NUTRITIONAL SUPPLEMENT FOR IMPROVED CALCIUM ABSORPTION

Abstract

An inventive nutritional supplement for increased Ca absorption is disclosed. The inventive nutritional supplement incorporates Ca in combination with specified amounts of L-Arginine and L-Lysine. The inventive nutritional supplement may also include Copper, Zinc, Manganese and Vitamin D3 as specified herein.

Claims

1. A nutritional supplement composition for aiding the absorption of calcium to improve bone density comprising of: 21 g-36 g Calcium per 100 g; 425 mg-770 mg Zinc per 100 g; 53 mg-92 mg Copper per 100 g; 107 mg-183 mg Manganese per 100 g; 260 mcg-550 mcg Vitamin D3 per 100 g; and at least 15 g L-Arginine and L-Lysine per 100 g; wherein L-Arginine and L-Lysine are present in a two to one ratio, respectively.

2. The nutritional supplement composition of claim 1 wherein the 21 g-36 g Calcium comprises calcium carbonate.

3. The nutritional supplement composition of claim 1 wherein the 21 g-36 g Calcium comprises calcium aspartate.

4. The nutritional supplement composition of claim 1 wherein the 21 g-36 g Calcium comprises dicalcium phosphate.

5. The nutritional supplement composition of claim 1 wherein the 21 g-36 g Calcium comprises calcium glycinate.

6. The nutritional supplement composition of claim 1 wherein the 21 g-36 g Calcium comprises calcium alginate.

7. The nutritional supplement composition of claim 1 wherein the 21 g-36 g Calcium comprises calcium lysinate.

8. The nutritional supplement composition of claim wherein the 21 g-36 g Calcium is selected from two or more of the group of calcium carbonate, calcium aspartate, dicalcium phosphate, calcium glycinate, calcium alginate, calcium lysinate.

9. The nutritional supplement composition of claim 1 in an oral dosage form selected from a tablet, a capsule, a lozenger, a chewable tablet and a bulk powder.

10. A nutritional supplement composition for aiding the absorption of calcium to improve bone density comprising of: 21 g-36 g Calcium per 100 g; and at least 15 g L-Arginine and L-Lysine per 100 g; wherein L-Arginine and L-Lysine are present in a two to one ratio, respectively.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0026] It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.

[0027] According to one aspect, the present invention provides a nutritional supplement in a powder form having per 100 g powder: 21-36 g Calcium, 425-770 mg Zinc, 53-92 mg Copper, 17-183 mg Manganese, and 260-550 mcg Vitamin D3. In addition, the supplement contains 30 mg Arg and 15 mg Lys.

[0028] The following Table 1 evidences the characteristics of the supplement disclosed in this embodiment:

TABLE-US-00001 TABLE 1 Assay Ranges Element Label Claim Per 100 g Per 1.4 g Capsule Specification Calcium 400 mg 21 g-36 g 294 mg-504 mg 73.5%-126.0% Zinc 8 mg 425 mg-770mg 5.95 mg-10.78 mg 74.4%-134.7% Copper 1 mg 53 mg-92 mg 0.742 mg-1.28 mg 74.2%-128.0% Manganese 2 mg 107 mg-183 mg 1.50 mg-2.56 mg 75.0%-128.0% Vitamin D3 (5 mcg) 200 IU 260 mcg-550 mcg 3.64 mcg-7.7 mcg 73.0%-154.0% Amino Acids* 270 mg NLT 15 g NLT 210 mg NLT 77.8% Arginine* 30 mg Not Tested Lysine* 15 mg Not Tested

[0029] The following Table 2 describes the inventive nutritional supplement comprising of a 1400 mg capsule for oral administration:

TABLE-US-00002 TABLE 2 Description Potency Overage Active/1 RMA/1 Calcium (Aspartate) 13% 3% 2.36 mg 18.715 mg Calcium (Dicalcium Phosphate) 29% 3% 32.34 mg 114.966 mg Calcium (Carbonate) 40% 3% 333.96 mg 860.722 mg Calcium (Glycinate) 17% 3% 29.49 mg 178.836 mg Calcium (Arginate) 10% 3% 0.949 mg 9.784 mg Calcium (Lysinate) 11% 3% 0.901 mg 8.444 mg Zinc (Glycinate) 10% 3% 8 mg 82.474 mg Copper (Glycinate) 8% 3% 1 mg 12.887 mg Manganese (Glycinate) 18% 3% 2 mg 11.455 mg Vitamin D-3 (Cholecalciferol) 100 IU/mg 10% 200 IU 2.222 mg L-Arginine Base 99% 3% 30 mg 31.240 mg L-Lysine (HCl) 80% 3% 15 mg 19.330 mg Magnesium Stearate 15.000 mg Rice Protein Concentra 33.925 mg 1400.000 mg Total Calcium 400 mg Total Zinc 8 mg Total Copper 1 mg Total Manganese 2 mg Total Vitamin D-3 200 IU

