New evidence draws an association between Vitamin K insufficiency and cognitive dysfunction, further argument for the potential of Vitamin K2.     MARCQ-EN-BAROEUL, FRANCE, AND EAST BRUNSWICK, NJ (26 APRIL 2022) – Frontiers in Nutrition published a new large-population cross-sectional study that demonstrated the association of vitamin K insufficiency with cognitive function.    In … Continue reading VIT K INSUFFICIENCY LINKED TO BRAIN HEALTH: NEW PAPER →

New evidence draws an association between Vitamin K insufficiency and cognitive dysfunction, further argument for the potential of Vitamin K2.

MARCQ-EN-BAROEUL, FRANCE, AND EAST BRUNSWICK, NJ (26 APRIL 2022) – Frontiers in Nutrition published a new large-population cross-sectional study that demonstrated the association of vitamin K insufficiency with cognitive function. 

In the study, “Association of Vitamin K Insufficiency with Cognitive Dysfunction in Community-Dwelling Older Adults”[1], Japanese researchers enrolled a total of 800 community-dwelling older adults (mean age = 75.9) and conducted a geriatric health examination, including a Mini-Mental State Examination (MMSE) and a blood test. Examining the concentration of undercarboxylated osteocalcin (ucOC) in serum, which is a biomarker for vitamin K insufficiency, they demonstrated the association of the concentration of undercarboxylated osteocalcin (ucOC) in serum, which is a biomarker for vitamin K insufficiency, with cognitive function. By using binary logistic regression analysis, the risk of cognitive impairment equivalent or below the mild cognitive impairment level for each tertile of ucOC was examined, with the lowest tertile as the reference.  

The results showed a significant association of impaired cognitive function and concentration of ucOC in the highest tertile of ucOC, with the odds ratio of 1.65 (95% CI, 1.06 to 2.59, P = 0.028). When the analysis was repeated with each domain of MMSE score*, the highest tertile of ucOC was associated with impaired orientation, calculation, and language.  

The finding of the present study was in line with the previous epidemiological studies, showing that lower vitamin K intake is associated with cognitive impairment. The researchers reported, “As far as we know, this is the first report on the significant association of single ucOC measurement and cognitive impairment. Our analysis also suggests that vitamin K insufficiency could be associated with selected categories of cognitive function. Since the single measurement of ucOC in serum is a simple and widely available method for vitamin K evaluation, it could be useful as a biomarker of neurodegenerative diseases affecting the cognitive functions.” 

These results are supported by another recently published paper from Spain[2] that assessed two years of changes in dietary K intake with cognitive function measured through neuropsychological performance tests. The researchers concluded that “An increase of the intake of dietary vitamin K was associated with better cognitive function scores, independently of recognized risk factors for cognitive decline, in an older adult Mediterranean population with high cardiovascular risk.” 

While the Japanese study examined “vitamin K,” there are several studies that showed that MenaQ7® Vitamin K2 as MK-7 improved K status as measured by ucOC, and these were done in healthy adult and child populations.[3,4]  

“We have worked with world-renowned researchers – as NattoPharma and that work continues at Gnosis by Lesaffre – to confirm the safe and effective health benefits of MenaQ7 Vitamin K2 as MK-7. Elucidating the important mechanism of activating K-dependent proteins, including osteocalcin and Matrix Gla protein (MGP), was a foundational piece of that work,” explains Dr. Hogne Vik, chief medical officer with Gnosis by Lesaffre, who referenced an important 2021 US-based review paper highlighting Vitamin K2 as a potential strategy for Alzheimer’s disease.[5] “Based on our research and the critical work that continues, we can hypothesize that K2 supplementation could prove beneficial in the brain development of children and support healthy brain function in adults.”  

Dr. Vik also noted that while Vitamin K2 as MK-4 has been noted as the main form of vitamin K in the brain, “it is important to mention that in-vivo research supports that supplementation with K2 as MK-7 increases MK-4 content in the brain tissue,” he concluded.  

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References: 

1 Azuma K et al. Association of Vitamin K Insufficiency With Cognitive Dysfunction in Community-Dwelling Older Adults. Front. Nutr. (2022) 8:811831. doi: 10.3389/fnut.2021.811831 

2 Camacho-Barcia L et al. Vitamin K dietary intake is associated with cognitive function in an older adult 

Mediterranean population. Age Ageing. 2022 Feb 2;51(2):afab246. Doi: 10.1093/ageing/afab246. 

3 Knapen MHJ et al. Three-year low-dose menaquinone-7 supplementation helps decrease bone loss in healthy postmenopausal women. Osteoporos Int. 2013 Sep;24(9):2499-507. doi: 10.1007/s00198-013-2325-6. Epub 2013 Mar 23. PMID: 23525894. 

