COMPOSITION AND METHOD FOR MODULATING HYDROGEN ION PHYSIOLOGY RELATED TO BRAIN HEALTH COMPONENT

Abstract

A nutritional supplement composition that extends the utility of the prior art methods to include enhanced utility for bone health via modulation of the RANK, RANKL, NFKB signaling system and incorporates unrelated, unforeseen benefits on brain health based on the beneficial impact of the same signaling system on brain health thus preventing loss of neurological function and/or normalizing impaired or deteriorating neurological function in humans based on: (1) mitigation of the adverse impact of dysregulated acid-base balance, (2) dysregulation of prostaglandin physiology, (3) abnormalities in RANK, RANKL, NFKB physiology. reversing elevated NFKB, RANK, RANKL signaling. The nutrients that are ideal for the desired result are Honokiol, Magnolol, Beta-caryophyllene, Palmitoylethanolamide, Hesperidin, Schisandrin, Ferulic Acid, Beta-carotene, Lutein, Lycopene, Sulforaphane, and Ellagic Acid.

Claims

1. A composition for supporting and promoting healthy hydrogen ion balance, healthy calcium metabolism, healthy muscle metabolism, and optimizing and preventing deterioration of brain health in the body of a human being, said composition comprising the following nutrients: a first component selected from the group consisting of Honokiol, Magnolol, Palmitoylethanolamide and Beta-Caryophyllene, each of which nutrients beneficially modulate the endocannabinoid metabolism to diminish the adverse impact of stress on neural tissues; a second component selected from the group consisting of Hesperidin, Schisandrin and Sulforaphane, each of which nutrients beneficially modulate a variety of cellular and molecular pathways of brain inflammation; and a third component selected from the group consisting of Ferulic Acid, Ellagic Acid, Lutein, Beta-Carotene and Lycopene each of which nutrients beneficially act via different pathways to mitigate the development of amyloid beta neurodegenerative pathology; said first, second, and third components collectively provided in an effective amount for supporting and promoting healthy hydrogen ion balance, healthy calcium metabolism, and healthy muscle metabolism in the body of said human being.

2. A composition as in claim 1 wherein at least one of said first, second and third components include at least one ingredient selected from the group consisting of folic acid, trimethylglycine, phosphatidyl choline, L-camitine, acetyl L-camitine, B vitamins, glyceryl phosphorylcholine, choline, SAMe (S adenosylmethionine), creatine, lipoic acid, coenzyme Q10, L-aspartic acid, serine, glycine and pyruvate.

3. A method of administering an effective amount of the composition of claim 1, comprising the steps of: 1) formulating the composition and 2) administering the composition by oral intake, absorption, circulatory transport and interstitial flux.

Description

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] It has been recently discovered that the RANKL/NFKB signaling pathway plays a critical role in osteoclast activation and bone loss. It has also been shown that the acidosis/COX pathway (as taught in the current HIP patent) activates the RANKL/NFKB signaling pathway. Further, it has been shown that the acidosis/COX pathway and the RANK/RANKL/NFKB pathways converge and act together to turn on osteoclast activity resulting in markedly accelerated bone loss.

[0016] One novel aspect of the present invention is that while the acidosis/COX pathway and the RANKL/NFKB pathway independently up-regulate osteoclast activity, they further enhance each other's biological impact by feeding into the same downstream signaling system. Thus, by combining novel nutritional approaches that beneficially impact multiple pathways and mechanisms of disease, synergistic benefits accrue and enhanced and more effective interventions are available.

[0017] Nutrients have been discovered that are suitably positioned to inhibit, or block the RANK, the RANKL and the NFKB signal pathways, thus markedly enhancing the effect of the prior known methods because of the impact on convergent pathways and the subsequently markedly enhanced benefits resulting from the synergistic effect of addressing several debilitating processes by adding multiple novel ways to reduce their detrimental effect.

[0018] Additional synergistic enhancements of the new novel nutrients that reduce signaling in the RANK/RANKL/NFKB pathways, also produce an array of beneficial unexpected “downstream” metabolic effects involving multiple different additional biochemical pathways such as cannabinoid, opiate, PPAR alpha, GPR55, and additional epigenetic signaling systems, thus extending the aggregate benefits beyond those initially anticipated. This means that by beneficially modulating these additional, unrelated pathways, the combined benefits far exceed the beneficial effects of any two individually applied approaches.

[0019] In addition, chronic metabolic acidosis has been shown to impair insulin-signaling in a manner that results in a biochemical and hormonal situation that is referred to as “insulin resistance.” Insulin resistance plays a major role in the development of diabetes, vascular disease, cardiovascular disease (by its impact on lipid metabolism (such as producing deleterious impact on serum cholesterol and triglyceride levels, for example)) and neurodegeneration. It has been shown that cerebral insulin resistance is a contributory factor to neurodegeneration and neuroinflammation, both of which are present in disorders such as Alzheimer's disease, vascular dementia, other dementing diseases, brain or other central nervous system injury, hemorrhage, stroke and so forth. Upregulation of RANK/RANKL/NFKB signaling plays key roles in these disorders. Down-regulation of this signaling cascade has been shown to ameliorate the underlying contributory factors and provide symptomatic improvement. The additional nutrients are specifically noted to down-regulate the RANK/RANKL/NFKB signal pathways in bone and brain. In addition, because of their beneficial impact on a variety of additional related metabolic pathways (as noted above) relying on unrelated and unexpected mechanisms, heretofore unforeseen neurochemical and neurobehavioral benefits accrue.

[0020] Additional novel approaches that synergize with the known procedures, for example, those described in aforementioned U.S. Pat. Nos. 6,964,969 and 8,703,209, activate effects on bone health (by their beneficial impact on RANK/RANKL/NFKB signaling) and provide a novel approach, in conjunction with the previously taught nutrients), that unexpectedly enhances brain function and prevents/preserves loss of nervous system function.

[0021] The nutrients taught in prior art patents referenced above that beneficially modulate the RANK/RANKL/NFKB pathway include: folic acid, trimethylglycine, phosphatidyl choline, L-camitine, acetyl L-camitine, B vitamins, glyceryl phosphorylcholine, choline, SAMe (S adenosylmethionine), creatine, lipoic acid, coenzyme Q10, L-aspartic acid, serine, glycine and pyruvate.

[0022] Additional agents which augment bone and/or muscle metabolism by various unrelated or not well-understood mechanisms include vitamin D (preferably vitamin D3), vitamin K, vitamin C, vitamin B5, boron, ipriflavone or other isoflavones, and branched chain amino acids (BCAA)

[0023] Novel nutrients that are combinable in various formulations dictated by the specific modulation of the desired signaling systems that are required are proposed. These novel nutrients may be used in combination with each other, or in further commination with the above listed nutrients disclosed in aforementioned U.S. Pat. Nos. 6,964,969 and 8,703,209. The novel nutrients include, inter alia: Honokiol, Magnolol, Beta-caryophyllene, Palmitoylethanolamide, Hesperidin, Schisandrin, Ferulic Acid, Beta-carotene, Lutein, Lycopene, Sulforaphane, and Ellagic Acid.

[0024] The invention herein has been described with reference to the disclosed embodiments including the combinations and permutations of the several nutrients, but it should be understood that the features and operation of the invention as described is susceptible to modification or alteration without departing significantly from the spirit of the invention. For example, the types and effective amounts of the various nutrients may be changed and or may be altered to fit specific applications. Additional similar nutrients may be uncovered that provide for addressing similar pathways that enhance bone health and provide for brain health. Accordingly, the specific embodiments described herein are for illustrative purposes only and the invention is not limited except by the following claims.