine [Na+] and [K+] were determined using flame photometry (IL943 Automatic Flame Photometer) after centrifuging for 15 minutes to remove any insoluble particles from the sample to be analyzed. Urine creatinine was determined on the spectrophotometer utilizing a Sigma Creatinine Kit (Sigma Diagnostics, No. 555). Urine osmolality was determined by the freezing point depression method on an osmometer after thawing frozen samples to room temperature.
  • FIG. 12 shows cumulative urine loss among the three formulations across recovery time. Effect sizes estimates for total urine loss were 0.39 (G5 vs. G18), 0.97 (G5 vs. G30), and 0.70 (G18 vs. G30).
  • FIG. 13 shows fluid retention during recovery for the three formulations tested.
  • Absolute change in bodyweight from baseline weight was significantly greater for G5 compared to G18 and G30 (P ⁇ 0.05).
  • Bodyweight losses, corrected for any fluid gains during recovery, were 0.93, 0.80 and 0.74 kg, respectively.
  • ANOVA analysis revealed a main effect of sodium (P ⁇ 0.001) and time (P ⁇ 0.0001), with an interaction between sodium and time (P ⁇ 0.0001) on individual urine volumes excreted. Independent of time (summed across time points), average urine volumes were 79.8, 68.0, and 49.7 g for G5, G18, and G30, respectively.
  • Urine conductivity varied by sodium level and time, with an interaction between sodium and time (P ⁇ 0.01). Independent of time (summed over all time points), average urine conductivity was 12.3, 12.8 and 14.8 mS-cm for G5, G18, and G30, respectively. Conductivity was significantly higher for G30 compared to G5 and G18.
  • Urine sodium and potassium concentrations were not different between sodium levels, but did differ by time. Urine sodium and potassium excretion, corrected for volume, did not differ between formulations, but did differ over recovery time. When summed across formulations, average [Na+] excreted was significantly higher at 0 minutes recovery (7 mEq), dropped to 4.4 mEq at 30 minutes into the drinking period, and remained between 2.2-2.4 mEq from 90 through 210 minutes of recovery.
  • the G30 formulation was compared to water (W), a commercial product POWERade® (P), and a G18 formulation identical to the G30 formulation except that the sodium level was adjusted to 18 mEq/L.
  • Specific electrolyte formulations are shown below. [Na + ], [K + ], [Cl ⁇ ], Osm Code mEq/L* mEq/L* mEq/L (mOsm/kg)* W 0 0 0 0 P 5 2 5.8 428 G18 18 3 9 320 G30 30 3 9 334 *Indicates measured analytical values
  • Beverage temperature was maintained between 41-45° F. and served at that temperature and the beverages were blinded to the subjects as well as the experimenters.
  • Workloads were set for the cross-trainer, stationary bike and treadmill sufficient to produce intensities between 70-75% of their measured maximum heart rates (determined from annual stress tests).
  • body weights were obtained prior to and following the orientation exercise session in order to predict sweat rates.
  • Subjects were provided with standardized meals to ensure consistent sodium intake ( ⁇ 2900 mg) prior to each of the two trials. Meals included dinner (evening prior to experiment), and breakfast and lunch on the day of testing. Subjects were given the option of eating all or a portion of the food provided but were instructed to record which foods and amount left uneaten. These items were then withheld from the food bags for the next trial. In addition, they were given bottled water to drink the evening before (500 ml) and during the testing day (1000 ml) to ensure adequate hydration. Subjects were asked to refrain from caffeine and alcohol use for 24-hours prior to the experiment. Most subjects ate all the food provided to them, however, intakes ranged from 2,109-2,278 kcal and 2,849-2,960 mg sodium. None of the subjects ate food other than what was provided.
  • the exercise session consisted of 30-minutes each on the cross trainer, stationary bike and treadmill at 75-80% maximum heart rate for a total of 90 minutes. Heart rates were taken at 15-minute intervals to ensure subjects maintained adequate intensity. Subjects refrained from drinking during the entire exercise period in an effort to produce 2-2.5% dehydration.
  • Urine volume was determined by weight and urine specific gravity was measured (A 300 Clinical Refractometer). Urine was the transferred into 4-ml cryovials for further analysis. Urine [Na+] and [K+] were determined using flame photometry (IL943 Automatic Flame Photometer) after centrifuging for 15 minutes to remove any insoluble particles from the sample to be analyzed. Osmolality was measured for each sample (Fiske 2400 Osmometer).
  • SPSS version 10.0 was used to analyze the data. ANOVA using a general linear model was used to determine differences among mean values. Data is reported as the mean+the standard deviation.
