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MenaQ7® Aortic Calcification Human Study Protocol

Protocol shows Vitamin K2 treatment on imaging measurement of existing calcification.   Ex-NattoPharma is excited to announce that Nutrients has published a new paper, “Bicuspid Aortic Valve Stenosis and the Effect of Vitamin K2 on Calcification Using 18F-Sodium Fluoride Positron Emission Tomography/Magnetic Resonance: The BASIK2 Rationale and Trial Design”, which examines the benefits of MenaQ7® … Continue reading MenaQ7® Aortic Calcification Human Study Protocol

Ex-NattoPharma is excited to announce that Nutrients has published a new paper, “Bicuspid Aortic Valve Stenosis and the Effect of Vitamin K2 on Calcification Using 18F-Sodium Fluoride Positron Emission Tomography/Magnetic Resonance: The BASIK2 Rationale and Trial Design”, which examines the benefits of MenaQ7® Vitamin K2 as MK-7 for patients with existing calcification.

 

Being conducted by the expert researchers at Maastricht University Medical Center and CARIM, the double-blind placebo-controlled study will randomize subjects into intervention and control groups, receiving an oral dose of 360 micrograms (mcg) menaquinone-7 (MK-7) or placebo, respectively. The MK-7 is MenaQ7® (provided by NattoPharma ASA, Oslo, Norway) and the total study duration is 18 months with 44 participants who have bicuspid aortic valve (BAV) and mild–moderate calcific aortic valve stenosis (CAVS).

 

According to Dr. Leon Schurgers, one of the paper’s authors: “18F-sodiumfluoride positron emission tomography (PET), magnetic resonance (MR) and computed tomography (CT) assessments will be performed showing for the first time providing incremental information to the standard methods (echocardiography and CT) used to measure aortic valve stenosis and calcification. In essence, the progression or regression of micro-calcification should be clearly observable for the first time.”

 

A possibility to regress calcification

 

“This is a breakthrough study for individuals with existing calcifications, and noteworthy as the traditional medical community is initiating a study in diseased patients,” says Dr. Hogne Vik, ex-NattoPharma Chief Medical Officer. “Previously published research in healthy populations show MenaQ7 can inhibit the progression of arterial stiffening, and even regress stiffening resulting in improved arterial flexibility. Now these researchers are looking to determine if vitamin K2 can regress calcification in patients with CAVS – while the only current treatment is valve replacement.”

 

BAV is associated with early development of CAVS and pathophysiologic mechanisms are incompletely defined. Numerous pharmaceutical therapies have been studied as potential intervention in the progression of CAVS, but have not yet presented successful treatment options. Therefore, the only treatment option currently available for severe CAVS is valve replacement.

 

“Recognizing that medical therapies are proving ineffective, researchers are shining a light on efficacious supplemental alternatives, which leads them to the clinical research that ex-NattoPharma has spearheaded. Specifically, our three-year cardiovascular study in healthy postmenopausal women taking just 180 mcg daily of Vitamin K2 as MK-7 (as MenaQ7), which demonstrated a cessation and even regression in arterial stiffness.

 

“The relevance of our three-year study has resulted in several studies by the medical community for patients with existing coronary artery calcification, aortic valve calcification, and peripheral artery calcification,” adds Dr. Vik.

MenaQ7® 3-Year Cardiovascular Study

Breakthrough heart study proves MenaQ7® K2 cardiovascular benefits   Thrombosis and Haemostasis, The International Journal for Vascular Biology and Medicine, has approved for publication in its May 2015 print issue a new study showing the positive impact of MenaQ7® Vitamin K2 as MK-7 (menaquinone-7) on cardiovascular health through its improvement of arterial flexibility.   The … Continue reading MenaQ7® 3-Year Cardiovascular Study

Breakthrough heart study proves MenaQ7® K2 cardiovascular benefits

 

Thrombosis and Haemostasis, The International Journal for Vascular Biology and Medicine, has approved for publication in its May 2015 print issue a new study showing the positive impact of MenaQ7® Vitamin K2 as MK-7 (menaquinone-7) on cardiovascular health through its improvement of arterial flexibility.

