Nutritional intervention is important for preventing diabetes, managing existing diabetes & preventing or at least slowing, the rate of development of diabetes complications. Dietary factors are of paramount importance in the management & prevention prediabetes. Balancing the right amount of macronutrients & micronutrients helps us to maintain a healthy diet & a healthy lifestyle. 

Micronutrients serve dual roles: they maintain the stabilization of the cellular structures at their optimal levels, but their inadequacy proceeds to alternate pathways and may cause ailments. These essential micronutrients have important physiological implications and exhibit direct associations with diabetes mellitus. 

Micronutrients are identified as vital nutrients that are required in trace amounts for homeostasis, enzyme regulation and functioning. Macro elements, vitamins, trace elements and organic acids are the four major classes of micronutrients. They enhance insulin action by activating insulin receptor sites. These trace elements play specific roles in the pathogenesis and progression of type 2 diabetes mellitus (T2DM) and the mode of action of a number of macro and trace elements is altered in T2DM. 

A personalized approach for preventing and managing prediabetes should consider biological and behavioral models, and embed nutrition education as part of lifestyle diabetes prevention studies. Functional foods may provide additional benefits in such an approach. 

Phytoconstituents in cinnamon such as cinnamomum aromaticum (Cassia), cinnamomum zeylanicum, etc. have been demonstrated its effect in managing diabetes and metabolic disorder by upregulating glucose uptake, increasing glycogen synthesis, inhibiting glycogen breakdown, and reducing glucose absorption in the small gut. Phytoconstituents in fenugreek namely, diosgenin, 4-hydroxyisoleucine, alkaloid and the fiber component, are the most studied bioactive fractions of the plant, which were found to exert beneficial effects on lowering blood glucose, glucose tolerance, insulin function, inflammatory response, lipid profile, and liver functions.

Diabetone tablets are blend of micronutrients and cinafen plus possess standardized extracts of cinnamon and fenugreek. The present research is an attempt to assess the efficacy & safety of Diabetone and Cinafen plus tablets in subjects with prediabetes. With the present research we can apply the knowledge of pharmacological benefits of micronutrients along with the clinical trials to address the important medical issue of growing prediabetic population to improve glycaemic control, control the disease progression and possibly to reverse the condition. To provide appropriate and timely care to prediabetic subjects, achieve good control of glycemia, reduce the risk of complications related to diabetes, minimise healthcare use, and associated costs by reversing the devastating condition and thereby improving the subjects’ quality of life, it is necessary to begin primary translational work as soon as possible.

As per the macronutrient recommendations for remission and prevention of Diabetes in Asian Indians, with adjusting the proper balance of carbohydrates, protein and fats in diet the remission, and prevention of progression to T2DM is observed.  In line with this study our hypothesis is in longer perspective, micronutrients and phytoconstituents based supplementation will provide good prognosis to the disease with less or no dependency on conventional antidiabetic medication together with reduced or no side effects. Moreover, improved glycemic control will avoid acute decompensation, delay or prevention of microvascular (retinopathy, nephropathy, and neuropathy) and macrovascular complications, reduce mortality, and maintain a good quality of life. A systematic clinical validation of the investigational products in comparison with placebo from the present study will provide a guideline and evidence for care givers and diabetologists to use the standardized nutrition and phytoconstituents in their clinical practice in the management of prediabetes.