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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
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.”
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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
Arterial stiffness and calcification have long been recognized as an unfortunate result of aging. But did you know that more research highlights these developments as an actively regulated process? And one nutrient plays a crucial role. Research is building to support the case for Vitamin K2’s role in ensuring a robust cardiovascular system … Continue reading MenaQ7 Vitamin K2: A Vital Supporter for Cardiovascular Health
Arterial stiffness and calcification have long been recognized as an unfortunate result of aging. But did you know that more research highlights these developments as an actively regulated process? And one nutrient plays a crucial role.
Research is building to support the case for Vitamin K2’s role in ensuring a robust cardiovascular system from an early age. The supportive balance of Vitamin K2 on heart health is via its interaction with Calcium. On one side, incoming Calcium is utilized by bones to help build and maintain a healthy bone mass. In the opposite direction, Calcium also tends to settle inside arteries and soft tissues, causing them to stiffen and impede blood flow.
While observational data suggest a link between Vitamin K2 intake and cardiovascular health, two groundbreaking MenaQ7 intervention trials were published (a three-year and a one-year clinical study), which evaluated the effect of nutritional doses of Vitamin K2 vs. placebo on arterial stiffness in healthy people.
The groundbreaking results have spurred Vitamin K2 as a powerhouse nutrient that should play a key role in products aimed at supporting our heart health.
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Gnosis by Lesaffre proudly offers its clinically proven Vitamin K2 as MK-7, MenaQ7®, protected by its award-winning Matrix technology. Learn more in our new brochure! Ensuring the stability of vitamin K2 compounds can be as complex as the finished product formulations that brand owners are conceiving – research shows that moisture and mineral salts … Continue reading MenaQ7® Matrix: The Premium Vit K2 Protected by Award-Winning Technology
Gnosis by Lesaffre proudly offers its clinically proven Vitamin K2 as MK-7, MenaQ7®, protected by its award-winning Matrix technology. Learn more in our new brochure!
Ensuring the stability of vitamin K2 compounds can be as complex as the finished product formulations that brand owners are conceiving – research shows that moisture and mineral salts are critical variables for degradation, driving the need for a protective technology to shelter the menaquinone molecules during shelf life.
Expertise is required to ensure the correct ingredient solution is provided depending on the final formulation and application. With more complex mineral formulations, the question is: how to protect that molecule through formulation and shelf life?
To that end, Gnosis by Lesaffre introduced its enhanced vitamin K2 protective technology – Vitamin K2 Matrix. This latest innovation is the result of a proprietary technology that protects the vitamin K2 as MK-7 molecule with no coating, no additives, and no additional ingredients, making it a true clean-label option, a sought-after quality for brand owners and consumers who demand to use ingredients with nutritional benefits that are as close to their natural state as possible.
Gnosis by Lesaffre is now offering its premium, clinically validated MenaQ7Ò Vitamin K2 as MK-7 protected by this award-winning technology. Applying the Matrix protective technology to MenaQ7Ò ensures a smoother process for formulators to bring any product concept they can conceive to life. Still, more importantly, it ensures that consumers receive the clinically validated bone and heart benefits they rightfully expect.
A key attribute of Vitamin K2 Matrix is the versatility offered to formulators. The technology supports supplements in traditional formats, such as tablets and capsules, that combine K2 in synergistic formulations with complex minerals, as well as positioning Vitamin K2 in new delivery systems such as ready-to-drink applications like protein or milk powders. Regardless of your need, Matrix provides a less cumbersome and more predictable formulation process for complex product formats.
The technology is so groundbreaking that Nutrition Industry Executive recognized it with a First Place NIE Award for the Excipients/Non-Actives/Delivery Systems Category.
Gnosis by Lesaffre is now offering its premium, clinically validated MenaQ7® Vitamin K2 as MK-7 protected by this award-winning technology. As you will read in our new brochure, applying the Matrix protective technology to MenaQ7® ensures a smoother process for formulators to bring any product concept they can conceive to life, guaranteeing consumers receive the clinically validated bone and heart benefits they rightfully expect. Together let us develop game-changing products for your consumers.
