Quality is king. This couldn’t be more true for the K2 supplements market.
In nature, vitamin K2 MK-7 predominantly contains seven double chemical bonds in a trans configuration, resulting in a linear molecule that is highly bioactive. These ‘all-trans’ MK-7 isomers act like a molecular key, unlocking the activity of K-dependent proteins in the body.
It is the activity of these K-dependent proteins (and therefore all-trans MK-7) that delivers benefits for bone health by helping to direct calcium to where it is needed. For example, osteocalcin activated by vitamin K2 works hand-in-hand with vitamin D3 to deposit calcium into the bones, supporting their strength.¹⁻³ What’s more, another K-dependent protein, matrix Gla protein (MGP), may play a role in promoting arterial elasticity and supporting healthy circulation.¹⁻⁷
It’s the linear shape of the all-trans MK-7 that allows vitamin K2 to activate these proteins and deliver crucial health benefits. However, if one or more of the molecular bonds are in the cis configuration, the shape of MK-7 differs, lowering its capacity to fit into the molecular lock and activate K-dependent proteins.
This is where many vitamin K2 products do not meet expectations.
A global challenge
Balchem, a leading global manufacturer of specialty ingredients for human nutrition and health, is advancing the vitamin K2 category with new insights from its ongoing quality assurance initiative. Recent testing of consumer vitamin K2 products sold on major online platforms in Poland reveals significant opportunities for enhanced stability and purity – areas where Balchem is leading with proven solutions.⁸
Balchem’s journey towards transparency started in 2018, when it collaborated with a third-party product testing lab to examine the vitamin K2 MK-7 content and isomeric purity of products in Germany.
More recently, Balchem took investigations global, joining forces with trusted and verified third-party labs in the US and Poland to test vitamin K2 products sold online. These investigations revealed a distinct trend that extends across the Western Hemisphere. The latest data shows that more than two thirds of the analyzed formulas failed to meet established quality standards and declaration information.⁸
These common discrepancies reflect two key elements of vitamin K2 quality that many manufacturers and consumers alike may not be aware of: isomeric purity and stability of the vitamin K2 MK-7 ingredient.
The science behind the standards
In all three of Balchem’s K2 investigations, a significant number of products contained high levels of the less biologically active cis isomers. This isomeric impurity, and the reduced bioactivity of the cis isomers, leads to recognisable differences between communicated product properties and laboratory values.
Currently, the market for vitamin K2 has limited regulatory requirements, and cis vs. trans testing for finished products is not routinely carried out. As Balchem’s analyses reveals, missing testing standards facilitate the marketing of less optimal products. This issue can be addressed through advanced testing and formulation excellence – and Balchem is leading by example with its patented K2VITAL™ ingredients, which are rigorously and independently tested, and proven to offer typically 99.7% all-trans isomeric purity.
Quality that’s built to last
In addition to isomeric purity, the majority of vitamin K2 products tested also showed lower MK-7 content than stated on the label. A key challenge for formulators that could contribute to this result is vitamin K2’s sensitive nature. The vitamin is vulnerable to ultraviolet light and oxygen, and highly susceptible to degradation in high-alkaline environments or when mixed with alkaline compounds, such as calcium carbonate.⁹
What’s more, in combination with certain minerals, including calcium and magnesium, unprotected vitamin K2 will break down.⁷ This can mean that the vitamin K2 content in many multivitamin or combination products can degrade rapidly during production or later in storage.
As part of its dedication to raising the industry standards for vitamin K2 quality, Balchem has developed K2VITAL DELTA, the world’s only patented double-microencapsulated vitamin K2 for combination with minerals. In this advanced solution, special double-coated beadlets shield the K2-MK7 on a molecular level, preserving its integrity in most environments, including blended supplements.
The value of K2VITAL DELTA was clearly demonstrated by a recent independent market study which used over 400 stability tests to examine vitamin K2-plus-minerals products.¹⁰ The results revealed that, three months after production, 100% of all K2VITAL DELTA-plus-minerals products met or were close to label claim, compared to only 8% of unprotected vitamin K2-plus-minerals products.¹⁰ With K2VITAL DELTA, manufacturers can develop blended supplements that meet their label claim and deliver the desired health benefits, without worrying about shelf life.
Leading the charge for change
Since its initial investigations into vitamin K2 quality, Balchem has been advocating for higher standards in the industry. To address its findings in the German market, Balchem reached out to local manufacturers, to inform them of the findings and explore co-development opportunities to enhance their offerings with the K2VITAL portfolio. As a result, numerous solutions available on one of the leading e-commerce platforms in Germany now feature the all-trans mark, assuring consumers of best-in-class K2.
By continuing to provide transparency regarding the quality of vitamin K2 products, Balchem is encouraging the further development of industry-wide standards – all to ensure consumers have access to high-quality solutions that provide genuine health benefits. Balchem aims to lead by example with K2VITAL ingredients, setting clear expectations for the future of integrity and reliability in vitamin K2 supplement manufacturing.
Learn more about Balchem’s true quality revolution for excellence in the vitamin K2 space here.
References
- National Institutes of Health. Vitamin K.
- Van Ballegooijen, A. J.; et al. The synergistic interplay between vitamins D and K for bone and cardiovascular health: a narrative review. International journal of endocrinology. 2017;(1), 7454376.
- Mandatori, D.; et al. The dual role of vitamin K2 in “bone-vascular crosstalk”: opposite effects on bone loss and vascular calcification. Nutrients. 2021; 13(4), 1222.
- Hariri, E.; et al. Vitamin K2—a neglected player in cardiovascular health: a narrative review. Open Heart. 2021;8(2), e001715.
- Chatrou, M. L.; et al. Intra-section analysis of human coronary arteries reveals a potential role for micro-calcifications in macrophage recruitment in the early stage of atherosclerosis. PLoS One. 2015; 10(11), e0142335.
- Schurgers, L. J. Vitamin K: key vitamin in controlling vascular calcification in chronic kidney disease. Kidney international. 2013; 83(5), 782-784.
- Westenfeld, R.; et al. Effect of vitamin K2 supplementation on functional vitamin K deficiency in hemodialysis patients: a randomized trial. American Journal of Kidney Diseases. 2012;59(2), 186-195.
- Balchem, Unpublished study
- Orlando, P., et al. Menaquinone 7 stability of formulations and its relationship with purity profile. Molecules. 2019; 24(5), 829.
- Kappa Bioscience unpublished study, Stability study: superiority confirmed in over 400 tests. The Kappa method: USP43 NF38 analysis of microencapsulated MK-7.
