Today, I’ll review the formulations and research that illustrates the role of medical foods which are a unique classification of formulations that are approved by the FDA.

Additionally, I will speak to the potential value of nutraceuticals and supplemental food-derived products in supporting cognitive health in aging individuals at risk for late-onset Alzheimer’s disease (LOAD).

And what are medical foods?

Medical foods are defined products and nutrient formulations that are specifically designed for the dietary management of a disease. Medical food products are regulated by the FDA.

Plus, medical foods contain nutrients or food-based therapeutic ingredients that provide a medical or health benefit, and thus the use of “medical” in the term.

Three medical foods will be highlighted in today’s episode that address three essential aspect of maintaining and optimizing cognitive function as you age—brain rejuvenation, brain protection (neuroprotection) and brain energetics (neuroenergetics).

With regard to brain rejuvenation, the formulation—Souvenaid® (Fortasyn Connect), which is available in Australia where it is designated as a “Food for Special Medical Purpose”, and it is also available in Singapore and parts of Europe.

Souvenaid® is a medical nutrition drink that contains a unique blend of ingredients known as Fortasyn® Connect, which is “formulated to support the growth of brain connections”, which means that it supports the synthesis of neuronal and synaptic membranes that are vital in synaptic function.

And that is an important point that I cover in The Diabetic Brain in Alzheimer’s Disease.

The Souvenaid formulation includes omega 3 fatty acids (EPA, DHA), phospholipids, choline, selenium, vitamin E, vitamin C, B12 B6, folic acid and uridine.

Several studies and trials have evaluated the benefits of Souvenaid® and in a consensus opinion of those studies published in 2019 it was determined that there was improvement in memory and cognitive performance in patients with MCI and early Alzheimer’s disease.

Nevertheless, it was also stated that “currently, there is not enough evidence to conclude that Souvenaid® decreases the rate of progression from MCI to dementia.”

However, you will often see if you do a search for that product that it is described by a few sources, including the Souvenaid website, that the formulation is suitable “for the early stages of Alzheimer’s disease” which is often associated with MCI.

And here is why:

Several analyses and clinical trials have shown benefits in memory and cognitive performance in patients with MCI and early Alzheimer’s disease as the 2019 consensus opinion analyses reported.

In the longest randomized clinical trial—3 years— in prodromal Alzheimer’s or MCI due to Alzheimer’s pathology—the LiPiDiDiet study, patients who were taking Souvenaid once daily for 3 years showed the following outcomes:

• Slowed the progression of memory and cognitive decline by 60%

• Reduced brain shrinkage by 33%

• Reduced the loss of everyday task performance by 45%

The LiPiDiDiet study conclusions were:

“This multi-nutrient intervention slowed decline on clinical and other measures related to cognition, function, brain atrophy, and disease progression. These results indicate that intervention benefits increased with long‐term use.”

Those findings were published in January of 2021.

The ingredient profile Souvenaid® formulation is designed for the rejuvenation of the critical membranes that surround the neuron which are particularly beneficial in the function of the synapse.

Neuronal cellular membrane integrity is vital for the myriad of synaptic signaling trafficking mechanisms that underlie synaptic plasticity.

And that is what Souvenaid® is designed to do—to enhance the formation and function of synapses that are a critical juncture in the communication and transmission between neurons, which are central to learning and memory formation processes.

I decided to talk about this formula to emphasize the ingredients and what their combined benefits can do for nourishing and rejuvenation critical brain synapses.

Please listen into this episode to hear my overview on the benefits associated with the Souvenaid ® ingredients.

The second formulation— CerefolinNAC®, which like Souvenaid, is composed of two key ingredients L-methylfolate—a bioactive folate, and N-acetyl cysteine.

The formula caplet contains L-methylfolate (Metafolin®), Algae-S Powder (Schizochytrium), 2 mg of Methylcobalamin and 600 mg of N-Acetyl-L-Cysteine. (N-acetylcysteine)

CerefolinNAC® is a prescription medical food “ formulated to meet the distinctive nutritional requirements of patients with a type of memory loss called mild cognitive impairment (MCI).”

CerefolinNAC® is “formulated to meet the distinctive nutritional requirements of patients with a type of memory loss called mild cognitive impairment (MCI).”

MCI is considered to be a prodromal stage that may convert to LOAD. However, not all individuals with MCI progress to LOAD.

CerefolinNAC® provides a bioactive form of folate—methylfolate and methylcobalamin which is a form of B12 that also functions as a methyl donor and is a like folate, a critical nutrient for supporting healthy methylation pathways that includes an efficient metabolism of homocysteine—a toxic amino acid derived from metionine metabolism.

How important are these B vitamins in cognitive health in aging individuals?

