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IRCT20250507065638N1 IRCT 2025-06-25 Shiraz University of Medical Sciences Comparison of the Effects of Whole Wheat and Barley Bread on health-related indicators in Obese or Overweight Individuals with Type 2 Diabetes WBOD Comparison of the Effects of Whole Wheat and Barley Bread on Appetite Control, Energy Intake, Anthropometric Indices, Body Composition, Blood Pressure, and Some Biochemical Markers in Obese or Overweight Individuals with Type 2 Diabetes 2025-08-01 anticipated 93 Complete https://irct.ir/trial/83595 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, the stratified block method will be used, in which individuals are classified based on the age confounder (<55 or ≥55 years) and then, by using the Random Allocation Software, they will be randomly divided into 3 groups of whole wheat bread (A), whole barley bread (B), and white bread (C) as the control group in a 1:1:1 ratio. 1- Group 1: Receiving 1.5 pieces of whole wheat bread daily for 8 weeks 2- Group 2: Receiving 2 pieces of whole barley bread daily for 8 weeks 3- Group 3: Receiving 1.5 pieces of white wheat bread daily for 8 weeks as the control group For allocation concealment, an out-of-study person will give individuals sealed envelopes that determine whether they are in the intervention or control group. Breads will be in the same shape and individuals will not be aware of their grouping. Only the principal investigator will know the type of loaves and the groupings, Blinding description: This study is designed as a single-blind trial, meaning that the patients will not be aware of the type of intervention they will receive until the end of the study. The breads will be identical in appearance, and participants wont know their group assignment. During the intervention, the researchers will label the products and groups using codes, so participants remain unaware of the specific intervention they are receiving. N/A Condition 1: Obese or overweight individuals with type 2 diabetes. Condition 2: Obese or overweight with type 2 diabetes. Intervention 1: First intervention group: Daily intake of 1.5 pieces of whole wheat lavash bread for 8 weeks (The composition of whole wheat lavash bread was determined by Bitaran Laboratory. The average weight of the bread is approximately 70 grams, which contains 59.18% by weight of carbohydrates and 2.04% by weight of fiber.) In this study, we will try to ensure that individuals in each group receive approximately 61-68 grams of digestible carbohydrates daily through the intervention bread. The breads are prepared from the Amirieh Bread Free Baking Complex in Shiraz. Intervention 2: Second intervention group: Daily intake of 2 pieces of whole barley lavash bread for 8 weeks (The composition of whole barley lavash bread was determined by Bitaran Laboratory. The average weight of the bread is approximately 56 grams, which contains 61% by weight of carbohydrates and 1.93% by weight of fiber.) In this study, we will try to ensure that individuals in each group receive approximately 61-68 grams of digestible carbohydrates daily through the intervention bread. The breads are prepared from the Amirieh Bread Free Baking Complex in Shiraz. Intervention 3: Control group: Daily intake of 1.5 pieces of white wheat bread for 8 weeks (The composition of White wheat lavash bread was determined by Bitaran Laboratory. The average weight of the bread is approximately 70 grams, which contains 60.3% by weight of carbohydrates and 1.3% by weight of fiber.) In this study, we will try to ensure that individuals in each group receive approximately 61-68 grams of digestible carbohydrates daily through the intervention bread. The breads are prepared from the Amirieh Bread Free Baking Complex in Shiraz. 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 We want to first publish the final results and then share the data with others.