 

The study titled “Menaquinone-7 Supplementation Improves Arterial Stiffness in Healthy Postmenopausal Women”[1] is significant because it confirms what previous population-based studies have only been able to show an association, according to Cees Vermeer, renowned vitamin K2 scientist and Chief Innovation Officer at the R&D Group VitaK of the Maastricht University Holding (the Netherlands), who led the study’s research team.

 

“This is the first study showing that long-term use of vitamin K2 in the form of MK-7 beneficially affects cardiovascular health,” says Vermeer. “Previous population-based studies have shown an association between vitamin K2 intake and cardiovascular risk, but this is the first intervention trial focused on Vitamin K2 supplementation with cardiovascular endpoints.”

 

Researchers at the R&D Group VitaK of the Maastricht University Holding in the Netherlands monitored 244 healthy post-menopausal women for three years using pulse wave velocity and ultrasound techniques. The participants, aged 55-65 years, were randomly assigned to take 180 mcg of MenaQ7® daily for three years, or placebo capsules. Results confirmed that MenaQ7® Vitamin K2 not only inhibited age-related stiffening of the artery walls, but also made an unprecedented statistically significant improvement of vascular elasticity.

 

“Our data demonstrated that a nutritional dose of vitamin K2 in fact improves cardiovascular outcomes,” Vermeer continues.

 

This same cohort was examined for another study proving MenaQ7’s bone benefits that published in Osteoporosis International in 2013[2].

 

Improvements in heart and bone health

 

“Both studies are significant because they are long-term – three years of participation and then examination of the results,” said Hogne Vik, ex-NattoPharma CEO. “Observing changes in heart health, and bone health for that matter, take time. Our patience and perserverence has paid off with a study accepted by a highly prestigious medical journal that proves what we have known all along: that MenaQ7 Vitamin K2 truly delivers benefits for hearts and bones.”

 

“This cardiovascular study is significant because it shows that vitamin K2 not only benefits our bone health, but is also important to heart health,” said Dennis Goodman, MD, board-certified cardiologist and Director of Integrative Medicine at NYU Langone Medical Center in New York. “Vitamin K2 ensures calcium binds to the bone mineral matrix and stays out of the arteries. This is important because if calcium accumulates in the arteries, it may cause blockages that can lead to serious cardiovascular events, such as heart disease and strokes.”

 

Dr. Goodman, who is completing a new book explaining the important role that vitamin K2 plays in achieving both bone and heart health, says flexibility of the arteries also has a direct connection to a person’s longevity. Calcification in the arteries has been shown to add 10 years to a person’s biological age, according to a study published in The New England Journal of Medicine (Rosenhek, et al., 2000). Another study published in the  scientific journal Atherosclerosis (Shaw et al., vol. 188, 206) shows your biological age could decrease or increase by 10 years based on the level of age-related arterial calcification.

 

“This study, which is actually showing an improvement in endothelial function, has the potential to dramatically impact the way we view prevention when it comes to cardiovascular health,” Goodman adds. “Further clinical studies will be important to confirm these exciting findings.”

 

References:
1 Knapen MH et al, Braam LAJL, Drummen NE, Bekers O, Hoeks APG, Vermeer C. Menaquinone-7 supplementation improves arterial stiffness in healthy postmenopausal women: double-blind randomised clinical trial. Thrombosis and Haemostasis. 2015 113 5: 1135-1144. 2 Knapen MH, Drummen NE, Smit E,, Vermeer C, Theuwissen E. Three-year low-dose menaquinone-7 supplementation helps decrease bone loss in healthy postmenopausal women. Osteoporos Int. 2013 Sep;24(9):2499-507.

