CN105578901A - Liquids and foods containing beta-hydroxy-beta-methylbutyrate (HMB) in free acid form - Google Patents

Abstract

Liquids, substantially clear liquids and foodstuffs are described that contain free acid HMB. The liquids, substantially clear liquids and foodstuffs are substantially free of crude fat and may contain soluble proteins, carbohydrates, vitamins, minerals, amino acids, flavorings and other components. The products are shelf-stable and are substantially free of separation, gelation, sedimentation and coagulation.

Description

Liquids and foods containing beta-hydroxy-beta-methylbutyrate (HMB) in free acid form

This application claims priority to US Patent Application 61/782,567, filed March 14, 2013, which is incorporated herein by reference.

field of invention

The present invention relates generally to nutritional supplements containing [beta]-hydroxy-[beta]-methylbutyrate (HMB), and more particularly to nutritional supplements containing HMB in the free acid form.

Background of the invention

HMB has been found useful in a variety of application contexts. Specifically, in US Patent No. 5,360,613 (Nissen), HMB is described as useful for lowering blood levels of total cholesterol and low-density lipoprotein cholesterol. In US Patent No. 5,348,979 (Nissen et al.), HMB is described as useful for promoting nitrogen retention in humans. US Patent No. 5,028,440 (Nissen) discusses the use of HMB to increase non-adipose tissue development in animals. Additionally, in US Patent No. 4,992,470 (Nissen), HMB is described as having an effect in enhancing the immune response in mammals. US Patent No. 6,031,000 (Nissen et al.) describes the use of HMB and at least one amino acid to treat disease-related wasting. In US Patent No. 6,103,764, HMB is described as enhancing the aerobic capacity of muscle in animals without substantially increasing muscle mass. Additionally, HMB has been described in US Patent No. 6,291,525 as useful for improving humans' perception of their emotional conditions.

HMB has been shown to have a positive effect on maintaining and increasing lean muscle in cancer cachexia and AIDS wasting. In addition, a positive effect on muscle damage and consequent inflammatory response induced by exercise (leading to muscle soreness, loss of strength, and increase in pro-inflammatory cytokines) was observed with HMB.

It has previously been observed that HMB alone or in combination with other amino acids is an effective supplement for restoring muscle strength and function in young athletes. Additionally, it has been observed that the combination of HMB with two amino acids arginine and lysine is effective in increasing muscle mass in the elderly.

It is common to supplement traditional nutrient sources with nutritional supplements. Nutritional supplements come in many forms; for the present invention, the focus is on nutritional supplements in non-emulsified, substantially clear liquid form. These substantially clear liquid supplements often include vitamins, carbohydrates, soluble proteins, amino acids, minerals and other nutrients. Due to the known benefits of consuming HMB, it is desirable to include HMB in these liquid supplements.

It may also be desirable to include HMB in other liquids, such as water, sports drinks, fruit juices, soft drinks, and other carbonated and non-carbonated beverages.

Simply adding CaHMB to these liquids, especially substantially clear liquid products that contain additional calcium, will result in an unstable product. Addition of CaHMB to these liquids has been observed to lead to agglomeration, coagulation, separation and precipitation over time. Such agglomeration, coagulation, separation and precipitation may occur because at least part of the CaHMB dissociates over time and the dissociated calcium and dissociated HMB interact with soluble proteins and/or other components (including vitamins) in the liquid. , salt, and minerals) interact to cause the observed aggregation, coagulation, separation, and precipitation. Thus, clear liquid supplements containing CaHMB are not shelf stable, especially when the product is subjected to high heat during standard sterilization.

CaHMB has been observed to react poorly with commercially available ready-to-drink products containing soluble proteins, as the addition of CaHMB caused changes in physical appearance, including precipitation and agglomeration.

However, in some instances, clear liquid nutritional supplement products with CaHMB have been described as having storage stability. For example, US Patent Application Publication No. 2011/0305799 describes a clear liquid beverage containing CaHMB. This clear liquid nutrient product has a pH in the range of 2.8 to 4.6, and the application states that within these pH ranges, the CaHMB remains engaged such that calcium and protein interactions in the formulation are minimized or avoided such that Gelation, precipitation and coagulation are minimized or avoided and a storage stable product is provided.

