Abstract

Diabetes is a high-prevalence, major chronic metabolic disease demanding effective interventions. Quercetin, a phytochemical with potential health benefits, has garnered interest for its therapeutic properties. This study was designed to capture the early efficacy and clinical safety aspects following quercetin administration in patients with type II diabetes mellitus (T2DM). The main study involved a randomized allocation procedure to assign non-insulin-treated patients attending the 4th Health Unit of Heraklion to intervention and control groups based on age and sex. The intervention group (n=50) received 500 mg of quercetin daily for 12 + (8 free intervals) + 12 weeks, alongside their usual treatment, while the control group (n=50) did not. After randomization, for the intermediary 12-week follow-up, data from 38 patients (intervention: 20; control: 18) were analyzed in this report. All subjects provided informed consent for the collection of anthropometric measurements, vital signs, daily habits data, and PiKo-6 spirometric readings. Additionally, participants responded to the Short Anxiety Screening Test (SAST) and the 36-Item Short Form Health Survey (SF-36) questionnaires. Thirty-eight participants were included (60% men and 40% women in the intervention group; 38.9% men and 61.1% women in the control group). In the treatment arm, Forced Expiratory Volume in the first second (FEV1) measured with PiKo-6 showed a Δ%- change for the intervention arm: +6.8%, control: -0.2% (p=0.059), systolic blood pressure; intervention: -7.4%, control: -3.7% (p=0.117), waist circumference; intervention: -1.5% control: -0.7% (p=0.455) and night-time sleep; intervention: +5.3%, control: +1.4% (p=0.926) were favourably influenced. The treatment group exhibited significant enhancements in both anxiety levels assessed by the anxiety symptoms scale (SAST-10, p=0.026) and quality of life evaluated by the SF-36 (p<0.001). Positive evidence is emerging for a pleiotropic effect of quercetin intake in patients with T2DM, specifically in terms of anxiety reduction and amelioration of life quality, in just 12 weeks of administration and without adverse effects, indicating clinical safety and underscoring its potential for integration in T2DM supportive care.

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