DESC:FIELD OF INVENTION
The present invention relates to the field of nutraceuticals and neurotherapeutics. More particularly, it pertains to a pediatric-compatible multi-component neuro nutritional composition capable of modulating NrF2, NMDA, cholinergic and RAGE pathways for the management of neuroinflammation, autism spectrum disorder and Traumatic brain injury recovery.

BACKGROUND OF THE INVENTION
Pediatric neurological health is increasingly challenged by modern environmental stressors, genetic predispositions, and adverse events such as birth complications, head trauma, and systemic inflammation. Neuroinflammation and oxidative stress are critical components of various pediatric neurodevelopmental and neurodegenerative conditions. Neurodevelopmental conditions like ASD affect approximately 1 in 100 children globally, while post-TBI cognitive impairment remains a major public health issue. The majority of interventions either rely on behavioral therapies or medications, which may have questionable long-term safety profiles and often lack mechanistic specificity.
Mounting research identifies key biological pathways implicated in pediatric neuroinflammation and neurodevelopmental disorders such as:
• Nrf2 (Nuclear Factor Erythroid 2–Related Factor 2): A transcription factor regulating antioxidant response elements, crucial for combating oxidative stress.
• NMDA (N-methyl-D-aspartate) Receptors: Involved in excitatory neurotransmission and synaptic plasticity and associated with glutamate excitotoxicity.
• Cholinergic Pathways: Important for attention, memory, and executive functioning, frequently impaired in neurodevelopmental conditions, plays pivotal role in cognitive functions.
• RAGE (Receptor for Advanced Glycation End Products): A mediator of inflammatory cascades, implicated in neuronal damage and neurodegeneration.
AU2023208131A1 relates to the combination of a sulforaphane precursor, an enzyme capable of converting the sulforaphane precursor to sulforaphane, an enzyme potentiator, and a milk thistle extract or powder. It also relates to the combination of sulforaphane or a derivative thereof and a milk thistle extract or powder and also relates to the combination of a broccoli extract or powder and a milk thistle extract or powder.
US8937050B2 discloses a method of treating autism or one or more autism spectrum disorders, comprising, administering to a subject diagnosed with autism or one or more autism spectrum disorders an effective amount of a pharmaceutical composition comprising a sulforaphane, a sulforaphane dithiocarbamate, or combination thereof.
Bent, S., Lawton, B., Warren, T. et al. Identification of urinary metabolites that correlate with clinical improvements in children with autism treated with sulforaphane from broccoli. Molecular Autism 9, 35 (2018).
Journal of Ethnopharmacology Volume 293, 15 July 2022, 115199 reads the neuroprotective effect of Bacopa monnieri (BM) in experimental model of autism spectrum disorder (ASD) in Wistar rats and explored its mechanism of action.
Chez MG, Buchanan CP, Aimonovitch MC, et al. Double-Blind, Placebo-Controlled Study of L-Carnosine Supplementation in Children with Autistic Spectrum Disorders. Journal of Child Neurology. 2002;17(11):833-837. doi:10.1177/08830738020170111501.
David Soto et al. L-Serine dietary supplementation is associated with clinical improvement of loss-of-function GRIN2B-related pediatric encephalopathy. Sci. Signal.12, eaaw0936(2019). DOI:10.1126/scisignal. aaw0936.
Despite the availability of individual supplements and pharmaceutical options 15 targeting these mechanisms, no single pediatric-friendly formulation has effectively integrated all the above into a safe, palatable, and regulatory-compliant product. There exists a critical gap in formulating evidence-based nutraceuticals that are nonhormonal, and free from heavy metals or allergens, yet able to impact multiple neurobiological targets simultaneously.
Therefore, the present invention aims to fulfill the unmet need by providing a safe, effective and pediatric-friendly neuro-nutritional composition that can modulate NrF2, NMDA, cholinergic and RAGE pathways for the management of neuroinflammation, autism spectrum disorder and Traumatic brain injury recovery

OBJECT OF THE INVENTION
Accordingly, the main object of the present invention is to provide multi-component neuro-nutritional composition that can modulate NrF2, NMDA, cholinergic and RAGE pathways for the management of neuroinflammation, autism spectrum disorder and Traumatic brain injury recovery.
Another object of the present invention is to provide a composition comprising Sulforaphane, L-Carnosine, L-Serine, Bacopa monnieri Extract and Phosphatidylserine.
Yet another object of the present invention is to provide a pediatric-friendly neuronutritional for management of autism spectrum disorder, Traumatic brain injury recovery and other pediatric neuroinflammatory conditions.
Yet another object of the present invention is to provide a vegetarian friendly composition suitable for children with dietary restrictions, metabolic
conditions or those requiring low glycemic formulations.

