A Pilot Study into the effects of MitoQ on Endothelial Dysfunction A single-centre, double blind, randomized, placebo-controlled pilot study comparing the effect of MitoQ on endothelial dysfunction in type 2 diabetics

Abstract

The vascular damaged caused by type 2 diabetes may be attenuated by supplementation of coenzyme Q10 using the New Zealand developed product MitoQ Blood Sugar. A pilot study was conducted to assess the feasibility of the proposed study design prior to undertaking a large randomised clinical trial in type 2 diabetics. A double blind parallel, placebo controlled single centre study that enrolled type 2 diabetics who were randomised to receive oral MitoQ Blood Sugar (20mg/day) or placebo for 4-weeks. Treatment effect was assessed by brachial artery flow dilatation by ultrasound and biomarkers: hsCRP, vascular adhesion molecules and p-selectin. The primary objective was to assess the feasibility of study design for protocol adherence and recruitment. The study met the criteria for protocol adherence but did not meet the predefined criteria for recruitment strategy feasibility. Compared with placebo, supplementation with MitoQ Blood Sugar did not improve brachial artery flow mediated dilatation 13.5±4% versus 6.6±3%, p=0.064 or reduce the levels for any biomarkers. This study was not designed to detect a difference in the treatment groups as it was designed to assess feasibility. It met one of the two primary outcomes. A larger randomised clinical study would be required to assess any treatment effect of MitoQ Blood Sugar on the vascular function in type 2 diabetics.