CaHMB used to be the preferred delivery form of HMB. Previously, there were many obstacles to the extended testing and commercial use of the free acid form of HMB, and since there was no perceived difference between the two forms from a pharmacokinetic point of view, the calcium salt was adopted as the commercial source of HMB. Until recently, the packaging and especially distribution of food supplements has been more amenable to handling the nutrient in powdered form and thus the calcium salt of HMB has been widely accepted. HMB-acid is liquid and more difficult to deliver or incorporate into products.

Currently, the manufacturing process of HMB enables the production of HMB free acid to a purity that allows oral administration of HMB free acid. In addition to having a commercial source pure enough for oral administration, the HMB-acid also requires buffering for oral administration, a process that has only recently been determined (due to the factors listed above that previously hindered the use of HMB-acid ).

It was postulated that administration of CaHMB would result in a rather rapid dissociation of HMB from the calcium salt form. However, recent studies and its corresponding patent application (US Patent Application No. 20120053240) have shown that the free acid form of HMB has rather unique pharmacokinetic effects compared to administration of CaHMB. The use of HMB free acid (also referred to as HMB-acid) improves the availability of HMB to tissues and thus provides a more rapid and efficient method of getting HMB to tissues than administration of CaHMB. It has been shown that HMB free acid is a better delivery form of HMB in many cases.

Thus, it is desirable to use the free acid form of HMB instead of CaHMB in order to take advantage of the unique pharmacokinetic effects of free acid HMB. However, it is expected that adding HMB-acid to a non-emulsified liquid nutritional supplement would have similar results as adding CaHMB to a liquid. Specifically, it is expected that the addition of HMB-acid will cause a layer of HMB-acid to appear on top of the liquid, that the HMB-acid will be observed to float through the liquid and/or that the HMB-acid will interact with other components in the liquid to cause agglomeration , sedimentation and changes in the physical appearance of the beverage. It is thus surprising and unexpected that the addition of HMB-acid to a liquid nutritional supplement results in an almost immediate disappearance of the HMB-acid and persistent retention in solution.

Thus, there is a need for beverages and non-emulsified substantially clear liquid nutritional supplements containing HMB in the free acid form.

Summary of the invention

In one embodiment, the invention is a liquid nutritional supplement comprising HMB in free acid form.

In another embodiment, the present invention is a clear liquid beverage containing HMB in free acid form.

The nutritional supplement or beverage may contain calcium and soluble protein.

In another embodiment, the present invention is a method of adding free acid HMB to a liquid nutritional supplement or beverage. The addition of free acid HMB can be done during manufacture of the liquid or beverage product, or it can be done just before the liquid or beverage is used.

Unexpectedly, although free acids HMB and calcium (if present) are thought to be unstable in clear liquid nutritional supplements containing soluble protein and stored, and would cause HMB and/or calcium (if present) to interact with soluble protein Instead of causing precipitation and separation, the present invention includes such nutritional supplements that contain soluble protein and free acid HMB and that are still storage stable. In addition, the addition of free acid HMB to a liquid free of soluble protein also unexpectedly did not result in precipitation and separation of the liquid (which would be expected to occur upon addition of free acid HMB).

Brief description of the drawings

Figure 1 shows a picture of the bottle showing the physical appearance of the liquid supplement studied in Example 1 at days 1, 4, 14 and 21.

Figure 2a shows a picture of a bottle of ISOPURE showing the physical appearance of the ISOPURE samples studied in Example 3 at days 0, 7, 14, 28 and 42.

Figure 2b shows a picture of a bottle of GNC-protein juice showing the physical appearance of the GNC-protein juice studied in Example 3 at days 0, 7, 14, 28 and 42.

Figure 2c shows a picture of a bottle of Gatorade Recovery showing the physical appearance of the Gatorade Recovery samples studied in Example 3 at days 0, 7, 14, 28 and 42.

