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Frequently Asked Questions About ThioGel and Alpha Lipoic Acid

 

 How do anti-oxidants work in the body?

The primary role of anti-oxidant products is to act as a scavenger of free radical molecules, inactivating various reactive oxygen species such as hydroxyl radicals, nitric oxide radical, peroxynitrite, hydrogen peroxide, hypochlorite, singlet oxygen, superoxide, and peroxyl radicals.  Anti-oxidants also work to reduce free radicals by a variety of other complex mechanisms.

 How does alpha lipoic acid work?

 Alpha lipoic acid and its reduced metabolite, dihydrolipoic acid (DHLA), form a redox couple and may scavenge a wide range of reactive oxygen species.  Both ALA and DHLA can scavenge hydroxyl radicals, the nitric oxide radical, peroxynitrite and hypochlorite.  ALA, but not DHLA, may scavenge singlet oxygen, and DHLA, but not ALA, may scavenge superoxide and peroxyl reactive oxygen species.  Unique among anti-oxidants, ALA and its redox couple, DHLA have been found to have anti-oxidant activity in aqueous, as well as in lipophilic regions, and in extracellular and intracellular environments.  Also unique among anti-oxidants, ALA appears to participate in the recycling of other important endogenous anti-oxidants such as vitamins E and C, ubiquinone and glutathione.

Exogenous ALA has been shown to increase ATP production, and it is thought that this is due to its role in the oxidation of pyruvate and alpha-ketoglutarate in the mitochondria, ultimately enhancing energy production.  This activity, and possibly its anti-oxidant activity, may account for its beneficial effect in diabetic polyneuropathy.

 Is there any toxicity or side effects from using alpha lipoic acid?

Alpha lipoic acid has an excellent safety record over decades of use.  There have been no adverse reactions reported, no known contraindications, and no known reports of ALA over-dosage.  ALA is regulated as a prescription drug in Germany and dosages of 600 mg per day have been well-tolerated in long-term treatment of diabetic neuropathy.

The only precaution is that ALA may lower blood glucose levels and individuals with diabetes should monitor blood glucose levels for possible adjustment of anti-diabetic medications.  Individuals with glucose tolerance problems should also be aware of possible ypoglycemia with ALA use.  Dr. Peter Dyck, renowned diabetologist at the Mayo Clinic, recently reported on a clinical study of ALA and indicated that the compound is “very safe”.  “There have been no known complications”.  It is also recommended that a daily multivitamin be taken when using ALA supplements, as ALA has been reported to deplete B complex vitamins due to its effect upon metabolism.

 Are all alpha lipoic acid products the same?

No!  Most ALA products utilize ALA that is a racemic mixture of S and R forms (etantiomers or structural mirror images).  More on the R form later.  The ALA raw material is supplied to manufacturers as a powder, that is extremely insoluble in water, and even less soluble at acidic pH.  The easiest and least expensive way to put the powdered ALA into a pharmaceutical dosage form is to either make ALA tablets or fill the ALA powder into gelatin capsules.  Essentially all manufacturers, except Ethical Alternative Products, produce their products with ALA powder.

Because ALA is insoluble in water and less soluble at an acid pH, the absorption of powdered ALA form the GI tract is both hindered and highly variable.  In addition to the difference in the physical state of the active ingredient ALA, many manufacturers have started using a substantially cheaper ALA made in China versus the long-standing industry premium ALA made in Europe.  Since the source of the raw material ALA is not specified in product labeling, there is no way to know which source is used in a given product.

Generally, the products made with China-sourced ALA are substantially less expensive than products made with European-source ALA. The China-source ALA meets analytical laboratory specifications that are similar to those established for European-source ALA, but lacks the long history of successful clinical use recorded by the European-source ALA.  The lower cost of the China-source ALA is enticing, but the risk, albeit small, of non-uniformity of continuing production supplies, unknown impurities, unknown absorption profiles, or the possibility of impaired clinical performance, offset the cost benefit.

 What is “solubilized” alpha lipoic acid?

 Solubilized ALA is a formulation of powdered ALA that has been converted to a lipid-based molecular dispersion.  Numerous pharmaceutical grade excipients are utilized in the solubilization process to achieve a stable formulation that can be accurately delivered during the encapsulation process.  The “solubilized” ALA retains its liquid character during years of storage in the finished softgel capsules.

