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Supplement Perspectives

Marketing Human Clinicals in Partnership with Brand Marketers

If you’re lucky, writes Eric Anderson, senior vice president of global sales and marketing at NattoPharma USA, Inc., that arrangement can make a real impact.

MenaQ7™ Vitamin K2 as MK-7 makes bones and hearts healthier. How can NattoPharma say this with confidence? Because we have conducted numerous human clinical studies proving it to be true. 

It is the same reason that our partners can assertively use claims on their products. Take California-based SuperNutrition, for example: It’s SimplyOne Heart Smart™ product that features MenaQ7 boasts the following claims right on the front of the box:

• Arterial flexibility*
• Cardiovascular health*

Now, it is important to differentiate that marketing does not beget science. The ultimate goal of research is discovery–whether a study supports one’s desired hypothesis is a different story, but that investment must be made before one can even conceive of a marketing strategy. Yet even when a hypothesis is confirmed, that does not mean the job is done. This is why every study ends with the statement “more research is needed.” Discovery is a never-ending journey; it must continue.

So I ask you: How impactful can a supplement-marketing program be without claims? And in this era of FDA oversight and FTC scrutiny, how can a company dare make a claim without the scientific research to support it? Better yet, how can companies shamelessly borrow science and say that is their support?

NattoPharma conducts clinical research to validate the benefits of Vitamin K2, providing our MenaQ7 as the source material used in these studies, so when a benefit is revealed, we (and our partners) are absolutely sure that is the case.  Only MenaQ7 is clinically validated–no other vitamin K2 can claim this.

This process began with observation: it was observed that populations consuming a lot of Vitamin K2 had stronger bones and healthier hearts (Rotterdam Study, published 2004). While observational data is no doubt interesting, we recognized more needs to be done to confidently prove that link. This is why NattoPharma embarked on intervention studies to compare the difference between groups taking a supplement versus a placebo, and actually witnessing a physiological outcome. We are not talking about a marker like cholesterol, but a real change in health compared to a control group.

Take, for example, our intervention trial that recently published in Thrombosis and Haemostasis[1]. In recent years, there has been a strong focus on the role of arterial stiffness impacting cardiovascular health, as well as the discovery of the vitamin K-dependent protein Matrix Gla Protein (MGP). MGP is the most potent modulator of vascular calci¬fication known, provided the body has enough vitamin K2 to activate it.

While it was believed that calcification (leading to a stiffening of the arteries) is an inevitable consequence of aging, recent studies reveal that arterial calcification is an actively regulated process. Healthy arterial tissues have been shown to contain 100 times more vitamin K2 than calcified arteries–meaning that simply supplementing with K2 can actively protect the cardiovascular system.

Observational data has suggested a link between vitamin K2 intake and cardiovascular health, but intervention trials with cardiovascular endpoints had been lacking.

To that end, researchers at the R&D Group VitaK of Maastricht University in the Netherlands monitored 244 healthy post-menopausal women for three years using pulse wave velocity and ultrasound techniques. The participants were randomly assigned to take a nutritional dose (180 mcg) of vitamin K2 as MK-7 (as MenaQ7) daily for three years, or placebo capsules.

After three years of treatment, the Stiffness Index ß in the MK-7 group had decreased significantly after compared to the slight increase in the placebo group. Results confirmed that vitamin K2 as MK-7 not only inhibited age-related stiffening of the artery walls, but also made a statistically significant improvement of vascular elasticity, especially in women having high arterial stiffness.

This study is a breakthrough because it is the first intervention trial whose results confirm the association made by previous population-based studies: that vitamin K2 intake is linked to cardiovascular risk. According to the researchers, the data demonstrated that a nutritional dose of vitamin K2 in fact promotes cardiovascular health.

Vitamin K2 makes bones and hearts healthier. It was observed, then it was proven, using MenaQ7 Vitamin K2 as MK-7. More research will be conducted to continue to reinforce those claims, but the work has been done to provide a foundation that allows our partners to confidently market their products.

Can your partners provide you that same confidence?

1 Knapen MHJ et al. Thrombosis and Haemostasis, 2015; 19;113(5).

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