[0030] The nutritional compositions of the invention may provide minimal, partial, or total nutritional support. In preferred exemplary embodiments, the supplement is administered in conjunction with a food or other nutritional composition. In these embodiments, the compositions can either be intermixed with the food or other nutritional compositions prior to ingestion by the subject or can be administered to the subject either before or after ingestion of the food or other nutritional composition.

[0031] The supplement may, but need not, be nutritionally complete. The skilled artisan will recognize nutritionally complete to vary depending on a number of factors including, but not limited to, age, clinical condition, and dietary intake of the subject to whom the term is being applied. In general, nutritionally complete means that the nutritional supplement of the present invention provides adequate amounts of all carbohydrates, lipids, essential fatty acids, proteins, essential amino acids, conditionally essential amino acids, vitamins, minerals, and energy required for normal maintenance. As applied to nutrients, the term essential refers to any nutrient which cannot be synthesized by the body in amounts sufficient for normal growth and to maintain health and which therefore must be supplied by the diet. The term conditionally essential as applied to nutrients means that the nutrient must be supplied by the diet under conditions when adequate amounts of the precursor compound is unavailable to the body for endogenous synthesis to occur. The nutritional supplement may be provided in any form known in the art, including a powder, a suspension, a paste, a pudding, a solid, a liquid, a liquid concentrate, or a ready-to-use product. According to certain exemplary embodiment, the nutritional supplement is in a form of a powder.

[0032] The increased Ca bioavailability of the inventive nutritional supplement is demonstrated as follows:

[0033] Several hundreds of subjects were dosed using the nutritional supplements of the present invention in order to determine the effects. The following examples results are included to further describe the present invention and are not intended to limit the scope of the invention to the embodiment of the nutritional supplement in the specific examples. The example results utilize subjects ranging from fifty to seventy-five years of age. In the example results below, the subjects were prescribed the specified dosage of the nutritional supplement described in the invention.

[0034] Your bone density test results are reported using T-scores. A T-score shows how much your bone density is higher or lower than the bone density of a healthy 30-year old adult. A healthcare provider looks at the lowest T-score to diagnosis osteoporosis. Dual energy X-ray absorptiometry (DEXA) is used to determine the condition of the bone, and expressed in T value.

[0035] According to the World Health Organization (WHO): A T-score of 1.0 or above is normal bone density. Examples are 0.9, 0 and 0.9. A T-score between 1.0 and 2.5 means you have low bone density or osteopenia. Examples are T-scores of 1.1, 1.6 and 2.4. A T-score of 2.5 or below is a diagnosis of osteoporosis. Examples are T-scores of 2.6, 3.3 and 3.9. The lower a person's T-score, the lower the bone density. A T-score of 1.0 is lower than a T-score of 0.5 and a T-score of 3.5 is lower than a T-score of 3.0.

Example 1

[0036] A sixty-five year old male subject, diagnosed with osteoporosis, took commercially available calcium supplements at the time of diagnosis. A bone scan taken initially showed that the T-score value of the subject was 2.4. After six months of taking the traditional commercially available calcium supplements, the T-score value showed that the condition of the bone density had very little improvement.

[0037] Subsequently, the subject was dosed with the nutritional supplement of the present invention, taking 2 capsules daily. Each capsule contained 1.4 g, by weight, of the nutritional supplement. In particular, each capsule contained (represented by elements): 2.36 mg Calcium (Aspartate), 32.34 mg Calcium (Dicalcium Phosphate), 333.96 mg Calcium (Carbonate), 29.49 mg Calcium (Glycinate), 0.949 mg Calcium (Arginate), 0.901 mg Calcium (Lysinate), 8 mg Zinc (Glycinate), 1 mg Copper (Glycinate), 2 mg Manganese (Glycinate), 200 IU Vitamin D3 (Cholecalcifrol), 30 mg L-Arginine Base, 15 mg L-Lysine (HCl), as well as 15.000 mg Magnesium Stearate, and 33.925 mg Rice Protein Concentrate. The Element Calcium in each capsule was 400 mg in total. Six months later, a bone scan was performed, and the T-score value had improved to 1.9. A year later, another bone scan was performed, and the T-score value had improved to 1.1. No side effects such as bloating, constipation, etc., were observed.