Figure 2d shows a picture of a bottle of Spartos protein water showing the physical appearance of the samples of Spartos protein water studied in Example 3 at days 0, 7, 14, 28 and 42.

Figure 3 is a graph depicting the stability results for 300 mg of HMB-acid at 120 days.

Figure 4 is a graph depicting the stability results of 1000 mg of HMB-acid at 120 days.

Figure 5 is a graph depicting the stability results for 3000 mg of HMB-acid at 120 days.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

In a preferred embodiment, the present invention is a non-emulsified, substantially clear liquid nutritional supplement (most commonly a beverage or drink) containing free acid HMB. The liquids of the present invention may contain water and free acid HMB. Additional components may include soluble proteins, amino acids, carbohydrates, vitamins and minerals such as calcium.

The invention comprises HMB-acid and liquid on its basis. In most cases, the liquid has a crude fat content of less than 1%. Those skilled in the art will appreciate that the present invention may include free fatty acids such as DHA or EPA and still be considered to have a crude fat content of less than 1%. Water, sports drinks, fruit juices, soft drinks, medicinal liquids, and substantially clear nutritional supplements such as EnsureClear, IsoPure Protein Drink, GNC Protein Juice, GatoradeRecover, and Spartos Protein Water may comprise the liquids of the present invention, but the invention is not limited to these liquids.

While the preferred embodiment is HMB-acid in liquid nutritional supplements, in another embodiment, HMB-acid can be added to food products such as honey, applesauce, shredded fruit, during manufacture or before consumption by the consumer Bars (fruitribbon) and other foods.

In the present invention, HMB-acid is present in an effective amount. Effective amounts include a range of about 0.01 grams to about 0.2 grams of HMB-acid per kilogram of body weight over a twenty-four (24) hour period. HMB-acid may also be administered to humans at an effective rate of 0.5 grams to about 30 grams of HMB-acid per day. Thus, a pre-prepared product including HMB-acid will have HMB-acid present substantially in these ranges. Individually provided HMB-acids to be added to liquids or foodstuffs will also have HMB-acids substantially within these ranges.

Any soluble protein source is suitable for use in the present invention, including but not limited to whey protein concentrate, whey protein isolate, casein hydrolyzate, hydrolyzed collagen, and combinations thereof.

The liquid nutritional supplement may also include calcium, most preferably in soluble form to minimize interactions with other components in the supplement such as free acid HMB or soluble protein, if present. Non-limiting examples of suitable forms of calcium include calcium carbonate, calcium citrate, calcium gluconate, calcium lactate, calcium phosphate and calcium pantothenate.

The liquid nutritional supplements of the present invention may also include vitamins such as vitamin D. As described in US Patent Application Publication No. 2010/0179112, the combination of vitamin D and HMB has a synergistic effect and thus it may be desirable to include vitamin D in the fluids of the present invention. Vitamin D may be included in any form, but most preferably vitamin D3, also known as cholecalciferol. The amount of vitamin D to be included can be any amount up to a toxic amount. Vitamin D is typically present in amounts of up to 4000 IU, but can be included in much higher amounts as described in US Patent Application Publication No. 2010/0179112.

The HMB-acid used in the present invention is usually in liquid form. Other forms of HMB-acid within the scope of the present invention include HMB-acid in gel or gel-matrix form. Any and all forms of HMB-acid can be used in the present invention.

In the present invention, free acid HMB can be added to the liquid at any point prior to use. For example, free acid HMB can be added to liquids or food products during the manufacturing process and at any time during the manufacturing process. Suitable methods of manufacture include, but are not limited to, a hotfill process, retort or aseptic filling of liquid products, and the HMB-acid can be added at any time during any of these manufacturing processes.

It is not necessary to subject the liquid or food to any non-standard manufacturing steps, such as additional heating or cooling steps, or additional mixing or slurrying. The HMB-acid can be added at any time during any manufacturing process and the product will be storage stable with minimal segregation or settling of the HMB-acid interacting with the liquid or other ingredients of the food product.

