# Patent

## Title
Method of preparing a nutritional powder comprising spray dried HMB

## Abstract

Spray dried nutritional powders include soluble calcium, protein, and at least one of a soluble citrate, a soluble phosphate, and combinations thereof as at least one chelating agent. At least a portion of the soluble calcium is calcium HMB. At least a portion of the protein is soluble protein. The spray dried nutritional powders have a weight ratio of soluble calcium binding capacity to total soluble calcium of from about 2.3:1 to about 12:1. The calcium HMB, the at least one chelating agent, and the protein are spray dried together.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation-in-part of, claims priority to, and any other benefit of, U.S. application Ser. No. 13/016,041, filed Jan. 28, 2011, now abandoned, which claims priority to and any other benefit of U.S. Provisional Application Ser. No. 61/299,632, filed Jan. 29, 2010, the entire disclosures of both applications being incorporated herein in their entirety by reference.


FIELD
The present disclosure relates generally to nutritional powders and more particularly to nutritional powders comprising spray dried beta-hydroxy-beta-methylbutyrate (HMB).
BACKGROUND
Beta-hydroxy-beta-methylbutyrate (HMB) is a naturally occurring amino acid metabolite that is known for use in a variety of nutritional products and supplements. HMB is commonly used in such products to help build or maintain healthy muscle in selected individuals.
HMB is a metabolite of the essential amino acid leucine and has been shown to modulate protein turnover and inhibit proteolysis. In most individuals, muscle converts approximately 5% of available leucine to HMB, thus producing about 0.2 to about 0.4 grams of HMB per day in a 70 kg male. In studies where various kinds of stress were induced in animals, HMB supplementation increased lean mass. Clinical studies also suggest that HMB has at least two functions in recovery from illness or injury including protection of lean mass from stress-related damage and enhancement of protein maintenance or synthesis. It has been suggested that HMB may also be useful for enhancing immune function, reducing the incidence or severity of allergy or asthma, reducing total serum cholesterol and low density lipoprotein cholesterol, increasing the aerobic capacity of muscle, and other uses.
Since HMB is most often administered to individuals to support the development and maintenance of muscle mass and strength, many HMB products have been formulated with additional nutrients that may also be helpful in promoting healthy muscle. Some of these HMB products contain additional nutrients such as fat, carbohydrate, protein, vitamins, minerals and so forth. Calcium HMB is a commonly used form of HMB when formulated in oral nutritional products, which products include tablets, capsules, reconstitutable powders, and nutritional liquids and emulsions. Reconstitutable powders are particularly useful in this regard because such powders are often more shelf-stable than their liquid counterparts for extended periods even when formulated with multiple ingredients such as amino acids, carbohydrates, protein, and fat. These powders, however, often give off an undesirable aroma or odor, which is especially pronounced in the headspace of packaged product immediately after opening prior to use.
There is therefore a need for nutritional powders comprising HMB that are substantially free of undesirable aromas and off odors, especially when packaged and stored for extended periods.
One technique for preparing such nutritional powders is spray drying the powder. This technique involves preparing a liquid or a slurry of the nutritional composition, and spray drying the liquid or slurry to form the nutritional powder. However, the presence of calcium HMB creates stability issues in the liquids or slurries used in the preparation of the powders. In particular, in such liquids or slurries, the calcium will disassociate from the HMB and interact with the protein present in the formulation, resulting in protein aggregation and sedimentation in the slurry. The protein aggregation and sedimentation is especially troubling for the production of a spray dried nutritional powder, as the protein aggregation and sedimentation can clog the spray drying equipment and, at the very least, require more frequent maintenance and cleaning of the equipment, which would have the effect of increasing manufacture time and costs.
Accordingly, there exists a need to minimize or reduce the stability issues that occur during the preparation of spray dried nutritional powders containing calcium HMB.
SUMMARY
It has now also been found that the undesirable aromas or odors from nutritional powders comprising HMB can be minimized or eliminated by formulating the nutritional powders with spray dried HMB, wherein the HMB is spray dried with at least a portion of at least one of the protein, the carbohydrate, and the fat in the composition.
One embodiment of the present disclosure is directed to a nutritional powder comprising HMB and at least one of protein, carbohydrate, and fat, wherein at least a portion of the HMB is spray dried in combination with at least a portion of at least one of the protein, carbohydrate, and fat in the nutritional powder.
Another embodiment of the present disclosure is directed to a nutritional powder comprising from about 0.1% to about 8% HMB, from about 5% to about 70% protein, from about 10% to about 75% carbohydrate, and from about 20% to about 85% fat, all by weight of the nutritional powder, wherein least a portion of the HMB is spray dried with at least a portion of at least one of the protein, the carbohydrate, and the fat in the composition.
Another embodiment of the present disclosure is directed to a method of preparing a nutritional powder comprising spray dried HMB. The method comprises preparing a liquid composition comprising HMB and at least one of protein, carbohydrate, and fat, and then spray drying the liquid composition to produce a nutritional powder having improved sensory properties.
It has now also been found that issues relating to physical stability during the preparation of the spray dried nutritional powder comprising calcium HMB can be minimized or eliminated through the use of the at least one chelating agent in combination with calcium HMB as disclosed herein.
Another embodiment of the present disclosure is directed to a nutritional powder comprising soluble calcium, protein, and at least one chelating agent selected from the group consisting of a soluble citrate, a soluble phosphate, and combinations thereof. At least a portion of the soluble calcium is calcium HMB. At least a portion of the protein is soluble protein. The powder has a weight ratio of soluble calcium binding capacity to total soluble calcium from about 2.3:1 to about 12:1. The calcium HMB, the protein, and the at least one chelating agent are spray dried together in accordance with this embodiment.
Another embodiment of present disclosure is directed to a method of preparing a nutritional powder comprising spray dried calcium HMB. The method comprises preparing an aqueous slurry by admixing at least one chelating agent followed by soluble calcium to water. At least a portion of the soluble calcium is calcium HMB, and the at least one chelating agent is selected from the group consisting of a soluble citrate, a soluble phosphate, and combinations thereof. The method also includes holding the aqueous slurry under agitation for at least 10 minutes; admixing protein to the aqueous slurry, where at least a portion of the protein is soluble protein; and spray drying the aqueous slurry to produce the nutritional powder. The nutritional powder has a weight ratio of soluble calcium binding capacity to total soluble calcium from about 2.3:1 to about 12:1. In accordance with this and other embodiments, the method further comprises admixing carbohydrate to the aqueous slurry prior the addition of the protein. Additionally, in accordance with this and other embodiments, the method further comprises admixing fat into the aqueous slurry after the addition of the carbohydrate but prior to spray drying.