SUMMARY OF THE INVENTION:
Accordingly, the present invention provides a composition comprising Sulforaphane, L-Carnosine, L-Serine, Bacopa monnieri Extract and Phosphatidylserine for modulating NrF2, NMDA, cholinergic and RAGE pathways for the management of neuroinflammation, autism spectrum disorder and Traumatic brain injury recovery.
In one aspect, the present invention provides a pediatric-friendly, orally administrable composition that formulated to support neurological health in children.
In another aspect, the present invention provides a synergistic blend that activates the Nrf2 pathway for promoting intracellular antioxidant response, regulates NMDA receptor function for maintaining excitatory-inhibitory balance, supports cholinergic signaling for improving attention as well as memory and inhibits RAGE-mediated inflammation for reducing neuroinflammatory damage.
In yet another aspect, the present invention provides a formulation that is particularly suitable for pediatric populations (age 2+) and adolescents, and also offer off-label benefits in early geriatric cognitive support.
In yet another aspect, the present invention provides a composition that is vegetarian friendly and comprises permitted Class-II preservatives and natural identical flavoring agents.
In yet another aspect, the present invention provides provide a vegetarian friendly composition suitable for children with dietary restrictions, metabolic
conditions or those requiring low glycemic formulations.
In yet another aspect, the present invention provides suitable excipients to form a stable oral dosage form, such as, but not limiting to, syrup, unit-dose sachets, orally disintegrating tablets, Granule Form in Sachet, liquid suspension with liposomal Emulsion.
In yet another aspect, the active ingredients Sulforaphane, L-Carnosine, L-Serine, Bacopa monnieri Extract and Phosphatidylserine are present in synergistic proportions such that the combined effect on Nrf2 activation, NMDA modulation, cholinergic enhancement, and RAGE inhibition is greater than the sum of effects of individual components when administered separately.
In another aspect, the composition comprises Sulforaphane, L-Carnosine, L-Serine, Bacopa monnieri Extract and Phosphatidylserine in a pre-determined ratio.
In yet another aspect the composition may comprise additional ingredients.
In yet another aspect, the present invention provides a method of preparation of composition for treating neuroinflammatory and neurodevelopmental conditions.
In yet another aspect, the present invention provides a method of managing or treating neuroinflammatory and neurodevelopmental conditions by administering an effective amount of orally administrable composition.

DETAILED DESCRIPTION OF THE INVENTION
Accordingly, the present invention provides a multi-component formulation comprising Sulforaphane, L-Carnosine, L-Serine, Bacopa monnieri Extract and Phosphatidylserine for modulating NrF2, NMDA, cholinergic and RAGE pathways for the management of neuroinflammation, autism spectrum disorder and Traumatic brain injury recovery.
The present disclosure can be understood more readily by reference to the following description, taken in conjunction with the accompanying Figures and Examples, all of which form a part of this disclosure.

At the very outset of the detailed description, it may be understood that the ensuing description only illustrates a particular form of the invention covered in the present disclosure. However, such a particular form is only an exemplary embodiment, and without intending to imply any limitation on the scope of the invention. Accordingly, the description is to be understood as an exemplary embodiment and teaching of invention and not intended to be taken restrictively.

Before the present disclosure or methods of the present disclosure are described in greater detail, it is to be understood that the specific products, methods, processes, conditions or parameters, are not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the methods. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the methods. Certain ranges are presented herein with numerical values being preceded by the term “about.” The term “about” is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. For example, "about" can mean within one or more standard deviations, or within ± 30%, 25%, 20%, 15%, 10% or 5% of the stated value.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, preferred methods and materials are described. For the purposes of the present invention, the following terms are defined below.

