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MenaQ7® Aortic Calcification Human Study Protocol

menaq7-aortic-calcification-human-study-protocol-publishes

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® 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.

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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