DETAILED DESCRIPTION
The nutritional powders comprise spray dried HMB and other nutrients. These and other exemplary features of the nutritional powders, including methods of making such powders, as well as some of the many optional variations and additions thereof, are described in detail hereafter.
The term “HMB” as used herein, unless otherwise specified, refers to beta-hydroxy-beta-methylbutyrate (also referred to as beta-hydroxyl-3-methyl butyric acid, beta-hydroxy isovaleric acid) and sources thereof. All weights, percentages, and concentrations as used herein to characterize HMB are based on the weight of HMB, except that all weights, percentages, and concentrations as used herein to characterize calcium HMB are based on the weight of calcium HMB monohydrate, unless otherwise specified.
The term “nutritional powder” as used herein, unless otherwise specified, refers to nutritional powders comprising HMB and at least one of protein, carbohydrate, and fat, which are reconstitutable with an aqueous liquid, and which are suitable for oral administration to a human.
The terms “fat” and “oil” as used herein, unless otherwise specified, are used interchangeably to refer to lipid materials derived or processed from plants or animals.
All percentages, parts and ratios as used herein, are by weight of the total composition, unless otherwise specified. All such weights as they pertain to listed ingredients are based on the active level and, therefore, do not include solvents or by-products that may be included in commercially available materials, unless otherwise specified.
All references to singular characteristics or limitations of the present disclosure shall include the corresponding plural characteristic or limitation, and vice versa, unless otherwise specified or clearly implied to the contrary by the context in which the reference is made.
All combinations of method or process steps as used herein can be performed in any order, unless otherwise specified or clearly implied to the contrary by the context in which the referenced combination is made.
The various embodiments of the nutritional powders of the present disclosure may also be substantially free of any optional or selected essential ingredient or feature described herein, provided that the remaining nutritional powder still contains all of the required ingredients or features as described herein. In this context, and unless otherwise specified, the term “substantially free” means that the selected nutritional powder contains less than a functional amount of the optional ingredient, typically less than about 0.5%, including less than about 0.1%, and also including zero percent, by weight of such optional or selected essential ingredient.
The nutritional powders and corresponding manufacturing methods of the present disclosure can comprise, consist of, or consist essentially of the essential elements of the disclosure as described herein, as well as any additional or optional element described herein or otherwise useful in nutritional powder formula applications.
Product Form
The nutritional powders are typically in the form of flowable or substantially flowable particulate compositions, or at least particulate compositions that can easily be scooped and measured with a spoon or similar other device, wherein the compositions can easily be reconstituted by the intended user with a suitable aqueous liquid, typically water, to form a liquid nutritional formulation for immediate oral or enteral use. In this context, “immediate” use generally means within about 48 hours, most typically within about 24 hours, preferably right after reconstitution. In accordance with exemplary embodiments disclosed herein, the nutritional powders are produced by spray drying.
The nutritional powders may be formulated with sufficient kinds and amounts of nutrients so as to provide a sole, primary, or supplemental source of nutrition, or to provide a specialized nutritional powder for use in individuals afflicted with specific diseases or conditions. In one specific embodiment, the nutritional powder may be formulated for use with individuals for maintaining or building muscle mass.
The nutritional powders may be reconstituted with water prior to use to a caloric density tailored to the nutritional needs of the ultimate user, although in most instances the powders are reconstituted with water to form compositions comprising from about 100 kcal to about 500 kcal per 240 ml, including from about 150 to about 350 kcal per 240 ml, and also including from about 200 kcal to about 320 kcal per 240 ml. The amount of calcium HMB in the reconstituted liquids most typically ranges from about 0.4 g per 240 ml to about 3 g per 240 ml, including from about 0.75 g per 240 ml to about 2 g per 240 ml, and including about 1.5 g per 240 ml.
Although the serving size for the reconstituted nutritional liquid can vary depending upon a number of variables, a typical serving size ranges from about 100 ml to about 300 ml, including from about 150 ml to about 250 ml, and including from about 190 ml to about 240 ml.
Macronutrients
The nutritional powders comprise at least one of protein, carbohydrate, and fat. In accordance with certain embodiments, the nutritional powders comprise protein. In accordance with the preceding and other embodiments, at least a portion of the protein is soluble protein. In addition, in accordance with certain embodiments, the nutritional powders disclosed herein include protein and at least one of carbohydrate and fat. Generally, any source of protein, carbohydrate, and fat that is known or otherwise suitable for use in nutritional products may be suitable for use herein, provided that such macronutrients are also compatible with the essential elements and other desired properties of the nutritional powders as defined herein.
Although total concentrations or amounts of the protein, carbohydrate, and fat may vary depending upon the nutritional needs of the intended user, such concentrations or amounts most typically fall within one of the following embodied ranges, inclusive of any other essential protein, carbohydrate, and fat ingredients as described herein.
Protein concentrations may range from 0 to about 90%, including from about 5% to about 75%, including from about 8% to about 50%, and also including from about 12% to about 30%, by weight of the nutritional powder.
Carbohydrate concentrations may range from 0 to about 99%, including from about 20% to about 90%, including from about 30% to about 80%, and also including from about 40% to about 70%, by weight of the nutritional powder.
Fat concentrations in the nutritional powders may range from 0 to about 99%, including from about 5% to about 75%, including from about 10% to about 35%, and also including from about 15% to about 20%, by weight of the nutritional powder.
The range or level of protein, carbohydrate, and fat in the nutritional powders may also be characterized in addition to or in the alternative as a percentage of total calories in the nutritional powder as set forth in the following table.