 ThioGel costs more than some other brands.  Why is it more expensive?

The cost to produce ThioGel softgels is considerably higher than powder-based products because the manufacturing cost to solubilize and fill liquid softgel capsules far exceeds the costs of forming tablets or filling powder into gelatin capsules.  In addition, Ethical Alternative Products uses only the proven European-source ALA, which costs more than five times that of China-source ALA.  ThioGel is also produced in a first-class pharmaceutical manufacturing facility that produces all products in accordance with FDA GMP’s.

 What benefit do I get from taking ThioGel instead of a cheaper brand?

The highest plasma levels of ALA and peace of mind.  There are many companies that make many supplement products at the lowest possible price, with little or no concern for the safety or efficacy of the products they sell.  Ethical Alternative Product’s only business is making and selling high performance, high quality anti-oxidant products.  All companies would have you believe they have invested  as much into their products as Ethical Alternative Products, but the user has nothing but words to judge these suppliers, as well as Ethical Alternative Products.

We stand by our assertion that the solubilized ALA provides the greatest bioavailability of ALA and are willing to discuss our product and product research & manufacturing with any of our customers.  We can document ThioGel performance & quality manufacturing for any customer who wishes to contact our senior management.

Peace of mind comes from knowing that the product that you are consuming everyday for many years, is giving the expected performance, and is made to the highest quality & safety standards.  We all know that this is not always the case in the nutritional supplement market.

There is also an advantage associated with taking sealed softgel caps vs. 2-part gelatin capsules.  Some reports of burning in the esophagus have been reported when gelatin capsules separate during ingestion.

 What is important about getting higher blood levels of ALA?

Getting higher blood levels of a product means that more of the product is entering the circulation and that more of the product is being distributed throughout the body.  With the “solubilized” formulation, higher and more consistent levels of ALA are available for anti-oxidant activity.

 Has Ethical Alternative Products conducted studies to prove their claim of higher plasma levels of alpha lipoic acid?

Ethical Alternative Products performed animal and human studies at the Lovelace Respiratory Research Institute in Albuquerque, NM that clearly demonstrated the superior absorption of “solubilized” ALA vs. powdered formulations.  These studies also demonstrated great variability in the absorption of different brands of ALA powder formulations.  These studies have not been published, but can be made available to customers who are seeking documentation that ThioGel does give the highest plasma levels of ALA.

 How often should ThioGel softgels be taken?

There is no established dose of ALA for the many different areas of use.  A 200 mg daily dose is typically used for general anti-oxidant protection.  Doses up to 600 mg per day have been used for treating diabetic neuropathy and for treating Hepatitis C.  When more than 200 mg. is taken per day, the dosage should be divided over the day to maintain blood levels of ALA over a longer period of time.  Because peak levels of ALA are reached at about 30 minutes after ingestion, and the material also has a half-life in the circulation of about 30 minutes, divided dosing is recommended.  If an individual was taking 400 mg. per day, a typical dosing schedule would be 200 mg. in the morning and 200 mg. in the afternoon.  If taking 600mg. per day, a typical schedule might be 200 mg. in the morning, 200 mg. in the afternoon, and 200 mg. in the evening.

 Does Ethical Alternative Product’s make ThioGel with the R form of alpha lipoic acid?

 Ethical Alternative Products does not offer a ThioGel product that only contains the R-form of ALA.  ThioGel contains a racemic mixture of ALA that is 50% S-form and 50% R-form.  The R-form is the naturally-occurring form of ALA and has greater biological activity in the mitochondria and some other biological systems.  At present, it is not known whether R-alpha lipoic acid is more effective as an antioxidant than racemic lipoic acid when taken by humans in pharmacologic doses.

Because the cost of R-alpha lipoic acid is more than twice the cost of the racemic mixture, it is more cost-effective to use the racemic mixture to obtain an equivalent amount of the R-form.  Even if cost were not a factor, there is an uncertainty risk associated with using the recently available R-form products.   The racemic mixture is the product that has been extensively studied in human clinical trials, and has been used successfully for several decades by patients and consumers.  To lower product cost, most R-form products are made with China-sourced ALA powder, Which has not had the benefit of exhaustive laboratory and clinical studies and long-term patient and consumer use.

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