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Home > MaxHealthLabs Liposomal Supplements > MaxHealthLabs Intra-Cellular Liposomal Information > MaxHealthLabs Clinical Trials - Increased Bioavailability > MaxHealthLabs Clinical Trials | MaxhealthLabs Intra-Cellular Liposomal Vitamin C Delivers Increased Bioavailability!

MaxHealthLabs Clinical Trials | MaxhealthLabs Intra-Cellular Liposomal Vitamin C Delivers Increased Bioavailability!

Vitamin C Clinical Trial



Comparative Bioavailability of Three Forms of Vitamin C
This study has been completed.
Sponsor:Xyrion Medical, Inc.
Collaborators:Xyrion Medical, Inc.Xanogene Anti-Aging and Genomic Clinic,Martinez, Luis MD
Principle Investigator: Dr. Martinez, Luis M.D
Information provided by (Responsible Party):Xyrion Medical, Inc.
Clinical Trials Identifier:XM09201219
First received: Oct 4, 2013
Last updated: NA
Last verified: Oct 12, 2013
Locations: Miami, Florida USA
Sponsors and Collaborators: Xyrion Medical, Inc.,Xanogene Anti-aging and Genomic Clinic, Dr. Martinez, Luis MD


Official Title:

A Randomized, Single-blind study Comparing the Bioavailability of Three Forms of Oral Vitamin C in Plasma Concentrations Over 3 Hours.



Purpose

The purpose of this study is to compare levels of sodium ascorbate (vitamin c) in the blood over a 3 hour period following a 6,000 mg dose of vitamin c from sodium ascorbate in oral pill form, 6,000 mg dose of vitamin c from sodium ascorbate in oral liposomal form, (Brand MaxHealthLabs Intra-Cellular Vitamin C), and 6,000 mg dose of vitamin c from sodium ascorbate in oral liposomal form (a competitor of MaxHealthLabs with liposomal foil packs/sachets).

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 natural encapsulation 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; dissolvedhydrophilic 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. 21 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. Seven subjects were used in each Group. We also have repeated this same study for Vitamin D and Glutathione delivery in pill form against liposomal delivery.

Footnotes:

Xyrion Medical Research has no affiliation with any brand or product. Although there are several other brands of liposomal vitamin c, 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.



Condition Clinical Trial
Bioavailability Dietary Supplement: oral liposomal vitamin c company with foil packs/sachets---(LC0512/605 EXP0214)
Dietary Supplement: Intra-Cellular Vitamin C(Lot #0813181 EXP:08/14)
Dietary Supplement: standard pill form vitamin c (Lot #130250 EXP: 4-23-16)


Study Type:Randomized Single-Blind Controlled Trial

Study Design: Allocation:Randomized Controlled Trial Testing Method: High-pressure liquid chromatography (HPLC) with electrochemical (EC) detection STD Value: .2-2.0 mg/dL
Endpoint Classification: Plasma Bioavailability Study
Clinical Trial Model: Pilot Study
Masking: Single Blind Study
Primary Purpose: Basic Science and Research


Primary Outcome Measures:

Plasma and vitamin c concentration [ Time Frame: 0, 1, 2, and 3 hours]

Enrollment: 21

Study Start Date: August 2013

Primary Completion Date:

October 10, 2013 (Final data collection date for primary outcome measure)



ARMS Assigned Clinical Treatment
Group 1 Comparator: 6,000 mg of
Intra-Cellular Vitamin C----7 subjects
Dietary Supplement: sodium ascorbate
Other Name: vitamin c
Group 2 Comparator: 6,000 mg liposomal vitamin c
(oral liposomal vitamin c company with foil packs/sachets)----7 subjects
Dietary Supplement: sodium ascorbate
Other Name: vitamin c
Group 3 Comparator: 6,000 mg
standard pill form vitamin c-----7 subjects
Dietary Supplement: ascorbic acid
Other Name: vitamin c


Eligibility

Ages Eligible for Study: 18 Years to 84 Years

Genders Eligible for Study: Both

Inclusion Criteria:

Healthy as determined by laboratory results and medical history Females not of child bearing potential Agrees to maintain normal vitamin c intake up to 48 hours before trial. At 48 hours vitamin c 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 gastro esophageal 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 vitamin C
  • Use of supplements containing vitamin C
  • 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:

Our first observation is that indeed liposomal vitamin c appears to be highly bioavailable in comparison to pill form of parallel dosage-----See Figure 1.