Embodiment B
Embodiment C



Embodiment A
(% of Total
(% of Total


Nutrient
(% of Total Calories)
Calories)
Calories)







Protein
1-98
 5-70
15-35


Carbohydrate
1-98
10-75
30-50


Fat
1-98
20-85
35-55









Non-limiting examples of suitable protein or sources thereof for use in the nutritional powders include hydrolyzed, partially hydrolyzed or non-hydrolyzed proteins or protein sources, which may be derived from any known or otherwise suitable source such as milk (e.g., casein, whey), animal (e.g., meat, fish), cereal (e.g., rice, corn), vegetable (e.g., soy, potato, pea) or combinations thereof. Non-limiting examples of such proteins include whey protein concentrates, whey protein isolates, whey protein hydrolysates, acid caseins, sodium caseinates, calcium caseinates, potassium caseinates, casein hydrolysates, milk protein concentrates, milk protein isolates, milk protein hydrolysates, nonfat dry milk, whole cow's milk, partially or completely defatted milk, condensed skim milk, soy protein concentrates, soy protein isolates, soy protein hydrolysates, pea protein concentrates, pea protein isolates, pea protein hydrolysates, collagen proteins, potato proteins, collagen proteins, and combinations thereof.
Non-limiting examples of suitable carbohydrates or sources thereof for use in the nutritional powders include maltodextrin, hydrolyzed or modified starch or cornstarch, glucose polymers, corn syrup, corn syrup solids, rice-derived carbohydrates, sucrose, glucose, fructose, lactose, high fructose corn syrup, honey, sugar alcohols (e.g., maltitol, erythritol, sorbitol), and combinations thereof.
Non-limiting examples of suitable fats or sources thereof for use in the nutritional powders include coconut oil, fractionated coconut oil, soy oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm and palm kernel oils, palm olein, canola oil, marine oils, cottonseed oils, and combinations thereof.
Soluble Protein
In accordance with certain embodiments disclosed herein, at least a portion of the protein used to formulate the nutritional powders is soluble protein. The term “soluble protein” as used herein, unless otherwise specified, refers to those proteins having a solubility of at least about 90% as measured in accordance with a Protein Solubility Measurement Test that includes the following steps: (1) suspend the protein at 2.00% (w/w) in water; (2) stir vigorously for one hour at 20° C. to form a suspension; (3) remove an aliquot of the suspension, and determine protein concentration as total protein; (4) centrifuge the suspension at 31,000 rpm and at 20° C. for one hour; (5) determine the protein concentration in the supernatant (the soluble protein); and (6) express the soluble protein as a percentage of the total protein.
The soluble protein may represent from about 50% to 100%, including from 55% to 100%, including from about 60% to about 100%, including from about 40% to about 85%, including from about 60% to about 80%, and also including from about 65% to about 75%, by weight of the total protein in the nutritional powder. The concentration of soluble protein may range from at least about 0.5%, including from about 0.5% to about 26%, including about 1% to about 26%, and also including from about 2% to about 15%, also including from about 3% to about 10%, and also including from about 4% to about 8%, by weight of the nutritional powder.
The amount of soluble protein included in the nutritional powder may also be characterized as a weight ratio of soluble protein to calcium HMB, where the nutritional powder includes a weight ratio of soluble protein to calcium HMB of at least about 3, including from about 3 to about 12, including from about 4 to about 12, also including from about 6.1 to about 12, also including from about 7 to about 11, and also including from about 8 to about 10.
Any soluble protein source is suitable for use herein provided that it meets the solubility requirement as defined herein. Non-limiting examples of suitable soluble protein includes sodium caseinate (>95% solubility as determined by the Protein Solubility Measurement Test), whey protein concentrate (>90% solubility as determined by the Protein Solubility Measurement Test), calcium caseinate (>95% solubility as determined by the Protein Solubility Measurement Test), milk protein isolate (>95% solubility as determined by the Protein Solubility Measurement Test), and combinations thereof. In certain embodiments, non-soluble proteins may also be included in the nutritional powders provided that the soluble protein component is represented in accordance with the requirements as set forth herein.
Soluble protein suitable for use herein may also be characterized by the content of phosphoserine in the protein, wherein the soluble proteins in this context are defined as those proteins having at least about 100 mmoles, including from about 150 to about 400 mmoles, including from about 200 to about 350 mmoles, and also including from about 250 to about 350 mmoles, of phosphoserine per kilogram of protein.
When the soluble protein is defined in terms of phosphoserine content, it has been found that the weight ratio of the soluble protein (with the defined phosphoserine content) to the calcium HMB may be at least about 3:1, including at least about 5:1, and also including at least about 7:1, and also including from about 9:1 to about 30:1. In this context, the proteins having the requisite content of phosphoserine are most typically in the form of monovalent caseinate salts such as sodium caseinate, calcium caseinate, potassium caseinate, and combinations thereof.
In one embodiment, the soluble protein may also be characterized by a mole ratio of monovalent caseinate phosphoserine to calcium HMB monohydrate of least about 0.2, including from about 0.2 to about 2, and also including from about 0.25 to about 1.7.
