Abstract:
The present invention provides nutritional compositions that are employed as oral supplementation to the human diet. The compositions of the present invention provide for supplementation to the diet of the cancer patient, as well as preventative dietary supplementation aimed at supporting the human immune system for those not currently suffering from cancer. The present invention is comprised of specific combinations of selected forms of unique sets of certain vitamins, minerals, protein, carbohydrates and phytochemicals.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This is a divisional patent application of U.S. Ser. No. 13/852,472, filed on Mar. 28, 2013, the entire contents of which is expressly incorporated herein by reference. 
     
    
     STATEMENT RE 
     Federally Sponsored Research/Development 
       [0002]    Not Applicable 
       BACKGROUND 
       [0003]    The present invention relates to nutritional compositions useful for increasing the efficacy of cancer therapies, including chemotherapy, radiation and target therapies; and more specifically to nutritional compositions to promote anti-tumor activity. 
         [0004]    Cancer is one of the most deadly diseases of all mankind. Preventing and treatment of cancer is, therefore, and extremely important endeavor for mankind to pursue. Much progress has been made over the last 50 years for the treatment of cancer, including chemotherapeutic, radiation and most recently, target therapies. A major shortcoming of these therapeutic treatments is their harmful effects to the human system since, in many cases, the practice of such therapies causes severe weight loss, hair loss, and in many cases, death. 
         [0005]    It is believed that one of the major causes of the ill-effects of cancer therapies is that they tax the human immune system. A healthy and potent human immune system is very important to combat the ill-effects of the cancer therapies. The present invention overcomes the shortcomings of the art of cancer therapy by providing compositions that work together to enhance the immune system such that the health of the cancer patient is not compromised by the harsh effects of the cancer therapies, and as a result, can overcome such effects, resulting in more efficient cancer remedial therapeutic treatments. 
       BRIEF SUMMARY 
       [0006]    The present invention provides nutritional compositions that are employed as oral supplementation to the human diet. The compositions of the present invention provide for supplementation to the diet of the cancer patient, as well as preventative dietary supplementation aimed at supporting the human immune system for those not currently suffering from cancer. 
         [0007]    It is a prime objective of the present invention to provide nutritive compositions that when used in combination with radiation, target or chemotherapy, provide for an increased activity in combating neoplastic growth. 
         [0008]    It is another objective of the present invention to provide for anti-neoplastic effects by dietary supplementation utilizing specific forms of nutrients such as selenium yeast and fish oil. 
         [0009]    It is another objective of the present invention to provide for compositions that help prevent cancer. 
     
