# US 2016/0256408 A1 · Method for stress management and overall health status improvement and compositions used therein

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- Number: US 2016/0256408 A1
- Document ID: US20160256408A1
- Status: Published application
- Kind: A1
- Application number: 15/058,821
- Filed: 2016-03-02
- Published: 2016-09-08
- Earliest claimed: 2015-03-02
- Assignees: OmniActive Health Technologies Limited
- Applicants: Omniactive Health Technologies Limited
- Inventors: Jayant DESHPANDE; James M. STRINGHAM; Vijaya JUTURU
- Web page: https://patentgrep.com/patent/US20160256408A1

## CPC

- A61K 31/047: having two or more hydroxy groups, e.g. sorbitol
- A61K 31/07: Retinol compounds, e.g. vitamin A (retinoic acids A61K31/203)
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 27/00: Drugs for disorders of the senses
- G01N 21/5907: {Densitometers}
- G01N 30/00: Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography {or field flow fractionation} (G01N3/00, G01N5/00, G01N7/00, G01N9/00, G01N11/00, G01N13/00, G01N15/00, G01N17/00, G01N19/00, G01N21/00, G01N22/00, G01N23/00, G01N24/00, G01N25/00, G01N27/00, G01N29/00 take precedence)
- G01N 33/487: of liquid biological material
- G01N 33/743: {Steroid hormones}
- G01N 30/88: Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
- G01N 2030/8813: {biological materials}
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

Carotenoid compositions are described for management, treatment, and/or prevention of stress by reducing cortisol levels and/or improving distribution and/or density of macular pigment and thus improving overall health status. More particularly, a subject in need thereof for the method has disturbed macular pigment optical density or increased levels of cortisol as markers of psychological and physiological stress. Methods are also described of administering macular carotenoid compositions in daily doses of at least or about 0.005 mg/kg body weight of lutein, and at least or about 0.001 mg/kg body weight of meso-zeaxanthin and zeaxanthin isomer along with at least one food grade excipient and evaluating overall health status. The composition may be derived from plant extract containing xanthophylls and/or xanthophylls esters. The composition also reduces cortisol levels in the blood and relieves physiological stress, thus improving overall health status of a subject in need thereof.

## Claims

### Claim 1

A method for treatment of stress in a subject, comprising:
a. identifying a subject in need thereof;
b. administering a daily dose of macular carotenoid composition in an amount effective to treat stress in the subject, the macular carotenoid composition comprising at least 0.005 mg/kg body weight of lutein and, at least 0.001 mg/kg body weight of zeaxanthin isomers, including meso-zeaxanthin, along with one or more food grade excipients; and
c. measuring a parameter selected from at least one from the group consisting of macular pigment optical density, anxiety score, and blood cortisol; and
d. evaluating an improvement in overall health status of a subject.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the subject in need thereof is affected by lowered macular pigment optical density and suffering from psychological stress.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the subject in need thereof is affected with increased anxiety score and suffering from psychological stress.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the subject in need thereof is affected with increased cortisol levels and suffering from physiological stress.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the subject in need thereof is affected with psychological stress or physiological stress or a combination thereof, and suffering from disturbed overall health status.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the method manages at least one stress selected from the group consisting of psychological stress, physiological stress, and chronic stress.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the subject in need thereof is administered with an effective amount of the carotenoid composition, the macular carotenoid composition comprising the lutein including trans-lutein, and the zeaxanthin isomers including (R,R)-zeaxanthin and meso-zeaxanthin, of which the ratio of trans-lutein and zeaxanthin isomers being in the range of at or about 4:1 to at or about 6:1 and the ratio of the isomers of zeaxanthin being in the range of at or about 80:20 to at or about 20:80, to improve macular pigment optical density and reduce psychological stress.

### Claim 8 (depends on 7)

The method according to claim 7, wherein the subject in need thereof is administered with an effective amount of the macular carotenoid composition, the macular carotenoid composition is derived from the plant extract/oleoresin containing xanthophylls/xanthophylls esters, to improve overall health status of the subject.

### Claim 9 (depends on 8)

The method according to claim 8, wherein the subject in need thereof is administered with an effective amount of the macular carotenoid composition, the macular carotenoid composition comprising at least 85% by weight of total xanthophylls, of which at least 80% by weight being trans-lutein, at least 6% by weight being (R, R)-zeaxanthin and at least 6% by weight being (R, S)-zeaxanthin, to improve macular pigment optical distribution and improve overall health status of the subject.

### Claim 10 (depends on 9)

The method according to claim 9, wherein the subject in need thereof is administered with an effective amount of the macular carotenoid composition, the macular carotenoid composition comprising at least 0.005 mg/kg body weight of the lutein and at least 0.001 mg/kg body weight of the zeaxanthin isomers, to reduce cortisol levels and to improve overall health status of the subject.

### Claim 11 (depends on 1)

The method according to claim 1, wherein the zeaxanthin isomers include R,R-zeaxanthin.

### Claim 12 (depends on 1)

The method according to claim 1, wherein the subject in need thereof is a mammal.

### Claim 13 (depends on 1)

The method according to claim 1, wherein the subject in need thereof is a human.