It should be understood, however, that any phosphoserine-containing protein may be suitable for use herein provided that it has the requisite phosphoserine content and that the phosphoserine used in calculating the ratios are not bound, complexed, or otherwise attached to a polyvalent cation such as calcium or magnesium.
It should also be noted that alternative definitions as described herein for soluble proteins may include proteins that have little or no phosphoserine content, so that the soluble protein fraction of the compositions may include soluble protein with or without phosphoserine. The soluble protein for use herein may therefore be defined by any one or more of the soluble protein characterizations, separately or in combination.
The phosphoserine moieties within the protein may therefore be available for binding with the calcium released from the calcium HMB so that the above ratios of soluble protein to calcium HMB are the ratio of protein with phosphoserine moities that are unbound, unattached, or otherwise available to bind soluble calcium from the calcium HMB during formulation. It could be, for example, that a mixture of calcium caseinate and sodium caseinate are used in the composition, but the ratio of proteins defined by a phosphoserine content to calcium HMB is calculated based on the protein fraction from the sodium caseinate and additionally any protein from the calcium caseinate fraction that is not bound to calcium.
HMB
The HMB component of the nutritional powders may be obtained from any HMB source suitable for use in a nutritional product. Such sources include HMB as a free acid, a salt, an anhydrous or hydrated salt, an ester, a lactone, or other forms that otherwise provide a bioavailable form of HMB for the nutritional powder.
Non-limiting examples of suitable HMB sources include HMB salts, hydrated or anhydrous, of sodium, potassium, magnesium, chromium, calcium, or other non-toxic salt forms. Calcium HMB is used in accordance with certain embodiments disclosed herein, and is most typically formulated or otherwise obtained as calcium HMB monohydrate, a commercially available source of which is available from Technical Sourcing International (TSI) of Salt Lake City, Utah USA.
The total concentration of HMB in the nutritional powders may range up to about 10%, including from about 0.1% to about 10%, including from about 0.1% to about 8%, and also including from about 0.2% to about 5.0%, and also including from about 0.3% to about 3%, and also including from about 0.4% to about 1.5%, by weight of the nutritional powder. Such concentrations may represent the concentration of HMB or the HMB source for use in the composition. In accordance with certain embodiments, when the HMB source is calcium HMB, the total concentration of calcium HMB (e.g., calcium HMB monohydrate) in the nutritional powders may range up to about 10%, including from about 0.1% to about 10%, including from about 0.1% to about 8%, and also including from about 0.2% to about 5.0%, and also including from about 0.3% to about 3%, and also including from about 0.4% to about 1.5%, by weight of the nutritional powder.
All or a portion of the HMB, including but not limited to calcium HMB, used in the preparation of the final nutritional powder is in the form of spray dried calcium HMB, as described herein.
Chelating Agents
In accordance with certain embodiments, the nutritional powders disclosed herein include at least one chelating agent. As discussed above, the presence of calcium HMB in the formulation used to produce the nutritional powder can adversely affect the manufacture and production of spray dried powders. In particular, the presence of the calcium HMB in the formulation will tend to cause protein present in the formulation to aggregate or form sediment, as a result of disassociated calcium from the calcium HMB interacting with the protein. The aggregation and sedimentation of the protein prompts the need for more frequent cleaning and maintenance of the spray drying equipment, as the aggregation and sedimentation may cause the equipment to operate less efficiently, and in some instances clog. The presence of the chelating agent in the formulations of the nutritional powders disclosed herein can reduce or minimize the aforementioned physical stability issues caused by the presence of the calcium HMB in the nutritional powders containing protein. The chelating agents are effective to minimize or reduce the aggregation and sedimentation during the production of the spray dried nutritional powder when the chelating agent and the calcium HMB are given time to chelate prior to the introduction of protein to the formulation. Accordingly, as discussed in greater detail below, the chelating agent and the calcium HMB are introduced into the slurry used to prepare the spray dried nutritional powder and held for at least 10 minutes prior to introduction of the protein into such slurry.
Nonlimiting examples of suitable chelating agents for use in the nutritional powders disclosed herein include citrates and phosphates. Examples of soluble citrates include, but are not limited to, alkali metal salts of citrates, such as potassium citrate, and sodium citrate. Examples of soluble phosphates include, but are not limited to, alkali metal salts of phosphates, such as dipotassium phosphate, disodium phosphate (commonly available in anhydrous form), and the like, and alkali earth metal salts of phosphates, such as tricalcium phosphate.
Soluble Calcium Binding Capacity
The amount of chelating agents used to reduce or minimize the production issues associated with the calcium HMB, may be characterized in terms of the weight ratio of soluble calcium binding capacity (SCBC) to total soluble calcium in the nutritional powder. This ratio is determined according to the following formulas I and II:

Ratio=SCBC/[soluble calcium]  (I),

and

SCBC=(0.32×[soluble citrate]+0.63[soluble phosphate]+0.013×[soluble protein])  (II),

    
    
        where [soluble calcium], [soluble citrate], [soluble phosphate], and [soluble protein] represent the concentration (w/w) of each respective component in the nutritional powder.
    
