NattoPharma (Oslo, Norway) continues to build evidence that its MenaQ7 vitamin K2 MK-7 ingredient provides significant and unique benefits for heart health. At November’s SupplySide West trade show, the company shared details of a one-year clinical trial now undergoing peer review, plus two new studies underway.
NattoPharma announced the completion of its one-year, large-scale vascular-health study. The study is now in the peer-review process. Researchers investigated whether a daily dose of MenaQ7 (180 micrograms/day) could improve vascular health and vitamin K status in subjects with poor vitamin K status.
The randomized, placebo-controlled study enrolled 243 healthy subjects (77 men and 166 women) who had poor vitamin K levels. The researchers studied MenaQ7’s effects on vascular health and body composition by looking at effects on dp-ucMGP (inactive matrix Gla protein), which is a K-dependent marker for cardiovascular health.
They found that after one year of supplementation, MenaQ7 helped subjects significantly decrease dp-ucMGP. “The researchers conclude that one-year supplementation of MK7 tended to improve vascular health in men and women with a poor vitamin K status,” said NattoPharma in a press release. This effect was said to be more pronounced in postmenopausal women and in subjects with higher scores on the Arterial Stiffness Index (a screening test).
NattoPharma chose to perform this new one-year study in healthy male and female subjects as a follow-up to its large-scale, 244-subject, three-year study published in Thrombosis and Haemostasis in 2015, which was conducted in postmenopausal women. That study found that 180 micrograms of MenaQ7 daily helped significantly improve arterial flexibility. The company’s latest one-year study is a follow-up to show that these benefits in postmenopausal women extend to healthy men and women as well.
“Because the three-year study was done in healthy postmenopausal women, questions remained: ‘Well, does this help men?’” said Kate Quackenbush, director of communications, NattoPharma USA Inc., NattoPharma’s North American subsidiary in Edison, NJ, at SupplySide West. “This one-year study in healthy men and women shows that, again, with 180 micrograms, positive cardiovascular benefit.” She said the company hopes the study will publish in early 2019.
Two additional cardiovascular studies on MenaQ7 are now coming to completion, she said. Both study protocols have been published in the journal Nutrients. These studies are being conducted in patient populations with arterial calcification symptoms and are being driven by the medical community, using a higher dosage (360 micrograms MenaQ7).
The first study is the VitaK-CAC Trial1, which is examining the effects of MenaQ7 on coronary artery calcification (CAC). CAC is a precursor to atherosclerosis and a strong predictor of cardiovascular disease (CVD). Matrix Gla protein (MGP) is a member of the family of vitamin K2–activated, Gla-containing proteins. MGP helps bind calcium ions and inhibit vascular calcification. In the study, researchers sought to determine whether supplementation with MenaQ7 helped slow the progression of calcification.
In the double-blind, randomized, placebo-controlled trial, patients, including those with coronary artery disease (CAD), received 360 micrograms of MenaQ7 or a placebo daily, for 24 months. “We hypothesize that treatment with MK-7 will slow down or arrest the progression of CAC and that this trial may lead to a treatment option for vascular calcification and subsequent CVD,” the researchers wrote.
The second study underway is BASIK2, a prospective study looking at the effect of MenaQ7 on “imaging measurements of calcification in the bicuspid aortic valve (BAV) and calcific aortic valve stenosis (CAVS). BAV is associated with early development of CAVS,” the abstract states.2
The double-blind, randomized, placebo-controlled study is being conducted in 44 subjects with BAV and mild-to-moderate CAVS. The researchers posit that because MGP is vitamin K dependent, supplementation with 360 micrograms daily of MenaQ7 will help to activate MGP and help to intervene in the progression of CAVS. Subjects will undergo 18 months of follow-up and be assessed using Fsodiumfluoride (FNaF) positron emission tomography (PET)/magnetic resonance (MR) and computed tomography (CT).
“We expect that K2 supplementation will reduce the calcium metabolism in the aortic valve on 18NaF-PET (primary endpoint) and slow progression of CAVD as measured by the calcium score on CT and echocardiography after 18 months (secondary endpoints), compared to placebo,” the abstract states.
Focus on Heart Health
Overall, said Quackenbush, NattoPharma hopes that the rich body of research being done to show MenaQ7’s benefits for cardiovascular health helps convince the dietary supplement and medical establishments that vitamin K2 is a critical nutrient for hearth health, the same way that the company has done longstanding work to demonstrate the benefits of K2 for K2’s other primary health indication, bone health.
“We are optimistic that these studies will be a vaulting point for vitamin K2 to be recognized by practitioners as a vital nutrient for cardiovascular health, the same as vitamin D and omega-3s are now,” she said.
She pointed out that K2 helps to inhibit arterial calcification in ways that no other compound can. “Atherosclerosis is one of the main causes of cardiovascular disease, and cardiovascular disease is the number-one killer globally. The problem is that there is no compound at all that helps with arterial calcification, except for K2,” she said at SupplySide West. “K2 is the only one that is shown to impact—particularly reduce—arterial calcification in any way.”
Also, Quackenbush added, this is why K2 makes such a complementary pairing with a heart health ingredient like omega-3. “One of the reasons that omega-3 is such a great fit for K2 is because K2 is the missing piece,” she said. “While omega-3’s mechanism of action is linked to supporting healthy inflammation, triglycerides, blood pressure, and promotion of arterial health, it is not recognized for impacting vascular calcification. So we’ve had customers innovating in the market by adding K2 to their products because it is that missing heart-health piece.”
It’s also a complementary ingredient for those taking statins for high cholesterol. “CoQ10 is a fantastic heart-health nutrient, but when you take a statin for high cholesterol, it depletes CoQ10 levels in the body, so patients are told to supplement with CoQ10,” she explained. “At the same time, research shows statins also inhibit the synthesis of K2, but patients are not being directed by doctors to supplement with K2. So they’re basically taking something for cholesterol that is actually damaging their cardiovascular health. If they were directed to supplement with a K2 the way they are with CoQ10, they would be getting better heart-health support.”
NattoPharma is now continuing to work on educating practitioners, as well as the supplement market, about the important role of K2 in cardiovascular health. And the company is coming armed with more evidence via these new studies.
The company also intends to further explore the body’s other K-dependent proteins and what their benefits might be. “The body has 17 K-dependent proteins, and at this point, there’s really only substantial evidence for three of them”—for blood clotting, bone health, and heart health—Quackenbush said. “We have these other 14 K-dependent proteins where research has barely scratched the surface. So that’s what we’re really hoping to start exploring. We’re always looking to continue to build our body of evidence.”
In the meantime, she said, “MenaQ7 is the only patented K2 for cardiovascular health.”
- Study abstract: Vossen LM et al. “Menaquinone-7 supplementation to reduce vascular calcification in patients with coronary artery disease: rationale and study protocol (VitaK-CAC Trial).” Nutrients, vol. 7, no. 11 (October 28, 2015): 8905-8915
- Study abstract: Peeters FECM et al. “Bicuspid aortic valve stenosis and the effect of K2 on calcification using fsodium fluoride positron emission tomography/magnetic resonance: the BASIK2 trial design.” Nutrients, vol. 10, no. 4 (March 21, 2018)