# US 11,026,962 B2 · Betalain compositions and methods therefor

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- Number: US 11,026,962 B2
- Document ID: US11026962B2
- Status: Granted
- Kind: B2
- Application number: 16/712,124
- Filed: 2019-12-12
- Published: 2020-04-16
- Granted: 2021-06-08
- Earliest claimed: 2008-07-30
- Assignees: VDF Futureceuticals, Inc.
- Applicants: Vdf Futureceuticals, Inc.
- Inventors: Zbigniew Pietrzkowski
- Web page: https://patentgrep.com/patent/US11026962B2

## CPC

- A61K 31/706: containing six-membered rings with nitrogen as a ring hetero atom
- A23L 5/43: using naturally occurring organic dyes or pigments, their artificial duplicates or their derivatives
- A23L 33/105: Plant extracts, their artificial duplicates or their derivatives
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 31/7056: containing five-membered rings with nitrogen as a ring hetero atom
- A61K 36/21: Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 11/02: Nasal agents, e.g. decongestants
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/10: Anti-acne agents
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/20: Hypnotics; Sedatives
- A61P 25/22: Anxiolytics
- A61P 27/16: Otologicals
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- 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

## Abstract

Contemplated compositions and methods employ betalains for treatment of various conditions, and especially osteoarthritis, sinusitis, contact dermatitis, acne, an allergic condition, reduced mental alertness, reduced physical strength, reduced physical endurance, and/or impaired mood.

## Claims

### Claim 1

A method of reducing joint pain in an individual, comprising:
administering or providing for administration a dehydrated complex betalain mixture comprising a plurality of distinct betalains from a starting material, wherein the distinct betalains have a near natural composition and are present in the mixture at a total betalain concentration of at least 4 wt %;
wherein the dehydrated complex betalain mixture further comprises a plurality of sugars, wherein a ratio of the plurality of distinct betalains to the one or more sugars is at least 0.3; and
wherein the complex betalain mixture is formulated for oral administration and orally administered in an amount that reduces joint pain in the individual.

### Claim 2 (depends on 1)

The method of claim 1, wherein the starting material is selected from a group consisting of a beet juice, a raw beet or a portion of the raw beet, a beet processing waste liquid, a beet root culture or culture supernatants, a plant material comprising one or more betalains, and a near natural betalain product.

### Claim 3 (depends on 1)

The method of claim 1, wherein the starting material comprises beet juice.

### Claim 4 (depends on 1)

The method of claim 1, wherein the total betalain concentration in the dehydrated complex betalain mixture is at least 10 wt %.

### Claim 5 (depends on 1)

The method of claim 1, wherein the total betalain concentration in the dehydrated complex betalain mixture is at least 20 wt %.

### Claim 6 (depends on 1)

The method of claim 1, wherein the dehydrated complex betalain mixture further comprises a plurality of sugars, wherein a ratio of the plurality of distinct betalains to the one or more sugars is at least 2.0.

### Claim 7 (depends on 1)

The method of claim 1, wherein the dehydrated complex betalain mixture further comprises a plurality of sugars, wherein a ratio of the plurality of distinct betalains to the one or more sugars is between 2.5 and 4.5.

### Claim 8 (depends on 1)

The method of claim 1, wherein the complex betalain mixture is formulated in a tablet or capsule that contained between 10 and 100 mg of the complex betalain mixture.

### Claim 9 (depends on 1)

The method of claim 1, wherein the complex betalain mixture is formulated in a tablet or capsule that provides between 10 and 50 mg of total betalains.

### Claim 10 (depends on 1)

The method of claim 1, wherein the complex betalain mixture further comprises a non-steroidal anti-inflammatory drug and/or a cylooxygenase (COX) inhibitor.

### Claim 11 (depends on 1)

The method of claim 1, wherein the joint pain is due to osteoarthritis.

### Claim 12 (depends on 11)

The method of claim 11, wherein the joint pain is knee pain.

### Claim 13 (depends on 1)

The method of claim 1, wherein administering the dehydrated complex betalain mixture further reduces inflammation.

### Claim 14 (depends on 1)

The method of claim 1, wherein administering the dehydrated complex betalain mixture further reduces swelling.

### Claim 15

A method of reducing inflammation in an individual, comprising:
administering or providing for administration a dehydrated complex betalain mixture comprising a plurality of distinct betalains from a starting material, wherein the distinct betalains have a near natural composition and are present in the mixture at a total betalain concentration of at least 4 wt %;
wherein the dehydrated complex betalain mixture further comprises a plurality of sugars, wherein a ratio of the plurality of distinct betalains to the one or more sugars is at least 0.3; and
wherein the complex betalain mixture is formulated for oral administration and orally administered in an amount that reduces inflammation in the individual.

### Claim 16 (depends on 15)

The method of claim 15, wherein the total betalain concentration in the dehydrated complex betalain mixture is at least 10 wt %.

### Claim 17 (depends on 15)

The method of claim 15, wherein the dehydrated complex betalain mixture further comprises a plurality of sugars, wherein a ratio of the plurality of distinct betalains to the one or more sugars is at least 2.0.

### Claim 18 (depends on 15)

The method of claim 15, wherein the complex betalain mixture is formulated in a tablet or capsule that contained between 10 and 100 mg of the complex betalain mixture.

### Claim 19 (depends on 15)

The method of claim 15, wherein the complex betalain mixture is formulated in a tablet or capsule that provides between 10 and 50 mg of total betalains.

### Claim 20 (depends on 15)

The method of claim 15, wherein the complex betalain mixture further comprises a non-steroidal anti-inflammatory drug and/or a cylooxygenase (COX) inhibitor.