    


The weight ratio of SCBC to the concentration of total soluble calcium can be adjusted to minimize the concentration of unbound (disassociated) calcium that is present in the slurry that is used during the spray drying of the powder, or to minimize the weight ratio of such unbound (disassociated) calcium to HMB in the slurry. This adjustment improves the slurry's physical stability, and consequently minimizes or reduces the production issues associated with spray drying nutritional product comprising calcium HMB.
The ratio of the soluble calcium binding capacity, as defined above, to total soluble calcium of the nutritional emulsions is a weight ratio of at least about 2.3, including from about 2.3 to about 12.0, also including from about 3.0 to about 8.0, and also including from about 4.0 to about 6.5.
The nutritional powders of the present disclosure comprise soluble calcium as a desirable ingredient to facilitate developing or maintaining of healthy muscle in targeted individuals. In this context, the term “soluble calcium” refers to the equivalents of ionized or supernatant calcium in the slurry used to prepare the spray dried powder as measured at 20° C. At least a portion of the soluble calcium is provided by calcium HMB as described herein. Any other calcium source, however, may be used provided that such other source is compatible with the essential other ingredients of the nutritional powders disclosed herein as well as compatible with the requirements set forth by the ratio of SCBC to total calcium as described above.
The calcium in the nutritional powders may also be characterized by a ratio (on an equivalents basis) of soluble citrate to soluble calcium of not more than 5, including not more than 4, also including not more than 3, and also including from about 0.8 to about 3. In this context, the terms “soluble citrate” refers to the equivalents of citrate cations, respectively, present in supernatants of the nutritional slurry as measured at 20° C.
In accordance with certain embodiments, the weight ratio of calcium HMB to the soluble calcium ranges from about 6:1 to about 15:1, including from about 6:1 to about 12:1, also including from about 6:1 to about 10:1, and also including from about 6:1 to about 8:1.
Vitamin D
The nutritional powders may further comprise vitamin D to help maintain healthy muscle in the targeted user. Vitamin D forms include Vitamin D2 (ergocalciferol) and Vitamin D3 (cholecalciferol) or other forms suitable for use in a nutritional product.
The amount of Vitamin D in the nutritional powder typically ranges up to about 1000 IU, including from about 10 IU to about 600 IU, and also including from about 50 IU to about 400 IU per serving size as described herein.
Optional Ingredients
The nutritional powders may further comprise other optional ingredients that may modify the physical, chemical, hedonic or processing characteristics of the products or serve as pharmaceutical or additional nutritional components when used in the targeted population. Many such optional ingredients are known or otherwise suitable for use in other nutritional products and may also be used in the nutritional powders described herein, provided that such optional ingredients are suitable for oral administration and are compatible with the essential ingredients in the nutritional powders.
Non-limiting examples of such optional ingredients include preservatives, antioxidants, emulsifying agents, buffers, pharmaceutical actives, additional nutrients as described herein, colorants, flavors, thickening agents, stabilizers, and masking agents, and combinations thereof.
The nutritional powders may further comprise vitamins or related nutrients, non-limiting examples of which include vitamin A, vitamin E, vitamin K, thiamine, riboflavin, pyridoxine, vitamin B12, carotenoids, niacin, folic acid, pantothenic acid, biotin, vitamin C, choline, inositol, salts, and derivatives thereof, and combinations thereof.
The nutritional powders may further comprise minerals, non-limiting examples of which include phosphorus, magnesium, iron, zinc, manganese, copper, sodium, potassium, molybdenum, chromium, selenium, chloride, and combinations thereof.
Method of Use
The nutritional powders are reconstituted with water or other suitable liquid to provide a nutritional liquid. Such liquids from the powders described herein are useful in methods of providing supplemental, primary, or sole sources of nutrition, or in methods of providing individuals one or more benefits as described herein. In certain embodiments, the liquids may be administered orally as needed to provide the desired level of nutrition, most typically in the form of one to two servings daily, in one or more divided doses daily. For example, serving sizes typically ranging from about 100 ml to about 300 ml, including from about 150 ml to about 250 ml, and including from about 190 ml to about 240 ml, wherein each serving contains from about 0.4 g to about 3.0 g, including from about 0.75 g to about 2.0 g, and including about 1.5 g, of calcium HMB per serving.
Such methods are further directed to providing individuals upon administration of such products, most typically after daily use over an extended period of time of from about 1 month to about 6 months, including from about 1 month to about 3 months, one or more of 1) supporting maintenance of lean body mass, 2) supporting of strength, muscle strength or both, 3) decreasing protein breakdown and damage of muscle cells, and 4) helping with muscle recovery following exercise or other trauma, and 5) reducing muscle protein breakdown following exercise.
Such methods are also helpful to achieve one or more of 1) maintaining and supporting lean body mass in elderly with sarcopenia, 2) providing nutrition to support an active and independent lifestyle in individuals, especially in the elderly, 3) supporting recovery of muscle strength, 4) helping rebuild muscle and regain strength, and 5) improving strength, including muscle strength, and mobility.
Methods of Manufacture
The nutritional powders may be prepared by any collection of known or otherwise effective techniques, suitable for making and formulating a nutritional powder provided that the techniques include or are modified to include a spray drying step to provide the powder with the requisite spray dried HMB ingredient.
The spray drying step may likewise include any spray drying technique that is known for or otherwise suitable for use in the production of nutritional powders. Many different spray drying methods and techniques are known for use in the nutrition field, all of which may be suitable for use in the manufacture of the nutritional powders herein.
One method of preparing the nutritional powder comprises forming an aqueous slurry or liquid comprising HMB and at least one of protein, carbohydrate, and fat, and then spray drying the slurry or liquid to produce a spray dried nutritional powder comprising spray dried HMB and having improved sensory properties. The method may further comprise the step of spray drying, dry mixing (also known as dry blending), or otherwise adding additional nutritional ingredients, including any one or more of the ingredients described herein, to the spray dried nutritional powder.
In some embodiments, the methods of manufacture are formulated with calcium HMB, which is most typically formulated as calcium HMB monohydrate, as the HMB source for use in the methods.
