What is Glucotize?

GGlucotize is composed of Alpha-Lipoic acid, the most effective antioxidant, delivered in a proprietary controlled-release formulation developed by Medical Research Institute (MRI).

What is Alpha-Lipoic acid?

Alpha-Lipoic acid is a short-chain fatty acid that contains two sulfur atoms. It is a natural compound that is produced in small quantities in all human cells, and functions as a component of the pyruvate dehydrogenase and alpha-ketoglutarate dehydrogenase mitochondrial enzyme complexes. These enzymes are extremely important in oxidative glucose metabolism. In other words, these enzymes are necessary to convert glucose into cellular energy (ATP). In pharmacological doses (600-1200 mg), alpha-lipoic acid and its reduced form, dihydrolipoic acid (DHLA), function as extremely effective and versatile antioxidants. Numerous scientific studies have shown that alpha-lipoic acid is able to restore and recycle the endogenous network of antioxidants including vitamins C and E. Another important effect of alpha-lipoic acid is that it elevates intracellular glutathione (the major endogenous antioxidant in cells). Thus, alpha-lipoic acid functions in concert with other antioxidants. Other work has indicated that alpha-lipoic acid possesses metal-chelating activity, reactive oxygen scavenging activity, and plays a role in the repair of proteins, DNA, and lipids.

Is thioctic acid the same as alpha-lipoic acid?

Yes, thioctic acid is the term originally given to alpha-lipoic acid because the compound contains sulfur (thio). Since this compound is a fatty acid (lipid) and therefore soluble in fat (lipid), it is more commonly referred to as alpha-lipoic acid. In Germany, alpha-lipoic acid (thioctic acid) has been safely prescribed for treating diabetic neuropathy for over thirty years.

Why should I take Glucotize?

Glucotize has many beneficial health effects. Principal among these are the restoration and recycling of the endogenous antioxidants including vitamins C and E, ability to increase tissue glutathione (the major intracellular antioxidant), and the enhancement of mitochondrial function. Due to the negative impact caused by excessive free radical accumulation and the importance of the role that antioxidants play in neutralizing free radicals, alpha-lipoic acid delivered in Glucotize plays a major preventative role. alpha-lipoic acid in the form of Glucotize is an important addition to the dietary supplement regimen for any healthy individual, and those who at risk from or suffer from oxidative stress.

Why is it important to reduce oxidative stress?

Oxidative stress is markedly increased in individuals suffering from a variety of diseases, and may even play a causative role. Therefore, there is strong scientific and clinical evidence to support the idea of using of alpha-lipoic acid for reducing oxidative stress. It is important to note that in Germany, alpha-lipoic acid has been widely prescribed for over twenty years for the treatment of diabetic neuropathy, which is strongly linked to oxidative stress.

There are many alpha-lipoic acid products. What is the advantage of MRI's Glucotize?

Virtually all commercially available alpha-lipoic acid supplements can be referred to as immediate or quick release products, whether supplied in the form of a tablet or capsule. The term immediate or quick release means that once alpha-lipoic acid passes through the upper gastrointestinal track and into the stomach, it immediately begins to be absorbed into the plasma. In fact, within 20-30 minutes from the time that you take non-sustained release alpha-lipoic acid, it reaches its maximum concentration in the blood (plasma). Virtually all of alpha- lipoic acid taken in the immediate or quick release form is cleared (removed) from plasma within ninety minutes. In many cases, the result is that the alpha-lipoic acid is not in the body long enough to provide its maximum physiological benefits, including improving glycemic control or relieving the symptoms of neuropathy (e.g. tingling or burning). The primary advantage of the Glucotize formulation is that it increases the length of time effective concentrations of alpha-lipoic acid are present in plasma (several hours). This is what provides Glucotize with a pharmacokinetic advantage that is a marked improvement over other alpha-lipoic acid products in which alpha-lipoic acid is rapidly cleared in 30 minutes. Other alpha- lipoic acid tablets sometimes use an older technology, called enteric coating. This process coats the tablets to prevent a quick delivery; however, it does not regulate the delivery of the product, resulting in a quick spike of alpha-lipoic acid in the plasma followed by very rapid clearance. MRI has developed a proprietary formula using state-of-the-art technology that is commonly used in the pharmaceutical industry. The result is that MRI’s Glucotize delivers alpha-lipoic acid in a controlled, regulated rate over several hours.

If "immediate or quick release" alpha-lipoic acid products possess limited usefulness, why do so many other companies sell the product?

MRI has invested millions of dollars to develop and optimize the delivery technology employed in Glucotize. This formulation extends the physiological benefits of alpha-lipoic acid. This substantial investment is a major hurdle for most nutraceutical and dietary supplement manufacturers. Thus, this is the reason that the consumer is able to find more of the less expensive (and less efficacious) products on the shelf today.

Why is Glucotize more expensive than other alpha-lipoic acid products?