It is appreciated that certain features of the methods, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the methods, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. All combinations of the embodiments are specifically embraced by the present invention and are disclosed herein just as if each and every combination was individually and explicitly disclosed, to the extent that such combinations embrace operable processes and/or composites/scaffolds.

Reference throughout this specification to “certain embodiments”, “further embodiments”, “specific embodiments”, “further specific embodiment”, “one embodiment”, “a non-limiting embodiment”, “an exemplary embodiment”, “some instances”, or “further instances”, means that a particular feature, structure or characteristic described in connection with the embodiment may be included in at least one embodiment of the present disclosure.

As used herein, the terms ‘include’, ‘have’, ‘comprise’, ‘contain’ etc. or any form of said terms such as ‘having’, ‘including’, ‘containing’, ‘comprising’ or ‘comprises’ are inclusive and will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

The use of any and all examples, or exemplary language (e.g., “such as”) provided with respect to certain embodiments herein is intended merely to better illustrate the disclosure and does not pose a limitation on the scope of the disclosure otherwise claimed.

As used herein, the term “invention”, “present invention”, “disclosure” or “present disclosure” as used herein is a non-limiting term and is not intended to refer to any single embodiment of the particular invention but encompasses all possible embodiments as described in the specification.

The terms “process(es)” and “method(s)” are considered interchangeable within this disclosure.

For convenience, certain terms used in the specification and examples are collected in this section below:
NMDA: N-methyl-D-aspartate receptor
NrF2: Nuclear factor erythroid 2-related factor 2
RAGE: Receptor for Advanced Glycation End products
ADHD: Attention Deficit Hyperactivity Disorder
ASD: Autism spectrum disorder (ASD)
TBI: traumatic brain injury
AChE: Acetylcholinesterase
In one specific embodiment, the present invention discloses a pediatric-friendly multi-component formulation comprising Sulforaphane, L-Carnosine, L-Serine, Bacopa monnieri Extract and Phosphatidylserine for modulating NrF2, NMDA, cholinergic and RAGE pathways for the management of neuroinflammation, autism spectrum disorder and Traumatic brain injury recovery.