In accordance with certain embodiments, when the nutritional powders for spray drying are formulated with calcium HMB, the nutritional powders are formulated with at least one chelating agent in the following manner so as to minimize or avoid the aggregation and sedimentation issues associated with the use of calcium HMB. Firstly, the chelating agents are admixed into an aqueous slurry or liquid. The calcium HMB is then admixed to the aqueous slurry or liquid containing the chelating agents. The aqueous slurry or liquid containing the chelating agents and the calcium HMB are then held for at least 10 minutes under agitation, so to allow the disassociated or unbound calcium from the calcium HMB to chelate with the chelating agents in the slurry or liquid. Following the hold time, the protein, of which at least a portion is soluble protein as discussed herein, is admixed into the aqueous slurry or liquid. In accordance with certain of the preceding embodiments, when the nutritional powder formulation contains carbohydrates, the at least a portion of the carbohydrates is added before the protein is added to the slurry. Any other portion of carbohydrates may be dry mixed into the nutritional powder following spray drying. In accordance with certain of the preceding embodiments, when fat is present in the formulation of the nutritional powder, the fat is added after the protein and any carbohydrate are added, but before spray drying. The following paragraphs outline an exemplary, more detailed description of the formulation of slurries which may be used in the preparation of the exemplary spray dried nutritional powders disclosed herein.
In one suitable method of manufacturing the nutritional powder, at least three separate slurries are prepared, including a protein-in-fat (PIF) slurry, a carbohydrate-mineral (CHO-MN) slurry, and a protein-in-water (PIW) slurry. The PIF slurry is formed by heating and mixing the selected oils (e.g., canola oil, corn oil) to a specified temperature and then adding an emulsifier (e.g., lecithin), fat soluble vitamins, and a portion of the total protein (e.g., milk protein concentrate) with continued heat and agitation. The CHO-MN slurry is formed by adding with heated agitation to water: minerals (e.g., potassium citrate, dipotassium phosphate, sodium citrate), trace and ultra trace minerals (TM/UTM premix), thickening or suspending agents (e.g., gellan, carrageenan), and calcium HMB and any additional other HMB source. The heated agitation occurs at a specified temperature range. The resulting CHO-MIN slurry is held for 10 minutes with continued heat and agitation before adding any additional minerals (e.g., potassium chloride, magnesium carbonate, potassium iodide) and any carbohydrates (e.g., frucotooligosaccharide, sucrose, corn syrup). The third, PIW slurry is then formed by mixing with heat, at a specified temperature range, and agitation the remaining protein (e.g., sodium caseinate, soy protein concentrate) into water.
The resultant slurries are then blended together with heated agitation, at a specified temperature range, and the pH adjusted to the desired range, typically from 6.6-7.0, after which the composition is subjected to high-temperature short-time (HTST) processing during which the composition is heat treated as is known in the art, emulsified and homogenized. Water soluble vitamins and ascorbic acid are added, the pH is again adjusted to the desired range if necessary, flavors are added, and water is added to achieve the desired total solid level. The resultant slurry is then subjected to spray drying to form the nutritional powder.
In accordance with one or more of the methods of manufacture disclosed herein, a method is directed to the preparation of a nutritional powder comprising spray dried HMB. The method includes preparing an aqueous slurry by admixing at least one chelating agent followed by soluble calcium to water. At least a portion of the soluble calcium is calcium HMB, and the at least one chelating agent is selected from the group consisting of a soluble citrate, a soluble phosphate, and combinations thereof. The method also includes holding the aqueous slurry under agitation for at least 10 minutes; admixing protein to the aqueous slurry, where at least a portion of the protein is soluble protein; and spray drying the aqueous slurry to produce the nutritional powder. The nutritional powder has a weight ratio of soluble calcium binding capacity to total soluble calcium from about 2.3:1 to about 12:1. In accordance with the preceding and other exemplary embodiments, the method further comprises admixing carbohydrate to the aqueous slurry prior the addition of the protein. Additionally, in accordance with the preceding and other embodiments, the method further comprises admixing fat into the aqueous slurry after the addition of the protein and any carbohydrate but prior to spray drying.
In accordance with some of the exemplary methods of manufacture disclosed herein, all of the HMB in the nutritional powder is spray dried as described herein, including from about 50% to about 100%, by weight of the nutritional powder is spray dried as well. In certain embodiments therefore, most or all of the ingredients in the nutritional powder, including all of the HMB in the powder, are spray dried together to form a spray dried nutritional powder wherein 100% of the HMB is therefore spray dried HMB.
Also in accordance with some of the exemplary methods of manufacture disclosed herein, a portion of the HMB in the nutritional powder may be spray dried with some or all of at least one of the protein, carbohydrate, and/or the fat in the nutritional powder, including from about 20% to about 90%, also including from about 40% to about 90%, and also including from about 50% to about 80%, by weight of the total HMB as spray dried HMB. In such nutritional powders, a portion of the HMB may be non-spray dried and thus represent from about 10% to about 80%, including from about 10% to about 60%, and also including from about 20% to about 50%, by weight of the total HMB in the nutritional powder.
The nutritional powders are preferably spray dried to a moisture content of less than about 3.0%, most typically from about 1.0% to about 2.8%, by weight of the finished powder.
EXAMPLES
The following examples illustrate specific embodiments and/or features of the nutritional powders comprising spray dried HMB. The examples are given solely for the purpose of illustration and are not to be construed as limitations of the present disclosure, as many variations thereof are possible without departing from the spirit and scope of the general inventive concepts. All exemplified amounts are weight percentages based upon the total weight of the composition, unless otherwise specified.
The exemplified compositions are nutritional powders prepared in accordance with the manufacturing methods described herein, such that each exemplified nutritional powder comprising spray dried HMB has minimal or no protein aggregation or sedimentation issues associated with the calcium HMB, along with minimal or no off odors when packaged in sealed containers, and then a portion of which is later removed and reconstituted with water to the desired caloric density to form a nutritional liquid containing 1.5 g of calcium HMB monohydrate per 240 ml of reconstituted liquid. The 240 ml liquid represents a single serving suitable for oral administration within 48 hours following such constitution.
In general, each of the exemplified compositions can be manufactured by 1) preparing a first liquid slurry (CHO/MIN) comprising adding chelating agents, followed by calcium HMB monohydrate and any minerals to water, then after a 10 minute hold time, adding the carbohydrates, and, 2) preparing a second liquid slurry comprising oils, stabilizers, oil soluble vitamins, and protein (PIF), 3) preparing a third liquid slurry comprising protein an water (PIW), 4) blending the first and second slurries together, and then blending the resulting slurry with the third slurry, 5) subjecting the resulting blend to homogenization and heat treatment, 6) standardizing the resulting homogenized blend with vitamins, flavors, trace and ultra trace minerals, and other heat sensitive ingredients, and then 7) spray drying the standardized blend to form a spray dried nutritional powder. The spray dried powder is then package and hermetically sealed in appropriate containers suitable for long term storage prior to use, during which the product may be opened and product reconstituted to form a nutritional liquid and administered in accordance with the methods described herein.
Examples 1-4
Examples 1-4 illustrate nutritional powders of the present disclosure, the ingredients of which are listed in the table below. All ingredient amounts are listed as kilogram per 1000 kilogram batch of product, unless otherwise specified.