Several studies have shown that elevated homocysteine levels are associated with increased brain atrophy, and B vitamin therapy lowers aberrant levels homocysteine—a potentially toxic molecule that is linked to a decrease in brain grey matter which is referred to as brain shrinkage or atrophy.

The CerefolinNAC® ingredients are also beneficial for aging individuals at risk, or who have been diagnosed with cardiovascular disease which makes CerefolinNAC® cardioprotective and neuroprotective.
Listen in to hear the rest of the CerefolinNAC® ingredients story.

The last medical food overview I cover in this episode is Axona.

Axona is a prescription medical food containing a proprietary formulation of medium chain triglycerides (MCTs).

MCTs are derived from coconut and palm kernel oils and there are four that are commonly designated in the family of MCTs— caproic acid (C6), caprylic acid (C8), capric acid (C10), and lauric acid (C12).

Axona is primarily composed of caprylic acid or C8, which is also referred to as octanoic acid.

Research shows the MCTs and particularly C8 and C10 can fulfill a critical need for an energy substrate for the aging brain.

MCTs are metabolized to a ketone body—beta-hydroxybutyrate (BHB) in the liver, which provides cells and neurons with an alternative energy source to glucose.

I cover this in depth in my book, The Diabetic Brain in Alzheimer’s Disease, along with the importance of ketogenic, intermittent fasting and caloric restriction diet therapy that supports and protects mitochondrial energy metabolism in the brain.

In today’s episode I also briefly share about my favorite nutrients and extracts supplements that are based on a considerable amount of research regarding their significant benefit in heart and brain health.

Remember, anything that is good for your cardiovascular health is also very good for brain.

The importance of a healthy heart-brain axis cannot be overemphasized. The same holds true for the gut-brain axis.

Here is an overview of my favorite polyphenol, carotenoid and sulforaphane supplements.

First, my highly recommended polyphenol extracts available in many supplemental products include many resveratrol extracts, fisetin, grape seed extract, curcumin, genistein, EGCg (Epigallocatechin gallate), luteolin, found in celery and other vegetables, and quercetin.

Carotenoid supplements include astaxanthin—found in krill oil products, and lycopene, zeaxanthin and lutein.

A study published in May of this year (2022) found that people with the highest levels of the antioxidants—lutein and zeaxanthin and beta-cryptoxanthin (a carotenoid found in oranges, tangerines, mangoes, papaya, and peaches) in their blood were less likely to develop dementia decades later than people with lower levels of these antioxidants.

Another recent study (June 2022) determined while men and women consumed about the same level of carotenoids, the requirements for carotenoids such as lutein and zeaxanthin in women are much higher due to their increased vulnerability to macular degeneration and LOAD.

Another aspect of that vulnerability in women and increased need to more carotenoid intake is they store of these fat-soluble carotenoids in their body fat which makes them less available to the brain.

Lastly, sulforaphane which in supplemental form is usually derived from broccoli seed or sprouts is one of the most powerful phytochemicals available in a supplement.

Sulforaphane-rich foods include cruciferous vegetables such as kale, spinach and chard, and in broccoli, brussels sprouts, cabbage and other vegetables.

Please listen in to my last episode #14 for a more comprehensive overview on food-derived polyphenols, carotenoids and sulforaphane that are abundant in the Mediterranean, MIND and Improved MIND Diet.

The polyphenols, carotenoids and sulforaphane found in foods and available as supplements provide and unparalleled abundance of nutrients that not only provide antioxidant and anti-inflammatory cardio- and neuroprotection, but they also are integral to:

• neurogenesis,

• synaptic plasticity,

• cerebral blood flow,

• blunting of beta-amyloid aggregation and their neurotoxic effects, and the support for their degradation (autophagy) and clearance,

• enhancement of metabolic health (mitochondrial energy metabolism, prevention of metabolic diseases),

• functional benefit of phytoestrogens, and

• optimizing healthspan and longevity.

Ant the same benefits are associated with many vitamins and other nutrients such as B vitamins, glutathione and NAC that I covered here today, and vitamin D, C and E, CoQ10, alpha-lipoic acid and many others.

Now, for the most part I’ve covered in the ingredient-associated benefits of the medical foods and supplements which are an essential component of the cornerstones which I incorporate into my BrainDefend® body-brain health and renewal program—Protect, Rejuvenate and Energize.

A reminder to make sure your supplement is a product that’s made by a good manufacturer, and one that features proprietary extracts which often includes a delivery system technology to facilitate their absorption.

Several studies and analyses over the past years have demonstrated that supplements bought on Amazon have been found to have labels that don’t match contents, meaning that the ingredient levels are either non-existent of far below what the label states.