Example 2

[0038] A fifty-four year old female subject was diagnosed with calcium deficiency. An initial bone scan taken showed that the score value of the subject was 1.3. Then the subject began dosage with the nutritional supplement of the present invention, taking 2 capsules daily with her meals. In particular, each capsule contained (represented by elements): 1.73 mg Calcium (Aspartate), 23.77 mg Calcium (Dicalcium Phosphate), 245.46 mg Calcium (Carbonate), 21.68 mg Calcium (Glycinate), 0.698 mg Calcium (Arginate), 0.662 mg Calcium (Lysinate), 5.95 mg Zinc (Glycinate), 0.74 mg Copper (Glycinate), 1.5 mg Manganese (Glycinate), 146IU Vitamin D3 (Cholecalcifrol), 30 mg L-Arginine Base, and 15 mg L-Lysine (HCl). The Element Calcium in each capsule was 294 mg in total. Six months later, a bone scan taken showed her T-score value improved to 0.8. No side effects such as bloating, constipation, etc., were observed.

Example 3

[0039] A seventy-five year old female subject had injured her thoracic vertebra when she stumbled and fell. She was diagnosed with osteoporosis and a bone scan taken showed that the T-score value of the subject was 2.5. Additionally, she occasionally suffered from thoracic and lumbar pain during that time.

[0040] She was dosed with the nutritional supplement of the invention while receiving treatment for her injuries. Her dosage was two capsules daily with her meals. Each capsule was 1.8 g in weight. In particular, the capsule contains (represented by elements): 2.97 mg Calcium (Aspartate), 40.75 mg Calcium (Dicalcium Phosphate), 420.79 mg Calcium (Carbonate), 37.16 mg Calcium (Glycinate), 1.20 mg Calcium (Arginate), 1.14 mg Calcium (Lysinate), 10.78 mg Zinc (Glycinate), 1.28 mg Copper (Glycinate), 2.56 mg Manganese (Glycinate), 272 IU Vitamin D3 (Cholecalcifrol), 34 mg L-Arginine Base, and 17 mg L-Lysine (HCl). The Element Calcium in each capsule was 504 mg in total. During this period, other drugs prescribed to the subject were not excluded. After six months, a subsequent bone scan was taken showed her T-score value improved to 2.2. Additionally, the occurrence of pain for the subject was also reduced. A year later, the T-score value from the bone scan was 1.7.

Example 4

[0041] A seventy year old male subject was diagnosed with calcium deficiency. An initial bone scan taken showed that the T-score value of the subject was 1.8. Then he began dosage of the nutritional supplement of the present invention, taking 2 capsules daily with his meals. In particular, each capsule contained (represented by elements): 2.07 mg Calcium (Aspartate), 28.30 mg Calcium (Dicalcium Phosphate), 292.22 mg Calcium (Carbonate), 25.80 mg Calcium (Glycinate), 0.83 mg Calcium (Arginate), 0.79 mg Calcium (Lysinate), 6.98 mg Zinc (Glycinate), 0.87 mg Copper (Glycinate), 1.75 mg Manganese (Glycinate), 254 IU Vitamin D3 (Cholecalcifrol), 30 mg L-Arginine Base, and 15 mg L-Lysine (HCl). The Element Calcium in each capsule was 350 mg in total. Six months later, a bone scan taken showed a T-score value of 1.3. A year later, a bone scan taken showed a T-score value of 1. No side effects such as bloating, constipation, etc., were observed.

[0042] These example results support the conclusion that the nutritional supplements of the present invention significantly increase calcium absorption and improvement of bone density. As such, the unique combination disclosed in the present invention improves absorption over typical calcium supplement.

[0043] Although particular embodiments have been described in detail herein, it is to be understood that the invention is not limited to those particular embodiments, and that various changes and modifications may be effected therein by a skilled in the art without departing from the scope or spirit of the invention as defined in the appended claims.