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Glutathione Clinical Study

Glutathione Clinical Study

This study has been completed.

Sponsor: Xyrion Medical, Inc.

Collaborators: Xyrion Medical, Inc. Xanogene Anti-Aging and Genomic Clinic

Information provided by (Responsible Party): Xyrion Medical, Inc.

Clinical Trials Identifier: XM10201329

First received: Oct 1, 2013

Last updated: NA

Last verified: Nov. 5, 2013

Locations: Miami, Florida USA

Sponsors and Collaborators: Xyrion Medical, Inc., Xanogene Antiaging and Genomic Clinic

Official Title:

A Randomized, Single-blind study Comparing the BioAvailability of Three Forms of Oral Glutathione in Plasma Concentrations Over 24 Hours.

Purpose The purpose of this study is to compare levels of glutathione in the blood over a 24 hour period following a 3,000 mg dose of glutathione in oral pill form, 3,000 mg dose of glutathione from glutathione in oral liposomal form, (Brand MaxHealthLabs Intra-Cellular Glutathione), and 3,000 mg dose of Glutathione in another oral liposomal form (other brand sachet/foil pack of liposomal glutathione).

In the last few years it has been noted that there are new brands of nutritional supplements which make claims of increased bioavailability and cellular absorption, mostly through new delivery systems. One of these delivery systems noted is the use of the liposome. Regarding this new use of oral liposomal nutritional products and their supposed effectiveness for increasing bioavailability, Wikipedia notes: “A very small number of dietary and nutritional supplement companies are currently pioneering the benefits of this unique science towards this new application. This new direction and employment of liposome science is in part due to the low absorption and bioavailability rates of traditional oral dietary and nutritional tablets and capsules. The low oral bioavailability and absorption of many nutrients is clinically well documented. Therefore the naturalencapsulation of lypophilic and hydrophilic nutrients within liposomes has made for a very nutrient to be delivered to the cells and tissues.”

Liposomes are artificially-prepared vesicle composed of a lipid bilayer. The liposome can be used as a vehicle for administration of nutrients and pharmaceutical drugs depending upon the need. A liposome encapsulates a region of aqueous solution inside a hydrophobic membrane; dissolved hydrophilic solutes cannot readily pass through the lipids. Hydrophobic chemicals can be dissolved into the membrane, and in this way liposome can carry both hydrophobic molecules and hydrophilic molecules. To deliver the molecules to sites of action, the lipid bilayer can fuse with other bilayers such as the cell membrane, thus delivering the liposome contents.

Through our previous research we were unable to substantiate and or establish clear evidence and proof as to the capacity of oral liposomal delivery to in fact increase bioavailability of any nutritional supplement. Due to lack of any real and known scientific evidence and clinical trials we therefore performed our own. 15 subjects were used in this randomized clinical trial (please see Subject Inclusions and Exclusions below as well as average age of subjects in Figure 3). Subjects were carefully chosen and divided into these groups. 5 subjects were used in each Group.

Footnotes:

Xyrion Medical Research has no affiliation with any brand or product. Although there are several other brands of liposomal glutathione, the researchers here chose the two brands within due to their being unit dosed, non pill, and non spray forms. These were the only ones found in the marketplace that satisfied all these factors. It should be noted that liposome carriers are heavily entrenched in the pharmaceutical industry and used as novel drug delivery systems (sometimes targeted) via IV or parenteral delivery.





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Inclusion Criteria:

Healthy as determined by laboratory results and medical history Females not of child bearing potential Agrees to maintain normal glutathione intake up to 48 hours before trial. At 48 hours glutathione intake was limited Both non-smoker smokers Exclusion Criteria:

Pregnant, breastfeeding, or planning to become pregnant during the trial Alcohol >2 drinks per day; alcohol or drug abuse within the past year Cardiac conditions Duodenal ulcer or gastric ulcer, gastritis, hiatus hernia, or gastroesophageal reflux disease (GERD) within past 3 months History irritable bowel syndrome, malabsorption or significant GI disease History of kidney stones Use of medications known to interact with glutathione Use of supplements containing glutathione Use of anticoagulants (warfarin), barbiturates, tetracycline antibiotics, beta-blockers, cyclosporine, prednisone, tricyclic antidepressants, diuretics and nitrate medications History of or current diagnosis of cancer Uncontrolled hypertension History of diabetes, renal disease and/or liver disease Unstable psychiatric disorder History of or current immunocompromise History of hemochromatosis or hemoglobinopathies Participation in a clinical research trial <30 days Use of acute medication w/in 72 hours of trial dosage Unstable medications <90 days Abnormal liver function Serum creatinine > 1.5 x upper limit of normal (ULN) Anemia of any etiology Blood donation w/in the last 2 months Allergy or sensitivity to test articles, foods or beverages provided during the study Cognitive impairment and/or unable to give informed consent Conclusion:

Onset observations show that indeed liposomal glutathione appears to be very effective in raising blood serum levels in comparison to pill form of like dosage-----See Figure 1.

