COMPOSITION AND METHOD TO ENHANCE COGNITIVE SUPPORT AND BRAIN HEALTH

Abstract

The present disclosure relates to relates to improved dietary supplement compositions formulated in a therapeutic effective amount for enhancing cognitive support and brain health. Specifically, the present disclosure relates to dietary and nutritional supplement compositions administered to a mammal in a therapeutically-effective amount to provide cognitive support and enhance overall brain health. The present disclosure further relates to a method of supporting cognitive health in a mammal comprising administering to the mammal in need thereof a therapeutically effective amount of a nutritional supplement comprising a combination of a carotenoid and an adaptogen.

Claims

1. A dietary supplement composition formulated in a therapeutic effective amount for enhancing cognitive skill and brain health, the composition comprising: a carotenoid and an adaptogen.

2. The dietary supplement composition according to claim 1, wherein the carotenoid is a xanthophyll.

3. The dietary supplement composition according to claim 2, wherein the xanthophyll is lutein.

4. The dietary supplement composition according to claim 3, wherein the lutein is lutein/zeaxanthin or lutein esters.

5. The dietary supplement composition according to claim 1, wherein the adaptogen is an ashwagandha.

6. The dietary supplement composition according to claim 5, wherein the adaptogen is Shoden® ashwagandha extract standardized to not less than 35% glycowithanolides.

7. A dietary supplement composition formulated in a therapeutic effective amount for enhancing cognitive skill and brain health, the composition comprising: lutein esters and an ashwagandha extract.

8. The dietary supplement composition according to claim 7, wherein the composition comprises about 10-80 mg lutein esters per day and about 60-600 mg ashwagandha extract per day.

9. The dietary supplement composition according to claim 7, wherein the composition comprises 40 mg lutein esters per day and 60 mg ashwagandha extract per day.

10. The dietary supplement composition according to claim 7, wherein the composition comprises 40 mg lutein esters per day and 120 mg ashwagandha extract per day.

11. The dietary supplement composition according to claim 7, wherein the composition comprises combining lutein esters powders and ashwagandha extract powders into a beadlet.

12. The dietary supplement composition according to claim 7, wherein the composition comprises a physical blend of lutein esters powders and ashwagandha extract powders.

13. The dietary supplement composition according to claim 7, wherein the composition comprises ashwagandha extract powder dispersed in a lutein esters oil.

14. The dietary supplement composition of claim 7 wherein the composition provides an immediate therapeutic effect to enhance cognitive performance.

15. The dietary supplement composition according to claim 7, wherein the composition is in a single or multiple combination of dosage pills, capsules, tablets, softgels, lozenges, powders, liquids, soft chews or gummies.

16. A method of supporting cognitive health in a mammal is provided, the method comprising: orally administering to the mammal in need thereof a therapeutically effective amount of a composition comprising about 10-80 mg lutein esters and about 60-600 mg ashwagandha extract.

17. The method of claim 16, wherein the composition is formulated in a therapeutic effective amount to support cognitive skills and brain health.

18. The method of claim 16, wherein the method further includes administering the composition on a daily basis.

19. The method of claim 16, wherein the composition is administered in a dosage from about 10-80 mg per day lutein esters combined with about 60-600 mg per day ashwagandha extract.

Description

DETAILED DESCRIPTION

[0038] The present disclosure relates to an improved dietary supplement composition formulated in a therapeutic effective amount to enhance cognitive skills and maintain brain health. The composition is believed to produce a brain maintenance effect by shielding against the impact of aging on cognitive performance, as well as potentially enhance cognitive abilities for memory enhancement, learning and gaming. The present disclosure relates to providing a formula for oral consumption, in the form of a dietary supplement. The ingredients used in the present composition are food or dietary ingredients, and do not include chemicals or drugs that are not suitable for human/animal consumption as foods or dietary supplements. The disclosure further relates to a method of supporting cognitive health in a mammal is provided, comprising orally administering to the mammal in need thereof, a therapeutically effective amount of an improved dietary supplement composition formulated to support cognitive skills and brain health, wherein the composition is administered daily.

[0039] It is a key embodiment of the present disclosure that the broad-spectrum compositions consist of dietary ingredients which have a positive effect on cognitive support and brain health. It is these particular functionalities that make the present dietary supplement composition unique. Additionally, it is a unique feature of the present composition to include ingredients that improve brain wave function, a physical manifestation of improved cognitive function, as well as improve neurotransmission, a chemical manifestation of improved cognitive function.

