Second Human Clinical Study Confirms Hydrolyzed Kollagen I.V.X.HEM™ Efficacy With Only 500mg/daily - For Skin, Wound Healing & Connective Tissue Disorders!

Murrieta, California – January 23, 2014 - Certified Nutraceuticals, Inc. is pleased to announce the positive results of the 60 day Human Clinical Study for the efficacy of the supplement Kollagen I.V.X.HEM™ (100% Hydrolyzed Collagen Avian Egg Membrane - Patent Pending).

This Hydrolyzed Collagen Egg Membrane is a protein characterized by a developmentally advanced proportion of collagen that is effectively matched to skin and other tissues. It elevates the fibroblast activity and promotion stimulating their growth and strengthening the matrix. A fibroblast is a type of cell that synthesizes the extracellular matrix and collagen.

The Hydrolyzed Egg Membrane contains several bacteriolytic enzymes and other components that alter the effect of heat-resistant gram-positive and gram-negative pathogens increasing the skin's ability to withstand a variety of inflammatory processes. Hydrolyzed Egg Membrane contains very powerful compounds including: elastin, collagen, desmosine, isodesmosine and transforming growth factor-β and a complex of glycosaminoglycans such as glucosamine, chondroitin, and hyaluronic acid and other effective compounds. The compounds are proven to be of use for pain management associated with joint disease due to the distinctive concentration of the potent, natural compounds in the Hydrolyzed Egg Membrane. Therefore, in this trial our goal was to examine the effectiveness of this substance on patients with symptoms associated with Osteoarthritis and related inflammatory diseases/conditions which could prove to be far reaching.

For this study we chose 20 patients' ages 21 years to 80 years (10 males / 10 females) with confirmed joint damage, cartilage injuries, and skin disorders, diagnosed with imaging/scoping with low to high pain scales. The optimal dosage administered is 500mg. daily dietary supplement taken with citric juice on an empty stomach.

Significant Findings and Positive Clinical Responses from Study – Respondents/Testers Input

Arthritic patient with multiple affected areas (knees, elbows, hip and spine) with extremely limited activity even with aid of a walker significantly improved overall. The participant clearly reported that she could not walk around the indoor shopping mall, now is walking 3days a week. She could also navigate daily functions without assistance, cooking, cleaning the house, and personal care.

Optimal Health and Oral pH Testing for Inflammatory Markers

When the body is alkaline it converts free radicals to harmless water and oxygen which helps to maintain energy and vitality. The acid / alkaline balance relates to the chemistry of the body's fluids and tissues as measured by pH. The cells of the body must have a slightly alkaline environment to survive. With a blood pH of 7.365, the cells are in homeostasis and they receive nourishment and release waste with ease. Therefore the entire inflammatory process is suppressed. The body is designed to operate within a very narrow pH range. Optimally the pH should be on the alkaline side, with a blood pH of around 7.365, with a range of 7.34 to 7.45. Even some minor pH fluctuations in either direction creates distress signals in the body, causing various symptoms that start out small and then ramp up as the imbalance continues. Included in these of course is skin eruptions, eczema, inflammation, arthritis, chronic fatigue, weakened immunity, etc. Below we see the base salivary level (acidic) followed by the end of trial salivary pH (alkaline – optimal). The graphs below show the pH average readings of the participants at the start of the trial and the end of the trial. At the start of the trial the pH readings clearly show a more acidic salivary pH indicating a sharp inflammatory state in the body. When we look at Table: 2 graph (termination of trial at day 60), it shows a higher and more balanced pH. This now shows the body returning to levels we see in a healthy adult without disease and the inflammation causative to the disease process.

Table: 1

Table: 2

Table: 3

Graph clearly illustrates the pain reduction level on Hydrolyzed Egg Membrane. In the Single-Arm Pilot Trial the percentage of the study participants experienced greater flexibility and superior free movement. Participants also had a better range of motion for unstable and painful areas of their bodies. Another area of clinical importance was that more than 70% of the trial participants experienced an exemplary improvement in their pain and flexibility at 14 days into the trial.