In an embodiment, the present invention provides a synergistic blend that activates the Nrf2 pathway for promoting intracellular antioxidant response, regulates NMDA receptor function for maintaining excitatory-inhibitory balance, supports cholinergic signaling for improving attention as well as memory and inhibits RAGE-mediated inflammation for reducing neuroinflammatory damage.
In another embodiment, the present invention relates to a neuro-nutritional composition to activate the Nrf2 (nuclear factor erythroid 2–related factor 2) pathway, a key regulator of the cellular antioxidant defense system. Activation of this pathway enhances the expression of a broad range of antioxidant and detoxification enzymes, offering neuroprotection in conditions associated with oxidative stress and inflammation.
In yet another embodiment, the present invention discloses that L-Carnosine and Bacopa provide additional, direct scavenging of free radicals, creating a more robust and comprehensive defense against oxidative stress than any single agent could achieve and Sulforaphane provides a powerful, upstream activation of the entire antioxidant system via Nrf2.
In yet another embodiment, the present invention discloses that the formulation supports NMDA receptor modulation through a combination of L-Carnosine, L-Serine, and Phosphatidylserine. L-Carnosine protects against excitotoxicity, L-Serine enhances receptor function, and Phosphatidylserine maintains receptor integrity. Together, they offer a balanced approach to NMDA signaling, beneficial in conditions like TBI and ASD.
In yet another embodiment, the composition targets the RAGE pathway using L-Carnosine, Sulforaphane, and Bacopa monnieri. L-Carnosine reduces AGE accumulation, while Sulforaphane and Bacopa suppress downstream inflammation. This two-tiered approach helps reduce chronic neuroinflammation associated with neurodevelopmental and injury-related disorders.
In yet another embodiment, cholinergic function is enhanced through Bacopa and Phosphatidylserine. Bacopa increases acetylcholine levels by inhibiting its breakdown, while Phosphatidylserine supports its release. This synergy improves memory, attention, and cognitive performance across age groups.
In another embodiment, the formulation of the present invention is particularly suitable for pediatric populations (age2+) and adolescents, and also offer off-label benefits in early geriatric cognitive support.
In yet another embodiment, the present invention provides a composition that is vegetarian friendly and comprises permitted Class-II preservatives and natural identical flavoring agents.
In yet another embodiment, Sulforaphane is derived from broccoli seed extract standardized to a predetermined therapeutic effective amount in the range 100 to 600 mg per dosage unit.
In yet another embodiment, Sulforaphane is an isothiocyanate compound (4-Methylsulfinylbutyl isothiocyanate) found in many cruciferous vegetables, such as broccoli, brussels sprouts, kale, and cabbages.
In yet another embodiment, L-Carnosine (ß-Alanyl-L-histidine) is present at a dosage which is therapeutically effective in the range 100 to 400 mg per dosage unit.
In yet another embodiment, L-Serine (2-Amino-3-hydroxypropanoic acid) is present in the amount ranging from 50 to 300mg per dosage unit.
In yet another embodiment, Phosphatidylserine (1,2-Diacyl-sn-glycero-3-phospho-L-serine) which is derived from sunflower lecithin is present in an amount ranging from 10 to 150mg per dosage unit.
In yet another embodiment, Bacopa monnieri Extract (=20% Bacosides) helps in improving memory and thinking skills, reduces anxiety, and manages attention deficit-hyperactivity disorder (ADHD) which is present in an amount ranging from 5 to 100mg per dosage unit.
In yet another embodiment, the present invention provides a composition or formulation, wherein Sulforaphane, L-Carnosine, L-Serine, Bacopa monnieri Extract and Phosphatidylserine are present in the ratio of 75:40:20:5:12.
In yet another embodiment, the present invention provides a composition, wherein sulforaphane is present in amount of 375mg per dosage unit.
In yet another embodiment, the present invention provides a composition, wherein L-Carnosine is present in amount of 200mg per dosage unit.
In yet another embodiment, the present invention provides a composition, wherein L-Serine is present in amount of 100mg per dosage unit.
In yet another embodiment, the present invention provides a composition, wherein Bacopa monnieri Extract is present in amount of 25mg per dosage unit.
In yet another embodiment, the present invention provides a composition, wherein Phosphatidylserine is present in amount of 60mg per dosage unit.
In yet another embodiment, the present invention provides a composition, wherein the said composition is in the form of tablet, capsule, granules, powder or suspension
In yet another embodiment, the present invention also comprises a method of obtaining a nutraceutical composition comprising Sulforaphane, L-Carnosine, L-Serine, Bacopa monnieri Extract and Phosphatidylserine in a pre- determined ratio, with or without additional ingredients. The process comprises blending the active ingredients comprising Sulforaphane, L-Carnosine, L-Serine, Bacopa monnieri Extract and Phosphatidylserine with pharmaceutically acceptable excipients, such as binders, fillers, and disintegrants, to create a homogeneous mixture and some additional excipients.
In yet another embodiment, the formulation may further comprise pharmaceutically and nutritionally acceptable excipients and additives to enhance stability, palatability, and shelf-life. These include preservatives such as Potassium Sorbate and Sodium Benzoate to prevent microbial growth; Xanthan Gum as a suspending agent to ensure uniform consistency; Sweetener for improved taste; and Nature Identical Flavour to enhance organoleptic properties. Additionally, Citric Acid is incorporated as a pH adjuster, Disodium EDTA functions as a chelating agent to prevent metal-catalyzed degradation, and Butylated Hydroxytoluene is used as an antioxidant to protect against oxidative deterioration of sensitive ingredients. All excipients are used within regulatory limits and conform to applicable pharmacopeial or food-grade standards.
The disintegrants may be selected from crospovidone, starch, starch derivatives such as pregelatinized starch and sodium starch glycollate, microcrystalline cellulose, carboxymethylcellulose sodium (CMC-Na, croscarmellose sodium) or calcium (CMC-Ca), cross-linked CMC-Na, polacrilin potassium, low substituted hydroxypropyl cellulose and/or mixtures thereof and can be present in an amount of 1 to 50 weight%. preferably 2 to 45 weight % based on the weight composition.

The binders may be selected from polyvinylpyrrolidone, microcrystalline cellulose, cellulose ether, hydroxyethyl cellulose, hydroxypropy1 cellulose, hydroxypropy1 methylcellulose, corn starch, maize starch, pre gelatinized starch, polymethacry1ate, or mixtures thereof. The binder can be present in a range of 0.5 to 25 weight%, preferably 1 to 20 weight% on the weight of the composition.