MenaQ7® PURE used as source material confirming K2 inhibits muscle damage from calcification. Nutrients, an international, peer-reviewed journal for studies related to Human Nutrition, has approved for publication in September 2015 a new study showing the protective effect inhibiting muscle damage from calcification of Vitamin K2 as MK-7 (menaquinone-7; MenaQ7® PURE provided by ex-NattoPharma) … Continue reading Study says MenaQ7® PURE K2 Shown to Protect Against Calcification
MenaQ7® PURE used as source material confirming K2 inhibits muscle damage from calcification.
Nutrients, an international, peer-reviewed journal for studies related to Human Nutrition, has approved for publication in September 2015 a new study showing the protective effect inhibiting muscle damage from calcification of Vitamin K2 as MK-7 (menaquinone-7; MenaQ7® PURE provided by ex-NattoPharma) supplementation on cardiovascular calcification.
The study, “High-Dose Menaquinone-7 Supplementation Reduces Cardiovascular Calcification in a Murine Model of Extraosseous Calcification,” is significant because it adds to the substantial body of evidence demonstrating the cardiovascular benefits of Vitamin K2 as MK-7, lending further understanding to the mechanism by which it inhibits calcification damage to cardiovascular muscle.
“Cardiovascular calcification is prevalent in the aging population and in patients with chronic kidney disease (CKD) and diabetes mellitus, giving rise to substantial morbidity and mortality,” says Dr. Leon Schurgers, associate professor and senior scientist at the department of biochemistry, the Cardiovascular Research Institute CARIM of University of Maastricht (The Netherlands), and lead researcher on the study. “The aim of this study was to evaluate the impact of high-dose MK-7 supplementation on the development of cardiovascular calcification and the impact on cardiovascular function in a murine model of chronic kidney disease characterized by extraosseous calcification.”
As it is well documented that kidney disease patients frequently suffer cardiovascular complications like calcification of the aorta and coronary arteries, the scientists applied an in-vivo rat model system for kidney disease.
The animals were divided into four groups: Two control groups with intact kidneys and on standard diet with respect to content of Phosphate and Calcium ± supplementation with 100µg Vitamin K2 as MK-7 (MenaQ7® PURE from ex-NattoPharma)/g; and two treatment groups where 5/6 of their kidneys were removed (mimicking kidney patients) receiving a diet with high content of both Phosphate and Calcium ± supplementation with 100µg MK-7/g.
After 12 weeks, the animals were examined for calcification of the aorta, the myocardium, and in kidneys, as well as for certain other changes in the tissues. Using a sensitive technique for arterial calcification (atomic absorption spectroscopy), this study shows that high-dose MK-7 inhibits calcification in aorta and in the myocardium – parts of the arterial bed most often affected in kidney patients. MK-7 also normalized the kidney disease-induced high serum phosphate level.
Interestingly, a 10-fold increase in matrix Gla protein (MGP) gene expression in the MK-7 supplemented animals was recorded. According to the authors, this is the first time that MK-7 has been shown to affect the synthesis of MGP in the vascular wall – and not only locally in the arterial wall. This indicates an increased amount of MGP available for activation to inhibit calcification.
Decreasing cardiovascular calcification and aortic alkaline phosphate tissue concentrations
The researchers stated that MK-7 supplementation inhibited cardiovascular calcification and decreased aortic alkaline phosphate tissue concentrations. The effect of MK-7 was – at least in part – mediated via MGP and subsequent inhibition of ectopic calcification. Since vitamin K has no reported side effects, it seems a promising therapeutic agent for CKD patients, the researchers concluded.
“Ex-NattoPharma has enjoyed a long-standing R&D program with the University of Maastricht and CARIM with the specific goal of understanding and validating the benefits of Vitamin K2 as MK-7 for human health,” says Hogne Vik, ex-NattoPharma CEO. “This study is monumental because it shows that our MenaQ7 Vitamin K2 protected smooth muscle cells from calcification. Being able to provide the researchers with our new nature-identical MenaQ7 PURE to add to our growing body of clinical validation marks a true milestone for us.”
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.