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NEW VITAMIN K2 CLINICAL TRIAL ANNOUNCED

Diabetic pregnant woman

 

VETA Trial will evaluate the therapeutic effect of vitamins K2 and D3 paired with Empagliflozin on various diabetic and quality-of-life parameters.

 

 

MARCQ-EN-BAROEUL, FRANCE, AND EAST BRUNSWICK, NJ (8 Sept 2022)A new study protocol1 has been published on ClinicalTrials.gov (NCT05417880) detailing a trial initiated by Gnosis by Lesaffre partner Scotmann Pharmaceuticals, Pakistan, who will execute a large-scale, multi-centered study to examine the impact of the combination of Empagliflozin, an  oral anti-diabetic,  with vitamins K2 and D3 on various diabetic parameters, including quality-of-life. Scotmann Pharmaceuticals, Pakistan uses Gnosis by Lesaffre’s vitamin K2 MK7 from natural fermentation, which has been validated in numerous clinical trials.  

 

Globally, there were 437.9 million prevalent cases of Type 2 Diabetes in 2019, with an age-standarized point prevalence of 5,282.9 per 100,000 populations, which represents a 49% increase since 1990.2 The VETA Trial (Vitamin D, K2 plus Empagliflozin combination in Type Two Diabetes Mellitus) is a six-month prospective, randomized, controlled, open-label, multicenter trial conducted in collaboration with the University of Health Sciences Lahore (Pakistan) and the Pakistan Society of Internal Medicine. The study will enroll 340 participants, aged 40-60 years and having Type 2 Diabetes Mellitus (T2DM) for at least 10 years.  

 

The participants will be allocated to either: the control group (continuing current oral anti-hyperglycemic other than SGLT2 inhibitors and no added D3 or K2 supplementation), the interventional groups receiving either 10mg Empagliflozin (a medication used together with diet and exercise to treat Type 2 diabetes; as VORETA tablets) or 10mg Empagliflozin plus the combination of 2,000 IUs of vitamin D3 and 100 mcg of Vitamin K2 as MK7 (as SunnyD PRO soft gel). The doses of both Empagliflozin tablets and the combination D3 + K2 soft gel will be taken once daily. 

 

The main goals of the study are to:  

  • Explore the effects on hyperglycemic parameters (including HbA1c, FBS and RBS) 
  • Explore the effects on hyperlipidemic parameters (including HDL-C, LDL-C and Triglycerides) 
  • Assess the improvements in Diabetic Quality of Life parameters (DQol)  
  • Explore the effects on arterial calcification markers

 

“The idea is to follow the holistic approach guidelines for the management of T2DM,” says Dr. Syeda Saba Alsam, Head of Medical Affairs and Research with Scotmann Pharmaceuticals, Pakistan, noting that baseline screening of serum 25(OH)D3 levels would be done on all patients. “Since Vitamin D deficiency is highly prevalent in this cohort and a typical Pakistani diet lacks Vitamin K2, we are exploring the potential beneficial effects of these two micronutrients in Diabetic patients.”  

 

 

“While treatment is crucial for diabetes, the proper nutrient intake is also important for this group of patients. Deficiency of vitamin D is globally recognized; however, the research suggests that vitamin D3 should be combined with vitamin K2 for synergistic impact. Further, it has been shown that vitamin K2 supplementation can effectively improve clinical features of diabetes,” says Sophie Legrain, Gnosis by Lesaffre Director of R&D, noting a study3 that showed vitamin K2 intake, specifically, produced a 7% reduction in T2DM risk with each 10mcg increment. “It is exciting to see our partner exploring the impact K2 and D3 could have for patients adding it to their therapy.” 

 

 

References:

 

 

1https://clinicaltrials.gov/ct2/show/NCT05417880?term=vitamin+k2&draw=2
2 Safiri S et al. Prevalence, Deaths and Disabiity-Adjusted-Life-Years (DALYs) Due to Type 2 Diabetes and its Attributable Risk Factors in 204 Countries and Territories, 1990-2-19: Results from the Global Buden of Disease Study 2019.
Front. Endocrinol., 25 Feb 2022. 13:838027.                                                                                           
3 Beulens JW, et al. Dietary phylloquinone and menaquinones intakes and risk of type 2 diabetes. Diabetes Care. 2010;33:1699–705. 