  • Total cumulative fluid output was significantly different among formulations. W resulted in significantly more urine loss than the other three formulations (0.726 ⁇ 0.225 L). P and G18 were not significantly different from each other at 0.496 ⁇ 0.184 L and 0.428 ⁇ 0.196 L, respectively. G30 was different from W and P, but not from G18 (0.367 ⁇ 0.263 L). Urine output at each data collection point was not significantly different among formulations for time points 60, 90 or 120. However, at time point 180, W resulted in greater urine loss compared to the other three formulations.
  • Fluid retention or the amount of fluid consumed that was not excreted as urine, was different among formulations. This was calculated in both relative terms (ml/kg) and as a percentage calculated as (fluid in ⁇ fluid out)/fluid in. Relative fluid retention for W was 17.07 ⁇ 5.22 ml/kg, significantly less than the other formulations. P, G18, and G30 were 20.43 ⁇ 6.50 ml/kg, 19.48 ⁇ 4.83 ml/kg, and 21.26 ⁇ 4.83 ml/kg, respectively.
  • Percent fluid retained was different among formulations (62.94 ⁇ 9.05% for W, 74.25 ⁇ 11.15% for P, 76.52 ⁇ 10.32% for G18, and 81.45 ⁇ 10.34% for G30) with W significantly less than P, G18 and G30 at minutes 180 and 240. Additionally, fluid retention was significantly greater in the G30 trial compared to W and P at the end of recovery (minute 240 ). G18 was not different from P or G30. See FIG. 15 .
  • Average urine osmolality was different among formulations. W resulted in the lowest urine osmolality (348.33 mOsm) and was not different from P (400.66 mOsm) but was significantly different from G18 (431.74 mOsm) and G30 (500.42 mOsm). G18 was not different from P or G30. P was significantly less than G30. See FIG. 17 .
  • the other trials did not differ from each other. See FIG. 19 .
  • Urine protein was measured via reagent strips (Uristix) to determine whether or not dehydration has an effect on protein excretion.
  • TABLE III is a chart indicating the frequency and amount of protein detected in the urine at each time point for each of the four formulations.
  • Protein Treatment Time (mg/dl) Water POWERade ® G18 G30 Pre- Negative 16 17 17 17 Exercise Post- Negative 16 13 10 13 Exercise Trace 0 3 5 3 60 Negative 9 8 10 8 Trace 6 5 5 5 5 5 30-100+ 1 2 0 3 100+ 1 1 90 Negative 10 12 11 9 Trace 4 4 0 5 30-100 1 1 0 2 100+ 1 120 Negative 16 16 11 13 Trace 0 1 1 4 30-100 1 180 Negative 15 16 10 13 Trace 0 0 1 2 240 Negative 15 16 10 11 Trace 0 0 1 5
  • G30 and G18 were few and rather random. Although the G30 formula was initially less acceptable than the G18 for overall acceptance, flavor, sweetness, and tartness at the initial sensory read (32 minutes into recovery time), the differences between these two beverages decreased rapidly with time. While G18 generally had a numerical score advantage at 42, 62, and 82 minutes in these categories, the advantage was statistically insignificant. The G30 formula scored lower than the G18 for tartness at 62 minutes.
  • the G18 formula was rated less salty than ideal at all evaluation times. G18 was rated more sour than ideal at 32, 42, and 82 minutes. There were no differences in perceived saltiness between G18 and G30. Compared to G18, G30 was less sour at 42 and 62 minutes, sweeter at 82 minutes, and less off at 62 minutes. The G30 formula was rated less salty than ideal at all evaluation times.
  • subjects were divided into two groups to assess the effect of controlling pre-experiment diet (over 24 hours) on physiology measures. As in the previous phase, subjects were fed a standard diet for dinner the evening prior to testing, and for breakfast and lunch the day of the test.
  • the total caloric intake was 2200 calories and approximately 2400 mg of sodium. Subjects who weighed over 150 pounds had slightly higher (+200) calories and sodium intake (+100 mg). All subjects were given a written copy of the dietary and exercise guidelines, and subjects were instructed not to substitute foods, but additional liquids (within guidelines) were permitted until 3 hours prior to the experiment.
  • Subjects were then weighed for a baseline bodyweight, and a sensory (GI Symptoms, Energy levels) questionnaire was completed. Subjects cycled in a warm environment (80° F., 40% RH) for 1.5 hours to elicit an exercise-induced dehydration near two percent of initial bodyweight. A previously determined workload was used to set an exercise intensity equivalent to 70-75% of maximal heart rate as determined by earlier maximal treadmill tests. Heart rate was monitored every 10 minutes using a telemetered HR monitor (Polar) and to assure sufficient intensity of exercise.