Ingredient
Example 1
Example 2
Example 3
Example 4



















Whey Protein
282.051
293.892
289.892
284.892


Concentrate


Calcium Caseinate
192.308
192.308
192.308
192.308


Maltodextrin
165.416
165.416
165.416
165.416


Milk Protein Isolate
138.782
138.782
138.782
138.782


Cocoa
76.932
76.932
76.932
76.932


Sunflower Oil Creamer
21.474
21.474
21.474
21.474


Oil Preblend
19.231
19.231
19.231
19.231


Chocolate Cream
15.256
15.256
15.256
15.256


Calcium HMB
13.157
1.316
5.316
10.316


Monohydrate


Oat Fiber
10.897
10.897
10.897
10.897


Tricalcium Phosphate
8.526
8.526
8.526
8.526


Vitamin Mineral
8.462
8.462
8.462
8.462


Preblend


Dipotassium Phosphate
8.333
8.333
8.333
8.333


Rich Dark Chocolate
7.051
7.051
7.051
7.051


Carrageenan
6.474
6.474
6.474
6.474


Potassium Chloride
5.128
5.128
5.128
5.128


Salt
3.205
3.205
3.205
3.205


Xanthan Gum
3.205
3.205
3.205
3.205


Choline Bitartrate 41%
2.782
2.782
2.782
2.782


Choline


Acesulfame K
2.718
2.718
2.718
2.718


Vanilla
1.923
1.923
1.923
1.923


Disodium Phosphate
1.667
1.667
1.667
1.667


Anhydrous


Whey Protein Isolate
1.282
1.282
1.282
1.282


Beta Carotene 1%
1.128
1.128
1.128
1.128


Sucralose
692.3 g
692.3
692.3
692.3


Potassium Citrate 38% K
641.0 g
641.0
641.0
641.0


Alpha ketoglutaric Acid
321.0 g
321.0
321.0
321.0


Egg Albumin Powder
321.0 g
321.0
321.0
321.0


L-Glutamine
321.0 g
321.0
321.0
321.0


Taurine
321.0 g
321.0
321.0
321.0









Examples 5-8
Examples 5-8 illustrate nutritional powders of the present disclosure, the ingredients of which are listed in the table below. All ingredient amounts are listed as kg per 1000 kg batch of product, unless otherwise specified.














