The effects of fortified-bread with pomegranate peel powder on anthropometric indices, lipid profile, glycemic indices, oxidative stress markers, mood and inflammation level in patients with type 2 diabetes

The aim of the present study is to evaluate the effects of fortified-bread with pomegranate peel powder consumption on anthropometric indices, lipid profile, glycemic indices, oxidative stress markers, and mood in patients with type 2 diabetes

This is a randomized, double-blind placebo-controlled, clinical trial. Ninety participants will randomly be allocated to either fortified-bread with pomegranate peel powder (n = 45) or placebo (n = 45).

Type 2 diabetic participants aged 40–60 years will be recruited from Isfahan Endocrine & Metabolism Research Center (IEMRC), Isfahan, Iran. Subjects will be randomly divided into control and intervention groups by simple randomization. Random assignment will be done using a table of random numbers. Participants will consume fortified-bread with 3.5 percent pomegranate peel powder and regular-bread in the intervention and the placebo group, respectively. Participants will replace 100 grams of fortified- or whole-bread with their daily bread.

The cases will be enrolled in the study if they meet the following inclusion criteria 1) Willing to participate in the study; 2) Diagnosis of diabetes in the last 5 years; 3) Body mass index (BMI) <30; 4) Glycosylated hemoglobin less than 8. The exclusion criteria are as following 1) Individuals with a history of cancer, cardiovascular disease, renal, hepatic, and thyroid disorders; 2) Using insulin or oral insulin-stimulating agents.

Individuals will randomly be divided into two groups to receive either 100g wheat-bread with 3.5 percent PPP or placebo, daily for 12 weeks.

Fasting glucose; glycosylated hemoglobin; fasting insulin; serum lipid profile; mood status; inflammatory and antioxidant indices

A stratified randomized permuted block( with block size 4) will be generated by an independent bio-statistician. Random assignment will be done by the use of a table of random numbers. The participant's enrollment and assignment to the groups will be carried out by a trained nutritionist.

Fortified-bread with pomegranate peel powder(PPP) and its placebo (wheat bread) will be manufactured by the Simin bread workshop (Isfahan, Iran). Both fortified-bread and its placebo provided by the Simin bread workshop will be packed for each patient according to the randomization sequence. Fortified-bread and its placebo will be in similar packages and patients and researcher will not be aware of the content of the packages until the end of the trial. The intervention group will consume 100 gr of whole-wheat-bread with 3.5 percent PPP twice a week. The control group will consume 100 gr of whole-wheat-bread twice a week. The intervention will be continued for 3 months.