Evaluation Series on Safety and Efficacy of Nutritional Supplements in Newly Diagnosed Hyperglycemia: A Placebo-Controlled, Randomized Study.

BACKGROUND:Diabetes is endemic with developing economies contributing to the bulk of this pandemic. Despite the evidence of incremental benefit of glycemic control starting early in life, acceptance of and adherence to modern medications remain suboptimal. AIMS:To determine the hemoglobin A1c (HbA1c)-lowering efficacy and safety of nutritional supplement, PreCrea(®), in adult Indians with newly diagnosed hyperglycemia. MATERIALS AND METHODS:Double-blind, randomized study conducted in six diabetes centers in India. A total of 193 treatment-naïve subjects with newly diagnosed hyperglycemia and fasting plasma glucose (FPG) >100 mg/dL were randomized into either PreCrea(®) 600 mg (n = 90) or matched placebo (n = 89) capsules twice daily, along with lifestyle modification, for 12 weeks. The main outcomes were changes in HbA1c and FPG levels, attainment of the American Diabetes Association (ADA)-defined goals for HbA1c, and clinical and biochemical measures of safety. RESULTS:At 12 weeks, mean HbA1c in PreCrea(®) group reduced by 0.91% compared with 0.08% increase in the placebo group (P < .001). The reductions in the mean FPG at week 4 (P < .001) and week 12 (P = 0.04) were significant compared to the baseline. ADA goal of HbA1c <7% increased from 15.5% at the baseline to 35.6% at week 12 in PreCrea(®) subjects. Clinical safety and biochemical safety did not change. Hypoglycemia and weight gain were not observed with PreCrea(®). CONCLUSIONS:Nearly 1% point reduction in HbA1c at week 12 with PreCrea(®) is comparable with most first-line glucose-lowering drugs. The safety and tolerability of PreCrea(®) highlights its potential as a first-line therapy in newly detected hyperglycemia.