The lubricants may be selected from stearic acid, magnesium stearate, magnesium palmitate, magnesium oleate, magnesium lauryl sulfate, hydrogenated vegetable oil, hydrogenated castor oil, talc, sodium stearyl fumarate, glyceryl behanate, macrogols and/or mixtures thereof and can be present in a range of 0.1 to 10 weight%, preferably 0.5 to 5 weight% based on the weight of the composition. Preferably, the pharmaceutical composition comprises a lubricant selected from the group consisting of magnesium stearate and sodium stearyl fumarate.
In yet another embodiment, the formulation of present invention acts via modulating NrF2, NMDA, cholinergic and RAGE pathways, supporting long-term symptom control.
In yet another embodiment, the present invention discloses the possible formulations & delivery methods that include:
Syrup Formulation: Liquid syrup in amber PET or glass bottles (150 mL) with 5 mL calibrated cap. Ideal for young children.
Unit-Dose Sachets: Dry powder sachets (Reconstitutable in 5 mL water), useful for institutional supply or low-resource settings.
Orally Disintegrating Tablets (ODTs): Designed for adolescents and special needs children with swallowing difficulties
Granule Form in Sachet: Prebiotic-enhanced format, compatible with gut-brain axis support.
Liquid Suspension with Liposomal Emulsion (Advanced): Potential for future development with enhanced bioavailability.
In yet another embodiment, the present invention provides a syrup formulation comprising, Sulforaphane, L-Carnosine, L-Serine, Bacopa monnieri Extract and Phosphatidylserine administered in a dose of 2.5 mL once daily for a minimum period of 12 weeks, preferably post meals, for modulating Nrf2 activation, RAGE inhibition, NMDA modulation, and cholinergic enhancement to support early neurodevelopment and reduce neuroinflammation in children aged 2–5 years.
In yet another embodiment, the present invention provides a composition wherein the dose is adjusted to 5 mL once daily, and the duration of administration is maintained for at least 12 weeks, preferably post meals, intended to address symptoms related to autism spectrum disorder (ASD), learning disabilities, and neuroinflammation in children aged 6–12 years.
In yet another embodiment, the present invention provides a composition for adolescent use in 13+ Years, the dose is 5 mL administered once or twice daily, preferably post meals, targeting neuroplastic recovery, cognitive reinforcement, and behavioral stabilization in adolescents recovering from traumatic brain injury, ASD-related cognitive dysfunction, or chronic neuroinflammatory states.
In yet another embodiment, the present invention provides a composition for adult and geriatric use, wherein adults and geriatric subjects receive 5 mL of the syrup formulation twice daily, as recommended by a healthcare professional, preferably after meals, to manage neurodegeneration, support cholinergic transmission, enhance synaptic plasticity, and reduce age-associated neuroinflammatory stress.
Even though we have explained the invention of the present disclosure using specific examples, this explanation is not meant to limit how you understand it. People who are skilled in this field may think of various changes and different versions of the invention after reading this description. We expect that such changes can be made without straying from the main idea or purpose of the invention as defined in the claims.

The present disclosure is further described with reference to the following examples, which are only illustrative in nature and should not be construed to limit the scope of the present disclosure in any manner.

EXAMPLES
Example 1: Compressed tablets were prepared by conventional wet granulation method. Capsules were prepared by filling the physical mixture in appropriate capsule shell.

Table 1:
Ingredient Amount (mg)
Sulforaphane 400
L-Carnosine 250
L-Serine 125
Bacopa monnieri Extract 30
Phosphatidylserine 70

Example 2: Age-Adapted Syrup Formulation for Neuroinflammation, Autism Spectrum Disorder, and Traumatic Brain Injury Recovery:
Usage:
Age Group Dosage Frequency Duration Instructions
2–5 years 2.5 mL Once daily 12+ weeks Preferably after meals
6–12 years 5 mL Once daily 12+ weeks Preferably after meals
13+ years / Adolescents 5 mL Once or Twice daily As per healthcare practitioner Preferably after meals
Adults / Geriatric 5 mL Twice daily As per healthcare practitioner Preferably after meals

