Efficacy and safety of a multi-ingredient dietary supplement (Glucocil®) in prediabetics: A randomized, double-blind, placebo-controlled study

Abstract

Background: Interest in natural food supplements as effective alternative therapeutics for managing dysglycemia has grown substantially over the past decade owing to their minimal side effects and holistic health rejuvenation.

Objective: In the present randomized, double-blind, placebo-controlled 90-day study, the efficacy of Glucocil®, a proprietary formulation of 14 natural ingredients, was investigated in a cohort of 37 pre-diabetic individuals (21 experimental and 16 placebo).

Materials and Methods: Glucocil® was bio-engineered using a proprietary manufacturing technology utilizing safety-affirmed ingredients and progressive high-shear wet milling operation with sequential addition of selected phytoconstituents, vitamins and other ingredients. Subjects were advised to consume  4,800 mg of either placebo (soybean oil; 1,200 mg/ soft gel) or Glucocil® soft gels (1,200 mg/soft gel) each day over a period of 90 consecutive days. Either at the end of the study or at intermittent intervals of 30 and 60 days, fasting blood glucose, oral glucose tolerance, fasting insulin, glycated hemoglobin levels as well as lipid profile were assessed to ascertain the efficacy of the formulation. Anthropogenic parameters were also determined to ascertain the visible changes (if any) inflicted by the formulation. Lastly, safety of the formulation was assessed in terms of cardiovascular parameters and liver function parameters.

Results: HbA1c decreased from 6.44 to 5.80 in the Glucocil® group with significant within-group improvement (p=0.0002), whereas placebo decreased from 6.22 to 6.06 without significant within-group change (p=0.2930). The mean HbA1c change was greater with Glucocil® (−0.64) than placebo (−0.17), with a significant between-group difference (p=0.0301). OGTT 2-hour glucose decreased significantly within the Glucocil® group (−24.11 mg/dL; p=0.0131), but not significantly versus placebo between groups (p=0.5406). However, both fasting insulin and fasting blood glucose didn’t undergo an equally appreciable drop. Consumption of Glucocil® did not bring about any appreciable change in body weight or other anthropometric factors. No noticeable change was found in lipid profile of the individuals in the treatment group as compared to the placebo group, except for a slight increase in HDL effected by consumption of Glucocil®. Safety assessment of this formulation was carried out in terms of assessment of cardiovascular (pulse rate, systolic and diastolic blood pressure) and liver function parameters. 

Conclusion: This investigation provided valuable insights in evaluation of safety and efficacy of Glucocil®, a novel antidiabetic supplement made fully from natural ingredients and free from any noticeable side effects. 

Keywords: Glucocil®- A novel phytonutrient formulation; Clinical trial; Pre-Diabetics; Blood glucose; HbA1c; Metabolic health; Safety