Clinical Research with HA

Summaries for studies done with Synthovial Seven® and Episilk products

Will the Real Hyaluronan (Hyaluronic Acid) please stand up?

There are many Hyaluronic Acid products available now on the market. This review from the Journal of Applied Nutrition examines the different kinds of HA available and talks about their effectiveness. Not all Hyaluronic Acid is created equal. Keep in mind when reading this study that our patented Synthovial Seven® is high molecular weight HA in the 2.4-3 million Daltons!

Excerpt from the review summary-

"..dietary supplements containing HA are not equivalent due to the inherent properties of the three major types of HA commercially available as dietary supplement materials. Consumers and health care professionals need to be aware of the different types of HA and their very large differences in properties (even before ingestion). One source, hydrolyzed chicken sternal cartilage, is clearly unlike native HA, does not match the biological properties of native HA, and consequently should not be represented as HA to consumers on product labels..."

Click here to read this entire review (pdf)

Proven bioavability and absorption with High Molecular Weight HA

Oral Absorption Study

Washington. D.C., April 18, 2004 – A consortium of scientists released clinical research results about oral delivery of radiolabeled Hyaluronan (HA) and its ability to be taken up by joints. Dr. Alex Schauss, Director of AIBMR, presented the findings at the 2004 Experimental Biology conference, conducted by the Federation of American Societies for Experimental Biology.

Scintigraphy of dog chest showing HA uptake in bones, joints and salivary glands

Hyaluronan has been used for years in veterinary and human medicine as an injection to replace lost joint fluid. The study was led by Dr. Schauss and conducted by a consortium of scientists from the Life Sciences Division of the American Institute for Biosocial and Medical Research Inc. in Puyallup, Washington and the National “FJC” Research Institute for Radiobiology and Radiohygiene, National Institute for Health in Budapest, Hungary. The research was supported by Weider Nutrition International.

 “This is the first time hyaluronic acid has been reported to be absorbed orally, which paves the way for HA dietary supplements to be introduced and deliver on anti-aging and joint health promises,” said Dr. Luke Bucci, Ph.D., Vice President of Research for Weider Nutrition International. Until now, there was no data on pharmacokinetics after oral intake and the therapeutic use of hyaluronic acid was limited to injections or topical applications. The results of this study, which examined the absorption, excretion and distribution of radiolabeled HA after a single oral administration in Wistar rats and Beagle dogs, demonstrated that HA is absorbed and distributed to organs and joints after a single oral administration.

Excerpt from Abstract # 129.4- Absorption, distribution and excretion of 99mtechnetium labeled hyaluronan after single oral doses in rats and beagle dogs

Scintigraphy of rat chest showing HA uptake in bones, joints and salivary glands

This study examined the absorption, excretion and distribution of radiolabeled hyaluronan (HA) after a single oral administration in Wistar rats and Beagle dogs. High Molecular Weight HA from bacterial fermentation was radioactively labeled with 99-technetium and its oral uptake in rats and dogs was studied. Uptake of HA into the bloodstream (5% of an oral dose) was found, and scintigraphy found uptake of labeled HA into joints (FASEB, 2004). A. G. Schauss, L. G. Balogh, A. G. Polyak, D. G. Mathe, R. G. Kiraly and G. G. Janoki American Institute for Biosocial and Medical Research, Inc and National Institute for Health.

Thus, purified, high molecular weight HA is bioavailable and delivered to joints. From these results, approximately 4.5 billion molecules of HA may reach each knee joint after oral ingestion of 3 mg of HA in humans. These results demonstrate that HA is absorbed and distributed to organs and joints after a single oral administration.

An abstract with complete research details was published in the April issue of FASEB Journal.

Title of study: Supporting Knee Joints With Oral Hyaluronic Acid.

Chief Investigator: K. Dean Reeves, M.D., F.A.A.P.M & R. (Fellow of the American Academy of Physical Medicine and Rehabilitation). Human Subject Committee: Shawnee Mission Medical Center, Shawnee Mission Kansas (Greater Kansas City Area)
Dr. Reeves-Chief Investigator for HA Study

Purpose of study: This study is designed to compare the effects of Synthovial Seven® with a control treatment for patients with knee conditions. Link to Dr. Reeves Website- click here.

Layman's Explanation: Synthovial Seven® is a pure form of hyaluronic acid. Hyaluronic acid is a special protein that is the normal lubricant in human joints. When present in a joint, even a joint with minimal or no cartilage, it can provide a cushion effect. Hyaluronic acid in our joints is a long and complex molecule, and makes a ball shape which resists compression. However, with inflammation or other conditions the complex hyaluronic acid molecule breaks down to smaller pieces and is not effective in keeping a ball shape. Therefore it cannot provide a cushion of protection in the joint. Hyaluronic acid is also found in all connecting tissues of the body such as ligaments and tendons where it performs special functions of lubrication and helps orient ligament and tendon fibers.