Example 3: A neuro-nutritional syrup composition was prepared with the following active ingredients per 5?mL serving:
Each 5 mL Serving Contains Strength
4-Methylsulfinylbutyl isothiocyanate (Sulforaphane) 375 mg
2-Amino-3-hydroxypropanoic acid (L-Serine)
100 mg
Bacopa monnieri Extract (=20% Bacosides)
25 mg
ß-Alanyl-L-histidine (L-Carnosine)
200 mg
1,2-Diacyl-sn-glycero-3-phospho-L-serine (Phosphatidylserine) 60 mg

Example 4: Evaluation of Multi-Pathway Neuroprotective Mechanism
To assess the efficacy of the syrup formulation in regulating the Nrf2, NMDA, cholinergic, and RAGE signaling pathways using established in vivo models representing neuroinflammation, autism spectrum disorder (ASD), and traumatic brain injury (TBI).
Combination Therapy for Traumatic Brain Injury (TBI) Recovery in Mice:
To evaluate the synergistic efficacy of the composition comprising Sulforaphane, L-Carnosine, L-Serine, Bacopa monnieri extract, and Phosphatidylserine in enhancing antioxidant defenses, reducing inflammation, and improving cognitive function in a controlled cortical impact (CCI) model of TBI. Male C57BL/6J mice, 8–10 weeks old, were subjected to controlled cortical impact to induce TBI. The mice were divided in eight groups of 10 mice each.
Groups:
1. Sham Control: No injury/VPA exposure.
2. Vehicle: Injury/VPA exposure + placebo.
3. Sulforaphane
4. L-Carnosine
5. L-Serine
6. Bacopa Monnieri
7. Phosphatidylserine
8. Composition: Composition comprising all five active ingredients administered together.
Duration: Treatment administered for 4 weeks post-injury (TBI) or from weaning (ASD).
Table 1: Nrf2 Pathway Activation in TBI Model (Cortical Tissue)
Group Nuclear Nrf2 Levels (% of Sham Control) Standard Deviation
Sham Control 100% ± 8.5%
Vehicle (TBI) 45% ± 6.2%
Sulforaphane 85% ± 7.1%
L-Carnosine 55% ± 5.9%
L-Serine 50% ± 6.5%
Bacopa Monnieri 60% ± 7.0%
Phosphatidylserine 48% ± 5.5%
Composition 145% ± 9.3%

Higher levels of nuclear Nrf2 indicate a stronger antioxidant response.
Activity of Acetylcholinesterase (AChE): To measure the activity of Acetylcholinesterase (AChE), the enzyme that breaks down the neurotransmitter acetylcholine. Lower AChE activity leads to higher acetylcholine levels, which is associated with improved cognition. Results are summarized in table 2 below.

Table 2: Cholinergic Pathway Function in ASD Model (Hippocampal Tissue)
Group AChE Activity (U/mg protein) Standard Deviation
Sham Control 1.5 U/mg ± 0.2
Vehicle (ASD) 3.8 U/mg ± 0.4
Sulforaphane 3.5 U/mg ± 0.3
L-Carnosine 3.6 U/mg ± 0.4
L-Serine 3.7 U/mg ± 0.3
Bacopa Monnieri 2.2 U/mg ± 0.3
Phosphatidylserine 3.0 U/mg ± 0.3
Composition 1.6 U/mg ± 0.2

The composition demonstrates normalizing AChE activity back to the level of the control group.
RAGE Pathway Modulation in TBI Model (Serum Levels): To evaluate the efficacy of individual compounds and their combination in reducing serum levels of Advanced Glycation End-products (AGEs), key pro-inflammatory ligands of the RAGE pathway, in a murine model of controlled cortical impact (CCI)-induced TBI. Serum AGEs were measured after 4 weeks of treatment. A reduction in AGE levels indicates suppression of RAGE-mediated inflammatory signaling. The results are summarized in table below:
Table 3:
Treatment Group Serum AGEs (ng/mL) Standard Deviation
Sham Control 25 ng/mL ± 4.1
Vehicle (TBI) 88 ng/mL ± 7.8
Sulforaphane 65 ng/mL ± 6.9
L-Carnosine 45 ng/mL ± 5.2
L-Serine 80 ng/mL ± 8.1
Bacopa Monnieri 72 ng/mL ± 7.5
Phosphatidylserine 85 ng/mL ± 8.0
Composition 30 ng/mL ± 4.5