public Zahra Mirshekaran
Nutrition and Food Sciences School, Razi Blvd., Shiraz
Shiraz Iran (Islamic Republic of) 7153675500 +98 71 3725 1001 zahra.78.mirshekaran@gmail.com Shiraz University of Medical Sciences scientific Zahra Sohrabi
School of Nutrition and Food Sciences, Razi Blvd., Shiraz
Shiraz Iran (Islamic Republic of) 7153675500 +98 71 3725 1001 zahra_2043@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Overweight or obesity individuals aged 18 and above who either meet one of the diagnostic criteria for type 2 diabetes or have been diagnosed with diabetes and are taking medication to control their blood glucose 18 years no limit Both Insulin use Daily consumption of whole bread when examining people's dietary habits before the study began Pregnancy or breastfeeding Smoking or alcohol use Following special diets such as ketogenic, vegetarian, weight control diet, diabetic diet, etc. Chronic digestive disorders including chronic diarrhea, Crohn's and ulcerative colitis, and celiac disease Antibiotics taken within the past month Hospitalization within the past month Taking fiber supplements routinely or within the past month Individuals requiring a low-residue diet E11 E66 Type 2 diabetes mellitus Overweight and obesity Treatment - Other Treatment - Other Placebo First intervention group: Daily intake of 1.5 pieces of whole wheat lavash bread for 8 weeks (The composition of whole wheat lavash bread was determined by Bitaran Laboratory. The average weight of the bread is approximately 70 grams, which contains 59.18% by weight of carbohydrates and 2.04% by weight of fiber.) In this study, we will try to ensure that individuals in each group receive approximately 61-68 grams of digestible carbohydrates daily through the intervention bread. The breads are prepared from the Amirieh Bread Free Baking Complex in Shiraz. Second intervention group: Daily intake of 2 pieces of whole barley lavash bread for 8 weeks (The composition of whole barley lavash bread was determined by Bitaran Laboratory. The average weight of the bread is approximately 56 grams, which contains 61% by weight of carbohydrates and 1.93% by weight of fiber.) In this study, we will try to ensure that individuals in each group receive approximately 61-68 grams of digestible carbohydrates daily through the intervention bread. The breads are prepared from the Amirieh Bread Free Baking Complex in Shiraz. Control group: Daily intake of 1.5 pieces of white wheat bread for 8 weeks (The composition of White wheat lavash bread was determined by Bitaran Laboratory. The average weight of the bread is approximately 70 grams, which contains 60.3% by weight of carbohydrates and 1.3% by weight of fiber.) In this study, we will try to ensure that individuals in each group receive approximately 61-68 grams of digestible carbohydrates daily through the intervention bread. The breads are prepared from the Amirieh Bread Free Baking Complex in Shiraz. Body mass index. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: By calculating using the formula using height and weight. Waist circumference. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: meter. Body weight. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: scale. Waist-to-height ratio. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: By dividing the waist measurement by height. Waist-to-hip ratio. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: By dividing the waist measurement by hip measurement. Body shape index. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: By calculating with the formula using body mass index, waist circumference and height. Body roundness index. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: By calculating using the formula with using waist circumference and height. Body fat mass. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Body composition analyzer. Skeletal muscle mass. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Body composition analyzer. Body fat percentage. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Body composition analyzer. Appetite score. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Visual Analogue Scale questionnaire. Energy intake. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: 24-hour dietary recall (24hr). Fiber intake. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: 24-hour dietary recall (24hr). Macronutrients intake. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: 24-hour dietary recall (24hr). Micronutrients intake. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: 24-hour dietary recall (24hr). Fasting blood sugar. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Colorimetric method with Pars Azmoon kit and autoanalyzer. 2-hours postprandial glucose. Timepoint: At the beginning of the study and the end of the study (8 weeks after the intervention). Method of measurement: Colorimetric method with Pars Azmoon kit and autoanalyzer. Hemoglobin A1C. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Colorimetric method with Pars Azmoon kit and autoanalyzer. Homeostasis model assessment-estimated insulin resistance (HOMA-IR) index. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: By calculating using the formula with using glucose and insulin. Fasting insulin. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kit. High-sensitivity C-Reactive Protein. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kit. Systolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Digital sphygmomanometer. Diastolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Digital sphygmomanometer. Triglyceride. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Colorimetric method with Pars Azmoon kits and autoanalyzer. HDL (high-density lipoprotein). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Colorimetric method with Pars Azmoon kits and autoanalyzer. LDL (low-density lipoprotein). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Colorimetric method with Pars Azmoon kits and autoanalyzer. Total cholesterol. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Colorimetric method with Pars Azmoon kits and autoanalyzer. Atherogenic index of plasma. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: By calculating with the formula using triglyceride and high-density Lipoprotein. Shiraz University of Medical Sciences Approved 2025-06-08 Research Ethics Committees of Shiraz University of Medical Sciences Nutrition and Food Sciences School, Razi Blvd., Shiraz Shiraz Fars Iran (Islamic Republic of)