4 Theuwissen E et al. Vitamin K status in healthy volunteers. Food Funct. 2014 Feb;5(2):229-34. doi: 10.1039/c3fo60464k. PMID: 24296867. 

5 Popescu A and German M. “Vitamin K2 Holds Promise for Alzheimer’s Prevention and Treatment.” Nutrients. 2021,13,2206. 

* Explanation of MMSE: The maximum MMSE score is 30 points. A score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia. On average, the MMSE score of a person with Alzheimer’s declines about 2 to 4 points each year. 

About Gnosis by Lesaffre 

Gnosis by Lesaffre harnesses the power of microorganisms and biotransformation processes like fermentation to cultivate nutritional actives, probiotics, and nutritional and functional yeasts that benefit human health and wellbeing. The team draws on its focused research and applications capabilities to collaborate with nutraceutical and pharmaceutical brands to develop game-changing products for their customers. 

For more information, please contact: 

Kate Quackenbush, Communications Director, k.quackenbush@gnosis.lesaffre.com, +1 609-454-2992 x220 

  PhD candidate supported by a research grant awarded to NattoPharma (now Gnosis by Lesaffre) attains his degree, continues to build evidence of K2 cardiovascular and bone benefits.   MARCQ-EN-BAROEUL, FRANCE AND EAST BRUNSWICK, NJ (10 MAR 2022) – PhD candidate Grzegorz Wasilewski defended his thesis on February 22, 2022, at Maastricht University, Cardiovascular Research … Continue reading Researcher Defends Vitamin K2 Doctoral Thesis →

PhD candidate supported by a research grant awarded to NattoPharma (now Gnosis by Lesaffre) attains his degree, continues to build evidence of K2 cardiovascular and bone benefits.

MARCQ-EN-BAROEUL, FRANCE AND EAST BRUNSWICK, NJ (10 MAR 2022) – PhD candidate Grzegorz Wasilewski defended his thesis on February 22, 2022, at Maastricht University, Cardiovascular Research Institute Maastricht (CARIM), The Netherlands. His work was supported by funding from the Norwegian Research Council and a research grant awarded to NattoPharma ASA (now Gnosis by Lesaffre). 

The thesis, “Calcium Paradox – the role of vitamin K in the bone-vascular axis”1, highlighted the published work Wasilewski has done in conjunction with and under the leadership of Prof. Leon Schurgers, Professor of Biochemistry of Vascular Calcification and Vice-Chair of Biochemistry at CARIM, Maastricht University. This research includes an important review paper2, an in-vivo study exploring the combination of phosphate binder therapy with vitamin K2 to inhibit vascular calcification in kidney patients3, and an in-vitro study examining the impact of K2 as MK-7 supplementation in osteogenesis4.  

“Scientists from Maastricht University have recently shown that combining vitamin K2 with phosphate binder treatment reduces vasculature and cartilage calcification. Additionally, they also discovered a novel role of vitamin K2 in beneficially affecting osteoblast maturation from induced pluripotent stem cells. Their findings might be clinically relevant for chronic kidney disease patients and for those seeking stem-cell therapies,” Wasilwski said in his defense. 

“With these discoveries, we are a step closer towards management of vascular calcification in chronic kidney disease patients. Using our novel experimental animal model of chronic kidney disease and vitamin K-deficiency demonstrates the beneficial role of combining phosphate binders with vitamin K2 in reducing vascular calcification compared to phosphate binders alone,” he added, noting that future clinical trials are needed to address whether vitamin K2 needs to be implemented in standard treatment therapy with phosphate binders. “Further, we have discovered a novel non-canonical role of vitamin K2 in aiding collagen synthesis in our iPSC model of osteoblast differentiation. Our results are fascinating as it changes the perspective on how MK-7 can impact skeletal disorders as well as paving the way for stem cell-based personalized therapy.” 

Since 2004, NattoPharma has worked closely with the Maastricht University in documenting benefits of the company’s exclusive vitamin K2 as MK-7 brand MenaQ7®. The research grant awarded to the NattoPharma International Research Network provided training in innovative therapeutic strategies that include MenaQ7, integrating early detection and prevention, to yield novel approaches to the management of chronic vascular and metabolic diseases that affect the increasing aging population of Western societies.  

Wasilewski was under the supervision of Prof. Leon Schurgers, a co-leader in the multidisciplinary research project together with Dr. Hogne Vik, Chief Medical officer at NattoPharma (now Gnosis by Lesaffre). This project is emblematic of NattoPharma’s continuation of the multi-year vitamin K2 research partnership with CARIM (as announced in 2020), to which Gnosis by Lesaffre has committed.  

