Gnosis by Lesaffre study to test effect of vitamins K2, D3 and Empagliflozin on quality of life for diabetics

13 Sep 2022 --- A new clinical trial aims to perform a large-scale investigation on the impact of combining the oral anti-diabetic medication Empagliflozin with vitamins D3 and K2. The study will utilize the company’s naturally fermented vitamin K2 MK7 product to test the combination’s effect on the quality of life and a range of other diabetic parameters.

The study will examine the effects of 2000 IU of vitamin D3 and 100 mcg of K2 on arterial calcification, hyperglycemic factors, hyperlipdemic factors such as HDLs, LDLs and triglycerides and possible quality of life improvements.

“This study is intended to explore the potential benefits of adding the combination of vitamins K2 and D3 with anti-diabetic medication, emphasizing the impact and necessity for proper nutrient intakes, especially for patient populations that experience calcification as a symptom of their condition, like those dealing with Type 2 Diabetes Mellitus,” Kate Quackenbush, communications director at Gnosis by Lesaffre, tells NutritionInsight.

“For the industry, this study presents further credibility of our efforts – that supplementation is a viable alternative for repairing nutrient deficiencies for all, but it can be a valuable added therapy working in concert with required medications,” she explains.

Attacking a mounting problemThe amount of people suffering from diabetes has risen almost 50% in the past 30 years.
Gnosis by Lesaffre notes that Type 2 diabetes is a growing epidemic, stating that in 2019, there were 437.9 million cases around the globe, a 49% increase in just under 30 years. 

Finding new ways to lessen the effects of the disease and improve the lives of those suffering is essential. 

Additionally, the company holds that many diabetic patients are likely lacking in this nutrient.

“Due to the state of global deficiency in both vitamins K2 and D3, I think we would be hard-pressed to find a diabetic not falling into that category,” says Quackenbush.

Following the science
The study will be a six-month prospective and employ a controlled, randomized, double-blind, multi-center trial and include 340 participants aged 40 to 60 years who have been diagnosed with Type 2 diabetes for at least ten years. 

It will be done in partnership with the University of Health Sciences Lahore in Pakistan and the Pakistan Society of Internal Medicine.

“Gnosis by Lesaffre did not fund this study,” says Quackenbush. “Scotmann Pharmaceuticals, Pakistan is a long-time partner to which we supply our natural vitamin K2 from fermentation.”

“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 at Scotmann Pharmaceuticals. 

“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.”  

The study will test the effects of vitamin D3 and vitamin K2’s effects on various quality of life factors for diabetic patients.Big doses for big results
All of the study’s participants will receive 10 mg of Empagliflozin. The test group will receive the prescribed vitamin K2 100 mcg to be taken once a day in the form of a SunnyD Pro soft gel and vitamin D3 2000 IU, while the control group will not receive the additional supplements. 

The recommended daily allowance of vitamin D is 400 IU, and there has been much recent research on the potentially harmful effects of consuming too much vitamin D. However, Gnosis by Lesaffre affirms that there is no danger in taking this amount of the vitamin.

“The daily dose of vitamin D is safe, and we do not expect that it would bring any adverse effects to the participants of the study,” Quackenbush stresses. “The Food and Nutrition Board established in 2010 that signs and symptoms of toxicity are unlikely at daily intakes below 250 mcg (10,000 IU).”

“Moreover, many clinical trials used at least 2000 IU of vitamin D3 without reporting any safety concerns,” she continues.

She concludes that “the Endocrine Society states, for example, that to maintain serum 25(OH)D levels above 75 nmol/L (30 ng/mL), adults might need at least 37.5 to 50 mcg (1,500–2,000 IU)/day of supplemental vitamin D.”

By Beatrice Whilander, with additional reporting by William Bradford Nichols