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Greek study will use the highest dosage of Vitamin K2 as MK-7 so far, further proof of MenaQ7® K2 safety. Oslo, Norway and East Brunswick, NJ (8 June 2021) – Ex-NattoPharma is excited to announce that a new 1.5-year clinical trial using MenaQ7® Vitamin K2 as MK-7 has been registered on ClinicalTrials.gov. The trial … Continue reading MenaQ7 K2 Cardio Study Registered
Greek study will use the highest dosage of Vitamin K2 as MK-7 so far, further proof of MenaQ7® K2 safety.
Oslo, Norway and East Brunswick, NJ (8 June 2021) – Ex-NattoPharma is excited to announce that a new 1.5-year clinical trial using MenaQ7® Vitamin K2 as MK-7 has been registered on ClinicalTrials.gov. The trial will examine the cardiovascular impact in a patient population and will use the highest dosage of K2 as MK-7 to date: 1mg daily.
The new multi-centre, placebo-controlled, randomized, open-label intervention clinical trial, “The Effect of Vitamin K2 Supplementation on Arterial Stiffness and Cardiovascular Events in PEritonial DIAlysis (VIKIPEDIA)”, will be conducted with Peritoneal Dialysis (PD) patients. The investigators at Aristotle University of Thessaloniki in Greece will study the effect of K2 supplementation (through normalization of dp-ucMGP) on arterial stiffness and the occurrence of cardiovascular events.
Chronic Kidney Disease (CKD) is a state of progressive vascular calcification and cardiovascular disease. End Stage Kidney Disease patients receive renal replacement therapy either by hemodialysis or by PD, according to lead researcher Stefanos Roumeliotis , MD, PhD. “Several studies have shown that hemodialysis patients have vitamin K depletion and accelerated vascular calcification ,and this finding led to the initiation of several randomized controlled trials exploring the effect of vitamin K2 supplementation on vascular calcification in hemodialysis patients.
“VIKIPEDIA is the first study to assess whether high dosage of Menaquinone-7 could improve arterial stiffness, mortality, cardiovascular disease, 24-hour ambulatory blood pressure and dialysis efficacy in patients with PD,” he explains. “MenaQ7® was chosen to be used in the study because the compound showed its efficacy to improve vitamin K status in many clinical trials with kidney patients.”
At baseline, all eligible patients who have provided a written, informed consent will be enrolled in the study. Αortic stiffness and vitamin K status will be assessed by PWV and plasma dp-ucMGP levels respectively. Before randomization, the investigators will draw blood (serum and plasma) and PD fluid samples from all patients to measure blood count and routine biochemical parameters, including urea, creatinine, potassium, sodium, calcium, phosphorus, c-reactive protein, alkaline phosphatase, albumin, parathormone, 25-OH D3, magnesium, glycated hemoglobin, thyroid function hormones. Since both vitamin D and magnesium are considered of utmost importance in vitamin K metabolism, after baseline, patients with vitamin D and/or magnesium depletion will be treated with oral supplements to achieve normal levels of both elements, before randomization. The cohort will then be categorized to one of the two groups (placebo or active group) and the treatment period will last 1.5 years. To ensure that the two parallel groups will include patients that will not differ significantly in vitamin K and stiffness, patients will be accordingly stratified. After randomization, all patients will continue their routine, standard medical treatment and patients in the treatment group will additionally receive daily, per 1 mg of vitamin K2 (MenaQ7®, ex-Nattopharma, ASA, Hovik, Norway).
It is important to note, according to Dr. Hogne Vik, Chief Medical Officer with ex-NattoPharma, that researchers recognized the importance of optimal level of vitamin D and magnesium to support function of vitamin K2. That is why patients deficient with vitamin D or magnesium will be treated with theses nutrients to reach normal levels before randomization.
“People with kidney problems exhibits low vitamin K status, which has been shown to increase cardiovascular disease as well as mortality risk,” explains Dr. Vik. “Vitamin K2 supplementation was shown to be effective to improve vitamin K status in kidney patients to some extent. However, none of these trials have been conducted in PD patients, but only in pre-dialysis CKD or haemodialysis subjects or kidney transplant patients.
“VIKIPEDIA represents two important firsts: it will be the first trial in PD patients, and the first time this high dosage of vitamin K2 as MK-7 will be used, which supports high safety profile of this nutrient,” adds Dr. Vik. “We are thrilled because this study will add to the already substantial evidence that MenaQ7 Vitamin K2 is an important cardiovascular-support nutrient, and it presents great hope for an at-risk patient population.”
The study is scheduled to start in September 2021. The researchers will collaborate with long-time ex-NattoPharma research partner Masstricht University to evaluate vitamin K status.
https://clinicaltrials.gov/ct2/show/NCT04900610?term=peritoneal&cond=vitamin+k&draw=2&rank=1
About ex-NattoPharma
As the Vitamin K2 world leader, ex-NattoPharma’s ironclad science portfolio is the foundation for today’s understanding of K2 and is the basis for all industry claims about the benefits of K2.
