Natto: New MenaQ7 PURE Study to Validate Calcification Mechanism in Cardio Tissues

Nutrients publishes rationale and protocol for study of a needy patient population

OSLO, NORWAY and METUCHEN, NJ (October 15th 2015) – Nutrients, an international, peer-reviewed journal for studies related to Human Nutrition, has approved a new study rational that aims to show the protective effect of vitamin K2 as MK-7 (menaquinone-7; MenaQ7® PURE provided by NattoPharma) supplementation on holding the progression of coronary artery calcification for publication in October 2015.

The study, “Menaquinone-7 supplementation to reduce vascular calcification in patients with coronary artery disease: rationale and study protocol (VitaK-CAC trial),” will be significant because it will add to the substantial body of evidence demonstrating the cardiovascular benefits of Vitamin K2 as MK-7, lending further understanding to the mechanism by which it inhibits calcification to cardiovascular muscle.

“Coronary artery calcification (CAC) develops early in the pathogenesis of atherosclerosis and is a strong and independent predictor of cardiovascular disease (CVD). Arterial calcification is caused by an imbalance in calcification regulatory mechanisms. An important inhibitor of calcification is vitamin K-dependent matrix Gla protein (MGP). Both preclinical and clinical studies have shown that inhibition of the vitamin K-cycle by vitamin K antagonists (VKA) results in elevated uncarboxylated MGP (ucMGP) and subsequently in extensive arterial calcification,” says Dr. Leon Schurgers, associate professor and senior scientist at the department of biochemistry, the Cardiovascular Research Institute CARIM of University of Maastricht (The Netherlands), and researcher on the study. “This led us hypothesize that supplementation with vitamin K2 as MK-7 may slow down progression of CAC.”

The researchers designed the VitaK-CAC trial to analyze the effects of menaquinone-7 (MK-7) supplementation on progression of CAC. The double-blind, placebo-controlled trial will randomize patients with coronary artery disease (CAD) with a baseline Agatston CAC-score between 50 and 400 into an intervention-group (360 microgram MK-7) or placebo-group for 24 months. The primary endpoint is the difference in CAC-score progression between both groups. Secondary endpoints include changes in arterial structure and function and associations with biomarkers.

The researchers hope that the MK-7 supplementation will slow down the progression of CAC in patients with CAD. The results of this study are expected by the end of 2017.

“So far, no treatment options are available for limiting or holding the progression of vascular calcification,” adds Dr. Schurgers, “and this trial may lead to a novel treatment option for vascular calcification and cardiovascular disease.”

“All of the work showing the efficacy of MK-7 inhibiting cardiovascular and soft tissue calcification is recognized to the extent that scientific experts are conducting clinical studies in advanced CAC patients,” says Hogne Vik, NattoPharma CEO. “We hope this trial demonstrates the benefit of vitamin K2 as MK-7 (as our MenaQ7 PURE material) for diseased populations, lending further support and understanding to the mechanism of action by which this essential nutrient inhibits arterial calcification.”

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About MenaQ7®

MenaQ7® is the best documented, commercially available vitamin K2 as MK-7 with guaranteed actives and stability, clinical substantiation, and international patents granted and pending. MenaQ7® is available in two varieties: natural vitamin K2 as MK-7 Crystals and nature-identical synthetic vitamin K2 as MK-7 PURE. For more information on the health benefits of MenaQ7, visit menaq7.com.

About NattoPharma

NattoPharma ASA, based in Norway, is the world’s leader in vitamin K2 research and development. NattoPharma is the exclusive international supplier of MenaQ7® Vitamin K2 as MK-7, and has a multi-year research and development program to substantiate and discover the health benefits of vitamin K2 for applications in the marketplace for functional food and dietary supplements. With a global presence, the company established its North American subsidiary, NattoPharma USA, Inc., in Metuchen, NJ. For more information, visit nattopharma.com.

For more information, please contact:

Hogne Vik, CEO NattoPharma
Cell phone: +47 97 53 53 26
E-mail: hogne.vik@nattopharma.com

Kate Quackenbush, Director of Communications
NattoPharma USA, Inc.
Phone: 609-643-0749
E-mail: kate.quackenbush@nattopharma.com

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About Us

NattoPharma, the world leader in Vitamin K2 Research and Development, has invested millions of dollars in in-vitro, in-vivo, and clinical studies to document the effects of MenaQ7® Vitamin K2 as MK-7. This commitment has created the only patented and clinically validated K2 on the market. After establishing the first commercial Vitamin K2 with its flagship brand, MenaQ7®, NattoPharma has consistently answered and met market needs through the development of new production technologies:• In 2012, the company introduced MenaQ7® Crystals, which represented an important breakthrough in the new generation of Vitamin K2 products, producing the purest natural MK-7 available.• In 2014, NattoPharma introduced the only all-trans nature-identical synthesized Vitamin K2, MenaQ7® PURE. Not only did the company succeed in changing the market with MenaQ7® PURE – offering a high-quality, competitively priced ingredient – but its efforts were rewarded with the NutrAward for Best Functional Ingredient at Natural Products West/engredea 2015. Vitamin K2 is essential for the body to utilize calcium to build healthy, strong bones and to inhibit calcium deposits in the arteries. Published clinical studies have demonstrated the high bioavailability and proof of efficacy for Nattopharma’s all-trans MK-7 products in healthy and diseased populations, for bone and cardiovascular health. NattoPharma continues to build its competitive advantage through focuson IPR and has patents both granted and pending related to relevant healthbenefits and market segments, creating extra value for its customers. And NattoPharma staff consists of professionals people with longstanding experience in medical and biochemical research as well as pharmaceutical and food supplement development. By understanding and controlling the chemistry, NattoPharma provides the market all-trans MK-7 products, while our sales and marketing team has extensive knowledge of international market demands with which it supports our partners.