EFFECT OF PROPRIETARY CHROMIUM COMPLEX AND ITS INDIVIDUAL COMPONENTS VERSUS CHROMIUM PICOLINATE, CHROMIUM POLYNICOTINATE AND CHROMIUM DINICOCYSTEINATE ON ENDOTHELIAL FUNCTION, BIOMARKERS AND LIPID PROFILE IN TYPE 2 DIABETICS – A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDYAbstract
Background: Hyperglycemia may induce endothelial dysfunction. Chromium Supplementation enhances endothelial relaxation and may improve endothelial dysfunction. Present study was planned to evaluate effect of proprietary chromium complex(PPC) and its individual components on endothelial dysfunction and lipid profile in type 2diabetics. Methodology: Study was done in two parts. In part I, PPC 400mcg produced significant improvement in endothelial function compared to PPC 200mcg and placebo. In part II, 96 eligible subjects were randomized to chromium chloride 400mcg, Phyllanthus emblica 6mg and Shilajit 6mg, chromium picolinate 400mcg, chromium polynicotinate 400mcg and chromium dinicocysteinate 400mcg and compared to PPC 400mcg. Efficacy parameters were change in endothelial function(>6% change in reflection index(RI), biomarkers of oxidative stress and lipid profile after 12weeks treatment. Laboratory safety parameters were measured at baseline and post treatment. Results: Total 96 subjects completed the study. PPC 400mcg produced better improvement in reflection index (−3.34%±1.00% to −7.23%±1.88% (p<0.001) compared to chromium chloride 400mcg (-3.79%±0.82 to-3.22%±0.85), Phyllanthus emblica 6mg and Shilajit 6mg (-1.44%±0.58 to-5.67%±0.54), chromium picolinate 400mcg (-4.68%±1.24 to -2.46%±0.90), chromium polynicotinate 400mcg (-4.3%±1.2to-3.71%±1.1), chromium dinicocysteinate 400mcg (-4.85%±0.74 to-3.82%±0.74). Further, PPC 400 mcg produced significant improvement of biomarkers of oxidative stress and lipid profile compared to other groups. All treatments were well tolerated. Conclusion: PPC 400 mcg showed significant improvement in endothelial function, lipid profile and biomarkers of oxidative stress in type 2 diabetics, followed by the combination of Phyllanthus emblica and Shilajit extracts, chromium picolinate, chromium polynicotinate, chromium dinicocysteinate and chromium chloride. Further, it can be inferred that PPC 400 mcg has significant synergistic activity.
P. Usharani *, C. Gayatri Devi, K. Kiran Kishore and C. Uday Kumar
Department of Clinical Pharmacology and Therapeutics, Nizam's Institute of Medical Sciences, Panjagutta, Hyderabad, Telangana, India.
02 November, 2016
27 January, 2017
20 April, 2017
01 May, 2017