MenaQ7® K2 Launched in Australia/New Zealand

Major market penetration kicks off with leading brands   Ex-NattoPharma ASA, world leader in vitamin K2 research and development, in collaboratoin with Complementary Medicines Group (CMG) Australia, announces successful penetration into the Australian and New Zealand markets, including supplying major Sponsor brands.   This collaboration has resulted in exciting developments. First, Blackmores, Australia’s leading natural … Continue reading MenaQ7® K2 Launched in Australia/New Zealand

Major market penetration kicks off with leading brands

 

Ex-NattoPharma ASA, world leader in vitamin K2 research and development, in collaboratoin with Complementary Medicines Group (CMG) Australia, announces successful penetration into the Australian and New Zealand markets, including supplying major Sponsor brands.

 

This collaboration has resulted in exciting developments. First, Blackmores, Australia’s leading natural health brand, will utilize ex-NattoPharma’s MenaQ7® Vitamin K2 in a soon-to-be-released product that will be sold both online and through brick-and-mortar stores across Australia. BioCeuticals, supplier of high-quality practitioner-specific nutritional and therapeutic supplements, has also signed on to use its MenaQ7® Vitamin K2 in an upcoming product.

 

Another product concept released

 

In addition, another new product concept has already been released: Essential Nutrition Vitamin K2, a standalone bone health product featuring ex-NattoPharma’s MenaQ7® Vitamin K2 as MK-7, the only clinically validated and patented vitamin K2 as MK-7. The product is currently being sold online at www.essentialnutrition.net.au, and it will in November 2014 be sold exclusively through Go Vita, a 150-store retail natural products chain.

 

“Bone health is a serious concern, and the introduction of MenaQ7 Vitamin K2 to the Australian and New Zealand markets has been significant. We are energized,” says Craig Fallshaw, CMG Founder. “It is so validating to bring the only clinically validated, patented vitamin K2 as MK-7 to these markets.” In close collaboration with ex-NattoPharma ASA, CMG has leveraged relationships to bring the current product offering to market, as well as other opportunities for future products, and increase awareness of this important bone health ingredient. Most recently, CMG was a sponsor of the Complementary Medicines Australia (CMA) National Conference and 15th Annual Awards Dinner on October 30, 2014, where it was named the 2014 Wholesaler/Distributor of the Year.

 

“We are very pleased to make significant progress in Australia and New Zealand introducing our proprietary, patented, and clinically proven MenaQ7® Vitamin K2 as MK-7,” says Hogne Vik, CEO of ex-NattoPharma ASA. “We look forward to a long and successful relationship with CMG and its partner groups.”

 

About CMG
Complementary Medicines Group (CMG) is a service provider to the complementary medicine, food and over-the-counter pharmaceuticals industries. Offering raw materials, contract manufacturing, and marketing services, CMG was named the Complementary Medicines Australia 2011 Manufacturer, Wholesaler, or Distributor of the Year, and the 2014 Wholesaler/Distributor of the Year. For more information, visit cmgrouponline.com/au

MenaQ7® Full Spectrum K2 to Launch at SSW

Ex-NattoPharma Introducing the first and only full-spectrum Vitamin K2 that provides MK-6, 7, 8 & 9   Ex-NattoPharma further strengthens its reputation as the most comprehensive Vitamin K2 supplier by introducing a breakthrough unlike anything on the market: MenaQ7® Full Spectrum K2. This latest innovation is the result of a proprietary technological breakthrough, creating a … Continue reading MenaQ7® Full Spectrum K2 to Launch at SSW

Ex-NattoPharma Introducing the first and only full-spectrum Vitamin K2 that provides MK-6, 7, 8 & 9

 

Ex-NattoPharma further strengthens its reputation as the most comprehensive Vitamin K2 supplier by introducing a breakthrough unlike anything on the market: MenaQ7® Full Spectrum K2. This latest innovation is the result of a proprietary technological breakthrough, creating a Vitamin K2 that provides menaquinones (MK) 6, 7, 8 and 9, a range of isomers vital for cardiovascular health.

 

“Ex-NattoPharma has driven the creation of the Vitamin K2 market, sponsoring the important research validating the importance of K2 for human health, and this work has shaped the MenaQ7 brand,” says ex-NattoPharma Chief Medical Officer Dr. Hogne Vik. “The important epidemiological studies that led us to our ground-breaking human clinical research used fermented cheese as the source of Vitamin K2, which led us to create MenaQ7 Full Spectrum.”

