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MenaQ7® PURE Study Protocol Published (VitaK-CAC)

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.”

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MenaQ7 study with children

45 mcg per day of vitamin K2 was shown to support the needs of healthy bones in children

Growing Strong Bones

Childhood is the most essential period for developing and building healthy bone mass.
However, research shows children have 8 to 10 times higher levels of inactive osteocalcin, which means they are not optimally building the bone mass they require during this period.[3]

In turn, today we see an increase in low-energy fractures in children. Thankfully there is a way to mitigate this situation.

Studies show that children who have optimal levels of Vitamins K2 and D3 have fewer bone fractures than children with lower status of these two vitamins. [4,5]

MenaQ7® is the only Vitamin K2 on the market proven to benefit bone health in children.

[3] Theuwissen E et al. Food & Function. 2013;5(2):229-34
[4] Popko J et al. Nutrients. 2018 Jun 6;10(6):734.
[5] Karpiński M et al. J Am Coll Nutr. 2017 Jan;36(1):64-71

MenaQ7® study show

180 mcg per day of vitamin K2 maintain bone health in postmenopausal women

Well-Being in Times of Change

It is well recognized that women approaching and going through menopause are prone to develop weaker bones.

During this period, hormonal changes lower oestrogen levels, leading to bone loss and increased fracture risk.

Compromised bone health is estimated to affect 200 million women worldwide. Supporting bone health in women during this period of life is growing in importance, particularly as an ageing population seeks to maintain their quality of life.

The combination of Vitamins K2 and D3 is shown to have a more beneficial effect on this demographic’s bone strength than either vitamin taken alone.[5]

MenaQ7® is the only clinically proven K2 to deliver on the promise of maintaining bone health in postmenopausal women.[2]

[5] Ushiroyama T et al. Maturitas. 202 Mar 25;41(3):211-21.
[2] Knapen MHJ et al. Osteoporos Int. 2013 Sep;24(9):2499-507.

Supporting Mothers for Healthy Babies

Pregnancy is a time of extraordinary change and the WHO estimates 20-30% of pregnant women suffer from some kind of vitamin deficiency. Post-natal supplements are important for many women during this period of their lives to ensure not only their health, but their babies as well.

In particular, pregnant women are advised to increase their calcium levels to support the growing babies’ bone and teeth – and to maintain the mothers own bone mass, which is depleted during pregnancy and nursing.

Research shows that women's bone metabolic status significantly changes over the period between pregnancy and during nursing [6], and as much as 50% of newborns are K deficient. Incorporating Vitamins K2 with D3 in post-natal supplements would benefit both mother and child through their combined optimization of calcium.

[6] Miyamoto T et al. Sci Rep. 2019 May 13;9(1):6787.

MenaQ7® study show

180 mcg per day is beneficial for bone and cardiovascular health.

Do What You Love Longer!

Calcification is believed to be an inevitable and unfortunate result of aging, but studies show that arterial calcification is, in fact, an actively regulated process where Vitamins K2 and D3 play a critical role.

In 2020 the ageing population (people over the age of 65) grew to approximately 727 million. Supporting bone and heart health is vitalto ensure quality of life as we age.

A 2013 study [8] evaluating the cardiovascular effect of Vitamin K2 (MenaQ7®) plus Vitamin D or Vitamin D alone showed more beneficial results when the two nutrients were combined than when D was taken alone.

MenaQ7® is the only clinically Vitamin K2 as MK-7 proven to reduce arterial stiffness in adult populations.[9]

[8] Kurnatowska I et al. Pol Arch Med Wewn. 2015;125(9):631-40.
[9] Knapen MHJ et al. Thromb and Haemost. 2015 May;113(5):1135-44.

 

Active Lifestylers

The bone and joint market is still expected to be driven by aging populations, but trends like Healthy Aging and Fitter for Longer open the market for younger demographics. Since 2000, views have drastically evolved about the importance of staying active and the role bone/joint health plays in one’s ability to do so.

Bone fractures are an obvious hindrance to staying active. In fact, every 3rd woman and every 5th man over the age of 50 will experience osteoporotic fractures. It is also worth noting that young female athletes have higher fracture risks than male counterparts.

Knowing the intricate balance between Vitamins D3 and K2, and its combined benefits for bone and heart health, a product that aims to support active lifestylers should incorporate both.

Start supercharging your D3 here