According to the MaxGXL patent documents filed in 2001 with the United States Patent office by Dr. Robert Keller, MaxGXL is "N-acetylcysteine, N-acetyl-d-glucosamine, [and] vitamin C whereby the amount of vitamin C is in an amount of at least 1000 mg. or greater to facilitate the absorption of N-acetylcysteine across the cellular membrane; and a pharmaceutically acceptable carrier for oral administration". The patent documents on Max GXL further state that MaxGXL will contain: "one or more of the following substances from the group consisting of alpha-lipoic acid, sylmarin, quercitin, l-glutamine, a probiotic, and dietary protein...to stimulate the natural production of glutathione".
Molecular Structure of Glutathione
The MaxGXL patent document mentions a number of disease states associated with reduced glutathione levels, but Max GXL has not been studied in the treatment of these diseases, and no disease treatment claims can scientifically or legally be made based on the Max GXL patent document.
The Patent states:
N-acetylcysteine (NAC) N-acetylcysteine has proven to be the most efficient single molecule dietary source of glutathione precursor. It is a precursor and the main limiting factor necessary for the body to manufacture reduced glutathione. NAC is well absorbed by the intestine and readily converted by the mammalian cell (particularly in the liver) to glutathione". However, Cysteine, contained in certain foods such as undenatured whey protein, may be the best food source of glutathione.
Molecular Structure of N Acetyl Cysteine
Vitamin C: The absorption of N-acetylcysteine (NAC) and transport across the cellular membrane is facilitated by the presence of ascorbic acid (vitamin C). Vitamin C maximizes NAC transport across biological cell membranes and helps to conserve existing glutathione stores within the cell cytosol.
Alpha Lipoic Acid:The utilization of N-acetylcysteine within the biological cell to synthesize glutathione is improved by the presence of alpha lipoic acid. Alpha lipoic acid increases the cell's ability to make glutathione. It enables the key enzyme required for glutathione synthesis to work under optimum conditions and induces a substantial increase in intracellular reduced glutathione
Busse E. Zimmer G. Schopohl B, et al. Influence of alpha-lipoic acid on intracellular glutathione in vitro and in vivo; Arzneimittel-Forschung 1992;42:829-831; and Han D. Handelman G. Marcocci, et al. Lipoic Acid Increases de novo Synthesis of Cellular Glutathione by Improving Cystine Utilization, Biofactors 1997;6:321-338.
Sylimarin: Silimarin [milk thistle extract] serves to improve and restore liver function. It quenches free radicals, reduces potential toxicity, and stimulates protein synthesis necessary to create new liver cells. Also known as "silibin", "silybin" or "silybinin", Silymarin is a generic term for extract from the mature fruits of Silybum marianum (sometimes Carduus marianus), commonly known as milk thistle;
Madaus AG publication: Legalon. Koln, Germany, 1989 and Valenzuela A, et al. Silymarin Protection Against Hepatic Lipid Peroxidation Induced by Acute Ethanol Intoxication in Rats, Biochemical Pharmacology, 1985:34(12):2209-2212.
Quercetin Quercetin is used for its ability to eliminate toxic compounds found in the liver. It has anti-hepatotoxic, antiviral, anti-inflammatory and antibacterial properties.
Shakhova et al., Zh. Obsheh. Khim., 32, 390 (1962). Wang and co-workers have described a lethal quercetin-digoxin interaction in an animal model (pigs) and stated that the results of their study indicated that a very serious pharmacokinetic interaction occurred between quercetin and digoxin (dosed at 0.02 mg/kg). The authors further recommended that the "co-administration of digoxin and quercetin or quercetin-containing dietary supplement should be avoided". Although the dose used in these pigs was large (50 mg/kg, or the equivalent of a little over 3,000 mg in a 140 lb human, about 40 times the daily dose provided by Max GXL), the dose was lethal in 66% (2 of 3) of the animals. Therefore it is NOT recommended that individuals who are taking digoxin supplement with Max Gxl without the express approval of their cardiologist or health care professional.
Wang et al. Life Sci. 2004 Jan 23;74(10):1191-7
L-glutamine: L-glutamine is an essential dietary component for the support of gastrointestinal growth and function and it is utilized as fuel in the small intestines. It is used by the intestinal tract in large amounts for energy during periods of physiological stress. It has been shown to preserve liver glutathione after lethal hepatic injury and nourish tissues in the GI tract, liver and immune system,
Souba, W.W., et al. The Role of Glutamine in Maintaining a Healthy Gut and Supporting the Metabolic Response to Injury and Infection. J. Of Surgical Res., 1990:48(4):83-91.