 

According to researchers closely linked to these epidemiological studies1-3: “Vitamin K is a fat-soluble vitamin that plays and unequivocal role in the activation of Gla-proteins. Although all K-vitamins have the same function, they differ in bioavailability and bioactivity.

 

“The Rotterdam and Prospect studies have shown that food-derived vitamin K (such as from cheeses) improves long-term cardiovascular health outcomes because it more specifically delivers the long-chain menaquinones MK-6, 7, 8 and 9.”

 

“While fermented cheeses are the best dietary source of menaquinones in the West, most will not be able to consume enough to obtain optimal amounts of Vitamin K2, nor is cheese a practical source for extracting the menaquinones,” adds Dr. Vik. “To that end, ex-NattoPharma has once again broken the mold and offers to the market a raw material that delivers the range of menaquinones found in foods.”

 

Full-spectrum and suitable for all

 

The first and only Vitamin K2 to deliver to deliver a gamut of menaquinone isomers, MenaQ7® Full Spectrum is naturally fermented using chickpea protein, offering an all-trans Vitamin K2 that is free from gluten, soy and all-known allergens, and is suitable for vegans and vegetarians. MenaQ7® Full Spectrum provides the vital menaquinone isomers MK-6, 7, 8 and 9 for optimal and maximal delivery of vitamin K2 with respect to absorption, half-life and biological activity.

 

“Ex-NattoPharma has once again created a raw material that speaks directly the natural dietary supplement consumer, who is drawn to comprehensive nutritional sources,” says Daniel Rosenbaum, NattoPharma CEO. “We welcome the opportunity to meet with companies at this year’s SupplySide West to officially launch this market-changing innovation.”

 

MenaQ7® Full Spectrum Vitamin K2 will be centerpiece of ex-NattoPharma’s SupplySide West booth P115.

New MenaQ7® Vitamin K2 Cardiovascular Study Publishes

Vascular Diseases and Therapeutics publishes 1-year study confirming MenaQ7® Vitamin K2 as MK-7 supplementation improves vascular health A new one-year clinical trial has just been published showing that a daily nutritional dose of MenaQ7® Vitamin K2 as MK-7 improved vascular health, adding to the substantial body of evidence confirming MenaQ7® Vitamin K2 is clinically validated … Continue reading New MenaQ7® Vitamin K2 Cardiovascular Study Publishes

Vascular Diseases and Therapeutics publishes 1-year study confirming MenaQ7® Vitamin K2 as MK-7 supplementation improves vascular health



A new one-year clinical trial has just been published showing that a daily nutritional dose of MenaQ7® Vitamin K2 as MK-7 improved vascular health, adding to the substantial body of evidence confirming MenaQ7® Vitamin K2 is clinically validated to offer cardiovascular support.  

According to the authors of “Effect of Menaquinone-7 (vitamin K2) on vascular elasticity in healthy subjects: results from a one-year study”, Matrix Gla-Protein (MGP) is involved in the prevention of arterial calcification. During vitamin K-insufficiency, MGP is produced in its inactive form: dp-ucMGP. Two 3-year intervention studies in the general population have shown that increased vitamin K intake may decrease arterial stiffening, but the difference with placebo became only significant in the third year of treatment. “In the present trial the researchers investigated whether in a pre-selected group of vitamin K-insufficient subjects (men and women) an effect of vitamin K-supplementation may be demonstrated within one year,” the authors wrote.

Completed by the expert researchers at VitaK, the placebo-controlled randomised clinical trial was performed in 243 subjects (40-70 years old) characterized by circulating dp-ucMGP concentrations above the median of the general population. Arterial stiffness was concluded from the carotid-femoral pulse-wave velocity (cfPWV), and other vascular characteristics were measured by echotracking of the common carotid artery. Treatment was performed with either 180 µg/day of Vitamin K2 as MK-7 (as MenaQ7® from NattoPharma) or placebo for one year.

