# US 11,759,477 B2 · Compositions of nitrates and methods of use thereof

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 11,759,477 B2
- Document ID: US11759477B2
- Status: Granted
- Kind: B2
- Application number: 17/690,611
- Filed: 2022-03-09
- Published: 2022-06-23
- Granted: 2023-09-19
- Earliest claimed: 2007-02-26
- Assignees: Heartbeet Ltd.
- Applicants: Heartbeet Ltd.
- Inventors: Jon Lundberg; Eddie Weitzberg
- Web page: https://patentgrep.com/patent/US11759477B2

## CPC

- A61K 33/00: Medicinal preparations containing inorganic active ingredients
- A23L 2/02: containing fruit or vegetable juices
- A23L 2/52: Adding ingredients (adding preservatives A23B70/10)
- A23L 33/105: Plant extracts, their artificial duplicates or their derivatives
- A23L 33/135: Bacteria or derivatives thereof, e.g. probiotics
- A23L 33/16: Inorganic salts, minerals or trace elements
- A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- A61K 9/0095: {Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006)}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00)
- A61K 31/375: Ascorbic acid, i.e. vitamin C; Salts thereof
- A61K 33/14: Alkali metal chlorides; Alkaline earth metal chlorides
- A61K 33/30: Zinc; Compounds thereof
- A61K 36/185: Magnoliopsida (dicotyledons)
- A61K 36/21: Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
- A61K 36/235: Foeniculum (fennel)
- A61K 36/28: Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K 36/31: Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
- A61K 36/5777: {Theobroma, e.g. cocao or cocoa}
- A61K 36/742: {Coffea, e.g. coffee}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 9/12: Antihypertensives
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
- C01D 9/00: Nitrates of sodium, potassium or alkali metals in general {(preparation as fertilizers or of fertilizers containing them C05D5/00)}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- C01D: COMPOUNDS OF ALKALI METALS, i.e. LITHIUM, SODIUM, POTASSIUM, RUBIDIUM, CAESIUM, OR FRANCIUM (metal hydrides {monoborane, diborane or addition complexes thereof} C01B6/00; salts of oxyacids of halogens C01B11/00; peroxides, salts of peroxyacids C01B15/00; sulfides C01B17/22; thiosulfates, dithionites, polythionates C01B17/64; compounds containing selenium or tellurium C01B19/00; binary compounds of nitrogen with metals C01B21/06; azides C01B21/08; {compounds other than ammonia and cyanogen, containing nitrogen and other non-metals C01B21/082}; metal amides C01B21/092; nitrites C01B21/50; phosphides C01B21/50; {compounds of noble gases C01B23/0005}; phosphides C01B25/08; salts of oxyacids of phosphorus C01B25/16; carbides C01B32/90; compounds containing silicon C01B33/00; compounds containing boron C01B35/00; cyanides C01C3/08; salts of cyanic acid C01C3/14; salts of cyanamide C01C3/16; thiocyanates C01C3/20)

## Abstract

Inorganic anions nitrate and nitrite influence metabolic rate and glucose homeostasis. Infusion of nitrite iv caused an acute drop in resting energy expenditure (oxygen consumption) and nitrate, when given perorally, caused a reduction in oxygen consumption during exercise and a depression of the increase in blood glucose observed after an oral glucose tolerance test. The doses of nitrate and nitrite did not cause any detectable change in methemoglobin levels of blood. Also, nitrate and nitrite did not alter lactate levels in blood. This discovery provides useful treatments to regulate the energy expenditure and glucose homeostasis of a mammal by administration of inorganic nitrite and/or nitrate.

## Claims

### Claim 1

A nutritional supplement or a nutritional food composition comprising a botanical source of inorganic nitrate and a nitrite salt, wherein the nitrate from said botanical nitrate source and the amount of said nitrite salt is in a molar ratio of about 5:1 to 100:1, wherein one dose of the composition provides said nitrite salt in an amount of about 3 mg to 4 g.

### Claim 2 (depends on 1)

The nutritional supplement or a nutritional food composition according to claim 1, wherein the molar ratio of the amount of nitrate from said botanical source of nitrate to the amount of said nitrite salt is about 10:1.

### Claim 3 (depends on 1)

The nutritional supplement or a nutritional food composition according to claim 1, wherein said botanical source of nitrate is selected from a concentrate or an extract of a nitrate containing plant, vegetable, or fruit.

### Claim 4 (depends on 3)

The nutritional supplement or a nutritional food composition according to claim 3, wherein said nitrate concentrate or extract is prepared from a vegetable chosen from spinach, beet root, fennel, lettuce, cabbage, and Chinese cabbage.

### Claim 5 (depends on 1)

The nutritional supplement or a nutritional food composition according to claim 1, wherein said composition is in the form of a lozenge.

### Claim 6

The nutritional supplement or a nutritional food composition according to 1, wherein said composition is in the form of, or constitutes a part of, a food product.

### Claim 7 (depends on 1)

The nutritional supplement or a nutritional food composition according to claim 1, wherein said nitrite salt is an inorganic nitrite salt selected from sodium, potassium, calcium, zinc, arginine, and ammonium salts of nitrite.