    
     DETAILED DESCRIPTION 
       [0010]    The present invention teaches a combination of specific nutritients suitable for oral consumption by the human body. The compositions of the present invention when orally ingested on a daily basis, in combination with or without therapeutic treatments for cancer, specifically chemotherapy, target therapy and radiation therapy, work in a synergistic fashion together to aid the cancer patient in eliminating the cancer, healing of the cancer and recovery from the cancer. The compositions of the present invention may also be ingested on a daily, or periodic basis to help prevent cancer. 
         [0011]    Although the mechanism of action of the compositions of the present invention are not well understood, many cases have been reported of cancer patients benefiting from the use of the present invention in combination with the therapeutic treatments for cancer. It is believed that the key ingredients of the present invention work synergistically together to aid in the anti-neoplastic processes. The recent publication entitled “Reduction of Splenic Immunosuppressive Cells and Enhancement of Anti-Tumor Immunity by Synergy of Fish Oil and Selenium Yeast” (Wang h, Chan Y-L, et al. (2013) PLoS ONE 8(1): e52912.Dol:10.1371/journal.pone.005912) provides evidence that indeed the compositions of the present invention provide said synergistic action, and also that the compositions taught by the present invention are novel and useful for the prevention and treatment of cancer. 
         [0012]    These compositions include as preferred embodiment selenium. The preferred form of selenium is selenium yeast. The preferred amount of selenium yeast is from about 5 mcg to about 500 mcg, and more preferred between about 10 mcg to about 250 mcg, and most preferably from between 25 mcg to about 150 mcg. The preferred selenium yeast are  Saccharomyces cerevisiae, Saccharomyces exiguous, Saccharomyces pastorianus, Saccharomyces boulardii, Saccharomyces bayanus, Saccharomyces eubayanus, Saccharomyces florentinus, Saccharomyces fragilis.    
         [0013]    Another essential ingredient of the present invention is fish oil. The preferred fish oil has an EDA/DHA ratio of from between 1 part EPA to about 5 parts DHA, and from between 5 parts EPA to 1 part DHA, and more preferably from about 2 parts EPA to 1 part DHA, and most preferably from about 3 parts EPA to about 2 parts DHA. The EPAIDHA content of the fish oil preparations of the present invention are from between 10% to about 90%, more preferably from between 30% to about 70% and most preferably from about 40% to about 60%. The preferred amounts of fish oil EPAIDHA preparation of the present invention is from 0.50 mg to about 1.5 g, and more preferably between 250 mg to about 1000 mg, and most preferably between 350 mg to about 750 mg. 
         [0014]    Another essential component of the present invention is Beta Carotene. The preferred form of beta carotene is the naturally occurring form. The preferred amount is between 500 iu and 10,000 iu, and more preferably between 1500 iu and 7500 iu, and most preferably between about 1000 iu and 3000 iu. 
         [0015]    Resverotrol is another important nutrient of the present invention. The preferred form of Resverotrol is from plan extract. The preferred amount of Resverotrol in the extract is from between 50% to about 98%, and most preferably about 95%. The preferred amount of Resverotrol extract to be employed in the present invention is from about 5 mg to about 1500 mg, and more preferably from about 50 mg to about 300 mg, and most preferably from about 75 mg to about 150 mg. 
         [0016]    Additionally, Vitamin D3 may be added to the nutritional compositions of the present invention. The preferred form of Vitamin D3 is Cholecalciferol. The preferred amount of Vitamin D3 is from between 50 iu and 3000 iu, and more preferably between from about 70 iu to about 500 iu, and most preferably from about 100 iu to about 250 iu. 
         [0017]    Another prime nutrient that may be included in the embodiments of the present invention is Vitamin K. The preferred form of Vitamin K is Phytonadione. The preferred amount of Vitamin K is between 2.5 mcg to about 250 mcg, more preferably from between 15 mcg to about 100 mcg, and most preferably between 20 mcg to about 75 mcg. 
         [0018]    Another nutrient important to the efficacy of the present invention is Vitamin B6. The preferred form of Vitamin B6 is Pyridoxine hydrochloride. The preferred amount is between 0.1 mg to about 100 mg, most preferably between about 0.5 mg to about 25 mg, and most preferably from about 0.75 mg to about 10 mg. 
         [0019]    Additionally, Vitamin B12 may be included in the present invention. The preferred form of Vitamin B12 is Cyanocobalamin. The preferred amount of Vitamin B12 is between about 0.3 mcg to about 900 mcg, most preferably between about 0.75 mcg to about 50 mcg, and most preferably between 1 mcg and 10 mcg. 
         [0020]    Another nutrient that is important to the present invention is Folic Acid. The preferred amount of Folic Acid is between about 25 mcg to about 1000 mcg, most preferably between about 100 mcg to about 750 mcg, and most preferably between 200 mcg and 400 mcg. 
         [0021]    The mineral Zinc is important to include in the present invention. The preferred amount of Zinc is between about 0.65 mcg to about 4000 mcg, most preferably between about 1 mcg to about 400 mcg, and most preferably between 3 mcg and 50 mcg. 
         [0022]    The mineral Chromium is important to include in the present invention. The preferred form of Chromium is from yeast. The preferred amount of Chromium is between about 30 mcg to about 3000 mcg, most preferably between about 50 mcg to about 500 mcg, and most preferably between 25 mcg and 100 mcg. 
         [0023]    The mineral Molybdenum is important to include in the present invention. The preferred form of Molybdenum is from yeast. The preferred amount of Molybdenum is between about 2.5 mcg to about 1000 mcg, most preferably between about 10 mcg to about 130 mcg, and most preferably between 15 mcg and 60 mcg. 
         [0024]    The amino acid glutamine is important to include in the present invention. The preferred amount of glutamine is between about 2.1 g to about 250 g, most preferably between about 11 g to about 135 g, and most preferably between 10 g and 50 g. 
         [0025]    The amino acid arginine is important to include in the present invention. The preferred amount of argenine is between about 0.71 g to about 25 g, most preferably between about 3.0 g to about 15 g, and most preferably between 5 g and 13 g. 
         [0026]    The amino acid taurine is important to include in the present invention. The preferred amount of taurine is between about 1.1 g to about 29 g, most preferably between about 2.3 g to about 15 g, and most preferably between 3 g and 11 g. 
         [0027]    The amino acid lysine is important to include in the present invention. The preferred amount of taurine is between about 0.81 g to about 49 g, most preferably between about 5.3 g to about 35 g, and most preferably between 6 g and 18 g. 
         [0028]    Another important nutrient is Coenzyme Q-10. The preferred amount of Coenzyme Q-10 is from about 30 mg to about 1000 mg, most preferably from between about 50 mg to 300 mg, and most preferably between about 60 mg to about 180 mg. 
         [0029]    The following examples are illustrative only and do not limit the invention in any fashion. 
       Example 1 
       [0030]      
         [0000]    
       