The sustained plasma elevation of Group 1 Liposomal (Intra-Cellular Glutathione) is intriguing in that the 6 hour average is at or near the 1 hour average and even above the 3 hour average. The ability to keep sustained raised levels in each time period is significant. The tenable elevation implies a somewhat “time release” mechanism taking place. The amplified use of this particular liposomal (Group----Intra-Cellular Glutathione) could potentially be useful for medical practitioners that use IV therapy as a treatment either as an adjunct therapy or even possibly in lieu (more discussion on this below). Further research is needed to determine at what exact hour(s) the trough levels are reached.

There is a definite functional disparity between Group 1 Liposomal (Intra-Cellular Glutathione) and Group 2 (other liposomal glutathione company with foil packs/sachets). The average increase from the baseline for Group 2 (other liposomal glutathione company with foil packs/sachets) is only 15 points (272 to 287 ug/mL) whereas the average increase from baseline for Group 1 (Intra-Cellular Glutathione) is 94 points (264 to 358 ug/mL). This average increase indicates that Group 1 (Intra-Cellular Glutathione) is performing at a high level of absorption. Comparison of Group 2 Liposomal (other liposomal glutathione company with foil packs/sachets) to Group 3 (Pill Form) shows only a mild difference between the two favoring Group 2 Liposomal (other liposomal glutathione company with foil packs/sachets) ---See Figure 2 ). Due to the performance of Group 1 Liposomal (Intra-Cellular Glutathione) it would seem that Group 2 (other liposomal glutathione company with foil packs/sachets) would have behaved in like manner. More study is needed to determine why Group 2 (other liposomal glutathione company with foil packs/sachets) did not perform nearly as well as Group 1 (Intra-Cellular Glutathione).

Not surprisingly, pill form (Group 3) function was as expected. It is well documented clinically that oral glutathione cannot be absorbed orally in std pill form (Ann Pharmacotherapy. 1995 Dec;29 (12):1263-73., Pharmacology Toxicology. 1994 Dec;75(6):343-7.) More studies are necessary, but on the surface the results show that Group 2 liposomal (other liposomal glutathione company with foil packs/sachets) has very little capacity to raise blood serum levels greater than traditional pill form glutathione, although almost all oral liposomal deliveries claims such ability as noted previously in the purpose of this trial. Both liposomal glutathione’s used in this trial claim the endowment to raise blood serum levels, but our findings indicate that only 1 actually did---Group 1(Intra-Cellular Glutathione).

As mentioned above a very appealing result stemming from this study is the possible use of a liposomal glutathione as a potential substitute or adjunct treatment to IV or parenteral therapy of glutathione. Our research cannot find any such study conducted where levels of any oral administration of liposomal glutathione sustained plasma levels which can potentially come close to or possibly equal IV therapy, and or a cross comparison either. Due to the potential pioneering use of a liposomal oral delivery (in particular MaxHealthLabs Intra-Cellular Glutathione—Group 1) as a viable treatment for raising and sustaining blood levels of glutathione at, near, or equal to IV therapy more analysis is necessary.

In conclusion, this trial clearly established that oral liposomal delivery of glutathione (Intra-Cellular Glutathione brand) indeed elevates plasma levels convincingly in comparison to pill form of glutathione. Again further investigation is needed to establish why Group 1 liposomal (Intra-Cellular Glutathione) performance was much more dramatic in raising serum levels over Group 2 liposomal (other brand sachet/foil pack of liposomal glutathione), but there are a few reasons as to why, based upon our assessment of the two liposomal products used for the trial. One reason is based upon our assessment of the differing manufacturing technologies. Our research indicates that nearly all liposomal nutritional companies use a form of high pressure/high heat (homogenization to be exact) to form liposomes, which can easily translate into very unstable liposomes. Intra-Cellular brand claims patented manufacturing technology of very low pressure and low to almost no heat using a patented mixing chamber. This is one viable difference/reason as to the performance of Intra-Cellular brand liposomes. Another very instrumental force is the constitution and quality of lipid used to create the liposomes themselves. If a low grade/quality of lecithin is used, it will often render weak liposome membranes which can rupture and discharge content before ingestion. The foregoing are just a few major elements and influences as to the execution of a liposomal delivery system in raising plasma levels. Despite the virtual non performance of Group 2 liposomal (other brand sachet/foil pack of liposomal glutathione) we are still pleasantly intrigued about the future possibilities and potential of a variety of nutrients, (especially hard to absorb nutrients), being delivered orally through liposomal carriers….. especially through the MaxHealthLabs Intra-Cellular brand of liposomal delivery.









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