In the total study group, MK-7 induced a significant decrease of both dp-ucMGP and cfPWV. The authors conclude: “High vitamin K intake decreased age-related vascular stiffening. The effects were most obvious in women with poor vitamin K status, and were statistically significant after one year of treatment.”

“This study continues to build the rock-solid argument that MenaQ7 Vitamin K2 – not K1 or other unstudied Vitamin K2 ingredients – delivers important cardiovascular support,” says Hogne Vik, NattoPharma Chief Medical Officer. “In this study, the participants taking MenaQ7 maintained arterial flexibility and the stiffness did not increase, whereas placebo group became stiffer and less flexible.

Vik continues, “These results mirror what we have seen in epidemiological studies, where populations who consume a lot of dietary Vitamin K2 have healthier hearts and more flexible arteries, as well as our groundbreaking three-year study in healthy postmenopausal women. Vitamin K2 is indeed a vital cardiovascular support nutrient, and MenaQ7 is the only K2 as MK-7 clinically proven to do so.”

Vitamin K2 Needs RDI: New Paper

NattoPharma research partners publish important review paper clearly identifying the need for a Vitamin K2-specific RDI Widespread Vitamin K deficiency has had an indelible impact on global cardiovascular and bone health, yet there is no established RDI (Recommended Daily Intake) for Vitamin K2. To that end, Nutrients has published a new review paper1 clearly identifying … Continue reading Vitamin K2 Needs RDI: New Paper

NattoPharma research partners publish important review paper clearly identifying the need for a Vitamin K2-specific RDI



Widespread Vitamin K deficiency has had an indelible impact on global cardiovascular and bone health, yet there is no established RDI (Recommended Daily Intake) for Vitamin K2. To that end, Nutrients has published a new review paper1 clearly identifying that differences between Vitamins K1 and K2, elucidating the need for a K2-specific RDI, completed with the support of NattoPharma, the Vitamin K2 leader, as partner within the Horizon 2020 grants EVOluTION and INTRICARE.

Vitamin K and its essential role in coagulation (vitamin K [Koagulation]) have been well established and accepted. Many countries have an RDI for vitamin K based on early research, and its necessary role in the activation of vitamin K-dependent coagulation proteins is known. According to the authors of “Vitamin K2 Needs an RDI Separate from Vitamin K1,” in the past few decades, the role of vitamin K-dependent proteins in processes beyond coagulation has been discovered. Various isoforms of vitamin K have been identified, and vitamin K2 as long-chain menaquinones (i.e., menaquinone-7, or MK-7) specifically has been highlighted for its long half-life and extrahepatic activity, whereas the dietary form vitamin K1 and shorter-chain menaquinones have much shorter half-lives.

“In this review, we highlight the specific activity of vitamin K2 based upon proposed frameworks necessary for a bioactive substance to be recommended for an RDI. Vitamin K2 meets all these criteria and should be considered for a specific dietary recommendation intake,” the authors write.

NattoPharma announced its intention to spearhead the pursuit of a K2-specific RDI in 2018. The program began with a team of researchers at Maastricht University, the Netherlands, the group that has led the way discovering and validating the health benefits of Vitamin K2, guided by Dr. Leon Schurgers, Professor of Biochemistry of Vascular Calcification and Vice Chair of Biochemistry at the Cardiovascular Research Institute Maastricht (CARIM), Maastricht University. NattoPharma has worked closely with the Maastricht University in documenting benefits of the company’s exclusive branded MenaQ7® Vitamin K2 as MK-7, since 2004 – work that has been recognized with many peer-reviewed scientific papers and with recently awarded research grants.

 “We have been working with Maastricht University for almost two decades validating the health benefits of Vitamin K2, creating this category. Our work, in addition to others’, is building the necessary body of evidence required to convince regulatory bodies how essential Vitamin K2 is for the betterment of global human health,” says Kjetil Ramsøy, NattoPharma CEO. “This is no small undertaking, yet we at NattoPharma believe it is vital we reach a global recommendation for K2 intakes if we are to correct the K2 deficiency that has so negatively impacted the bone and cardiovascular health, and correcting this deficiency can benefit men and women, adults and children.”