Effect of bread fortification with pomegranate peel powder on glycemic indicators, antioxidant status, inflammation and mood in patients with type 2 diabetes: study protocol for a randomized, triple-blind, and placebo-controlled trial

BACKGROUND: 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. Functioning foods are therefore becoming increasingly popular because they provide health benefits and prevent oxidative stress. This research aims to assess strategies to alleviate oxidative stress and inflammation in patients with type 2 diabetes (T2DM). In the present study, the metabolic effect wheat bread fortified with pomegranate peel powder(PPP) will be assessed in participants with type 2 diabetes. METHODS: A randomized, triple-blind, placebo-controlled, and parallel arms clinical 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 PPP, respectively. Anthropometric data, fasting plasma glucose, hemoglobin A1C, lipid profile, insulin level, high-sensitivity C-reactive protein (hs-CRP), malondialdehyde (MDA), Total antioxidant capacity(TAC), and mood state, will be measured at the baseline and three months post-intervention. Beta-cell function (HOMA-B) and insulin resistance (HOMA-IR) will also be assessed. DISCUSSION: This trial will provide novel data on the impact of fortified bread with PPP on metabolic profile and mood state of patients with type 2 diabetes. The results will demonstrate the potential of such intervention in glycemic indices, antioxidant status, inflammation and mood in these patients. TRIAL REGISTRATION: Trial is registered in the Iranian Registry of Clinical Trials (ID: IRCT20191209045672N1). Date of registration 21/09/2020. https://en.irct.ir/trial/48132.