### Claim 8 (depends on 1)

The nutritional supplement or a nutritional food composition according to claim 1, wherein said composition further comprises one or more additives selected from natural and artificial flavours, sweeteners, salt, flavour enhancers, colour additives, emulsifiers, stabilizers, fats, and preservatives.

### Claim 9

A supplement or nutritional food composition comprising inorganic nitrate and inorganic nitrite in a molar ratio of about 5:1 to 100:1, and a nitrite-reduction enhancing compound, wherein said inorganic nitrate is selected from a concentrate or an extract of a nitrate containing plant, vegetable, or fruit, said inorganic nitrite is provided as a salt, and one dose of the composition provides said inorganic nitrite is an amount of about 3 mg to 4 g.

### Claim 10 (depends on 9)

The nutritional supplement or a nutritional food composition according to claim 9, wherein the ratio of said inorganic nitrate to said inorganic nitrite is about 10:1.

### Claim 11 (depends on 9)

The nutritional supplement or a nutritional food composition according to claim 9, wherein said nitrite-reduction enhancing compound is provided as a polyphenol or non-pathogenic bacteria.

### Claim 12 (depends on 9)

The nutritional supplement or a nutritional food composition according to claim 9, wherein said nitrate concentrate or extract is prepared from a vegetable chosen from spinach, beet root, fennel, lettuce, cabbage, and Chinese cabbage.

### Claim 13 (depends on 9)

The nutritional supplement or a nutritional food composition according to claim 9, wherein said composition is in the form of a lozenge.

### Claim 14 (depends on 9)

The nutritional supplement or a nutritional food composition according to claim 9, wherein said composition is in the form of, or constitutes a part of, a food product.

### Claim 15 (depends on 9)

The nutritional supplement or a nutritional food composition according to claim 9, wherein said inorganic nitrite is selected from sodium, potassium, calcium, zinc, arginine, and ammonium salts of nitrite.

### Claim 16 (depends on 9)

The nutritional supplement or a nutritional food composition according to claim 9, wherein said composition further comprises one or more additives selected from natural and artificial flavours, sweeteners, salt, enhancers, colour additives, emulsifiers, stabilizers, fats, and preservatives.

### Claim 17

A supplement or nutritional food composition comprising inorganic nitrate and inorganic nitrite in a molar ratio of about 5:1 to 100:1 nitrate to nitrite, a nitrite-reduction enhancing compound, and a source of polyphenols, wherein said inorganic nitrate is provided as a botanical source of nitrate, and said inorganic nitrite is provided as a salt and one dose of the composition provides said inorganic nitrite in an amount of about 3 mg to 4 g.

### Claim 18 (depends on 17)

The nutritional supplement or a nutritional food composition according to claim 17, wherein the ratio of said inorganic nitrate to said inorganic nitrite is about 10:1.

### Claim 19 (depends on 18)

The nutritional supplement or a nutritional food composition according to claim 18, wherein said botanical source of nitrate is selected from a concentrate or an extract of a nitrate containing plant, vegetable, or fruit.

### Claim 20 (depends on 17)

The nutritional supplement or a nutritional food composition according to claim 17, wherein said nitrate concentrate or extract is prepared from a vegetable chosen from spinach, beet root, fennel, lettuce, cabbage, and Chinese cabbage.

### Claim 21 (depends on 17)

The nutritional supplement or a nutritional food composition according to claim 17, wherein said source of polyphenols provides a polyphenol that is the nitrite-reduction enhancing compound.

### Claim 22 (depends on 17)

The nutritional supplement or a nutritional food composition according to claim 17, wherein said source of polyphenols is selected from apple, pear, grapes, lemon, orange, lime, peach, pomegranate, grapefruit, kiwi, ginger, pineapple, blackberries, black raspberries, blueberries, cranberries, red raspberries, cherries, bog whortleberry, lingonberries, black elderberry, black chokeberry, black currant, blueberry, cloudberries, strawberries, carrots, chili, rhubarb, onions, cacao products, green or black tea, nuts, Yerba mate, and coffee.

### Claim 23 (depends on 17)

The nutritional supplement or a nutritional food composition according to claim 17, wherein said composition has the form of a liquid, a paste, a bar, a cake, a powder, a granulate, an effervescent tablet, a tablet, a capsule, a lozenge, a chewing gum, a fast melting tablet or wafer, a sublingual tablet or a spray.

### Claim 24 (depends on 17)

The nutritional supplement or a nutritional food composition according to claim 17, wherein said composition is in the form of a lozenge.

### Claim 25 (depends on 17)

The nutritional supplement or a nutritional food composition according to claim 17, wherein said composition is in the form of, or constitutes a part of, a food product.

### Claim 26 (depends on 17)

The nutritional supplement or a nutritional food composition according to claim 17, wherein said inorganic nitrite is selected from sodium, potassium, calcium, zinc, arginine, and ammonium salts of nitrate and/or nitrite.

### Claim 27 (depends on 17)

The nutritional supplement or a nutritional food composition according to claim 17, wherein said composition further comprises one or more additives selected from natural and artificial flavours, sweeteners, salt, flavour enhancers, colour additives, emulsifiers, stabilizers, fats, and preservatives.