Nutrient-depleted diets cause people globally to be deficient in vitamin K and folate, increasing the risk of developing cardiovascular disease. Amid American Heart Month 2026, Gnosis by Lesaffre points to evolving science, suggesting that diets are no longer enough, but supplementation may address both deficiencies and their health impacts.
Globally, 73% of women of reproductive age are deficient in folate, and 54% of the world’s population does not consume a sufficient amount through food.
Nutrition Insight speaks with Stefania Sala, product manager at Gnosis by Lesaffre, about the company’s MenaQ7 (vitamin K2) and Quatrefolic (folate) supplement ingredients. She tells us how these nutrients are crucial for heart and bone health and fertility, and how brands most optimally formulate.
How significant is the unmet need around vitamin K2 and folate?
Sala: The state of deficiency for both vitamin K2 and folate is worrisome, but there is even more to consider. A recent survey showed that 54% of the global population has inadequate dietary intakes of folate.
We can also consider that among 193 countries examined in July 2023, 69 implemented mandatory folic acid fortification, 47 had a voluntary folic acid fortification, and 77 countries had no folic acid fortification.
Folic acid, the synthetic form of vitamin B9, is currently the standard of care. But we should consider that the potential risks associated with excessive folic acid intake, as clearly outlined in a 2025 systematic review, are encouraging manufacturers to consider active folate (5-methyltetrahydrofolate or 5-MTHF) as the preferred alternative.
For vitamin K2, there is a popular misconception that it is easy to obtain from diet alone, but the truth is, we eat far less vitamin K than we did 50 years ago. A large reason deficiency is so common in North America and Europe is that the typical diet doesn’t contain a lot of the vitamin K2-rich foods.
Research suggests that up to 97% of Western populations have a deficiency or insufficiency of vitamin K2. This high prevalence is linked to low dietary intake and the limited storage of this fat-soluble vitamin in the body.
This deficiency leaves the population with compromised heart and bone health. Most concerning is that children exhibit the greatest vitamin K deficiency at a time when their bodies are growing rapidly, yet also laying the foundation for well-formed cardiovascular health.
There has been a noticeable expansion of educational efforts by industry associations and healthcare professionals to highlight the significance of these nutrients and growing scientific research and consumer awareness around the importance of these nutrients for various aspects of health.
Overall, the unmet need around vitamin K2 and active folate appears to be gaining traction, and brands are increasingly prioritizing the inclusion of these nutrients in their formulations to better address consumer demands and health needs.
How should brands evaluate clinical evidence quality when selecting ingredients?
Sala: Ensuring that branded ingredients are clinically validated is an essential step in the evaluation process. Suppliers that are not investing to confirm the safety and efficacy of their ingredients are failing brand owners. MenaQ7 Vitamin K2 as MK-7 has been the source material for more than 22 published human clinical trials, and we have several new studies scheduled to be completed in 2026–2027.
Research suggests that up to 97% of Western populations have a deficiency or insufficiency of vitamin K2.One must consider the quality control systems that ingredient suppliers have in place. Both Quatrefolic and MenaQ7 are produced in European cGMP-certified plants that meet the highest quality standards and certifications, including FSSC 22000, ISO 22000, kosher, and halal.
For example, each Quatrefolic batch is thoroughly controlled before it is released on the market. Chemical and microbiological quality controls are performed by the site’s Quality Control Department.
As cardiovascular health positioning evolves beyond cholesterol management, how do vitamin K2 and active folate fit into next-generation heart health product concepts?
Sala: Active folate (5-MTHF) supports homocysteine metabolism, a key factor in vascular health that reduces the risk of stroke. In combination with vitamin K2, it can offer a complementary, science-backed approach that targets multiple aspects of cardiovascular function, aligning with the growing demand for holistic, life-stage–focused solutions.
What technical or stability considerations should manufacturers be aware of when pairing a fat-soluble vitamin like K2 with a water-soluble active folate?