Table: 4

takes a snapshot of general symptoms of targeted diseases and conditions of participants at the start of the trial followed every 10 days until 60 days - at end of trial. The graph clearly shows a significant drop in severe and moderate symptoms that atypically accompanied our target trial audience from start to finish. As we see, the percentile of participants for mild/tolerable symptoms at the start of the trial was very low (low activity threshold, pain, mobility inflammation, etc). At the conclusion of the trial the percentage of participants exhibiting mild and quite tolerable symptoms increased by over 85%, allowing participants to have a better quality of life all around.

Targeted Clinical Response Results

Supplementation with Hydrolyzed Egg Membrane produced a significant treatment response at seven days for flexibility (74.5% increase; P = 0.035) and at 60 days for general pain (91.7% reduction; P = 0.006), flexibility (70.6% increase; P =0.006) and range of motion associated pain (77.3% reduction; P = 0.020). There were no adverse events reported during the study and the treatment was reported to be well tolerated by study participants.

Conclusion

The reporting of results from this human clinical trial demonstrates that Hydrolyzed Egg Membrane is a practical treatment option for the overall management of Joint and Connective Tissue Disease, Symptoms, and related superfluous side effects. The study in particular noted an excellent response for participants suffering from Osteoarthritis. A clinical trial dosage of 500 mg taken once per day had a rapid response effect within a 7 day period and over 70% at day 14. The participants' clinical picture continued upward to 60 days into the trial receiving the full weight of the substances capabilities to reduce pain, inflammation, and swelling to regional swelling to some degree. The participant's quality of life had increased upwards of 80% after the conclusion of the trial. We found it very intriguing that the blood glucose levels of the 2 new participants started to normalize after half way into the trial. This is an exciting discovery and clearly needs a further look to establish how great the margin of treatability actually is. Hydrolyzed egg membrane should clearly be a viable option for the treatment/management of Joint and Connective Tissue Disease/Disorders, and marked pain syndrome with a substantial reduction of symptoms. We can state that our participants and clinical team exhibited or observed no side effects or allergens (as screened prior) throughout the trial of 60 days indicating not only efficacy but safety as well.

The Human Clinical Trial performed by Morton Scientific Group of Cambridge, Ontario, Canada and overseen by qualified Medical Doctors. Certified Nutraceuticals supplies the world market with Hydrolyzed Kollagen I.V.X.HEM™ in bulk powder which is manufactured at FDA - USDA approved facility and proudly promotes the products as Made in USA.

Certified Nutraceuticals' visionary CEO and the original inventor, Mr. Ahmad Alkayali, first introduced Hydrolyzed Collagen Beauty Supplement™ more than a quarter of a century ago. Since then, continued research and improvements by our innovation team, headed by co-inventor and president of Molecular Biology International (MBI), Robert den Hoed, resulted in this new advanced invention. MBI is the exclusive manufacturing facility for Certified Nutraceuticals' Kollagen I.V.X.HEM™. Certified Nutraceuticals specializes in innovative quality collagen and anti-aging nutrients for longevity and good health. We developed Patented kollaGen II-xs™, Pomegranate Ellagic 70™ extracted from the seed with powerful Ellagic acid and Punicalagins, Reverse- vine™ (patent pending) grapevine extract antioxidant featuring the newly discovered Trans-e-Viniferin which is considered to have more antioxidant effects beyond resveratrol, H.A.95™ Natural Hyaluronic acid synovial fluid to lubricate healthy joints, Olea25® (patent pending) 25% Hydroxytyrosol powder extracted from organic olive leaf with the highest ORAC value of any botanical ingredient discovered to date, patented TendoGuard™ - Collagen Type I, II, V, X and mucopolysaccharides for keeping tendons healthy and flexible, and our newest discovery of the Century- Telos95® - Telomere Health Support ingredient.

Kollagen I.V.X.HEM™ powder is 100% hydrolyzed & water soluble, and can be made easily into capsules, tablets, beverages, functional foods, and cosmetic applications.