This trial also discloses that there are vast differences in effectiveness of the two liposomal vitamin c’s that were used in this trial. Group 1 (MaxHealthLabs Intra-Cellular Vitamin C) performed extremely well in comparison to Group 2 (other brand sachet/foil pack of liposomal vitamin c). Of significant note is the fact that Intra-Cellular Vitamin C raised blood levels perpetually in each hour----See Figure 2. Other brand sachet/foil pack of liposomal vitamin c did not raise plasma levels of any significance in any hour even in comparison to pill form, and interestingly enough pill form of vitamin c outperformed group 2 (other brand sachet/foil pack of liposomal vitamin c) in some measurements. Further studies will be necessary and forthcoming, but on the surface the results show that Group 2 liposomal (other brand sachet/foil pack of liposomal vitamin c) has no mechanism to raise blood serum levels greater than traditional pill form Vitamin C, although almost all liposomal oral deliveries claims such ability as noted previously in the purpose of this trial.



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We are especially enthusiastic about this particular liposomal vitamin c (Intra-Cellular Vitamin C) and its potential to even raise blood levels past hour 3. Further testing will be needed to see how many additional hours blood levels would raise past 3 hours, and at what hour a trough may be dictated. It must be noted that in our research of all brands used notes that pill form makes no claims as to increased bioavailability. Both brands of liposomal vitamin c’s (Group 2,other brand sachet/foil pack of liposomal vitamin c, and Intra-Cellular Vitamin C----Group 1), make claims of increased bioavailability on their packaging. The dosage of 6,000 mg was carefully chosen taking into consideration renal threshold allowances for plasma levels to be increased (Adv Nutr March 2011 Adv Nutr vol. 2: 78-88, 2011).

One of the most exciting facts stemming from this study is the possible use of a liposomal vitamin c as a potential alternative or adjunct treatment to IV or parenteral therapy of vitamin c. MaxHealthLabs Intra-Cellular Vitamin C delivered at 6,000 mg when multiplied forward in a projection (equal to 25 grams) show very impressive levels at or near IV therapy of vitamin c. This is illustrated in Figure 4 where a subject was crossed over and also received IV therapy of vitamin c with 25 grams of vitamin c being delivered. Please see Figure 4 for side by side comparison of IV therapy and oral liposomal administration (MaxHealthLabs Intra-Cellular Vitamin C). Our research cannot find any such study conducted where levels of any oral administration of liposomal vitamin c sustained plasma levels which can potentially equal IV therapy and or a cross comparison either. Due to the potential pioneering use of a liposomal oral delivery (MaxHealthLabs Intra-Cellular Vitamin C in particular) in lieu of (or in tandem with) IV therapy there is a need for further research.





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In closure, this trial demonstrated that oral liposomal delivery of vitamin c (Intra-Cellular Vitamin C brand) raises plasma levels significantly in comparison to pill form of vitamin c. Further research is needed to ascertain why Group 1 liposomal (Intra-Cellular Vitamin C) performed much more effectively in raising plasma levels over Group 2 liposomal (other brand sachet/foil pack of liposomal vitamin c), but we have a few interpretations as to such based upon our assessment of these two liposomal products during this trial. One such interpretation is based upon the behind the scenes manufacturing technologies alone. 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 (of note is their manufacture in house, which is very rare for a natural product). This would be 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 fewmajor 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 vitamin c) 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.