Sala: Fat-soluble vitamins like vitamin K2 are generally more sensitive to oxidation, light, and heat compared to water-soluble vitamins like folate. The presence of a water-soluble folate in the same formulation may impact the stability of the vitamin K2, potentially leading to degradation or loss of potency over time.
To address stability concerns, manufacturers may need to consider using specialized encapsulation or delivery systems, such as softgels, liposomes, or emulsions, to protect fat-soluble vitamin K2 from the aqueous environment of folate. These delivery systems can help maintain the stability and bioavailability of both vitamin K2 and folate.
The optimal pH for the stability of vitamin K2 and folate may differ, as they have different pH-dependent solubility and stability profiles. Manufacturers should carefully evaluate the formulation pH to ensure it supports the stability of both ingredients.
The choice of excipients, such as antioxidants, chelating agents, or pH modifiers, can significantly impact the stability of the combined formulation. Careful selection and optimization of excipients are necessary to maintain the stability and integrity of both vitamin K2 and folate.
Manufacturers should also develop and validate robust analytical methods to accurately quantify the levels of both vitamin K2 and folate in the final product, especially during stability testing.
We work together with formulation teams to guide them to identify and address these considerations and guide them to the specific ingredient forms that would best work for their finished product ideas. We offer a variety of flexible solutions, including our MenaQ7 Matrix, which delivers clinically validated K2 with award-winning protection technology for more complex formulations.
We also offer Quatrefolic Pro, our next-generation folate that has been demonstrated to withstand exposure to high environmental temperatures without affecting stability, as well as improved handling properties.
With increasing scrutiny on health claims, what types of structure or function claims around vascular health, calcification, or homocysteine metabolism are currently supportable for K2 and active folate in key global markets?
Sala: In the market for Europe, the Middle East, and Africa, the European Food Safety Authority (EFSA) has recognized the role of folate in normalizing homocysteine levels with a dedicated claim: “Folate contributes to normal homocysteine metabolism.” This reduces the risk of heart disease and can support heart health.
In 2024, Quatrefolic received a structure-function claim in North America, focusing on vascular health: “Quatrefolic helps support healthy C-reactive protein levels (CRP), cardiovascular health, vascular health, endothelial health, and nitric oxide protection.”
At this point, EFSA does not recognize the role of vitamin K2 for protecting cardiovascular health.Based on its substantial body of clinical evidence, MenaQ7 has enjoyed approved structure-function claims in the US for decades. Specific to heart health, they are: “Helps support heart health, arterial flexibility, arterial health, and arterial elasticity.”
MenaQ7 is the only clinically proven to support arterial health in a three-year study with healthy post-menopausal women.
Unfortunately, at this point, EFSA does not recognize the role of vitamin K2 for protecting cardiovascular health. But Gnosis by Lesaffre is committed to continuing to drive the clinical evidence it requires, and we are confident vitamin K2 will be recognized with a dedicated claim.
The data suggest postmenopausal women and women of reproductive age may benefit disproportionately. How should brands responsibly approach this without over-medicalizing supplements?
Sala: Responsible brands can focus on life-stage–specific nutritional needs — particularly fertility, pregnancy, lactation, and menopause — while prioritizing transparent communication, avoiding disease-treatment claims, and collaborating with healthcare professionals to ensure products support normal physiological functions.
For example, Gnosis by Lesaffre recently partnered with the Maternal Foundation to reinforce our commitment to educating and supporting women’s health.
How do you expect clinical research, regulatory frameworks, and consumer education to shape the adoption of vitamin K2–folate blends in mainstream heart health categories over the next five years?
Sala: Ongoing consumer education about the importance of supporting cardiovascular health through targeted supplementation is expected to drive demand for these blends, particularly when products are positioned responsibly to meet specific life-stage or lifestyle needs.
Quatrefolic regularly posts B2B2C messages on its social media pages to inform about the effectiveness of active folate, supported by scientific evidence.