         
               
               
               
             
               
               
               
               
             
           
               
                   
                   
               
               
                   
                 Ingredient 
                 Amount 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Fish Oil 
                 70 
                 mg 
               
               
                   
                 Selenium (from Selenium yeast) 
                 2500 
                 mcg 
               
               
                   
                 Beta Carotene 
                 1000 
                 iu 
               
               
                   
                 Vitamin D3 
                 100 
                 iu 
               
               
                   
                 Vitamin K 
                 15 
                 mcg 
               
               
                   
                 Vitamin B6 
                 0.5 
                 mg 
               
               
                   
                 Vitamin B12 
                 1 
                 mcg 
               
               
                   
                 Folic Acid 
                 250 
                 mcg 
               
               
                   
                 Zinc 
                 5.0 
                 mg 
               
               
                   
                 Chromium 
                 25 
                 mcg 
               
               
                   
                 Molybdenum 
                 15 
                 mcg 
               
               
                   
                 Glutamine 
                 20 
                 g 
               
               
                   
                 Argenine 
                 5.1 
                 g 
               
               
                   
                 Taurine 
                 3.2 
                 g 
               
               
                   
                 Lysine 
                 7.3 
                 g 
               
               
                   
                 CoQ-10 
                 50 
                 mg 
               
               
                   
                 Niacin 
                 2.1 
                 mg 
               
               
                   
                 Riboflavin 
                 600 
                 mcg 
               
               
                   
                 Thiamin 
                 530 
                 mcg 
               
               
                   
                 Biotin 
                 2 
                 mg 
               
               
                   
                 Calcium 
                 200 
                 mg 
               
               
                   
                 Iron 
                 3 
                 mg 
               
               
                   
                 Phosphourous 
                 213 
                 mg 
               
               
                   
                 Iodine 
                 35 
                 mg 
               
               
                   
                 Copper 
                 500 
                 mcg 
               
               
                   
                 Manganese 
                 570 
                 mcg 
               
               
                   
                 Inositol 
                 1.2 
                 g 
               
               
                   
                 Sucrose 
                 3.5 
                 g 
               
               
                   
                 Whey Protein Isolate 
                 0.75 
                 g 
               
               
                   
                 Non-Fat Milk 
                 0.2 
                 g 
               
               
                   
                 Rice Protien 
                 0.23 
                 g 
               
               
                   
                 Calcium Caseinate 
                 0.14 
                 g 
               
               
                   
                 Soy Lecithin 
                 0.1 
                 g 
               
               
                   
                   
               
             
          
         
       
     
         [0031]    The above ingredients were admixed and shaken until homogeneous blend was obtained. The blended composition was poured into 250 mL of water, mixed and then consumed via drinking. 
       Example 2 
       [0032]      
         [0000]    
       
         
               
               
               
             
               
