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IRCT20191209045672N1 IRCT 2020-09-21 Esfahan University of Medical Sciences The effect of fortified- bread with pomegranate peel powder in the treatment of diabetes 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 2020-10-01 anticipated 90 Complete https://irct.ir/trial/48132 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: 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, Blinding description: 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. N/A Type 2 diabetes mellitus. Intervention 1: Intervention group: In this group, subjects will use 100 grams of enriched-bread with pomegranate peel powder daily for breakfast and snacks for 12 weeks. Intervention 2: Control group: In this group, subjects will consume 100 grams of regular wheat bread for 12 weeks for breakfast and snacks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The corresponding author will decide in this regard as soon as possible.
public Reza Amani
Isfahan University of Medical Sciences,Isfahan,Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 r_amani@nutr.mui.ac.ir Esfahan University of Medical Sciences scientific Reza Amani
Isfahan University of Medical Sciences,Isfahan,Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 r_amani@nutr.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age 40-60 Body mass index less than 30 Glycosylated hemoglobin less than 8 Willing to participate in the study, diagnosis of diabetes in the last 5 years Understanding the objectives of the study Written consent 40 years 60 years Both No complications of diabetes Using insulin or oral agents inducing insulin secretion Smoking Pregnancy Lactation Taking antioxidant supplements within the last 3 months Having a history of cancer, cardiovascular disease, renal, hepatic and thyroid disorders before the intervention E08 Diabetes mellitus type 2 due to underlying condition Treatment - Other Treatment - Other Intervention group: In this group, subjects will use 100 grams of enriched-bread with pomegranate peel powder daily for breakfast and snacks for 12 weeks. Control group: In this group, subjects will consume 100 grams of regular wheat bread for 12 weeks for breakfast and snacks. ٍEffect of fortified-bread with pomegranate peel powder on FBS level. Timepoint: Before intervention and after 12 weeks consumption of fortified-bread with pomegranate peel powder. Method of measurement: Measurement by laboratory kit. ٍEffect of fortified-bread with pomegranate peel powder on HbA1c level. Timepoint: Before intervention and after 12 weeks consumption of fortified-bread with pomegranate peel powder. Method of measurement: Measurement by chromatography. ٍEffect of fortified-bread with pomegranate peel powder on insulin level. Timepoint: Before intervention and after 12 weeks consumption of fortified-bread with pomegranate peel powder. Method of measurement: Measurement by laboratory kit. ٍEffect of fortified-bread with pomegranate peel powder on lipid profile level. Timepoint: Before intervention and after 12 weeks consumption of fortified-bread with pomegranate peel powder. Method of measurement: Measurement by laboratory kit. ٍEffect of fortified-bread with pomegranate peel powder on Malon dealdehyde level. Timepoint: Before intervention and after 12 weeks consumption of fortified-bread with pomegranate peel powder. Method of measurement: Measurement by laboratory kit. ٍEffect of fortified-bread with pomegranate peel powder on total antioxidant capacity level. Timepoint: Before intervention and after 12 weeks consumption of fortified-bread with pomegranate peel powder. Method of measurement: Measurement by laboratory kit. C-reactive protein measurement with high sensitivity. Timepoint: Before intervention and after 12 weeks consumption of fortified-bread with pomegranate peel powder. Method of measurement: Measurement by laboratory kit. Depression, anxiety and stress scales. Timepoint: Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder. Method of measurement: Questionnaire. Weight. Timepoint: Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder. Method of measurement: scales. Waist. Timepoint: Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder. Method of measurement: Measuring meter. Blood pressure. Timepoint: Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder. Method of measurement: Blood pressure measuring device. Esfahan University of Medical Sciences Approved 2020-05-12 Ethics Committee of Isfahan University of Medical Sciences Hezar Jerib Street,Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)