[0040] The first ingredient in the present composition is a carotenoid, which are generally in two categories—xanthophylls and carotenes. Xanthophylls include lutein, astaxanthin, zeaxanthin, etc. Lutein can be either free or ester forms. Naturally occurring lutein esters extracted from marigold flowers are not just one ester but a family of naturally occurring esters. They include mono- and di-esters. The main ester is lutein dipalmitate, but there are also smaller amounts of other esters such as palmitate, laurate, dilaurate, stearate, distearate, myristate and dimyristate esters. An extract of lutein esters may also include trans-zeaxanthin, a naturally occurring zeaxanthin.

[0041] In a preferred embodiment of the present disclosure, lutein esters are used, which as discussed above, has been shown to be more highly available than free ester. In a present composition, lutein esters are provided in a range of about 10-80 mg per day, which converts in a body to approximately 50% free lutein, with a free lutein range of 10-40 mg. In another embodiment of the present composition, lutein esters are provided in a range of about 20-50 mg per day, which converts in the body to approximately 50% free lutein, with a free lutein range of 10-25 mg. In another embodiment of the present composition, free lutein esters are provided in a range of about 10-25 mg per day, which coverts in the body to approximately 50% free lutein, with a free lutein range of 5-12.5 mg. As discussed above, there is new evidence that lutein plays a role in cognitive improvement, and therefore will work synergistically in the present formula.

[0042] The second ingredient of the present composition is an adaptogen, which improves brain health, reduces stress and anxiety, increases calm and relaxation, improves sleep ability, restores balance and improves physical performance. An adaptogen is an herb that has hormonal-like activity and protects the body against stress and other insults. Adaptogens are also known as phytohormones—i.e., plant extracts with hormonal-like activity. Adaptogens include but are not limited to rhodiola, ashwagandha, ginseng, astragalus, cordyceps, eleuthero, tulsi, turmeric, etc.

[0043] In the present composition, ashwagandha is the preferred adaptogen. Ashwagandha has the unique ability to help maintain homeostasis during intense stress, which is exactly what is needed by gainers to balance their performance. It is also believed that ashwagandha is useful for improving memory and cognitive functions, which are important attributes for the present composition. Ashwagandha is an Indian Ayurvedic herb also known as Indian ginseng, poison gooseberry, or winter cherry, and is also known by its Latin name Withania somnifera. Ashwagandha extract containing at least 5% withanolides (the bioactive components of Ashwagandha) with at least 35% glycowithanolides even more preferred. Preferred dosages for ashwagandha extract are between 60 mg and 600 mg per day, with more preferred dosages between 60 and 300 mg per day, with further preferred dosages between 60 and 120 mg per day. Ashwagandha extract bioavailability is high and effects can be felt within a few days making it a suitable selection for the present composition.

[0044] The present dietary supplement composition can be in any suitable delivery form including beadlets, pills (capsules, tablets, softgels, lozenges, chewables), gummies, powders for mixing to form beverages, ready to drink (RTD) beverages, or in foods such a snack bars, cookies or other food forms. Examples of compositions useful in the present disclosure include; lutein esters powders combined with ashwagandha extract powders; ashwagandha extract powder dispersed in lutein esters oil, with or without a dispersion agent; and, ashwagandha extract powder combined with encapsulated lutein esters oils.

[0045] In order to formulate these forms of oral consumables, there typically is the need to include inert ingredients. Inert ingredients do not perform any biological function, but instead help create the final form of the product suitable for consumption. Types of inert ingredients include fillers, coatings, lubrication aids, flow agents, binders, preservatives, flavors, fragrances, viscosity modifiers etc. The final product supplement, food or beverage may include any or all of these excipients as necessary to form the product, and it should be noted are not limited to these items listed.

[0046] In a most preferred embodiment, the delivery form of the present composition would be a unique single particle combination of the two ingredients, such as in a beadlet. This is a form distinct from a physical blend of the two ingredients. It is believed that the single particle combination product, which brings the two ingredients, for example lutein esters and ashwagandha extract—together in close proximity, results in a synergistic effect on cognitive health. Notwithstanding this preferred embodiment, other embodiments consisting of either a physical blend powders of the two ingredients, or combinations of oils and powders, are also preferred.

[0047] The present disclosure also relates to a method of supporting cognitive health in a mammal. “Mammal” may refer to humans, as well as, to animals and pets in particular. There is a growing market for supporting cognition and brain health in pets. A leading dog food manufacturer offers a senior dog food that is promoted as enhancing alertness and cognitive health in aging dogs. Therefore, the composition of the present disclosure may be offered in a therapeutically effect amount to enhance cognitive skills and brain health in animals, particularly pets such as cats, dogs, horses, etc. The dosages of ingredients would be ratioed depending in the weight of the particular animal. For example, the dosages described herein are generally designed for human use, with a reference human weight 100 kg. Thus, in comparison, for a 20 kg dog for example, the dosage is about ⅕ of the human dosages. Dosages and amounts of the present ingredients can be modified and changed to accommodate a variety of mammals.