               
               
               
             
           
               
                   
                   
               
               
                   
                 Ingredient 
                 Amount 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Fish Oil 
                 70 
                 mg 
               
               
                   
                 Selenium (from Selenium yeast) 
                 2500 
                 mcg 
               
               
                   
                 Beta Carotene 
                 1000 
                 iu 
               
               
                   
                 Vitamin D3 
                 100 
                 iu 
               
               
                   
                 Vitamin K 
                 15 
                 mcg 
               
               
                   
                 Vitamin B6 
                 0.5 
                 mg 
               
               
                   
                 Vitamin B12 
                 1 
                 mcg 
               
               
                   
                 Folic Acid 
                 250 
                 mcg 
               
               
                   
                 Iron 
                 3 
                 mg 
               
               
                   
                 Phosphourous 
                 213 
                 mg 
               
               
                   
                 Iodine 
                 35 
                 mg 
               
               
                   
                 Copper 
                 500 
                 mcg 
               
               
                   
                 Manganese 
                 570 
                 mcg 
               
               
                   
                 Inositol 
                 1.2 
                 g 
               
               
                   
                 Sucrose 
                 3.5 
                 g 
               
               
                   
                 Whey Protein Isolate 
                 0.75 
                 g 
               
               
                   
                 Non-Fat Milk 
                 0.2 
                 g 
               
               
                   
                 Rice Protien 
                 0.23 
                 g 
               
               
                   
                 Calcium Caseinate 
                 0.14 
                 g 
               
               
                   
                 Soy Lecithin 
                 0.1 
                 g 
               
               
                   
                   
               
             
          
         
       
     
         [0033]    The above ingredients were admixed and shaken until homogeneous blend was obtained. The blended composition was poured into 250 mL of water, mixed and then consumed via drinking. 
       Example 3 
       [0034]      
         [0000]    
       
         
               
               
               
             
               
               
               
               
             
           
               
                   
                   
               
               
                   
                 Ingredient 
                 Amount 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Fish Oil 
                 90 
                 mg 
               
               
                   
                 Selenium (from Selenium yeast) 
                 2540 
                 mcg 
               
               
                   
                 Beta Carotene 
                 1300 
                 iu 
               
               
                   
                 Vitamin D3 
                 80 
                 iu 
               
               
                   
                 Vitamin K 
                 15 
                 mcg 
               
               
                   
                 Vitamin B6 
                 0.5 
                 mg 
               
               
                   
                 Vitamin B12 
                 1 
                 mcg 
               
               
                   
                 Folic Acid 
                 250 
                 mcg 
               
               
                   
                 Zinc 
                 3.0 
                 mg 
               
               
                   
                 Chromium 
                 25 
                 mcg 
               
               
                   
                 Molybdenum 
                 25 
                 mcg 
               
               
                   
                 Glutamine 
                 29 
                 g 
               
               
                   
                 Argenine 
                 7.1 
                 g 
               
               
                   
                 Taurine 
                 3.2 
                 g 
               
               
                   
                 Lysine 
                 7.6 
                 g 
               
               
                   
                 CoQ-10 
                 100 
                 mg 
               
               
                   
                 Manganese 
                 570 
                 mcg 
               
               
                   
                 Inositol 
                 2.7 
                 g 
               
               
                   
                 Sucrose 
                 3.5 
                 g 
               
               
                   
                 Whey Protein Isolate 
                 0.75 
                 g 
               
               
                   
                 Non-Fat Milk 
                 0.2 
                 g 
               
               
                   
                 Rice Protien 
                 0.23 
                 g 
               
               
                   
                 Calcium Caseinate 
                 0.14 
                 g 
               
               
                   
                 Soy Lecithin 
                 0.1 
                 g 
               
               
                   
                   
               
             
          
         
       
     
         [0035]    The above ingredients were admixed and shaken until homogeneous blend was obtained. The blended composition was poured into 250 mL of water, mixed and then consumed via drinking. 
       Example 4 
       [0036]      
         [0000]    
       
         
               
               
               
             
               
               
               
               
             
           
               
                   
                   
               
               