  • GI Symptoms, Energy levels GI Symptoms, Energy levels
  • Beverages were mixed prior to the experiment using 1-liter and 2-liter volumetric flasks and beverage grade water that did not contribute any electrolytes to the beverage. Beverages were served chilled from the refrigerator (approximately 40° F.), although the last two beverages were likely to be closer to ambient temperature by the time they were served to the subjects. Beverages were distributed according to a rehydration scheme that involved dosing the volume according to specific times. At 30 minutes into recovery, subjects received their first of six cups of beverage, followed by another cup every ten minutes. Total beverage volume was equivalent to total sweat loss, and was portioned such that subjects received 50% of the total volume in the first 20 minutes and the remaining 50% in 12.5% portions every ten minutes for the remaining 40 minutes. All fluid was consumed within an hour.
  • Urine volume was determined by weight, and urine conductivity was immediately determined using a conductivity meter (WTW LF 340, model 19706-20). Urine was then aliquoted and stored at ⁇ 20° F. until later analysis for [Na + ] and [K + ]. Urine [Na + ] and [K + ] were determined using flame photometry (IL943 Automatic Flame Photometer) after centrifuging for 15 minutes to remove any insoluble particles from the sample to be analyzed.
  • flame photometry IL943 Automatic Flame Photometer
  • the percent of ingested fluid retained differed significantly. G25 resulted in significantly more fluid retention (79.6%) compared to G18 (73.5%) and G30 (75.1%). When corrected for bodyweight (ml/kg) or examined in absolute terms (kilograms), the significant effect disappears. Contrary to results from Project FR-1 phases 2, 3, and 4, G30 did not differentiate from G18 in this study.
  • Absolute change in body weight from baseline to end of recovery was ⁇ 0.72, ⁇ 0.62, and ⁇ 0.71 kilograms for G18, G25, and G30, respectively. Expressed as a percentage of initial weight, these values were ⁇ 0.98%, ⁇ 0.84%, and ⁇ 0.96% for G18, G25, and G30, respectively. Both absolute and percentage variables were significantly different for G25 versus G18 and G30 when subject variability was controlled for in the statistical model. G18 did not differ from G30.
  • SEC Specific Electrical Conductivity
  • Subjects were provided with standardized meals to ensure consistent sodium intake ( ⁇ 2700 mg) prior to each of the two trials. Meals included dinner (evening prior to testing), and breakfast and lunch on the day of testing. Subjects were given the option of eating all or a portion of the food provided but were instructed to record which foods and amount left uneaten. These items were then withheld from the food bags for the next trial. In addition, they were given bottled water to drink the evening before and during the testing day to ensure adequate hydration. Subjects were asked to refrain from caffeine and alcohol use for 24-hours prior to the experiment.
  • GI ratings After completing a pre-exercise survey (GI ratings), they began exercise. The exercise session consisted of alternate cycling/running at 15-minute intervals at 75-80% maximum heart rate for a total of 60 minutes. Heart rates were taken at 15-minute intervals to ensure subjects maintained adequate intensity. Subjects refrained from drinking during the entire exercise period in an effort to produce 1.5-2% dehydration.
  • Drink #5 (12.5%) was given at 70 minutes
  • drink #6 (12.5%) their final drink
  • a sensory questionnaire was given at 80 minutes.
  • 120, 180 and 240 minutes GI scales were given and urine samples were collected. After the final urine sample, subjects were taken back upstairs for a final nude body weight. They were given meals for the next trial (if necessary) and were released.
  • Urine volume was determined by weight and urine specific gravity was measured (A 300 Clinical Refractometer). Urine was the transferred into 4-ml cryovials for further analysis. Urine [Na + ] and [K + ] were determined using flame photometry (IL943 Automatic Flame Photometer) after centrifuging for 15 minutes to remove any insoluble particles from the sample to be analyzed. Osmolality was measured for each sample (Fiske 2400 Osmometer).
  • Fluid retention or the amount of fluid consumed that was not excreted as urine, was not different between treatments. This was calculated in both relative terms (ml/kg) and as a percentage calculated as (fluid in ⁇ fluid out)/fluid in. Relative fluid retention was 13.11 ⁇ 3.04 ml/kg and 13.32 ⁇ 3.52 ml/kg for G25 and G30, respectively. Percent fluid retained was also the same for both treatments (74.29 ⁇ 9.76% for G25 and 74.20 ⁇ 10.14% for G30). Predictably, percent fluid retention across time was also the same for each treatment (see below).
  • Subjects were asked to rate a number of psychophysiological characteristics on several different scales (e.g. categorical, 100 pt) throughout the experiment period to examine any sensory and perceptual changes associated with the treatments.
  • a GI distress and a Sensory (taste) form were used periodically throughout the test to examine subjects' perceptions. There were no important differences between the two beverages on ratings of perceived physiological and psychological well-being. Differences in beverage acceptance are as follows.