N-acetyl-d-glucosamine (NAG): N-acetyl-d-glucosamine is a key precursor in the biosynthesis of mucosal glycoproteins that form glycocalyx. The glycalyx is the most superficial, highly viscous layer of the gut mucosa that comes in contact with intestinal contents. The glycoprotein layer acts to protect the underlying tissues from exposure to enzymes, acid and bacterial assault while providing a selectively absorptive surface,
Wilmore, D. W., et al, The gut: a Central Organ After Surgical Stress; Surgery 1988: 104, (5):917-23.
Probiotics: Probiotics are mentioned in the patent, but do not appear to be in MaxGXL.
Biologically active whey protein A "biologically active whey protein composition comprising an undenatured whey protein concentrate obtained from raw milk" is mentioned in the patent, but does not appear to be in Max GXL. It appears that according to the MaxGXL patent document, Max GXL can be combined beneficially (and may act synergystically) with with bioactive whey proteins such as Immunocal.
Ingredients in MaxGXL:
Per packet of 3 capsules:L-glutamine (750 mg); N Acetyl Cysteine (375 mg); Cordyceps (300 mg); Vitamin C (250 mg); N Acetyl D-glucosamine (125 mg); Conjugated Linoleic Acid (100 mg); Quercetin (37.5 mg); Alpha Lipoic Acid (75 mg); Milk Thistle Extract (Silymarin), (25 mg); gelatin (capsules).
Recommended dose of Max GXL
The Recommended dose of Max GXL is 6 capsules per day (3 in the morning and a packet of 3 in the evening). If you are considering taking a larger dose, consult your physician or health care practitioner.
How supplied:
Max GXL is supplied in packets of 3 capsules each. There are 56 of these packets in each box of MaxGXL, and at the recommended dose of 2 packets per day, a box of Max GXL will last for 28 days.
Does MaxGXL have FDA approval?
Max GXL is a nutritional supplement and not a drug. The FDA does not approve nutritional supplements. Max GXL (like all nutritional supplements) cannot make a claim to diagnose, treat, cure, or prevent disease. The manufacturer makes these statements regarding MaxGXL: Max GXL Product Statement and Benefits
MaxGXL Clinical and Scientific Studies
We were not able to find any clinical or scientific studies or medical reviews of Max GXL published in the National Library of Medicine (MEDLINE) using a PubMed search. Additionally, we were not able to find any ongoing or future planned clinical trials or medical trials of MaxGXL. The manufacturer does list an unpublished study of Max GXL of an unknown number of patients (n=?), divided into 4 test groups who were studied from 3 to 6 months. The manufacturer states: "The graph below shows the increase in glutathione levels experienced by 4 groups of patients. Group 1 (normal health patients) were tested after 6 months of use, while Groups 2, 3 and 4 (HIV, Hepatitis C, and Chronic Viral Illness respectively) were tested after only 3 months of the MaxGXL regimen". Because the study period was significantly longer for study participants with normal health (twice as long), it is difficult to compare this group to the other 3 groups who were studied for a much briefer period of time. All four groups did have a substantial increase in their blood lymphocyte glutathione levels (416%, 347%, 270% and 262% after 3 months, 6 months, 6 months, and 6 months respectively in normal volunteers, HIV (Human Immunodeficiency Virus) patients, HCV (Hepatitis C virus) patients, and CFIDS/chronic viral illness patients), but p values (statistical significance) of these results were not provided. Because this product is a nutritional supplement, no medical claims were made by the manufacturer for these results.
Although there are no published studies on Max GXL itself, there are numerous published studies on its components, which are listed here in descending order of their concentration in Max GXL: L-glutamine; N Acetyl Cysteine; Cordyceps; Vitamin C; N Acetyl D-glucosamine; Conjugated Linoleic Acid; Quercetin; Alpha Lipoic Acid; Milk Thistle Extract (Silymarin).
Do antioxidants interfere with cancer chemotherapy?
One large recently published study suggests not. In a study of fifty randomized or observational human clinical trials published between 1965 and 2003 and involving 8,521 cancer patients using the antioxidants beta-carotene; vitamins A, C, and E; selenium; cysteine; B vitamins; vitamin D3; vitamin K3; and glutathione as single agents or in combination, Simone and co-workers found that "antioxidants and other nutrients do not interfere with chemotherapy or radiation therapy and can increase kill and increase survival". This was not a study of Max GXL, but the study did examine patients taking several of its components including N acetyl cysteine, and vitamin C. No specific interpretation can be made from this study regarding Max GXL, but this suggests that antioxidants like MAX GXL may be safe in patients undergoing cancer chemotherapy.
