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IRCT20160221026684N4 IRCT 2022-12-31 Behdane Baran Salem Abi The effect of cumin bread on blood sugar in type 2 diabetic patients The effect of bread containing cumin on blood sugar in type 2 diabetic patients 2023-01-10 anticipated 60 Complete https://irct.ir/trial/67438 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 60 patients with type 2 diabetes and meeting the inclusion criteria will be selected. After determining all available samples, stratified random allocation will be done in three layers of age, gender and average HbA1c. First, all patients are divided into two groups based on gender, and from both groups, an equal number of women will be placed in both the intervention and control groups, and an equal number of men will be placed in the intervention and control groups. In the next step, all the patients who are assigned to two groups in terms of gender will be divided into four groups in terms of age and will be placed again in the intervention and control groups. Finally, we will have two groups of patients with similar age and gender distribution for intervention and control. Intervention allocation or random allocation is in the form of a closed envelope that the individual chooses before entering the researcher's room. The envelope with the letter A will be the intervention group and B will be the control group, Blinding description: In this study, only the main researchers are aware of the type of bread. The participating volunteers and other people involved in the project have no information about the type of bread. Both breads are similar in terms of shape, color, smell, packaging and appearance, and blinding has been done between them. 3 Diabetes. Intervention 1: In the intervention group, it is recommended that the bread consumed by the diabetic patient should be cumin bread in all three meals and consume a total of 120 grams of cumin bread daily for 2 months (8 weeks). The bread consumed is delivered to the patient weekly. It was also emphasized to the study participants not to change their usual diet and physical activity level during the study period. Cumin bread: Bread made from wheat flour and cumin - the flour composition includes 96% wheat flour (with commercial name of Setareh) + 2% cumin powder + the remaining 2% includes yeast and permitted bread additives such as salt and standard ingredients that improve the quality of bread, which is converted into voluminous bread in the "Golnan Poratus" factory located in Karaj. Intervention 2: In the control group, it is recommended that the bread consumed by the diabetic patient be ordinary regular bread in all three meals and consume a total of 120 grams of this type of bread daily for 2 months (8 weeks). The bread consumed is delivered to the patient weekly. It was also emphasized to the study participants that they should not change their usual diet and physical activity level during the study period. ordinary bread: made from wheat flour - the flour composition includes 98% wheat flour (with commercial name of Setareh) + the remaining 2% includes yeast and permitted bread additives such as salt and standard raw materials that improve the quality of the bread, which is converted into thick bread in the "Golnan Poratus" factory located in Karaj. Yes - There is a plan to make this available What will be shared: HbA1c data : Data on the main outcome will be made available to other researchers with the permission of the first executor When: Starting one year after publication To whom: People working in academic institutions Conditions: Coordinate with project analyzer Where to obtain: Dr. Seyed ali Khodaie :03537280215 dr.seyedalikhodaie@yahoo.com How to obtain: Request data from Yazd University of Medical Sciences, approval of the director of the Diabetes Research Center, approval of the first executor of the project Comments:
public Seyed Ali Khodaie
North Shahid Sadoughi BLVD
Yazd Iran (Islamic Republic of) 8917693571 +98 35 3728 0215 dr.seyedalikhodaie@yahoo.com Yazd University of Medical Sciences scientific Seyed Ali Khodaie
North Shahid Sadoughi blvd
Yazd Iran (Islamic Republic of) 8917693571 +98 35 3728 0215 dr.seyedalikhodaie@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Type 2 diabetes HbA1c<9 At least 30 years old A resident of Yazd Absence of chronic systemic diseases 30 years no limit Both Drug and alcohol addiction Special diets Special sports programs Taking insulin Creatinine above 1.2 Pregnancy or breastfeeding Medical reasons (Chronic systemic diseases and mental-psychological diseases) E08 Diabetes mellitus due to underlying condition Treatment - Other Treatment - Other In the intervention group, it is recommended that the bread consumed by the diabetic patient should be cumin bread in all three meals and consume a total of 120 grams of cumin bread daily for 2 months (8 weeks). The bread consumed is delivered to the patient weekly. It was also emphasized to the study participants not to change their usual diet and physical activity level during the study period. Cumin bread: Bread made from wheat flour and cumin - the flour composition includes 96% wheat flour (with commercial name of Setareh) + 2% cumin powder + the remaining 2% includes yeast and permitted bread additives such as salt and standard ingredients that improve the quality of bread, which is converted into voluminous bread in the "Golnan Poratus" factory located in Karaj. In the control group, it is recommended that the bread consumed by the diabetic patient be ordinary regular bread in all three meals and consume a total of 120 grams of this type of bread daily for 2 months (8 weeks). The bread consumed is delivered to the patient weekly. It was also emphasized to the study participants that they should not change their usual diet and physical activity level during the study period. ordinary bread: made from wheat flour - the flour composition includes 98% wheat flour (with commercial name of Setareh) + the remaining 2% includes yeast and permitted bread additives such as salt and standard raw materials that improve the quality of the bread, which is converted into thick bread in the "Golnan Poratus" factory located in Karaj. HbA1c. Timepoint: At the beginning and end of the intervention (8 weeks after the start). Method of measurement: Chromatography (HPLC). Serum triglyceride level. Timepoint: At the beginning and end of the intervention (8 weeks after the start). Method of measurement: Enzymatic method. Serum total cholesterol level. Timepoint: At the beginning and end of the intervention (8 weeks after the start). Method of measurement: Enzymatic method. Behdane Baran Salem Abi Approved 2022-12-14 Ethics committee of shahid sadoughi university of medical sciences Diabetes Research Center, Talar-e-Honar Alley, Shahid Sadoughi Blvd, Yazd Yazd Yazd Iran (Islamic Republic of)