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Getting the Miracle Molecule Where It Needs To Go
by Gerald Bruno, PhD

 

 
I have taken the liberty of describing alpha lipoic acid as the “miracle molecule” because it is among the most valuable nutritional supplements we can take for our over-all well-being.  I believe that alpha lipoic acid ascends to the “miracle” level because it has a wide spectrum of biological activities that are useful in treating serious diseases, it is valuable in protecting against the formation or progression of serious diseases, and it can be a major contributor to achieving “healthy aging”.
 
At this point you are probably wondering - “If alpha lipoic acid is really a miracle molecule why haven’t I heard of it and why isn’t everybody taking it?”  There is no single answer to this question, but the major reason is that alpha lipoic acid is a naturally-occurring substance that cannot be patented.  Without patent protection, no company will invest the hundreds of millions to conduct controlled clinical studies to prove efficacy, and even greater amounts in advertising costs to make it a household name.  If alpha lipoic acid were patentable, I’m sure we would all be asking our family physicians “if it was right for us”.  Even without these investments, the alpha lipoic acid story is still pretty interesting.

The Science Behind Alpha Lipoic Acid
 
Alpha lipoic acid is a naturally occurring substance that was discovered in the early 1950's by Dr. Irwin Gunsalvas at the University of Illinois.  He was granted a patent on alpha lipoic acid in 1962, which led to its use in the treatment of chronic liver disease in the 1970's.  Since that time, many thousands of scientific studies have been undertaken to characterize the alpha lipoic acid molecule and to explore its biological properties in laboratory, animal and human studies.  Many accomplished scientists have contributed to our understanding of the alpha lipoic acid molecule, but prominent among these researchers are Dr. Bruce Ames (University of California, Berkeley), Dr. Tory Hagen (Linus Pauling Institute at Oregon State University) and Dr. Burton Berkson (Integrative Medical Center of New Mexico).  Dr. Ames did the pioneering work on the use of alpha lipoic acid, coupled with acetyl-L-carnitine, to delay aging, demonstrating a beneficial effect on mitochondrial function.  Dr. Hagen's work has focused attention on the many biological properties of alpha lipoic acid that he believes slow down the "process" of aging.  Dr. Berkson's work encompassed the use of alpha lipoic acid in combination with silymarin and selenium to protect the liver from the hepatitis c virus and other liver toxins.
 
Alpha lipoic acid stands out among the valuable anti-oxidants because of its unique fatty acid chemical structure.  It is commonly referred to as the "universal antioxidant' or the "anti-oxidants anti-oxidant", because it is soluble in both the aqueous and lipid compartments of the body, and is effective in regenerating the body's natural anti-oxidants, most notably glutathione.  The superior anti-oxidant properties of alpha lipoic acid alone would support my characterizing it as a miracle molecule, but more recent research has shed light on a wide range of other biological properties with corresponding functions beneficial to a "healthy lifespan".  Imagine consuming a product that will help you deal with a serious age-related condition, and instead of dangerous side-effects, that product has numerous other effects that are also beneficial to restoring a healthy balance.  In today's world that would surely qualify as a miracle.

Energy, Oxidative Stress, and Declining Natural Protection
 
Humans derive energy from the mitochondria found in all cells, through the complex process of cellular respiration.  The process uses the oxygen we breathe to "burn" or "convert" glucose and fatty acids (from food) to chemical energy.  During the respiration process, reactive oxygen species, or free radicals are formed that would be highly destructive to the cell structures if they were not neutralized by natural cellular anti-oxidants, most notably glutathione.  This natural process works effectively under normal conditions, but begins to break-down with aging and with abnormal metabolic conditions.  This break-down is reflected by a decline in the ability of natural anti-oxidants like glutathione to neutralize the free radicals produced in the cell.  This condition is called "oxidative stress" and is believed to be a major contributor to cellular aging and the degenerative diseases that accompany aging, such as cancer, cardiovascular disease, immune system decline, brain dysfunction, and cataracts.