HMB-acid can be added to liquids or food products after manufacture and before use. For example, HMB-acid may be provided separately from the liquid or food to allow the consumer to add to the liquid or food of his choice. Discontinuous measurement packages of HMB-acid (most commonly in concentrated form, and most commonly in gel form) may be provided for addition to given quantities of water, sports drinks, fruit juices, substantially clear nutritional liquids, and the like. The HMB-acid may be provided in single or multiple dose packs. The HMB-acid will mix into any drinkable liquid or food and is soluble in said liquid and food.

The present invention is not dependent on the pH of the liquid matrix to which the HMB-acid is added. The pH of the liquid matrix can be as low as about 2.0.

The observation in the present invention that the addition of HMB-acid to liquids and foods results in precipitation, gelation or coagulation in liquids and foods with little interaction of HMB-acids with other ingredients in said liquids or foods is surprising. Surprising and unexpected. It is known in the art that the addition of calcium HMB to liquids such as water or liquids containing soluble proteins results in partial dissociation of calcium and HMB into ionic forms, leading to precipitation, gelation and coagulation. Whereas U.S. Patent Application Serial No. 2011/0305799 describes the addition of calcium HMB to a substantially clear nutrient solution, which clarifies the fact that calcium HMB remains associated, thereby avoiding the interaction between calcium and protein, which makes These undesired effects are minimized. HMB-acid is by definition the dissociated form of HMB and the free acid form is expected to interact with soluble proteins and other components of the liquid which can lead to precipitation etc. Unexpectedly, the free acid form of HMB does not interact with any other ingredients, thereby providing a stable product with little to no separation or precipitation. It was also unexpected to observe that HMB-acid went into solution almost instantaneously when added to the liquid. It was expected that adding HMB-acid to a liquid would cause the HMB-acid to form a layer on top of the liquid or flow through the liquid, or that the HMB-acid would interact with other components in the liquid causing agglomeration, precipitation and changes in the physical appearance of the beverage. In fact, adding the HMB-acid followed by a little shaking resulted in the immediate disappearance of the HMB-acid and a crystal clear liquid.

Additionally, the addition of HMB-acid has little to no effect on the taste, texture, mouthfeel and stability of the liquid beverage base.

Those skilled in the art understand that it is also within the scope of the present invention to use markers for HMB-acid to be added to liquids without adding HMB-acid (usually in the form of a gel).

Test Example

Example 1 : Stability of Product Compositions with Added HMB (Free Acid and Calcium Salt Form)

Program:

1. N=2 (two flavors of a commercially available ready-to-drink soluble protein product; EnsureClear, pH approximately 2.74)

2. Label the glass bottles as A1-A3 and B1-B3. The flags correspond to the following conditions:

Table 1

mark condition A1 Peach Flavor Comparison A2 Peach Flavor CaHMB A3 Peach Flavor HMB FA B1 Blueberry Pomegranate Control B2 Blueberry Pomegranate CaHMB B3 Blueberry Pomegranate HMB FA

3. Add 1 g of CaHMB MTI1208-100-02TSI12070630 to bottles A2 and B2.

4. Add 0.8 g of HMB free acid MTI1103-100-09Lot11010084 to bottles A3 and B3.

5.40ml of peach flavored product was added to the bottles labeled A1-A3.

6.40ml of blueberry pomegranate flavored product was added to bottles labeled B1-B3.

7. The bottle was sealed with a rubber cap and crimped shut. Next, mix it well and put it on the shelf.

8. Appearance was recorded and photographed daily (without disturbing the bottle).

result:

Table 2 reports the physical appearance of ready-to-drink soluble protein products (n=2) after addition of CaHMB or HMB free acid and mixing. HMB was not added to the control bottle. Day 1 is recorded after initial mixing.

Table 2

In addition to the physical appearance, it was also recorded and photographed at the above-mentioned time node. These photos appear in Figure 1.