Two things separate ex-NattoPharma from other Vitamin K2 suppliers. First, we offer the ONLY K2 as MK-7 clinically validated to deliver health benefits. With more than 20 human clinical trials where MenaQ7 K2 was the actual source material, we have demonstrated the K2 mechanism, safe and effective dosages, and the importance of K2 for bone and cardiovascular health, all while simultaneously verifying our brand’s efficacy.
Second, NattoPharma provides the MOST comprehensive K2 portfolio – both natural fermented and nature-identical synthesis in various dilutions and solubilities – offering solutions for brand owners to make Vitamin K2 available in a broader range of finished product dose forms. The MenaQ7® Solution Platform opens opportunities to formulate with multiple active ingredients, guided by the experts of the ex-NattoPharma R&D team.
A ex-NattoPharma partnership does not end once kilos are delivered. We are invested in your success and positioned to ensure you achieve it.
Wiley’s Finest™ Introduces High Potency Wild Alaskan EPA/ DHA featuring MenaQ7® K2 for Adults Ex-Nattopharma is excited to announce its visionary partner, Ohio-based Wiley’s Finest™ Wild Alaskan Fish Oil, is preparing to launch its Adult EPA and DHA Omega-3 formula featuring MenaQ7® Vitamin K2 as MK-7. The Adult formula is the second product from … Continue reading MenaQ7®/Omega-3 Product By Wiley’s Finest
Wiley’s Finest™ Introduces High Potency Wild Alaskan EPA/ DHA featuring MenaQ7® K2 for Adults
Ex-Nattopharma is excited to announce its visionary partner, Ohio-based Wiley’s Finest™ Wild Alaskan Fish Oil, is preparing to launch its Adult EPA and DHA Omega-3 formula featuring MenaQ7® Vitamin K2 as MK-7. The Adult formula is the second product from Wiley’s Finest featuring MenaQ7®.
The new product combines both 500mg of concentrated EPA and DHA Omega-3 from Alaska Pollock Fish Oil with a meaningful dosage of MenaQ7® K2 per serving (80mcg). Wiley’s opted for this dose after reviewing studies that showed MenaQ7® K2 delivered positive health benefits at just 45mcg per day.
“Playing off the fact that Vitamin K2 is both a key nutrient in this formula and the name of the second highest mountain on earth, we decided to launch this product with the campaign theme of ‘Climb the Peak of Health’. We felt it would be a fun and inspirational way to engage our valued customers and encourage them to rise to the heights of good health,” explains Wiley’s Finest™ CEO Sam Wiley.
Wiley’s Finest™ Adult EPA and DHA Omega-3 formula featuring MenaQ7® is the second Wiley’s product including ex-NattoPharma’s clinically validated Vitamin K2 as MK-7. At last year’s Natural Products Expo West Wiley’s launched its award-winning kids liquid formula called Beginner’s DHA. In addition to being the first commercially available formula of its type for children in the natural foods channel, it was recently cited as one of the top five nutrition trends by NUTRA-ingredients at Expo West 2016.
Both the child and adult formulas are designed to support bone and cardiovascular health
The new formula is Contents Tested and Certified by NSF International; this continues Wiley’s Finest’s commitment to exceptional quality as the only full line of Omega-3 Fish Oil supplements that are NSF certified. NSF certification ensures that products meet the dose claimed on their label and are safe from environmental contaminants. Furthermore, each Fish Oil supplement is certified by the Marine Stewardship Council to prove that the wild fish source is sustainably and responsibly caught.
“Wiley’s insistance on using MenaQ7® Vitamin K2 as MK-7, the clinically validated and patented K2, reiterates their commitment to quality,” says Eric Anderson, senior vice president of global sales and marketing with ex-NattoPharma, the leader in vitamin K2 research and development. “By including MenaQ7® K2 again in their latest product offering, we applaud Wiley’s Finest™ for acknowledging that Vitamin K2 deficiency affects the majority of Western populations. Clinical studies show that Vitamin K2 is an under-consumed nutrient that is very difficult to obtain from diet alone. Wiley’s Finest products offer an important combination with supplemental EPA and DHA Omega-3 to support heart and circulatory health, while delivering bone support simultaneously, for young and now old.”
A one-year clinical trial has just been completed showing that a daily nutritional dose of MenaQ7® Vitamin K2 as MK-7 improved vascular health in both male and female healthy participants. This study adds support to the substantial body of evidence confirming Vitamin K2 is a cardiovascular-support nutrient. Completed by the expert researchers at VitaK, … Continue reading MenaQ7® 1-Year Cardio Study: Benefits in Men & Woman
A one-year clinical trial has just been completed showing that a daily nutritional dose of MenaQ7® Vitamin K2 as MK-7 improved vascular health in both male and female healthy participants. This study adds support to the substantial body of evidence confirming Vitamin K2 is a cardiovascular-support nutrient.