Ingredient
Example 5
Example 6
Example 7
Example 8



















Whey Protein
280.051
272.051
262.051
232.051


Concentrate


Calcium Caseinate
192.308
192.308
192.308
192.308


Maltodextrin
165.416
165.416
165.416
165.416


Milk Protein Isolate
138.782
138.782
138.782
138.782


Cocoa
76.932
76.932
76.932
76.932


Sunflower Oil Creamer
21.474
21.474
21.474
21.474


Oil Preblend
19.231
19.231
19.231
19.231


Chocolate Cream
15.256
15.256
15.256
15.256


Calcium HMB
15.157
25.157
35.157
50.157


Monohydrate


Oat Fiber
10.897
10.897
10.897
10.897


Tricalcium Phosphate
8.526
8.526
8.526
8.526


Vitamin Mineral
8.462
8.462
8.462
8.462


Preblend


Dipotassium Phosphate
8.333
7.051
7.051
7.051


Rich Dark Chocolate
7.051
7.051
7.051
7.051


Carrageenan
6.474
6.474
6.474
6.474


Potassium Chloride
5.128
5.128
5.128
5.128


Salt
3.205
3.205
3.205
3.205


Xanthan Gum
3.205
3.205
3.205
3.205


Choline Bitartrate 41%
2.782
2.782
2.782
2.782


Choline


Acesulfame K
2.718
2.718
2.718
2.718


Vanilla
1.923
1.923
1.923
1.923


Disodium Phosphate
1.667
1.667
1.667
1.667


Anhydrous


Whey Protein Isolate
1.282
1.282
1.282
1.282


Beta Carotene 1%
1.128
1.128
1.128
1.128


Sucralose
692.3 g
692.3 g
692.3 g
692.3 g


Potassium Citrate 38% K
641.0 g
641.0 g
641.0 g
641.0 g


Alpha ketoglutaric Acid
321.0 g
321.0 g
321.0 g
321.0 g


Egg Albumin Powder
321.0 g
321.0 g
321.0 g
321.0 g


L-Glutamine
321.0 g
321.0 g
321.0 g
321.0 g


Taurine
321.0 g
321.0 g
321.0 g
321.0 g









Examples 9-12
Examples 9-12 illustrate nutritional powders of the present disclosure, the ingredients of which are listed in the table below. All ingredient amounts are listed as kg per 1000 kg batch of product, unless otherwise specified.
















Example
Example
Example


Ingredient
Example 9
10
11
12



















Whey Protein
235.051
230.051
225.051
216.051


Concentrate


Calcium Caseinate
192.308
192.308
192.308
192.308


Maltodextrin
165.416
165.416
165.416
165.416


Milk Protein Isolate
138.782
138.782
138.782
138.782


Dutch Cocoa
76.932
76.932
76.932
76.932


Sunflower Oil Creamer
21.474
21.474
21.474
21.474


Oil Preblend
19.231
19.231
19.231
19.231


Chocolate Cream
15.256
15.256
15.256
15.256


Calcium HMB
60.157
65.157
70.157
79.157


Monohydrate


Oat Fiber
10.897
10.897
10.897
10.897


Tricalcium Phosphate
8.526
8.526
8.526
8.526


Vitamin Mineral
8.462
8.462
8.462
8.462


Preblend


Dipotassium Phosphate
8.333
8.333
8.333
8.333


Rich Dark Chocolate
7.051
7.051
7.051
7.051


Carrageenan
6.474
6.474
6.474
6.474


Potassium Chloride
5.128
5.128
5.128
5.128


Salt
3.205
3.205
3.205
3.205


Xanthan Gum
3.205
3.205
3.205
3.205


Choline Bitartrate 41%
2.782
2.782
2.782
2.782


Choline


Acesulfame K
2.718
2.718
2.718
2.718


Vanilla
1.923
1.923
1.923
1.923


Disodium Phosphate
1.667
1.667
1.667
1.667


Anhydrous


Whey Protein Isolate
1.282
1.282
1.282
1.282


Beta Carotene 1%
1.128
1.128
1.128
1.128


Sucralose
692.3 g
692.3 g
692.3 g
692.3 g


Potassium Citrate 38% K
641.0 g
641.0 g
641.0 g
641.0 g


Alpha ketoglutaric Acid
321.0 g
321.0 g
321.0 g
321.0 g


Egg Albumin Powder
321.0 g
321.0 g
321.0 g
321.0 g


L-Glutamine
321.0 g
321.0 g
321.0 g
321.0 g


Taurine
321.0 g
321.0 g
321.0 g
321.0 g

## Claims

1. A method of preparing a nutritional powder comprising spray dried calcium beta-hydroxy-beta-methylbutyrate (HIVIB), the method comprising:
preparing an aqueous slurry by admixing at least one chelating agent followed by soluble calcium to water, wherein at least a portion of the soluble calcium is calcium HMB and wherein the at least one chelating agent is selected from the group consisting of a soluble citrate, a soluble phosphate, and combinations thereof;
holding the aqueous slurry under agitation for at least 10 minutes;
admixing protein to the aqueous slurry containing the chelating agent and the soluble calcium, wherein at least a portion of the protein is soluble protein; and
spray drying the aqueous slurry to produce the nutritional powder,
wherein the powder has a weight ratio of soluble calcium binding capacity to total soluble calcium from about 2.3:1 to about 12:1.

2. The method of claim 1, further comprising:
admixing carbohydrate to the aqueous slurry prior the addition of the protein.

3. The method of claim 2, further comprising:
admixing fat into the aqueous slurry after the addition of the carbohydrate but prior to spray drying.

4. The method of claim 2, further comprising dryblending additional carbohydrate into the nutritional powder following the spray drying.

5. The method of claim 1, wherein the powder comprises from about 0.1% to about 8% by weight of calcium HMB.

6. The method of claim 5, wherein the powder comprises from about 12% to about 30% protein, from about 30% to about 80% carbohydrate, and from about 10% to about 35% fat, all by weight of the nutritional powder.

7. The method of claim 1, wherein the at least one chelating agent is selected from the group consisting of tricalcium phosphate, dipotassium phosphate, disodium phosphate, and potassium citrate.