Example 2 :

Study: Taste of products with added HMB (free acid and Ca salt form)

Program:

1. N=2 (two flavors of a commercially available ready-to-drink soluble protein product; EnsureClear, pH approximately 2.74)

2. Label the glass bottles as A1-A3 and B1-B3. The flags correspond to the following conditions:

table 3

mark condition A1 Peach flavor comparison 5 --> A2 Peach Flavor CaHMB A3 Peach Flavor HMB FA B1 Blueberry Pomegranate Control B2 Blueberry Pomegranate CaHMB B3 Blueberry Pomegranate HMB FA

3. Add 1 g of CaHMB MTI1208-100-02TSI12070630 to bottles A2 and B2 and mix.

4. Add 1.0 g of HMB free acid Lot 11010086 to bottles A3 and B3 and mix.

5. Taste the flavors in the bottles by the researcher.

6. Rinse mouth with water and wait 1 minute between each tasting of samples.

result:

Table 4 reports the taste of ready-to-drink beverage soluble protein products (n=2) after addition of CaHMB or HMB free acid and mixing. HMB was not added to the control bottle.

Table 4

in conclusion:

Soluble protein ready-to-drink products containing HMB free acid were unexpectedly more stable than those containing CaHMB. Additionally, the addition of HMB free acid had no effect on the physical appearance, mouthfeel or texture of the product (compared to the control), but only slightly changed the aftertaste (more sour, most likely due to the low pH of HMB free acid).

Example 3

Laboratory Study #21 Long Term Stability

1. Rinse 12 glass vials with ethanol and air dry overnight.

2. Label the glass vials as A1-A3, B1-B3, C1-C3, and D1-D3. The flags correspond to the following conditions:

table 5

mark condition A1 40ml A2 250mg CaHMB in 40ml A3 200mg HMB FA in 40ml B1 40ml B2 250mg CaHMB 6 in 40ml --> B3 200mg HMB FA in 40ml C1 40ml C2 250mg CaHMB in 40ml C3 200mg HMB FA in 40ml D1 40ml D2 250mg CaHMB in 40ml D3 200mg HMB FA in 40ml

3. Bottles A2-D2 used CaHMBMTI1208-100-02TSI12070630.

4. Bottles A3-D3 used HMB free acid MTI1103-100-09Lot11010084.

5. Add 40ml of ISOPURE protein drink to A1-A3, 40ml of GNC protein juice to B1-B3, 40ml of GatoradeRecover to C1-C3, and 40ml of Spartos protein water to D1-D3.

6. Flush with nitrogen and seal the bottle with a rubber cap and metal crimp cap.

7. Mix well.

8. Take pictures of bottles A1-A3, B1-B3, C1-C3, and D1-D3 every Friday. The photographs appear in Figures 2a-2d.

Tables 6-9 below provide nutritional information for each of the liquids tested (ISOPURE, GNC Protein Juice, Gatorade G3-Recover, and Spartos Protein Water).

Table 6

Nutrition Facts: GrapeFrostISOPURE—Figure 2a

Serving Size: 1 bottle (20fl.oz/591mL)

Amount per serving daily value calories 160 calories from fat 0 Total fat 0g 0% sodium 80mg 3% Potassium 45mg 1% total carbohydrates 0g 0% protein 40g 80% Vitamin A 0% Vitamin C 0% calcium 6% iron 0%

Table 7

GNC – Protein Juice – Mixed Berries – Figure 2b

Serving Size 14fl.Oz/414ml

Servings Per Container: 2

Amount per serving daily value calories 170 7 --> calories from fat 5 Total fat 0g 0% sodium 50mg 2% Potassium 0mg 0% total carbohydrates 26g 9% dietary fiber 1g sugar 24g protein 15g 30% Vitamin A 10%

Vitamin E 10% niacin 10% Vitamin B6 10% Vitamin B12 10% pantothenic acid 10%

Table 8

GatoradeG3 – Recover – Mixed Berries – Figure 2c

Serving Size 8fl.Oz/240ml

Servings Per Container: 2

pH3.68

Amount per serving daily value calories 110 calories from fat 0 Total fat 0g 0% sodium 105mg 4% Potassium 40mg 1% total carbohydrates 20g 7% dietary fiber 0g sugar 20g protein 8g 16% Vitamin A 0% Vitamin C 0% calcium 4% iron 0%