Glutathione: The Master Anti-oxidant
 
Glutathione is the body's primary defender against free radicals, but it cannot be taken in oral supplement form to counteract oxidative stress.  Naturally occurring anti-oxidants in fruits and vegetables can be of great benefit in counteracting oxidative stress, but are generally not consumed in sufficient quantities by the average individual.  Alpha lipoic acid supplementation provides a powerful, convenient and inexpensive means of augmenting the body's natural anti-oxidant defense system.   It crosses the blood brain barrier, and regenerates oxidized glutathione, Vitamins C & E, and Coenzyme Q10.   Unlike drugs that are designed to alter metabolic functions, alpha lipoic acid helps to restore normal oxidative balance, and positively impacts over-all well-being through its other beneficial biological properties.  Recent research suggests that alpha lipoic acid may exert its anti-oxidant effect by stimulating the formation of glutathione.

A Healthy Lifespan
 
Dr. Tory Hagen from the Linus Pauling Institute has studied the wide range of beneficial functions of alpha lipoic acid and concluded that “it is a remarkable compound that in animal experiments appears to slow down the process of aging”.  Dr. Hagen found evidence that alpha lipoic acid was a low-level stressor that turns on the basic cellular defenses of the body, including some that naturally decline with age.  In particular, alpha lipoic acid tends to restore levels of glutathione to those of a young animal.  In light of our aging epidemic, along with skyrocketing diabetes, high blood pressure, and heart disease, the diverse beneficial effects of alpha lipoic acid make the molecule a compelling interventional option.  Dr. Hagen’s studies have shown that mice supplemented with alpha lipoic acid have a cognitive ability, behavior, and genetic expression of almost 100 detoxification and anti-oxidant genes that are comparable to that of young animals. Dr. Hagen commented that “We never really expected such a surprising range of benefits from one compound. This is really unprecedented and we’re pretty excited about it”.  Dr. Hagen’s anti-aging interest is focused more on the potential use of alpha lipoic acid to make the later years in life healthier, than on the extension of life.

Protecting Your Liver
 
Our modern world has become an inhospitable environment for the overall well-being of the human liver.  In addition to infectious agents like the hepatitis c virus, the liver is exposed to a wide array of herbicides, pesticides, preservatives, mycotoxins, pollutants, and all-nature of chemicals that are used in food-processing and packaging and most other elements of our daily existence.  If that weren’t a big enough job for this critical detoxifying organ, the liver is also under attack from fat cells that accumulate in the liver of obese individuals.
 
Liver disease starts with inflammation, and if left untreated over time, inflamed liver tissue starts to scar or becomes fibrous.  If fibrosis is not treated or healed, irreversible damage can occur, called cirrhosis, which in turn can lead to liver cancer.  If the liver loses most or all of its functioning cells, a life-threatening condition called liver failure can occur.
 
Dr. Burton Berkson was an early pioneer in the use of alpha lipoic acid in liver disease, using intravenous alpha lipoic acid to treat acute liver failure associated with mushroom poisoning.  These early studies sparked Dr. Berkson’s interest in the remarkable alpha lipoic acid molecule, and he has continued to study the compound over the past 30 years, most notably exploring it’s use in treating hepatitis c in a triple antioxidant regimen.  Dr. Berkson’s successful use of alpha lipoic acid to treat three hepatitis c patients was first reported in 1999, and has since been updated in 2007 in an article in the Townsend Letter.  Two of the three patients still see Dr. Berkson and continue to improve after almost 10 years of treatment.
 
The key consideration in the use of alpha lipoic acid in hepatitis c and other liver diseases is protection and regeneration of the liver cells.  Alpha lipoic acid does not eradicate the hepatitis c virus in patients who are unresponsive to interferon therapy, but protects the liver cells from progression to liver fibrosis and liver failure.  It is generally believed that alpha lipoic acid exerts this effect through anti-oxidant protection of lipid structures in the cell, but just published research suggests that alpha lipoic acid also inhibits the progression to liver fibrosis by inhibiting hepatic plasminogen activator inhibitor (PAI-1) expression by inhibition of the signaling pathway.  If this study is confirmed in further research, alpha lipoic acid will add another profoundly important biological property to its already impressive portfolio.
 
Diabetic Neuropathy
 
Alpha lipoic acid is an approved drug in Germany for the treatment of diabetic neuropathy, but such a claim is not permissible in the United States without submission of substantiating clinical data and approval of the claim by the FDA.  Numerous clinical studies have been conducted on alpha lipoic acid for diabetic polyneuropathy, with most studies confirming that intravenous alpha lipoic acid improves neuropathic symptoms, with less clear-cut data reported on the use of oral alpha lipoic acid.  A study conducted by Peter Dyck, M.D. at the Mayo Clinic showed a large and rapid response in alleviating the pain of diabetic neuropathy when alpha lipoic acid was administered intravenously, but oral dosing had not been evaluated.
 
