On April 4th, 2024, L-Nutra, the premier nutri-technology company, unveiled the results of a pioneering clinical trial, published in Diabetologia, which aims to redefine the approach to managing Type 2 Diabetes. Conducted over a 12-month period and compared to the current standard of care, the study assessed the impact of a Fasting Mimicking Diet (FMD) on glycemic control and medication reduction, delivering compelling evidence to support the integration of the FMD program into primary care management of Type 2 Diabetes.
Over 30 million people in the U.S. suffer from diabetes, and nearly 98 million have pre-diabetes. These striking numbers directly correlate with unhealthy lifestyles and medications that mostly slow disease progression rather than reversing it. This new data suggests a viable, nutrition-led intervention that enhances the effectiveness of the standard of care, allowing the possibility of diabetes regression to be within reach.
The research involved 100 Type 2 Diabetes patients with a BMI greater than 27 and HbA1C levels above 6.5%, who were either on standard care or treated with Metformin. This randomized, controlled, assessor-blinded trial introduces a new paradigm in diabetes management, focusing on "glycemic management,'' a new metric used to measure efficacy by medication reduction.
Participants underwent 12 monthly cycles of FMD, totaling 5 days per month, alongside standard diabetes care, interspersed with 25 days of their regular diet. The control group received standard diabetes care only. The study aimed not only to evaluate the effectiveness of FMD in managing glycemic levels but also to assess its impact on medication reduction, insulin sensitivity, and various anthropometric measures.
Key Findings:
Medication Reduction: Participants in the FMD group were eight times more likely to reduce their medication dosage. Furthermore, 56% either stopped or reduced their medications, a stark contrast to the 10% in the control group.
Glycemic Management: FMD participants demonstrated superior glycemic management, with 53% showing improvement, compared to only 8% in the control group.
Insulin Sensitivity: The study highlighted enhanced insulin sensitivity among FMD participants, suggesting an improved response to insulin.
Anthropometric Benefits: Positive reductions were observed in weight, BMI, waist circumference, and body fat percentage without loss in fat-free mass.
This is the second successful FMD clinical trial in type 2 diabetes, showing safety and enhanced efficacy over standard of care alone. The results support our leadership within the 'Food is Medicine' movement by presenting a novel program that supports disease regression for most patients (needing less medications) and some with disease remission (needing no medication).Dr. William Hsu, Chief Medical Officer at L-Nutra and former VP of the Harvard Joslin Diabetes Center
He further added, "With reduced medication intake and improved glycemic control among participants, the FMD program, called L-Nutra Health, is poised to revolutionize Type 2 Diabetes management, offering hope and tangible results to those in need and potential cost reduction for payors."
L-Nutra's patented and clinically backed nutrition technology food formulations are effective in supporting metabolism, cell renewal, and muscle protection by mimicking the reset and rejuvenation pathways of fasting. This marks the first time that nutrition meets science to provide an efficacious intervention for the root cause of diabetes and pre-diabetes. After 25 years of development and 32 clinical trials conducted at 18 medical research centers, the Fasting Mimicking Diet (FMD) continues to demonstrate efficacy in supporting healthy blood sugar levels and critical markers for disease, as evidenced by reduction or elimination of medications.
"Diabetes patients have been underserved with two impossible options: either to adhere to a strict daily dieting and lifestyle routine, or never-ending prescriptions of medications with chemicals and side effects. This is what inspired me to leave medicine and the biotech industry to build the first nutrition technology company, L-Nutra," said Dr. Joseph Antoun MD, PhD, L-Nutra CEO & Chairman.
With the Fasting Mimicking Diet, we have successfully enhanced the natural rejuvenating power of fasting with food which has made the regression and remission of diabetes within every patient's reach. I invite doctors and patients around the world to consider the L-Nutra Health program which is nutrition-based, drug-free, and does not require everyday lifestyle changes.Dr. Joseph Antoun MD, PhD, CEO & Chairman, L-Nutra
(Newswise/NJ)