  • the G30 scored significantly higher than G25 in acceptance and liking of sweetness, tartness, flavor, and saltiness, and had a large effect size (0.7) advantage in aftertaste at 32 minutes. See FIG. 24 for overall acceptance. At 42 minutes, G30 was significantly more acceptable than G25 for aftertaste, and had a medium effects size advantage in tartness.
  • G25 was more tart than G30 at all times. See FIG. 25 . G25 was significantly more salty than G30 at 32 minutes and was not different at all other time points. G25 perception of saltiness was initially rated as ideal but became decreasingly less than ideal at all other time points. G30 was less than ideal saltiness at all time points. See FIG. 26 .
  • Subjects were provided with standardized meals to ensure consistent sodium intake ( ⁇ 3000 mg) prior to each of the experimental trials. Meals included dinner (evening prior to experiment), and breakfast and lunch on the day of testing. Subjects were given the option of eating all or a portion of the food provided. They were also instructed to record which foods were left uneaten. These items were then withheld from the food bags for the next trial. In addition, they were given bottled water to drink the evening before (500 ml) and during the testing day (1000 ml) to ensure adequate hydration. Subjects were asked to refrain from caffeine and alcohol use for 24-hours prior to the experiment.
  • the exercise session consisted of 30-minutes each on the cross trainer, stationary bike and treadmill at 70-75% maximum heart rate for a total of 90 minutes. Heart rates were taken at 15-minute intervals to ensure subjects maintained adequate intensity. Subjects refrained from drinking during the entire exercise period in an effort to produce 2-2.5% dehydration.
  • the fifth aliquot (12.5%) was given at 70 minutes, and the sixth and final aliquot (12.5%) and a sensory questionnaire was given at 80 minutes.
  • GI scales were given and urine samples were collected. After the final urine sample, subjects were weighed for a final nude body weight.
  • Urine volume was determined by weight and urine specific gravity was measured (A 300 Clinical Refractometer). Urine was then transferred into 4-ml cryovials for subsequent analysis of sodium and potassium concentrations using flame photometry (IL943 Automatic Flame Photometer) after centrifuging for 15 minutes to remove any insoluble particles from the sample to be analyzed. Osmolality was measured for each sample (Fiske 2400 Osmometer).
  • SPSS version 11.0 was used to analyze the data. ANOVA using a general linear model was used to determine differences between mean values. Data is reported as the mean+the standard deviation.
  • the average urine potassium concentration was significantly higher for the K20 trial (58.44 ⁇ 32.59 mEq/L) compared to P (42.24 ⁇ 40.19 mEq/L). G18 (47.26 ⁇ 37.05) and K10 (51.99 ⁇ 39.33) were not different from any of the treatments.
  • Formula K20 and Powerade scored significantly higher for saltiness acceptance than G18 at 32 minutes. This was the only case where a significant difference was found across products at any time. P showed a significant decline in overall acceptance with time. While P initially, had the numerically highest overall acceptance score, it was directionally the least acceptable overall. P also had directional decreases over time for all acceptance scales except aftertaste. Formula G18 had relatively low initial (32 minute) scores for liking of aftertaste, saltiness, and tartness. These scores rebounded into a more typical range at later times.
  • the exercise induced 2.5-3% dehydration in the subjects.
  • Final body weight as a percentage of initial body weight did not differ between treatments. Subjects returned to 98.96 ⁇ 0.21% of initial body weight following the G30 trial, 98.96 ⁇ 0.29% following K5, and 98.90 ⁇ 0.37% and 98.95 ⁇ 0.31% for K10 and K20, respectively.
  • fluid retention did not differ either: 16.59 ⁇ 5.09 ml/kg, 17.29 ⁇ 5.04 ml/kg, 16.69 ⁇ 6.06 ml/kg, and 16.66 ⁇ 5.31 ml/kg for G30, K5, K10 and K20, respectively.
  • the average urine potassium concentration was significantly higher for the K20 trial (56.59 ⁇ 33.43 mEq/L) compared to G30 (49.79 ⁇ 32.87 mEq/L), K5 (47.24 ⁇ 36.11) and K10 (46.87 ⁇ 28.96). The latter three were not different from each other. See FIG. 34 .

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US20110262596A1 (en) 2011-10-27
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AU2004289359A1 (en) 2005-05-26
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WO2005046360A2 (en) 2005-05-26
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AR046706A1 (es) 2005-12-21
AU2008212089B2 (en) 2009-11-19
AU2008212089A1 (en) 2008-10-02
GT200400233A (es) 2005-08-29
ITTO20040797A1 (it) 2005-02-12
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US20090148566A1 (en) 2009-06-11
WO2005046360A3 (en) 2005-07-14

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