How Distributed:
Max GXL is distributed through network marketing. It is not available in stores. The manufacturer does not require that customers sign up as a MaxGxl distributor to get discounts on this product, but the best discounts are available through a monthly automatic shipment ("preferred customer") program. The manufacturer will allow customers to cancel their automatic shipment at any time, without penalty or obligation.
Safety of Max GXL:
It is difficult to make a scientifically accurate "blanket statement" on the safety of a supplement that contains multiple ingredients without doing significant research on each individual ingredient, and then researching safety on the combination of those ingredients within a single supplement. That being said, there does not appear to be any single ingredient within Max GXL that would suggest that the supplement is unsafe.
There are cautions on supplementing with some of the individual ingredients contained in Max GXL, however. The Physician's desk Reference (PDR), states that alpha lipoic acid (an ingredient in Max GXL) should be avoided in pregnancy, and used with caution in diabetics, and in patients with glucose intolerance: "Because of lack of long-term safety data, alpha-lipoic acid should be avoided by pregnant women and nursing mothers. Those with diabetes and problems with glucose intolerance are cautioned that supplemental alpha-lipoic acid may lower blood glucose levels. Blood glucose should be monitored and antidiabetic drug dose adjusted, if necessary, to avoide possible hypoglycemia." Physicians Desk Reference safety statement on alpha lipoic acid
PRECAUTIONS for NAC:The Physician's desk Reference (PDR), states that acteylcysteine (NAC, an ingredient in Max GXL) should be avoided in nursing mothers and should only be used in pregnancy on the advice of a physician. It should be used with caution in patients with chronic liver disease, as well as in pre-term newborns, and may be harmful if administered early in the treatment of critically ill patients. The supplement may cause headaches and (rarely) kidney stones. NAC should be used with caution in those with a history ulcers. Additionally, NAC may interact with some medications including nitrates, and carbamazepine. No interactions with nutritional supplements, food or herbs have been reported.
"Supplemental NAC should be avoided by nursing mothers and should only be used by pregnant women if prescribed by a physician. N-acetylcysteine clearance is reduced in those with chronic liver disease as well as in pre-term newborns. NAC may be harmful if administered early in the treatment of critically ill patients. NAC may intensify headaches in those taking nitrates for the treatment of angina. Although the incidence of cystine renal stones is low, they do occur. Those who do form renal stones, particularly cystine stones, should avoid NAC supplements. NAC and its sulfhydryl metabolites, like other sulfhydryl-containing substances, could produce a false-positive result in the nitroprusside test for ketone bodies used in diabetes. NAC should be used with caution in those with a history of peptic ulcer disease, since mucolytic agents may disrupt the gastric mucosal barrier."
"Adverse reactions reported with oral NAC include nausea, vomiting, diarrhea, headache (especially when used along with nitrates) and rashes. There are rare reports of renal stone formation. Adverse reactions reported with intravenous NAC include bronchospasm, nausea, vomiting, stomatitis, rhinorrhea, headache, tinnitus, urticaria, rashes, chills and fever. There are rare reports of anaphylactic reactions. The most common symptoms of those experiencing anaphylactoid reactions are rash, pruritis, flushing, nausea, vomiting, angioedema, tachycardia, bronchospasm, hypotension, hypertension and ECG change. The anaphylactoid reactions are pseudo-allergic rather than immunologic."
Interactions for NAC: "Nitrates: Use of supplemental NAC along with nitrates may cause headaches. Carbamazepine: Use of supplemental NAC along with carbamazepine may cause reduced serum levels of carbamazepine. No interactions with nutritional supplements, food or herbs are known."
Animal studies showing adverse effects of NAC: According to research conducted at the University of Virginia Health System, N-acetylcysteine (NAC) can form a red blood cell-derived molecule that makes blood vessels think they are not getting sufficient oxygen. This leads to the development of pulmonary arterial hypertension (PAH), a serious condition characterized by high blood pressure in the arteries that carry blood to the lungs. Adverse effects seen in animal studies may not necesarily apply to humans, however it might be more prudent for patients with this type of hypertension to take a bioactive whey protein to increase glutathione rather than to use Max Gxl or other supplements containing NAC.
Source:
Journal of Clinical Investigation September, 2007; 117(9):2592-601
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PDR Safety Statements on individual ingredients in Max GXL:
Physicians Desk Reference safety statement on acetylcysteine (NAC)
Physicians Desk Reference safety statement on Cordyceps
Physicians Desk Reference safety statement on L Glutamine
Physicians Desk Reference safety statement on N Acetyl Glucosamine
Physicians Desk Reference safety statement on Conjugated Linoleic Acid
Physicians Desk Reference safety statement on Quercetin
Physicians Desk Reference safety statement on Silymarin (Milk Thistle)
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