Title of study: Effect of Lubricant Composition on the Fatique Properties of Ultra High Molecular Weight Polyethylene (UHMWPE) for Total Knee Replacement (TKR)-

Investigating Team: Department of Bioengineering, Clemson University

ABSTRACT:Clemson University Fatigue failure of ultra high molecular weight polyethylene (UHMWPE) has been cited as the prevalent surface failure mechanism for total knee arthroplasty (TKA). Hence, it becomes imperative to simulate in-vivo conditions in in-vitro simulations. In this study. the hypothesis that the physiological environment influences the fatigue properties of the polymer was explored. The present study examined the effect of adding hyaluronic acid in varying clinical concentrations on the fatigue crack growth response of UHMWPE. A fracture mechanics approach was adopted to relate the fatigue properties of the polymer determined using the ASTM E 647, to the physiological environment. The fractured surfaces were characterized using scanning electron microscopy to evaluate the effect of lubricant viscosity on the fatigue failure mechanisms. The serum protein adsorption on the surface of the specimens was studied by Fourier Transform Infrared Spectroscopy. Rheological analysis indicated that the viscosity of the lubricants with the three concentrations of hyaluronic acid -2.22 g/l, 0.55 g/l and 1.5 g/l were representative of those found in osteoarthritic and rheumatoid arthritic diseased joints and in the periprosthetic fluids, respectively HA was found to significantly affect lubricant viscosity and wettability. These are environmental factors, which are theorized to directly affect the fatigue properties of the polymer, and can be directly related to the clinical environment as well. Results showed that the presence of HA in the bovine serum not only affects the crack initiation of the polymer, but also causes a significant shift of the linear crack growth regime compared to 50% bovine serum alone (t-test, a = 0.05). Key words: fatigue, FTIR, Hyaluronic acid, UHMWPE

Click here to Read Letter from Clemson University to Hyalogic specifically asking to use Synthovial Seven® because of the high molecular weight of our product. (.pdf file 25 KB)

Research with Episilk™ Premium Cream (Pure Hyaluronic Acid)

Chief Investigator:Dr. A. Bulent Tanman, Dermatologist, Elit Saglik Clinics
Advisor: Prof. Dr. Ertugrul H. Aydemir, University of Istanbul, Faculty of Medicine, Cerrahpasa, Dept. of Dermatology

Excerpt from "Discussion About the Results "...According to the results, we can understand why hyaluronic acid is called a Natural Moisturizer of the Skin. Since Episilk Premium is a pure hyaluronic acid cream, I think it will help the patients to feel good; having much more smoother, shinier, moisturized skin and with improved wrinkles..."

Entire study results available in .pdf form- click to download(212 KB).

Title of study:Molecular and Rheological Characterization of Sodium Hyaluronate (HA) and Equine Synovial Fluid

Chief Investigators:Danielle Leiske, Willie E. (Skip) Rochefort of Oregon State University. This work is ongoing and this project was presented at the Society of Rheology Meeting in Lubbock, Texas in February 2005.

This is an excerpt from the introduction...

Sodium hyaluronate (also referred to as hyaluronic acid, or HA) is the largest molecular component of synovial fluid and contributes both viscous (lubricating) and elastic (shock-absorbing) properties that are important in \the lubrication and protection of cartilage. Hyaluronate (HA) is a polymer found in all parts of the body but is of particular importance in articular joints. The key to the viscoelastic behavior of synovial fluid is molecular weight and concentration of HA. Hyaluronate’s important role in joint lubrication has made it of particular interest in the biomedical field.

Certain types of joint diseases have been attributed to the breakdown of HA in the joint. Although the exact nature of the degradation of HA is not yet fully understood, it has been credited to the presence of deleterious enzymes and radicals. Any decrease in the size of HA molecules will result in a decrease of viscoelastic properties of synovial fluid, which could lead to cartilage damage. Viscosupplementation is a treatment developed to care for joint disease. It involves either intra-articular or intravenous injections of HA supplements to the diseased joint or patient. Initially this idea was developed to boost the viscoelastic properties of synovial fluid, however it was later realized that HA performs a biochemical role in joints in addition to its well described mechanical role. Nevertheless, the mechanical role of HA in joint fluid is important and worthy of study.

Entire study results available in .pdf form- click to download(602 KB).

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