Nutritional composition

Information

  • Patent Grant
  • 12029769
  • Patent Number
    12,029,769
  • Date Filed
    Monday, December 12, 2022
    2 years ago
  • Date Issued
    Tuesday, July 9, 2024
    5 months ago
  • Inventors
  • Original Assignees
    • (Tustin, CA, US)
  • Examiners
    • Kosson; Rosanne
    Agents
    • Fish IP Law, LLP
Abstract
The present invention provides nutritional compositions that are employed as oral supplementation to the human diet and methods for using such nutritional compositions. 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. Methods are provided that utilize specific combinations of selected forms selenium. chromium, and molybdenum in combination with fish oil.
Description
FIELD OF THE INVENTION

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.


BACKGROUND

The following description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.


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.


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.


SUMMARY OF THE INVENTION

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.


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.


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.


It is another objective of the present invention to provide for compositions that help prevent cancer.







DETAILED DESCRIPTION

The present invention teaches a combination of specific nutrients 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.


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: I 0.1371/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.


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 yeasts are Saccharomyces cerevisiae, Saccharomyces exiguous, Saccharomyces pastorianus, Saccharomyces boulardii, Saccharomyces bayanus, Saccharomyces eubayanus, Saccharomyces florentinus, Saccharomyces fragilis.


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 EPA/DHA 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 EPA/IDHA 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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


The amino acid arginine is important to include in the present invention. The preferred amount of arginine 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.


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.


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.


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.


The following examples are illustrative only and do not limit the invention in any fashion.


EXAMPLE 1















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



Arginine
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



Phosphorous
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 Protein
0.23
g



Calcium Caseinate
0.14
g



Soy Lecithin
0.1
g










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















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



Phosphorous
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 Protein
0.23
g



Calcium Caseinate
0.14
g



Soy Lecithin
0.1
g










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















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



Arginine
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 Protein
0.23
g



Calcium Caseinate
0.14
g



Soy Lecithin
0.1
g










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















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



Arginine
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



Phosphorous
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 Protein
0.23
g



Calcium Caseinate
0.14
g



Soy Lecithin
0.1
g










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















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



Arginine
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



Phosphorous
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 Protein
0.23
g



Calcium Caseinate
0.14
g



Soy Lecithin
0.1
g










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















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



Arginine
5.1
g



Taurine
3.2
g



Lysine
7.3
g



CoQ-10
50
mg



Biotin
2
mg



Calcium
200
mg



Iron
3
mg



Phosphorous
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










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.

Claims
  • 1. A method of treating cancer in an individual in need thereof, comprising: administering to the individual an effective amount of a nutritional supplement comprising: (a) 5 μg to 2,500 μg of selenium-containing yeast,(b) 0.5 mg to 1.5 g of fish oil, the fish oil having a combined EPA and DHA content of 10% to 90% and an EPA to DHA ratio between 1:5 and 5:1,(c) 500 IU to 10,000 IU of beta-carotene,(d) a milk protein,(e) a rice protein, and(f) inositol.
  • 2. The method of claim 1, wherein the fish oil has an EPA and DHA content of between 40% to 60%.
  • 3. The method of claim 1, wherein the fish oil has an EPA to DHA ratio of about 2:1.
  • 4. The method of claim 1, wherein the fish oil has an EPA to DHA ratio of about 3:2.
  • 5. The method of claim 1, wherein the nutritional supplement additionally comprises 5 mg to 1500 mg of a resveratrol-containing extract, the resveratrol containing extract comprising between 50% and 98% of resveratrol.
  • 6. The method of claim 1, wherein the nutritional supplement additionally comprises 25 μg to 1000 μg of folic acid.
  • 7. The method of claim 1, wherein the nutritional supplement additionally comprises one or more minerals, wherein the one or more minerals are selected from the group consisting of 0.65 μg to 4000 μg of zinc, 50 μg to 500 μg of chromium, and 2.5 μg to 1000 μg of molybdenum.
  • 8. The method of claim 1, wherein the nutritional supplement additionally comprises one or more amino acids, wherein the one or more amino acids are selected from the group consisting of 2.1 g to 250 g of glutamine, 0.71 g to 25 g of arginine, 1.1 g to 29 g of taurine, and 0.81 g to 48 g of lysine.
Parent Case Info

This application is a continuation of U.S. patent application Ser. No. 17/675,181, filed Feb. 18, 2022, a continuation of U.S. patent application Ser. No. 17/200,056, filed Mar. 12, 2021, which is a continuation of U.S. Pat. No. 10,946,052, filed May 15, 2020, which is a continuation of U.S. Pat. No. 10,653,733 filed Oct. 10, 2018, which is a continuation of U.S. Pat. No. 10,117,902, filed on Jul. 8, 2016, which is a divisional application of U.S. patent application Ser. No. 13/852,472, filed Mar. 28, 2013. These and all other referenced extrinsic materials are incorporated herein by reference in their entirety. Where a definition or use of a term in a reference that is incorporated by reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein is deemed to be controlling.

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Non-Patent Literature Citations (1)
Entry
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Related Publications (1)
Number Date Country
20230113424 A1 Apr 2023 US
Divisions (1)
Number Date Country
Parent 13852472 Mar 2013 US
Child 15205786 US
Continuations (5)
Number Date Country
Parent 17675181 Feb 2022 US
Child 18079155 US
Parent 17200056 Mar 2021 US
Child 17675181 US
Parent 16875805 May 2020 US
Child 17200056 US
Parent 16156990 Oct 2018 US
Child 16875805 US
Parent 15205786 Jul 2016 US
Child 16156990 US