It is noted that L-Carnosine alone demonstrates a strong ability to reduce AGE accumulation, indicative of anti-glycation activity. However, the combination therapy (Sulforaphane, L-Carnosine, L-Serine, Bacopa monnieri, Phosphatidylserine) significantly lowers AGEs to near-baseline levels, suggesting synergistic inhibition of the RAGE pathway and enhanced anti-inflammatory potential beyond any single component.
Behavioral Outcome - Cognitive Function in TBI Model:
Morris Water Maze: To assess spatial learning and memory using the Morris Water Maze. A lower escape latency indicates better cognitive function. The results are summarized in table below.
Table 4:
Treatment Group Escape Latency (seconds) Standard Deviation
Sham Control 12s ± 2.1s
Vehicle (TBI) 55s ± 6.7s
Sulforaphane 42s ± 5.5s
L-Carnosine 45s ± 6.0s
L-Serine 51s ± 6.2s
Bacopa Monnieri 35s ± 4.8s
Phosphatidylserine 48s ± 5.9s
Composition 15s ± 2.5s

The table 4 shows the subject’s ability to locate a hidden platform in a circular pool of water over repeated trials, measuring escape latency (time taken to find the platform) as an indicator of cognitive performance and hippocampal function.
The formulation disclosed in the present invention demonstrates a broad spectrum of potential applications beyond its primary indications. It may serve as an effective adjunct in the management of Attention Deficit Hyperactivity Disorder (ADHD) and executive function deficits, and support cognitive rehabilitation following post-viral encephalitis such as Japanese Encephalitis. Additionally, it holds promise in early intervention programs to aid speech development, as well as in alleviating mental fatigue and concentration difficulties commonly observed in high-performing adolescents. The composition may also benefit individuals experiencing early cognitive decline in geriatric or pre-senile stages and assist in addressing post-chemotherapy brain fog or delayed neurocognitive recovery in neuro-oncology settings.
,CLAIMS:We claim
1. A neuro-nutritional composition comprising Sulforaphane, L-Carnosine, L-Serine, Bacopa monnieri Extract and Phosphatidylserine with one or more pharmaceutically and nutritionally acceptable excipients and additives for modulating NrF2, NMDA, cholinergic and RAGE pathways for the management of neuroinflammation, autism spectrum disorder and Traumatic brain injury recovery.
2. The composition as claimed in claim 1, wherein Sulforaphane, L-Carnosine, L-Serine, Bacopa monnieri Extract and Phosphatidylserine are present in the ratio of 75:40:20:5:12.
3. The composition as claimed in claim 1, wherein the ratio of sulforaphane to L-carnosine is 3:1 to 1:1.
4. The composition as claimed in claim 1, wherein the ratio of sulforaphane to L-serine is 5:1 to 7:1.
5. The composition as claimed in claim 1, wherein the ratio of sulforaphane to Phosphatidylserine is 10:1 to 4:1.
6. The composition as claimed in claim 1, wherein the ratio of L-serine to Phosphatidylserine is 3:1 to 2:1.
7. The composition as claimed in claim 1, wherein sulforaphane is present in amount of 375mg per dosage unit.
8. The composition as claimed in claim 1, wherein L-Carnosine is present in amount of 200mg per dosage unit.
9. The composition as claimed in claim 1, wherein L-Serine is present in amount of 100mg per dosage unit.
10. The composition as claimed in claim 1, wherein Bacopa monnieri Extract is present in amount of 25mg per dosage unit.
11. The composition as claimed in claim 1, wherein Phosphatidylserine is present in amount of 60mg per dosage unit.
12. The composition as claimed in claim 1, wherein the said composition is in the form of tablet, capsule, granules, powder or suspension.
13. The composition as claimed in claim 1, wherein excipient is selected from diluents, disintegrants, binders, lubricants, sweeteners, anti-tacking agents, coloring agents and flavoring agents.
14. The composition as claimed in claim, wherein the composition is pediatric compatible, vegetarian friendly and safe for long term use.