Table 9

Spartos Protein Water—Figure 2d

Serving Size 8fl.Oz/240ml

Servings Per Container: 2

pH about 3.05

Amount per serving daily value calories 60 calories from fat 0 Total fat 0g 0% sodium 10mg <1% Potassium 20mg 1% total carbohydrates 9g 3% sugar 9g

protein 5g 10% Vitamin A 5% Vitamin C 5% calcium 5% Vitamin D 5% Vitamin E 5% Vitamin B6 15% folic acid 15% Vitamin B12 15% magnesium 5%

As shown in Figures 2a-2d, over 42 days, the calcium HMB added fluid was cloudy and contained precipitates. Calcium HMB bottles are A2, B2, C2 and D2 bottles. The bottles containing liquid and HMB-acid (A3, B3, C3 and D3) were clear and free of sediment at 42 days and looked identical to the control bottles (no HMB) (A1, B1, C1 and D1).

Example 4

The assay was designed to observe the stability of various concentrations of HMB-acid in soluble protein for 120 days.

In order to analyze HMB free acid in soluble protein (ISOPURE protein drink, Natures Hauppauge, NY), different concentrations of HMB free acid were added to recommended serving sizes of ISOPURE protein drinks. The three concentrations are 300mg/240ml, 1000mg/240ml, and 3000mg/240ml. HMB free acid was measured for each solution using HPLC at five different time points: 0, 30, 60, 90, and 120 days. The HMB free acid used was MTI1301-100-03 (Lot120111036). The ISOPURE protein drink used is Lot1212111132310. ISOPURE protein drink has a pH of approximately 2.54. All glassware and supplies used were autoclaved to prepare the three different concentrations of HMB free acid (in the ISOPURE protein drink) for the five different time points. Materials to be autoclaved are: glass vials, rubber and metal closures, pipettes, and graduated cylinders. Autoclave Method #1 for Dry Goods in Building 3 of the ISUResearchPark was used.

Table 10 shows the bottle markings:

Table 10

mark Concentration (mg/240ml) time frame A0 300 0 A1 300 30 days A2 300 60 days A3 300 90 days A4 300 120 days B0 1000 0 B1 1000 30 days B2 1000 60 days B3 1000 90 days B4 1000 120 days C0 3000 0 C1 3000 30 days C2 3000 60 days C3 3000 90 days C4 3000 120 days

For the bottles in Group A, 60mg of HMBFA was added to each of the five bottles followed by 48ml of ISOPURE protein drink. The concentration of HMBFA was 1.25 mg/ml.

For the bottles in Group B, 200mg of HMBFA was added to each of the five bottles followed by 48ml of ISOPURE protein drink. The concentration of HMBFA was 4.16 mg/ml.

For the bottles in group C, 600mg of HMBFA was added to each of the five bottles followed by 48ml of ISOPURE protein drink. The concentration of HMBFA was 12.5 mg/ml.

The ISOPURE protein drink had a protein concentration of 0.0677g/ml; the amount of protein in each sample was 3.25g.

Table 11 shows the actual weight (mg) and concentration (mg/48ml) of the samples.

Table 11

mark Weight (mg) Concentration (mg/ml) A0 72.6 1.51 A1 61.6 1.28 A2 67.8 1.41 A3 73.5 1.53

A4 65.3 1.36 B0 212.5 4.43 B1 213.6 4.45 B2 200.3 4.17 B3 206.1 4.29 B4 201.7 4.2 10 --> C0 614.4 12.8 C1 612.8 12.77 C2 610.6 12.72 C3 613.1 12.77 C4 613.9 12.79

Flush each vial with nitrogen and then seal the top of the vial with a rubber cap, crimp cap, and mix well.

One bottle of each concentration was tested for HMB at time points 0, 30, 60, 90, and 120 days using SOP113-04 HMB (modified standard line).

Table 12 shows the HMB standard curve to be used.

Table 12

To prepare samples for testing, 0.5 ml samples were transferred in quadruplicate to microcentrifuge tubes. Then 0.25ml of KIV internal standard was added to the standard and three of each sample set. Finally, 0.25ml of 0.2M phosphate buffer was added to the three samples with KIV internal standard and 0.5ml of 0.2M phosphate buffer was added to the sample without KIV.