Please visit TheAlzheimer’sSolution.com or BrainDefend.com if you have a chance to learn more about my book and programs.

Sincerely, Ralph Sanchez, MTCM, CNS, D.Hom

https://www.TheAlzheimersSolution.com

https://www.facebook.com/TheAlzheimersSolution/

https://www.linkedin.com/in/ralph-sanchez/

https://www.instagram.com/alzheimers_solution/

• Nutraceuticals are supplement formulations intended for clinical/professional use. The term, nutraceutical, is a hybrid term combining “nutrition” and “pharmaceutical” coined by a doctor in 1989, with no formal regulatory definition.

• Berberine, a plant extract derived from herbs like barberry and oregon grape root, has been compared to metformin in lowering elevated blood glucose and triglycerides in type 2 diabetes patients.

• Medical foods are FDA-regulated, physician-supervised formulations for the dietary management of disease; none currently exist in the treatment for Alzheimer’s, though several are designed to the cognitive deficits associated with mild cognitive impairment (MCI).

• Souvenaid, built on the Fortasyn Connect blend (omega-3s EPA/DHA, phospholipids, choline, uridine, selenium, vitamins E, C, B12, B6, folic acid), is designed to support synthesis of neuronal membranes and synaptic connections.

• In the 3-year LiPiDiDiet trial, Souvenaid slowed memory and cognitive decline by 60%, reduced brain shrinkage by 33%, and reduced loss of everyday task performance by 45% in people with mild cognitive impairment in Alzheimer’s disease.

• Choline is essential for membrane phospholipids, acetylcholine synthesis, and methylation (including homocysteine metabolism); about 90% of Americans fall below the Adequate Intake Level, and ApoE4 carriers may have higher requirements for choline intake.

• ApoE4 carriers also require higher intakes of DHA to optimize cognitive function; DHA supports membrane fluidity, synaptic signaling, and provides antioxidant/anti-inflammatory neuroprotection.

• CerefolinNAC contains L-methylfolate, methylcobalamin (B12), Algae-S (Schizochytrium, a DHA source), and N-acetylcysteine (NAC), and is formulated for patients with mild cognitive impairment.

• Elevated blood homocysteine levels is associated with increased brain atrophy (grey matter loss); B vitamins (folate, B12, B6, B2) help regulate homocysteine metabolism, and B12/folate deficiency is linked to lower brain volume and dementia risk.

• NAC (N-acetylcysteine) is an amino acid precursor for glutathione synthesis; glutathione is the body’s core antioxidant, protects against oxidative damage to DNA, RNA, and lipid membranes, and contributes to mechanisms underlying synaptic plasticity, learning, and memory.

• Axona is a prescription medical food based primarily on caprylic acid (C8 MCT), which is metabolized in the liver to the ketone body beta-hydroxybutyrate (BHB), providing an alternative energy source to glucose for the aging brain (a brief overview and illustration of liver-brain MCT and ketone metabolism is included in “The Diabetic Brain in Alzheimer’s Disease”.

• The BrainDefend program’s three cornerstones are Protect, Rejuvenate, and Energize:

– Protect involves neuroprotective nutrients (e.g., NAC, glutathione, DHA, polyphenols);
– Rejuvenate involves membrane-supporting nutrients (folate, DHA, polyphenols) that also enhance neurogenesis;
– Energize involves optimizing brain energy metabolism with targeted nutrition, nutraceuticals, and supplements, which are particularly relevant in preventing insulin resistance.

• A May 2022 study found people with the highest blood levels of lutein, zeaxanthin, and beta-cryptoxanthin (found in oranges, tangerines, mangoes, papaya, peaches) were less likely to develop dementia decades later.

• A June 2022 study found that while men and women consume similar amounts of carotenoids, women have higher requirements for lutein and zeaxanthin due to increased vulnerability to macular degeneration and late-onset Alzheimer’s, and their storage of these carotenoids in body fat makes them less available to the brain.

• Polyphenols, carotenoids, and sulforaphane activate the Nrf2-Antioxidant Response Element (ARE) pathway, which stimulates expression of over 300 genes for detoxification, antioxidant, and anti-inflammatory protection; these compounds also stimulate neurogenesis, support synaptic plasticity, improve cerebral blood flow, decrease beta-amyloid aggregation and support its clearance fron the brain.

• Studies have found that supplements bought on Amazon often have labels that don’t match contents, with ingredient levels non-existent or far below stated amounts, underscoring the importance of choosing reputable manufacturers.

Epidsode 15

Timestamp Highlights

Please listen in!

Ralph Sanchez, MTCM, CNS, D.Hom

BrainDefend®

www.TheAlzheimersSolution.com

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www.linkedin.com/in/ralph-sanchez

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