Completed by the expert researchers at VitaK, the placebo-controlled randomised clinical trial demonstrated the benefits of 180 µg/day of MK-7 (as MenaQ7® from ex-NattoPharma) on vascular health and body composition in 243 healthy subjects (77 men and 166 women) with a poor vitamin K status, as measured by dp-ucMGP (inactive Matrix Gla Protein, a marker for cardiovascular health).
According to the researchers, “We enrolled participants with poor K status; however, in West most are K deficient as measured by activation of K-dependent proteins.”
An effect on vascular health for both genders
In the total group, MK-7 decreased dp-ucMGP significantly compared to placebo after 1 year. The researchers conclude that 1-year supplementation of MK-7 tended to improve vascular health in men and women with a poor vitamin K status. The beneficial effect was more pronounced in post-menopausal women and in subjects with a high Stiffness Index.
“This study is extremely important because this is the second trial to demonstrate benefits of MenaQ7® for cardiovascular health. But where participants in our first study were healthy postmenopausal women, this is the first trial where the effects were examined in both men and women,” says Hogne Vik, ex-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.”
Nutrients publishes rationale and protocol for study of a needy patient population that will validate calcification mechanism in cardio tissues. 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 ex-NattoPharma … Continue reading MenaQ7® PURE Study Protocol Published (VitaK-CAC)
Nutrients publishes rationale and protocol for study of a needy patient population that will validate calcification mechanism in cardio tissues.
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 ex-NattoPharma ASA) 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.
Aim of limiting or holding the progression of vascular calcification
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, ex-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.”
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 … Continue reading MenaQ7 3-year Cardio Study
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].
“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.”
Vitamin K2 benefits bone and heart health
“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.
Clinical intervention trial with hemodialysis patients shows positive, safe response. A study[1] of hemodialysis patients examined the risk factors and response to Vitamin K2 supplementation, and confirmed this population’s specific need to correct Vitamin K2 deficiency. The study published in BMC Nephrology, and the vitamin K2 used in the study was MenaQ7® Vitamin K2 … Continue reading MenaQ7® K2 Study Publishes
Clinical intervention trial with hemodialysis patients shows positive, safe response.
A study[1] of hemodialysis patients examined the risk factors and response to Vitamin K2 supplementation, and confirmed this population’s specific need to correct Vitamin K2 deficiency. The study published in BMC Nephrology, and the vitamin K2 used in the study was MenaQ7® Vitamin K2 as MK-7 from ex-NattoPharma.
According to the researchers, the scientific data showed that the vitamin K2 intake in hemodialysis patients is estimated to be 40 percent lower than in the healthy individual group. It has been accepted by the European medical society that hemodialysis patients are vitamin K deficient, and they can benefit from vitamin K2 supplementation. However, this aspect had not yet been evaluated in Eastern Mediterranean populations.
“Ex-NattoPharma was excited to participate in this clinical intervention trial,” says Hogne Vik, chief medical officer of NattoPharma. “We have long recognized the important implications correcting a vitamin K2 deficiency can have on human health, particularly in patient populations who suffer intense vascular calcification as a result of their condition. This study adds to the body of evidence confirming the cardiovascular support MenaQ7® Vitamin K2 as MK-7 provides, and continues to solidify ex-NattoPharma as the global leader in K2 research and development.”
An improvement of vitamin K status in Eastern Mediterranean populations?
The study, based in Lebanon, assessed if there is a correlation between vitamin K status and vascular calcification score in hemodialysis patients, and if K2 supplementation would improve extra-hepatic vitamin K status in this Eastern Mediterranean populations.
Fifty hemodialysis patients were enrolled in this clinical study, and received daily 360 μg of menaquinone-7 (MenaQ7®) for 4 weeks. Extrahepatic vitamin K status represented as the level of dpucMGP (dephosphorylated-uncarboxylated matrix Gla protein, or “inactive” MGP, a K-dependent protein) and vascular calcification scores (AC-24) were measured at the beginning and at the end of the vitamin K2 treatment.
The main conclusion was that hemodialysis patients have profound vitamin K deficiency as assessed by high dp-ucMGP plasma levels. High dpucMGP level was significantly correlated with high aortic calcification scores and thus can be used as a non-invasive marker for vascular calcifications.
According to the researchers, “The daily administration of 360 μg of vitamin K2 (MK-7) decreased dpucMGP by 86 percent after 4 weeks and it was well tolerated. Further studies should be conducted to assess the change in vascular calcifications after an extended duration of therapy.”
Reference:
Aoun M et al. High Dephosphorylated-Uncarboxylated MGP in Hemodialysis patients: risk factors and response to vitamin K2, a pre-post intervention clinical trial. BMC Nephrol. 2017 Jun 7;18(1):191. doi: 10.1186/s12882-017-0609-3.