Effects of bread fortification with pomegranate peel powder on health status: Study design and protocol

Introduction: The oxidative stress caused by the creation and breakdown of reactive oxygen species affects glucose tolerance, B-cell function, insulin resistance, and metabolites containing free fatty acids. Therefore, owing to their health benefits and ability to prevent oxidative stress, functional foods have received particular attention. This research aims to assess strategies used to ameliorate oxidative stress and inflammation in patients with type 2 diabetes (T2DM). Methods and Analysis: A randomized controlled trial will be conducted on 90 patients with T2DM. Run-in courses will last for two weeks. The intervention and control groups will receive wheat bread with and without pomegranate peel powder, respectively. Several variables, including anthropometric data, fasting plasma glucose, hemoglobin A1C, lipid profile, insulin level, high-sensitivity C-reactive protein (hs-CRP), malondialdehyde (MDA), and mood state, will be measured at baseline and after three months of the intervention. Beta-cell function (HOMA-B) and insulin resistance (HOMA-IR) will also be assessed. Research findings will increase the scientific knowledge about the use of bread in health intervention targeting.Ethics and dissemination: The protocol has been approved by the Ethics committee of the faculty of Medicine of the University of Isfahan (IR.MUI.RESEARCH.REC.1399.087). The study results will be disseminated through peer-reviewed publications and presentations at scientific meetings.Trial Registration: Registered in the Iranian Registry of Clinical Trials (ID: IRCT2019209045672N1) on September 21, 2020.