Glucotize was developed over a 6-year period. It is the result of a systematic evaluation of many different controlled-release formulations. This process was tedious, time consuming, and expensive. However, it was necessary in order to identify a formulation that offers the most efficacious preparation of alpha-lipoic acid commercially available. Unfortunately, most nutraceutical and dietary supplement companies manufacture and market products lacking any peer-reviewed clinical (scientific) data to support their claims. In contrast, MRI invests a considerable percentage of its operating budget in support of clinical research. For example, MRI has completed a pharmacokinetic study designed to compare the controlled-release profile of Glucotize with that of immediate release alpha-lipoic acid. This study evaluated Glucotize and a major brand of immediate release alpha-lipoic acid in normal volunteers over a twenty-four hour period. The results of this study have been submitted to a leading peer-reviewed journal, and are under review. Briefly, this pharmacokinetic study found that the immediate or quick release form of alpha-lipoic acid possess a plasma half-life of approximately 30 minutes, and was cleared from the plasma in less than two hours. In contrast, alpha-lipoic acid delivered in Glucotize remained at a effective level in the plasma for over several hours. This elongated time that increased levels of alpha-lipoic acid are in the plasma seems to enhance its physiological effects. MRI has also sponsored a second clinical study designed to evaluate the safety, tolerability, and efficacy of Glucotize in patients with Type 2 diabetes. This study period was for twelve weeks, and was completed in June, 2000. The data indicated that Glucotize is very well tolerated, and did not produce any significant side effects or adverse events. Of equal importance are the observations that show Glucotize is able to significantly lower plasma fructosamine levels. Fructosamine is glycated albumin, a marker of oxidative stress, and provides an approximation of glucose control over a three-week period. This is a very important clinical finding, and has not been achieved previously with any other alpha-lipoic acid product. The results of this study have been submitted to a leading peer-reviewed journal, and are under review. Other factors that contribute to the cost of Glucotize are associated with the costs of manufacturing. Unlike other alpha-lipoic acid products, Glucotize is manufactured using state of-the-art technology frequently employed in the pharmaceutical industry for controlled-release formulations. In addition, Glucotize is manufactured in accordance with cGMPs (Good Manufacturing Practice) environment. This is the standard required for prescription pharmaceuticals. The emphasis of MRI on the highest quality manufacturing techniques and conditions ensures that Glucotize is manufactured under the strictest standards ensuring maximum batch-to-batch reproducibility, safety, and efficacy. It should also be noted that Glucotize is manufactured from the purest raw materials in Europe. Thus, while the cost of Glucotize may be higher than other alpha-lipoic acid products, MRI guarantees that you are being provided with the best and most efficacious form of alpha-lipoic acid commercially available.

Are there clinical data indicating that alpha-lipoic acid is present in human plasma longer when administered as Glucotize?

Yes. As described above, MRI recently sponsored a clinical study to investigate this important question. This study employed normal volunteers, who were given 600 mg of either Glucotize or immediate release alpha-lipoic acid. This study was a crossover design, which means that all subjects eventually received both Glucotize and immediate release alpha-lipoic acid. The amount of lipoic acid in their plasma was determined over a twenty-four hour period using a validated bioanalytical HPLC assay. The results indicate that Glucotize is detected in human plasma for up to three times longer than immediate release alpha-lipoic acid. The analyzed results of this study are available on MRI's web site here (PDF, 88KB, requires free Adobe Acrobat Reader).

Are there any clinical data to support the safety and/or efficacy Glucotize?

Yes. MRI has completed a clinical trial with 21 patients with Type 2 Diabetes. Glucotize was administered for twelve weeks in combination with other anti-hyperglycemic agents. In these subjects, Glucotize was tolerated very well. No patients left the study because of Glucotize related adverse events or side effects. There were no changes in liver enzymes, or in any other surrogate marker of safety or tolerability. Importantly, this study has shown promising results for lowering plasma fructosamine levels. Fructosamine is glycated albumin, and serves as a marker of glucose control over a three-week period. The analyzed results of this study are available on MRI's web site here (PDF, 88KB, requires free Adobe Acrobat Reader).

What is the recommended dose of Glucotize?

This answer depends on whether you are taking Glucotize as a preventative measure, or to help reduce severe oxidative stress. For example, to protect against free radical accumulation, and to improve your antioxidant status, a normal person (in good health) should take Glucotize daily (1 tablet before breakfast and one tablet before dinner; alternatively, some individuals prefer to take both tablets in the morning along with their multiple vitamin). For individuals suffering from or more susceptible to oxidative stress, it is suggested to take two tablets before breakfast and two tablets before dinner. In all cases, it is recommended to take Glucotize 30-60 minutes before eating, as some foods might interfere with the absorption of alpha-lipoic acid.

Is Glucotize safe? Are there any side effects and are there any reasons why it should not be taken? Are there any known interactions of Glucotize with other medications?

In normal individuals and those with Type 2 diabetes, Glucotize has demonstrated a very high level of safety and tolerability when used at the recommended doses. As with any supplementation regimen, you should consult with your personal physician or pharmacist. Women who are pregnant or lactating should consult their personal physicians before using this product. There are no known interactions of Glucotize with prescription medications. Glucotize (and any product containing alpha-lipoic acid) is contraindicated in individuals with known hypersensitivity to alpha-lipoic acid, or other sulfur-containing compounds. Glucotize is contraindicated in individuals that are thiamin-deficient.

Is alpha-lipoic acid present in any food? Can any benefit of alpha-lipoic acid be obtained from food sources, and is it as effective as Glucotize?

Spinach, potatoes and red meat are the richest natural sources of alpha-lipoic acid. Spinach provides the highest relative amount of alpha-lipoic acid among any food tested, containing approximately 3 milligrams (mg) of alpha-lipoic acid per gram of dry weight. However, to receive 300 mg of alpha-lipoic acid from spinach you would have to eat 100 grams of dried spinach (which corresponds to several kilograms of wet weight). Clearly, this is an impossible task. However, even if you could afford to buy and eat large quantities of spinach everyday, you would not achieve the controlled-release properties of Glucotize, which delivers, over several hours, alpha-lipoic acid to your blood plasma.

How Supplied

Glucotize is a dietary supplement product marketed in the US under the 1994 Dietary Supplement Health and Education Act (DSHEA). Glucotize is offered as an uncoated tablet (300 mg dose racemic alpha-lipoic acid), and can be purchased directly from MRI. Glucotize is available in child-resistant plastic bottles containing 120 tablets.