IP Library Granted Patent US 50,617
Granted Patent E1
US 50,617 · App. 17/687,712 · Granted Oct 7, 2025

Method for stress management and overall health status improvement and compositions used therein

Inventors: Jayant Deshpande (Congers, NY); James M Stringham (Durham, NC); Vijaya Juturu (Morristown, NJ)
A61K31/047A61K31/07A61P25/00A61P27/00G01N21/5907G01N30/00G01N33/487G01N33/743G01N30/88G01N2030/8813G01N2800/52
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Quick Facts
Patent No.
US 50,617
App. No.
17/687,712
Granted
Oct 7, 2025
Kind
E1
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 (30)

1. A method for treatment of improving, managing, and/or treating psychological stress and and/or physiological stress in a subject, comprising:

a.) identifying a subject in need thereof, wherein the subject in need thereof is affected by psychological stress as measured by macular pigment optical density (MPOD) levels and and/or physiological stress as measured by blood cortisol levels;

b.) administering a daily dose of macular carotenoid composition in an amount effective for increasing the MPOD levels and reducing the blood cortisol levels over a period of at least one month as compared to those of before the administration of the macular carotenoid composition so as to treat stress in the subject, the macular carotenoid composition consists consisting of at least 85% by weight of xanthophylls, the xanthophylls being lutein and zeaxanthin isomers, 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, wherein the macular carotenoid composition consists of at least 0.1 mg/kg body weight of the lutein and, at least 0.01 mg/kg body weight of the zeaxanthin isomers; and

c.) measuring MPOD and and/or blood cortisol levels; and

d.) evaluating an improvement in overall health status of the subject.

2. The method according to claim 1 , wherein the subject in need thereof is administered with an effective amount of the macular carotenoid composition, wherein the macular carotenoid composition is derived from the plant extract/oleoresin containing xanthophylls/xanthophylls esters, to improve overall health status of the subject.

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

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

5. A method for improving, managing, and/or treating psychological stress in a subject, comprising

a) identifying that the subject suffers from psychological stress;

b) administering over a period of at least one month a daily dose of carotenoid composition in an amount effective for treating psychological stress in the subject, the carotenoid composition consisting of at least 85% by weight of xanthophylls, the xanthophylls being lutein and zeaxanthin isomers, of which at least 80% by weight is trans-lutein, at least 6% by weight is (R, R)-zeaxanthin and at least 6% by weight is (R, S)-zeaxanthin, the lutein being present in the carotenoid composition in an amount of at least 0.1 mg/kg body weight and the zeaxanthin isomers being present in an amount of at least 0.01 mg/kg body weight;

c) measuring one or more markers selected from the group consisting of brain-derived neurotropic factor (BDNF), interleukins, TNF α, blood cortisol level and macular pigment optical density (MPOD) after performing step b); and

d) evaluating an improvement in psychological stress in the subject based on the measured marker.

6. The method according to claim 5 , wherein the psychological stress is selected from the group consisting of cognitive function, memory retention, verbal fluency, and cognitive decline, and a combination thereof.

7. The method according to claim 5 , wherein identifying that the subject suffers from psychological stress comprises at least one of measuring MPOD in the subject, measuring a blood cortisol level of the subject, and subjecting the subject to a health assessment questionnaire.

8. The method according to claim 5 , wherein administering the carotenoid composition to the subject improves the one or more markers selected from the group consisting of brain-derived neurotropic factor (BDNF), interleukins, TNF α, blood cortisol level, and macular pigment optical density (MPOD) in the subject as compared to the subject before administration of carotenoid composition.

9. The method according to claim 5 , wherein the subject is a mammal or human.

10. The method according to claim 5 , wherein the method further comprises measuring levels of macular pigment optical density (MPOD) in the subject.

11. The method according to claim 9 , wherein the subject exhibits MPOD below a baseline amount before administering the carotenoid composition, and the method further comprises administering an effective amount of the carotenoid composition to the subject to increase in the amount of levels of MPOD above the baseline amount.

12. The method according to claim 5 , wherein the carotenoid composition is administered for about 4 weeks to about 12 weeks.

13. The method according to claim 5 , wherein the carotenoid composition is administered in an amount of about 6 mg/day to about 30 mg/day.

14. The method according to claim 5 , wherein the carotenoid composition is administered in an amount selected from the group consisting of about 6 mg/day, 12 mg/day and 24 mg/day for a time period selected from the group consisting of about 8 weeks, about 10 weeks, and about 12 weeks.

15. The method according to claim 5 , wherein the carotenoid composition is administered for at least 6 months.

16. A method for improving, managing, and/or treating psychological stress and/or physiological stress in a subject, comprising:

a) testing the subject to determine that the subject suffers from psychological and/or physiological stress, based on a measured stress parameter;

b) over a period of at least one month administering a daily dose of carotenoid composition in an amount effective for changing the stress parameter to indicate that the subject suffers from reduced stress compared to before the administration of the carotenoid composition, the carotenoid composition consisting of at least 80% by weight of xanthophylls, the xanthophylls being lutein and zeaxanthin isomers, of which at least 80% by weight is trans-lutein, (R, R)-zeaxanthin and (R, S)-zeaxanthin being present in a ratio of between 80:20 and 20:80, wherein the carotenoid composition consists of at least 0.1 mg/kg body weight of the lutein and, at least 0.01 mg/kg body weight of the zeaxanthin isomers; and

c) measuring the stress parameter to evaluate physiological and/or psychological stress after step b); and

d) evaluating an improvement in overall health status of the subject.

17. The method according to claim 16 , wherein the stress parameter comprises at least one of macular pigment optical density (MPOD) level, score on a health status questionnaire, and blood cortisol level.

18. The method according to claim 16 , wherein the xanthophylls further comprise at least 6% by weight (R, R)-zeaxanthin and at least 6% by weight (R, S)-zeaxanthin.

Continuity (2)
Provisional Application 62126971 · Mar 2, 2015
Reissue 15058821 · Mar 2, 2016
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