                   
                 Ingredient 
                 Amount 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Fish Oil 
                 110 
                 mg 
               
               
                   
                 Selenium (from Selenium yeast) 
                 1500 
                 mcg 
               
               
                   
                 Beta Carotene 
                 200 
                 iu 
               
               
                   
                 Vitamin D3 
                 100 
                 iu 
               
               
                   
                 Vitamin K 
                 15 
                 mcg 
               
               
                   
                 Vitamin B6 
                 0.5 
                 mg 
               
               
                   
                 Vitamin B12 
                 1 
                 mcg 
               
               
                   
                 Folic Acid 
                 250 
                 mcg 
               
               
                   
                 Zinc 
                 5.0 
                 mg 
               
               
                   
                 Chromium 
                 25 
                 mcg 
               
               
                   
                 Molybdenum 
                 15 
                 mcg 
               
               
                   
                 Glutamine 
                 20 
                 g 
               
               
                   
                 Argenine 
                 5.1 
                 g 
               
               
                   
                 Taurine 
                 3.2 
                 g 
               
               
                   
                 Lysine 
                 7.3 
                 g 
               
               
                   
                 CoQ-10 
                 50 
                 mg 
               
               
                   
                 Niacin 
                 2.1 
                 mg 
               
               
                   
                 Riboflavin 
                 600 
                 mcg 
               
               
                   
                 Thiamin 
                 530 
                 mcg 
               
               
                   
                 Biotin 
                 2 
                 mg 
               
               
                   
                 Calcium 
                 200 
                 mg 
               
               
                   
                 Iron 
                 3 
                 mg 
               
               
                   
                 Phosphourous 
                 213 
                 mg 
               
               
                   
                 Iodine 
                 35 
                 mg 
               
               
                   
                 Copper 
                 500 
                 mcg 
               
               
                   
                 Manganese 
                 570 
                 mcg 
               
               
                   
                 Inositol 
                 1.2 
                 g 
               
               
                   
                 Sucrose 
                 3.5 
                 g 
               
               
                   
                 Whey Protein Isolate 
                 0.75 
                 g 
               
               
                   
                 Non-Fat Milk 
                 0.2 
                 g 
               
               
                   
                 Rice Protien 
                 0.23 
                 g 
               
               
                   
                 Calcium Caseinate 
                 0.14 
                 g 
               
               
                   
                 Soy Lecithin 
                 0.1 
                 g 
               
               
                   
                   
               
             
          
         
       
     
         [0037]    The above ingredients were admixed and shaken until homogeneous blend was obtained. The blended composition was poured into 250 mL of water, mixed and then consumed via drinking. 
       Example 5 
       [0038]      
         [0000]    
       
         
               
               
               
             
               
               
               
               
             
           
               
                   
                   
               
               
                   
                 Ingredient 
                 Amount 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Fish Oil 
                 90 
                 mg 
               
               
                   
                 Selenium (from Selenium yeast) 
                 1560 
                 mcg 
               
               
                   
                 Beta Carotene 
                 900 
                 iu 
               
               
                   
                 Vitamin D3 
                 92 
                 iu 
               
               
                   
                 Vitamin K 
                 23 
                 mcg 
               
               
                   
                 Vitamin B6 
                 5.5 
                 mg 
               
               
                   
                 Vitamin B12 
                 3 
                 mcg 
               
               
                   
                 Folic Acid 
                 250 
                 mcg 
               
               
                   
                 Zinc 
                 6.0 
                 mg 
               
               
                   
                 Chromium 
                 25 
                 mcg 
               
               
                   
                 Molybdenum 
                 15 
                 mcg 
               
               
                   
                 Glutamine 
                 23 
                 g 
               
               
                   
                 Argenine 
                 5.1 
                 g 
               
               
                   
                 Taurine 
                 2.2 
                 g 
               
               
                   
                 Lysine 
                 7.3 
                 g 
               
               
                   
                 CoQ-10 
                 50 
                 mg 
               
               
                   
                 Niacin 
                 2.1 
                 mg 
               
               
                   
                 Riboflavin 
                 600 
                 mcg 
               
               
                   