The difference in treatment effectiveness between intravenous and oral alpha lipoic acid is not unexpected, considering the poor solubility and absorption of alpha lipoic acid crystals, and underscores the importance of enhanced absorption and bioavailability formulations.  A recent article in the Netherlands Journal of Medicine reviewed all clinical studies with alpha lipoic acid for diabetic neuropathy and found that neuropathy symptoms were reduced by 50%.  They found that taking alpha lipoic acid by mouth was beneficial, and there was significant improvement with neuropathy pain with intravenous infusions.

Bridging the Gap Between Intravenous and Oral Dosing
 
At the time of the German clinical studies, all oral dosage forms contained crystalline alpha lipoic acid powder that was poorly soluble in water, and thus poorly absorbed into the bloodstream from the GI tract.  Believing that the effectiveness of oral dosage forms could be enhanced by solubilizing the crystalline powder, a startup discovery company embarked on a research project to develop an oral dosage form that would deliver alpha lipoic acid blood levels that approached intravenous dosing.  Using advanced formulation techniques, a solubilized alpha lipoic acid dosage form was developed that was similar to the high bioavailability formulations used for poorly soluble substances like ibuprofen (Advil) and coenzyme Q10.  This solubilized, enhanced bioavailability product was made commercially available about 10 years ago under the brand name ThioGel.

Studies were conducted in animals and humans that demonstrated a 2–3 fold increase in plasma levels of alpha lipoic acid using the solubilized product versus powder based products marketed at that time. As with all nutraceuticals and drug substances, adequate levels of alpha lipoic acid must reach the cells to achieve a clinically significant effect. Based on the diabetic neuropathy clinical studies, it appears that adequate cellular levels of alpha lipoic acid cannot be achieved, or are only marginally achieved at best, with common powder based oral products. The inadequate or marginal cellular uptake of alpha lipoic acid can be substantially increased with solubilized alpha lipoic acid, shifting the cellular uptake equation to a more substantial clinical effect.

Bioavailability: Getting Alpha Lipoic Acid Where It Needs To Go
 
Bioavailability is a large word that is hard to spell and probably even harder to understand.  Bioavailability has been defined as “the extent to which the active moiety enters the circulation, thereby gaining access to the site of action”.  In simpler terms, it is a measure of how much of a dose of orally administered product is absorbed from the intestines, enters the bloodstream, and is delivered to the cells (the site of action).  It is intuitively obvious that a drug or nutraceutical substance will not be effective if it is not absorbed into the blood and delivered to the cell where it exerts its biological effect.  This is fully recognized by drug companies, and the necessary formulation and pharmacokinetic studies are undertaken to assure maximum absorption and the desired biological effect.  This is generally not the case with nutraceuticals, but is beginning to be addressed by ingredient suppliers and a few research-oriented supplement manufacturers.
 
It is possible to increase the absorption and bioavailability of alpha lipoic acid administered in oral dosage forms by employing advanced formulation techniques to solubilize poorly soluble alpha lipoic acid powder.  Unfortunately, studies demonstrating clinical effectiveness are rare in the nutraceutical world, and we are left with extrapolation from laboratory data, anecdotal reports, and comparative kinesiology testing.  While these approaches do not measure up to controlled clinical studies, they do provide a measure of confidence in selecting a product formulation that will deliver the best clinical result.  The solubilized formulation of alpha lipoic acid is based on solid laboratory data, has been used successfully for many years by respected clinicians, and always tests in the top level in comparative kinesiology testing.

It is critically important to understand the absorption and bioavailability profile of natural substances to assure adequate absorption into the circulation and adequate uptake in the cells to exert the desired biological effect.  Consumption of powder-based formulations delivers substantially lower and variable amounts of alpha lipoic acid to the site of action in the cells, and these amounts my not be adequate to realize the desired biological effect.  Solubilized alpha lipoic acid delivers more of the “miracle molecule” to where it is destined to go.

 

 

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About the Author


Gerald Bruno, PhD, is the Founder and CEO of Ethical Alternative Products, a nutritional supplement manufacturer that specializes in science-based products that employ innovative formulations to enhance product performance.

www.gotoeap.com
 

 

 

 

 

 

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