Efficacy of a novel, biologically active food supplement in type 2 diabetes mellitus: a patient-blinded, prospective, clinical trial

Abstract

Despite significant achievements in the prevention and management of diabetes, its prevalence has risen exponentially, creating a paramount need for alternative therapies. The purpose of the study was to investigate the safety and efficacy of two novel, biologically active supplements (fenugreek, fennel, sage, olive, and cinnamon and other ingredients) in decreasing blood glucose levels (BGLs) in type 2 diabetes mellitus (T2DM). Between June 2008 and July 2009, 154 patients were screened for T2DM and inadequate glycemic control. Fifty-one subjects meeting inclusion/exclusion criteria were enrolled in a prospective clinical study. All patients (n = 51) were studied for 24 weeks (6 months), the first 3 weeks being the placebo phase, followed by 14 weeks of active supplement use and observation for 3 weeks. Patients returned to active supplement use for an additional 3 weeks. All participants were tested for fasting BGL once every week during a 22-week period. The average age of the subjects was 52.6 years (23 male; 28 female), and average reference BGL (on day 1) was 265.7 mg/dL. During the first 3-week placebo period, patients showed no detectable change in BGL. At week 10 (after 7 weeks of supplement use), BGL was reduced by 47% compared with baseline (mean + standard deviation, day1 vs week 10, 265.7 + 86.2 vs 131.6 + 31.7; paired t-test = -11.8, P < 0.001), and at week 17, BGL decreased by 59% (P < 0.001). Between weeks 18 and 20, during which no participant received placebo or supplements, BGL did not decrease. The glucose-lowering effect of the supplement was stable and prolonged to maintain BGL at a constant level. Patients reported satisfaction on a Likert scale, and no side effects were reported during the course of the study. The current study indicates that the new biologically active dietary supplements were effective in decreasing BGL in T2DM patients with no side effects and has therapeutic promise in regulating BGL.