                 Thiamin 
                 530 
                 mcg 
               
               
                   
                 Biotin 
                 2 
                 mg 
               
               
                   
                 Calcium 
                 200 
                 mg 
               
               
                   
                 Iron 
                 3 
                 mg 
               
               
                   
                 Phosphourous 
                 213 
                 mg 
               
               
                   
                 Iodine 
                 35 
                 mg 
               
               
                   
                 Copper 
                 500 
                 mcg 
               
               
                   
                 Manganese 
                 570 
                 mcg 
               
               
                   
                 Inositol 
                 1.2 
                 g 
               
               
                   
                 Sucrose 
                 3.5 
                 g 
               
               
                   
                 Whey Protein Isolate 
                 0.75 
                 g 
               
               
                   
                 Non-Fat Milk 
                 0.2 
                 g 
               
               
                   
                 Rice Protien 
                 0.23 
                 g 
               
               
                   
                 Calcium Caseinate 
                 0.14 
                 g 
               
               
                   
                 Soy Lecithin 
                 0.1 
                 g 
               
               
                   
                   
               
             
          
         
       
     
         [0039]    The above ingredients were admixed and shaken until homogeneous blend was obtained. The blended composition was poured into 250 mL of water, mixed and then consumed via drinking. 
       Example 6 
       [0040]      
         [0000]    
       
         
               
               
               
             
               
               
               
               
             
           
               
                   
                   
               
               
                   
                 Ingredient 
                 Amount 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Fish Oil 
                 70 
                 mg 
               
               
                   
                 Selenium (from Selenium yeast) 
                 2500 
                 mcg 
               
               
                   
                 Beta Carotene 
                 1000 
                 iu 
               
               
                   
                 Vitamin D3 
                 100 
                 iu 
               
               
                   
                 Vitamin K 
                 15 
                 mcg 
               
               
                   
                 Vitamin B6 
                 0.5 
                 mg 
               
               
                   
                 Vitamin B12 
                 1 
                 mcg 
               
               
                   
                 Folic Acid 
                 250 
                 mcg 
               
               
                   
                 Zinc 
                 5.0 
                 mg 
               
               
                   
                 Chromium 
                 25 
                 mcg 
               
               
                   
                 Molybdenum 
                 15 
                 mcg 
               
               
                   
                 Glutamine 
                 20 
                 g 
               
               
                   
                 Argenine 
                 5.1 
                 g 
               
               
                   
                 Taurine 
                 3.2 
                 g 
               
               
                   
                 Lysine 
                 7.3 
                 g 
               
               
                   
                 CoQ-10 
                 50 
                 mg 
               
               
                   
                 Biotin 
                 2 
                 mg 
               
               
                   
                 Calcium 
                 200 
                 mg 
               
               
                   
                 Iron 
                 3 
                 mg 
               
               
                   
                 Phosphourous 
                 213 
                 mg 
               
               
                   
                 Iodine 
                 35 
                 mg 
               
               
                   
                 Copper 
                 500 
                 mcg 
               
               
                   
                 Manganese 
                 570 
                 mcg 
               
               
                   
                 Inositol 
                 1.2 
                 g 
               
               
                   
                 Sucrose 
                 3.5 
                 g 
               
               
                   
                 Whey Protein Isolate 
                 0.75 
                 g 
               
               
                   
                 Rice Protein 
                 0.23 
                 g 
               
               
                   
                 Calcium Caseinate 
                 0.14 
                 g 
               
               
                   
                 Soy Lecithin 
                 0.1 
                 g 
               
               
                   
                   
               
             
          
         
       
     
         [0041]    The above ingredients were admixed and shaken until homogeneous blend was obtained. The blended composition was poured into 250 mL of water, mixed and then consumed via drinking. 
         [0042]    The above description is given by way of example, and not limitation. Given the above disclosure, one skilled in the art could devise variations that are within the scope and spirit of the invention disclosed herein. Further, the various features of the embodiments disclosed herein can be used alone, or in varying combinations with each other and are not intended to be limited to the specific combination described herein. Thus, the scope of the claims is not to be limited by the illustrated embodiments.