Abstract Background and Aims: To assess the effects of bread fortified with pomegranate peel powder (PPP) on inflammation, oxidative stress, and mood indices in patients with type 2 diabetes mellitus (T2DM). Methods and Results: In total, 90 T2DM patients were randomized to receive either bread fortified with 3.5% pomegranate peel powder (PPP) (n=45) or PPP-free bread during 12 weeks. Dietary intake throughout the trial was assessed using food records. Laboratory parameters including total antioxidant capacity (TAC), malondialdehyde (MDA), hs-CRP-reactive-protein (hs-CRP), and psychological disorders including depression, anxiety, and stress were assessed at the beginning and end of the study. Overall, 77 diabetic patients completed the trial (39 in the PPP group and 38 in the control group) and were included in the analysis. Based on the compliance assessment, adherence to the interventions was high in the trial. PPP bread intake led to a significant reduction in hs-CRP levels (change: -0.56 ± 1.29, P=0.01) and depression score (-1.33 ± 3.66, P=0.04)), in the intervention group. Other variables including MDA, TAC, anxiety, and stress, showed no significant changes for PPP-fortified bread. Conclusion: Our findings showed that while intake of PPP-fortified bread for 12 weeks had no significant effect on oxidative stress, hs-CRP, and mental health in T2DM patients, there might be some positive outcomes regarding inflammatory and mood states. Trial registration Iranian Registry of Clinical Trials: Trial was registered in the Iranian Registry of Clinical Trials (available at: www.irct.ir, with ID: IRCT20191209045672N1) on 21/09/2020.
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