“We are honored to have had the opportunity to support this distinguished researcher, and to see him come through this program making a substantial contribution to the argument that Vitamin K2 as MK-7 can indeed change the face of global health,” says Dr. Vik. “This work is so important as we continue to build an unshakeable science-based argument for Vitamin K2 as MK-7 is an essential nutrient worthy of its own Recommended Daily Intake (RDI), but also as a potential therapy for patient populations who express excessive calcification as a symptom of their condition.” 

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References: 

1 https://phd-defence.maastrichtuniversity.nl/phd-defence-grzegorz-b-wasilewski-tuesday-22nd-february-2022-1600-cet 

2 https://pubmed.ncbi.nlm.nih.gov/30805347/ 

3 https://pubmed.ncbi.nlm.nih.gov/34718756/ 

4 https://pubmed.ncbi.nlm.nih.gov/33585456/ 

About Gnosis by Lesaffre 

Gnosis by Lesaffre harnesses the power of microorganisms and biotransformation processes like fermentation to cultivate nutritional actives, probiotics, and nutritional and functional yeasts that benefit human health and wellbeing. The team draws on its focused research and applications capabilities to collaborate with nutraceutical and pharmaceutical brands to develop game-changing products for their customers. 

For more information, please contact: 

Kate Quackenbush, Communications Director, k.quackenbush@gnosis.lesaffre.com, +1 609-454-2992 x220 

  Literature review documents safe use and important health effects of vitamin K2 in child populations, noting consideration for pregnant and nursing women.   MARCQ-EN-BAROEUL, FRANCE AND EAST BRUNSWICK, NJ (12 JANUARY 2022) – Children has published an important review paper that documents vitamin K2’s role in various physiological processes, its safe history of use, … Continue reading Vit K2 Impacts Children’s Health, Disease: New Review →

Literature review documents safe use and important health effects of vitamin K2 in child populations, noting consideration for pregnant and nursing women.

MARCQ-EN-BAROEUL, FRANCE AND EAST BRUNSWICK, NJ (12 JANUARY 2022) – Children has published an important review paper that documents vitamin K2’s role in various physiological processes, its safe history of use, and that children express the greatest need for K2 supplementation.  

The paper, “The Impact of Vitamin K2 (Menaquinones) in Children’s Health and Disease: A Review of the Literature “1, presents a thoughtful organization of data highlighting the differences between vitamins K1 and K2, as well as K2 as menaquinone-4 (MK-4) and as MK-7; factors contributing to the prevalence of K deficiency; and how child populations can benefit from correcting this deficiency, according to Dr. Katarzyna Maresz, president of the International Science and Health Foundation, and co-author to this paper. 

“Vitamin K2 activates K-dependent proteins that support many biological functions, including bone mineralization, the inhibition of vascular stiffness, the improvement of endothelial function, the maintenance of strong teeth, brain development, joint health, and optimal body weight,” Dr. Maresz explains. “Due to the transformation of food habits in developed countries over the last five decades, vitamin K and, specifically, vitamin K2 intakes among parents and their offspring have decreased significantly, resulting in serious health implications. The therapeutics used in pediatric practice (antibiotics and glucocorticoids) are also to blame for this situation.”  

Dr. Maresz teamed with a nutritionist colleague at Jagiellonian University Medical College to complete the review, in which they discuss K2 as MK-7 supplementation is worth considering for expectant mothers as a means of setting their children on the best path to health. “The lack of adverse effects of MK-7 makes it the ideal choice for supplementation by pregnant and nursing women and children, both healthy and suffering from various malabsorptions and health disorders, such as dyslipidemia, diabetes, thalassemia major (TM), cystic fibrosis (CF), inflammatory bowel diseases (IBD), and chronic liver diseases,” the authors write. 

“As we continue our pursuit of a K2-specific Recommended Daily Intake (RDI), this review serves as a substantial argument,” says Dr. Hogne Vik, Chief Medical Officer with Gnosis by Lesaffre. “Particularly as it illustrates the overwhelming impact K2 deficiency has on child populations, and it illustrates how parents’ deficiencies feed into the state of their children’s health. We have stressed for more than a decade the impact that Vitamin K2 can have on children’s health. As thrilling as it was to see the first child-specific formulas featuring MenaQ7 K2 hit the market a few years ago, we have so much more to do to improve the health of our children.” 

