Effects of adjunct therapy of a proprietary herbo-chromium supplement in type 2 diabetes: A randomized clinical trialFNx01

Background: Chromium chelates/complexes are widely used as nutritional supplements to redress complications of type 2 diabetic mellitus (T2DM) patients. However, most of these chelates could be susceptible to oxidation into toxic Cr(VI) state. Complexation of Cr (III) with gallo-ellagi tannoids produces a herbochromium supplement (HCrS) that maintains its Cr3+ oxidation state under oxidizing circumstances in vitro. It was tested with conventional oral hypoglycemic drugs [(oral antidiabetic drugs (OAD)] for its beneficial effects in T2DM patients. Objective: A randomized clinical study with three OADs with or without HCrS was carried out in T2DM patients to evaluate the efficacy of the HCrS supplement. Materials and Methods: 150 T2DM patients were randomized into six treatment groups. After 60 days of treatment, fasting blood glucose and post-prandial blood glucose (FBG and PPBG, respectively), HbA 1c , HsCRP, oxidized low density lipoprotein (LDL), and urinary microalbumin levels and other diabetic symptoms were evaluated. Statistical Analysis: Findings were compared using one-way analysis of variance (ANOVA) with post hoc pairwise comparisons of groups using the least significant difference method. Results: Better control of FBG and PPBG levels were observed in patients receiving HCrS (−12.4 to −16.6%) compared to placebo groups (−3.4 to −9.4%). There was a 5.5–7.4% decrease in HsCRP and LDL levels in patients receiving HCrS, which is better than placebo treated groups. Significant decrease in urinary microalbumin level was observed in patients receiving HCrS (−20.0 to −22.5%) compared to placebo groups (−7.8 to