 

  

About Scotmann Pharmaceuticals, Pakistan

 

 

Scotmann is a pharmaceutical centre of excellence with a diversified portfolio of branded generics in biotech, cardiovascular, diabetes, gastroenterology, respiratory, inflammatory diseases, pain management, osteoporosis, psychiatry, and OTC segments. The company’s R&D is structured around partnerships with European Contract Research Organizations (CROs). These partnerships help Scotmann adhere to excellent manufacturing practices, ensuring that its products meet the highest international standards for safety and efficacy.

 

 

 

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 application 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 

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MenaQ7 study with children

45 mcg per day of vitamin K2 was shown to support the needs of healthy bones in children

Growing Strong Bones

Childhood is the most essential period for developing and building healthy bone mass.
However, research shows children have 8 to 10 times higher levels of inactive osteocalcin, which means they are not optimally building the bone mass they require during this period.[3]

In turn, today we see an increase in low-energy fractures in children. Thankfully there is a way to mitigate this situation.

Studies show that children who have optimal levels of Vitamins K2 and D3 have fewer bone fractures than children with lower status of these two vitamins. [4,5]

MenaQ7® is the only Vitamin K2 on the market proven to benefit bone health in children.

[3] Theuwissen E et al. Food & Function. 2013;5(2):229-34
[4] Popko J et al. Nutrients. 2018 Jun 6;10(6):734.
[5] Karpiński M et al. J Am Coll Nutr. 2017 Jan;36(1):64-71

MenaQ7® study show

180 mcg per day of vitamin K2 maintain bone health in postmenopausal women

Well-Being in Times of Change

It is well recognized that women approaching and going through menopause are prone to develop weaker bones.

During this period, hormonal changes lower oestrogen levels, leading to bone loss and increased fracture risk.

Compromised bone health is estimated to affect 200 million women worldwide. Supporting bone health in women during this period of life is growing in importance, particularly as an ageing population seeks to maintain their quality of life.

The combination of Vitamins K2 and D3 is shown to have a more beneficial effect on this demographic’s bone strength than either vitamin taken alone.[5]

MenaQ7® is the only clinically proven K2 to deliver on the promise of maintaining bone health in postmenopausal women.[2]

[5] Ushiroyama T et al. Maturitas. 202 Mar 25;41(3):211-21.
[2] Knapen MHJ et al. Osteoporos Int. 2013 Sep;24(9):2499-507.

Supporting Mothers for Healthy Babies

Pregnancy is a time of extraordinary change and the WHO estimates 20-30% of pregnant women suffer from some kind of vitamin deficiency. Post-natal supplements are important for many women during this period of their lives to ensure not only their health, but their babies as well.

In particular, pregnant women are advised to increase their calcium levels to support the growing babies’ bone and teeth – and to maintain the mothers own bone mass, which is depleted during pregnancy and nursing.

Research shows that women's bone metabolic status significantly changes over the period between pregnancy and during nursing [6], and as much as 50% of newborns are K deficient. Incorporating Vitamins K2 with D3 in post-natal supplements would benefit both mother and child through their combined optimization of calcium.

[6] Miyamoto T et al. Sci Rep. 2019 May 13;9(1):6787.

MenaQ7® study show

180 mcg per day is beneficial for bone and cardiovascular health.

Do What You Love Longer!

Calcification is believed to be an inevitable and unfortunate result of aging, but studies show that arterial calcification is, in fact, an actively regulated process where Vitamins K2 and D3 play a critical role.

In 2020 the ageing population (people over the age of 65) grew to approximately 727 million. Supporting bone and heart health is vitalto ensure quality of life as we age.

A 2013 study [8] evaluating the cardiovascular effect of Vitamin K2 (MenaQ7®) plus Vitamin D or Vitamin D alone showed more beneficial results when the two nutrients were combined than when D was taken alone.

MenaQ7® is the only clinically Vitamin K2 as MK-7 proven to reduce arterial stiffness in adult populations.[9]

[8] Kurnatowska I et al. Pol Arch Med Wewn. 2015;125(9):631-40.
[9] Knapen MHJ et al. Thromb and Haemost. 2015 May;113(5):1135-44.

 

Active Lifestylers

The bone and joint market is still expected to be driven by aging populations, but trends like Healthy Aging and Fitter for Longer open the market for younger demographics. Since 2000, views have drastically evolved about the importance of staying active and the role bone/joint health plays in one’s ability to do so.

Bone fractures are an obvious hindrance to staying active. In fact, every 3rd woman and every 5th man over the age of 50 will experience osteoporotic fractures. It is also worth noting that young female athletes have higher fracture risks than male counterparts.

Knowing the intricate balance between Vitamins D3 and K2, and its combined benefits for bone and heart health, a product that aims to support active lifestylers should incorporate both.