# # # 

Reference: 

1 Kozioł-Kozakowska, A.; Maresz, K. The Impact of Vitamin K2 (Menaquionones) in Children’s Health and Diseases: A Review of the Literature. Children 2022, 9, 78. https://doi.org/10.3390/children9010078 

About Gnosis by Lesaffre 

Gnosis by Lesaffre harnesses the power of microorganisms and biotransformation processes like fermentation to cultivate nutritional actives, probiotics, and nutritional and functional yeasts that benefit human health and wellbeing. The team draws on its focused research and applications capabilities to collaborate with nutraceutical and pharmaceutical brands to develop game-changing products for their customers. 

For more information, please contact: 

Kate Quackenbush, Communications Director, k.quackenbush@gnosis.lesaffre.com, +1 609-454-2992 x220 

One of the most-recognized and sought-after certifications is « Non-GMO Project Verified ». The good news: If your supplement product features MenaQ7 K2, you have always met this need. Consumers have been asking for Non-GMO transparency for more than two decades. A 2020 survey of 2000 individuals in the US and Canada shows that “USDA Organic” and … Continue reading MenaQ7 K2 Non-GMO Verified … Always →

One of the most-recognized and sought-after certifications is « Non-GMO Project Verified ». The good news: If your supplement product features MenaQ7 K2, you have always met this need.

Consumers have been asking for Non-GMO transparency for more than two decades. A 2020 survey of 2000 individuals in the US and Canada shows that “USDA Organic” and “Non-GMO Project Verified” are the most recognizable and sought-after certifications on food products. Further, it has now become all but mandatory in the natural product industry especially as brands prepare to comply with new laws and store policies. 

The good news: If your dietary supplement product features MenaQ7 Vitamin K2 as MK-7, you have always been compliant. If your K2 product has not included MenaQ7, you may want to reconsider your supplier. 

Pioneering the K2 Category

While many suppliers are entering the market offering Vitamin K2, MenaQ7 Vitamin K2 as MK-7 started the category when it was first introduced 15 years ago. All the science confirming safe and efficacious bone and heart health benefits used MenaQ7 as the actual source material. Those studies – 22+ to date with more currently underway – were conducted in healthy and patient populations, adults as well as children. 

But being a pioneer is not just about driving the clinical evidence; it also meant that MenaQ7 be held to the highest standards, including achieving Non-GMO Verification from the Non-GMO Project, a non-profit 501(c)3 organization that offers North America’s only third-party verification and labeling for non-GMO (genetically modified organism) food and products. The complete MenaQ7 line was verified 8 years ago, while the following certifications were also obtained:  

• Novel Food Status

• Self-Affirmed GRAS

• Halal

• Kosher

• Suitable for Vegans

• Allergen-free

• Free from Pesticides and Toxins

What Does This Mean For Brand Owners?

Companies that seek to invest to offer the highest quality products must insist their raw material suppliers support their efforts. This means not only ensuring their ingredients are clinically validated, but that they achieve the certifications that will allow finished products to stand out on crowded shelves.  

Remember that 2020 consumer survey? Among the 15 certification marks that appear on food products, 63% of consumers recognize USDA Organic and 54% recognize the Non-GMO Project butterfly logo. The next most recognized certification was Gluten-Free (32%) and then Fair Trade (30%). 

Choosing MenaQ7 Vitamin K2 as MK-7 means you are one step closer to being able to label your finished product as “Non-GMO,” earning an important and growing faction of consumers’ purchases. 

Greek study will use the highest dosage of Vitamin K2 as MK-7 so far, further proof of MenaQ7® K2 safety.   Oslo, Norway and East Brunswick, NJ (8 June 2021) – Ex-NattoPharma is excited to announce that a new 1.5-year clinical trial using MenaQ7® Vitamin K2 as MK-7 has been registered on ClinicalTrials.gov. The trial … Continue reading MenaQ7 K2 Cardio Study Registered →

Greek study will use the highest dosage of Vitamin K2 as MK-7 so far, further proof of MenaQ7^® K2 safety.

Oslo, Norway and East Brunswick, NJ (8 June 2021) – Ex-NattoPharma is excited to announce that a new 1.5-year clinical trial using MenaQ7^® Vitamin K2 as MK-7 has been registered on ClinicalTrials.gov. The trial will examine the cardiovascular impact in a patient population and will use the highest dosage of K2 as MK-7 to date: 1mg daily.

The new multi-centre, placebo-controlled, randomized, open-label intervention clinical trial, “The Effect of Vitamin K2 Supplementation on Arterial Stiffness and Cardiovascular Events in PEritonial DIAlysis (VIKIPEDIA)”, will be conducted with Peritoneal Dialysis (PD) patients. The investigators at Aristotle University of Thessaloniki in Greece will study the effect of K2 supplementation (through normalization of dp-ucMGP) on arterial stiffness and the occurrence of cardiovascular events.