EXAMPLES

[0048] The following are an explanation and results of usage trials utilizing combinations of the above ingredients in a dietary supplement useful for enhancing cognitive support and brain health. Studies were conducted to evaluate the effectiveness of the following formulations:

[0049] Formula 1: A dietary supplement formulation having 40 mg Opitlut® lutein esters and 60 mg Shoden® ashwagandha extract, was prepared. Formula 1 includes the following concentrations of ingredients: Ashwanganda: 20-22%; Lutein Esters concentrate: 17-21%; Modified food starch: 34-37%; Polysorbate: 3-5%; Acacia: 5-8%; Sugar: 2-4%; Fatty acid esters: 1-2%; and Tocopherols: 0.5%.

[0050] Beadlets of Formula 1 were prepared using known methods. Specifically, the ingredients were mixed together in a high shear mixer. The resulting wet mass is then fed into an extruder, and the extrudate is then fed into a spheronizer. The beadlets created in the spheronizer are then dried in a fluid bed drier.

[0051] Formula 2: A dietary supplement formulation having 40 mg Opitlut® lutein esters and 120 mg Shoden® ashwagandha extract, was prepared. Formula 2 includes the following concentration of ingredients: Ashwanganda: 33-35%; Lutein Esters concentrate: 14-18%; Modified food starch: 30-35%; Polysorbate: 3-5%; Acacia: 5-8%; Sugar: 2-4%; Fatty acid esters: 1-2%; and Tocopherols: 0.3%. Beadlets of Formula 2 were prepared using known methods as described above for Formula 1.

[0052] Formula 3—A dietary supplement formulation having 40 mg Opitlut® lutein esters and 60 mg Shoden® ashwagandha extract, was prepared. Formula 3 includes the following concentration of ingredients: Ashwanganda: 22%; Lutein Esters concentrate: 18%; Acacia: 20%; Microcrystalline cellulose: 25%; Sucrose 14.5%; and d-alpha Tocopherols: 0.5%. Beadlets of Formula 3 were prepared using known methods as described above for Formula 1.

[0053] Formula 4—A dietary supplement formulation having 40 mg Opitlut® lutein esters and 120 mg Shoden® ashwagandha extract, was prepared. Formula 4 includes the following concentration of ingredients: Ashwanganda: 35%; Lutein Esters concentrate: 15%; Acacia: 20%; Microcrystalline cellulose: 20%; Sucrose 9.5%; and d-alpha Tocopherols: 0.5%. Beadlets of Formula 3 were prepared using known methods as described above for Formula 1.

[0054] Trial Procedure and Data—In order to test the effects of the combination of ingredients on cognitive activity, two sets of experiments on mice were conducted. In the first set of experiments, test substances were administered orally to 8 animals in each group for 10 days. On the 10.sup.th day, the mice were evaluated for spatial learning by the T-Maze test, which is a simple maze used in animal cognition experiments. A risk assessment index was determined according to the formula−Risk Assessment Index=(frequency of tries)/(frequency of tries+Open Arm Entry). In the second set, the same procedure was used, however a pole climbing test was administered. The average of shock avoidance plus mistakes was determined (measured in seconds). For both sets of experiments, beadlets of Formula 3 and Formula 4 were tested, in addition to a placebo beadlet consisting of all the non-active ingredients in the formula (40% acacia, 40% microcrystalline cellulose, 19% sucrose, 1% d-alpha tocopherols). The results are shown in Table 1 below:

TABLE-US-00001 TABLE 1 Pole Climbing test Beadlet Beadlet T-Maze test Avoidance/mistakes Human Dose Mouse Dose Risk Index (seconds) Treatment Active Ingredients (mg/day) (mg/kg) (ave for 8 mice) (ave for 8 mice) Placebo None 300 61.5 12.9 12.8 Formula 3 Optilut 20 mg/ 300 61.5 16.4 11.0 Shoden 60 mg Formula 4 Optilut 20 mg/ 360 73.8 18.0 7.9 Shoden 120 mg

[0055] The results show that cognitive abilities as measured by the T-Maze test and the Pole Climbing test improved with the combination of lutein and ashwagandha, and also improved with increasing dose of ashwagandha in the combination.

[0056] It should be noted that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the spirit and scope of the present invention and without diminishing its attendant advantages. Further, references throughout the specification to “the invention” are nonlimiting, and it should be noted that claim limitations presented herein are not meant to describe the invention as a whole. Moreover, the invention illustratively disclosed herein suitably may be practiced in the absence of any element which is not specifically disclosed herein.