The concentrations of each HMBFA sample are now: 0.625 mg/ml, 2.08 mg/ml, and 6.25 mg/ml, respectively.

Samples were considered stable with expected variation of ±5% HMB concentration over four months (with ±3% assay variation allowed). A linear regression was performed on the data as a second measure of stability.

result

HMB in ISOPURE sports drink prepared at three concentrations of HMB free acid was analyzed using HPLC at 0, 30, 60, 90 and 120 days. Components of the ISOPURE sports drink interfered with our KIV internal standard peak, so an external standard-based calculation was used to quantify HMB in each sample. The quantified amount of HMB for each sample was compared to the expected amount of HMB at each test time point and expressed as a percentage of the expected. The results are given in Figures 3-5. Overall, three different concentrations of HMB-FA in sports drinks decreased numerically over time, but no significant linear decrease was detected, p>0.05. The change is less than 8.0%. The 300, 1000, and 3000 mg/part HMB-FA samples ranged from the expected 98.6-91.84%, 98.1-94.96%, and 97.28-93.57%, respectively.

Figure 3 shows a sample of soluble protein containing 300 mg HMB free acid/serving (evaluated for 120 day stability). The decrease in HMB free acid was less than 8% of the expected amount of HMB free acid and there was no significant linear decrease, p<0.05.

Figure 4 shows soluble protein containing 1000 mg HMB free acid/serving (evaluated for 120 day stability). The decrease in HMB free acid was less than 8% of the expected amount of HMB free acid and there was no significant linear decrease, p<0.05.

Figure 5 shows soluble protein containing 3000 mg HMB free acid/serving (evaluated for 120 day stability). The decrease in HMB free acid was less than 8% of the expected amount of HMB free acid and there was no significant linear decrease, p<0.05.

This experimental example demonstrates that the addition of HMB-acid to a beverage containing soluble protein causes HMB-acid to remain stable at room temperature for up to 120 days.

Claims (16)

CLAIMS 1. A substantially clear, non-emulsified liquid composition comprising from about 0.5 grams of beta-hydroxy-beta-methylbutyric acid (HMB-acid) to about 30 grams of HMB-acid. 2. The composition of claim 1, wherein said composition further comprises a soluble protein. 3. The composition of claim 1, wherein said composition further comprises calcium. 4. The composition of claim 1, wherein said composition further comprises vitamins and minerals. 5. The composition of claim 1, wherein said substantially clear, non-emulsified liquid is storage stable. 6. The composition of claim 1, wherein said substantially clear, non-emulsified liquid is selected from the group consisting of nutritional liquids, sports drinks, fruit juices, and carbonated drinks. 7. The composition of claim 1, wherein said substantially clear, non-emulsified liquid has a pH of from about 2.0 to about 4.7. 8. The composition of claim 1, wherein said substantially clear, non-emulsified liquid has a pH of from about 2.0 to about 2.8. 9. The composition of claim 8, wherein the substantially clear, non-emulsified liquid has a pH of from about 2.0 to about 2.75. 10. A method of preparing a substantially clear, non-emulsified liquid composition comprising HMB-acid, wherein said HMB-acid is added to a nutritional composition at any time during the manufacturing process. 11. A concentrate comprising from about 0.5 grams of HMB-acid to about 30 grams of HMB-acid. 12. The concentrate of claim 11, wherein the concentrate is added to a ready-to-drink (RTD) beverage or food. 13. The concentrate of claim 12, wherein the concentrate is added to a ready-to-drink (RTD) beverage or food by a consumer of the RTD beverage or food. 14. The method of preparing the nutritional composition of claim 1, wherein the HMB-acid is added to a ready-to-drink (RTD) beverage. 15. The method of making the nutritional composition of claim 1, wherein the HMB-acid is added to the liquid at any point during the manufacturing process. 16. A method of preparing a liquid composition comprising adding HMB-acid to a substantially clear, non-emulsified liquid composition, wherein the HMB-acid is added to the physical appearance, mouthfeel or At least one characteristic in texture is not adversely affected.