Chronic Kidney Disease (CKD) is a state of progressive vascular calcification and cardiovascular disease. End Stage Kidney Disease patients receive renal replacement therapy either by hemodialysis or by PD, according to lead researcher Stefanos Roumeliotis , MD, PhD. “Several studies have shown that hemodialysis patients have vitamin K depletion and accelerated vascular calcification ,and this finding led to the initiation of several randomized controlled trials exploring the effect of vitamin K2 supplementation on vascular calcification in hemodialysis patients.

“VIKIPEDIA is the first study to assess whether high dosage of Menaquinone-7 could improve arterial stiffness, mortality, cardiovascular disease, 24-hour ambulatory blood pressure and dialysis efficacy in patients with PD,” he explains. “MenaQ7^® was chosen to be used in the study because the compound showed its efficacy to improve vitamin K status in many clinical trials with kidney patients.”

At baseline, all eligible patients who have provided a written, informed consent will be enrolled in the study. Αortic stiffness and vitamin K status will be assessed by PWV and plasma dp-ucMGP levels respectively. Before randomization, the investigators will draw blood (serum and plasma) and PD fluid samples from all patients to measure blood count and routine biochemical parameters, including urea, creatinine, potassium, sodium, calcium, phosphorus, c-reactive protein, alkaline phosphatase, albumin, parathormone, 25-OH D3, magnesium, glycated hemoglobin, thyroid function hormones. Since both vitamin D and magnesium are considered of utmost importance in vitamin K metabolism, after baseline, patients with vitamin D and/or magnesium depletion will be treated with oral supplements to achieve normal levels of both elements, before randomization. The cohort will then be categorized to one of the two groups (placebo or active group) and the treatment period will last 1.5 years. To ensure that the two parallel groups will include patients that will not differ significantly in vitamin K and stiffness, patients will be accordingly stratified. After randomization, all patients will continue their routine, standard medical treatment and patients in the treatment group will additionally receive daily, per 1 mg of vitamin K2 (MenaQ7^®, ex-Nattopharma, ASA, Hovik, Norway).

It is important to note, according to Dr. Hogne Vik, Chief Medical Officer with ex-NattoPharma, that researchers recognized the importance of optimal level of vitamin D and magnesium to support function of vitamin K2. That is why patients deficient with vitamin D or magnesium will be treated with theses nutrients to reach normal levels before randomization.

“People with kidney problems exhibits low vitamin K status, which has been shown to increase cardiovascular disease as well as mortality risk,” explains Dr. Vik. “Vitamin K2 supplementation was shown to be effective to improve vitamin K status in kidney patients to some extent. However, none of these trials have been conducted in PD patients, but only in pre-dialysis CKD or haemodialysis subjects or kidney transplant patients.

“VIKIPEDIA represents two important firsts: it will be the first trial in PD patients, and the first time this high dosage of vitamin K2 as MK-7 will be used, which supports high safety profile of this nutrient,” adds Dr. Vik. “We are thrilled because this study will add to the already substantial evidence that MenaQ7 Vitamin K2 is an important cardiovascular-support nutrient, and it presents great hope for an at-risk patient population.”

The study is scheduled to start in September 2021. The researchers will collaborate with long-time ex-NattoPharma research partner Masstricht University to evaluate vitamin K status.

https://clinicaltrials.gov/ct2/show/NCT04900610?term=peritoneal&cond=vitamin+k&draw=2&rank=1

About ex-NattoPharma

As the Vitamin K2 world leader, ex-NattoPharma’s ironclad science portfolio is the foundation for today’s understanding of K2 and is the basis for all industry claims about the benefits of K2.

Two things separate ex-NattoPharma from other Vitamin K2 suppliers. First, we offer the ONLY K2 as MK-7 clinically validated to deliver health benefits. With more than 20 human clinical trials where MenaQ7 K2 was the actual source material, we have demonstrated the K2 mechanism, safe and effective dosages, and the importance of K2 for bone and cardiovascular health, all while simultaneously verifying our brand’s efficacy.

Second, NattoPharma provides the MOST comprehensive K2 portfolio – both natural fermented and nature-identical synthesis in various dilutions and solubilities – offering solutions for brand owners to make Vitamin K2 available in a broader range of finished product dose forms. The MenaQ7^® Solution Platform opens opportunities to formulate with multiple active ingredients, guided by the experts of the ex-NattoPharma R&D team.

A ex-NattoPharma partnership does not end once kilos are delivered. We are invested in your success and positioned to ensure you achieve it.