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IRCT20221220056876N1 IRCT 2023-01-02 Esfahan University of Medical Sciences Effect of red beetroot in subjects with pre-diabetes Effect of red beetroot on metabolic factors in subjects with pre-diabetes 2023-01-21 anticipated 74 Complete https://irct.ir/trial/67579 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the participants are randomly assigned to two groups of consuming beetroot powder (intervention) or placebo group. For randomization, the WinPepi software was used and the participants of each group (intervention and placebo) were placed in two strata (metformin users and non-users). The number of participants in each stratum was determined based on the prevalence of metformin use in prediabetic people. In the output of the software, the sequence of participants in two strata was determined, and in each stratum, the participants have been assigned to the intervention or placebo group. After randomization, the list of generated codes was deleted, Blinding description: For blinding, intervention sachets will be similar to placebo sachets in terms of shape, texture, color, weight, and other physical characteristics. The intervention sachets contain beetroot powder and the placebo sachets contain rice powder, which has been prepared at the same color as the beetroot powder using an approved food color. 3 Prediabetes. Intervention 1: Intervention group: Red beetroot powder prepared by Pak Shilan Negin Salamat private company located in Chaharmahal and Bakhtiari province, producing all kinds of fruit powder, summer vegetables, and dried vegetables, 7 grams twice a day (14 grams daily) for 12 weeks. (3 months), it is eaten with yogurt, salad, or a meal during lunch and dinner. Intervention 2: Control group: Rice powder prepared by Pak Shilan Negin Salamat private company located in Chaharmahal and Bakhtiari province, producing all kinds of fruit powder, summer vegetables, and dried vegetables, 7 grams twice a day (14 grams daily) for 12 weeks (3 months ), it is eaten with yogurt, salad, or a meal during lunch and dinner. Yes - There is a plan to make this available What will be shared: All data from this research can be shared after de-identifying individuals. When: 3 months after the results are published. To whom: All researchers. Conditions: Data requests will be considered only after the publication of results. Where to obtain: The main research executor: Elham Hosseini E-mail address: hosseini@res.mui.ac.ir How to obtain: After the publication of the results, people intending to use data collected in this research can make their request by submitting their proposal to the main executor. If the proposal is accepted by the executor, the data will be provided to the requester. Comments:
public Elham Hosseini
hezar jerib Ave.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3183 hosseini@res.mui.ac.ir Esfahan University of Medical Sciences scientific Elham Hosseini
Hezar Jerib Ave.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3183 hosseini@res.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age 20-80 years old BMI 18-35 kg/m2 20 years 80 years Both People with type 1, type 2, or gestational diabetes mellitus Use of any anti-diabetic agent except metformin Taking medication that affects glucose metabolism such as glucocorticoids, less than eight weeks before the start of the study Receiving growth hormone in less than six months before the start of the study Allergy to beetroot consumption A smoker or a history of smoking and alcohol consumption in the previous two years History of cardiovascular diseases (open heart surgery, cardiac congestion, heart failure, and uncontrolled blood pressure), liver cirrhosis/liver transplant, and/or kidney disease (CKD) History of inflammatory diseases such as rheumatoid arthritis A history of hypothyroidism or hyperthyroidism History of suffering from severe digestive diseases or mental illnesses Having often physical activity (more than 5 hours a week) Taking antioxidant supplements or hormonal treatments 4 weeks before the study Pregnant or lactating women R73.02 Impaired glucose tolerance (oral) Treatment - Other Placebo Intervention group: Red beetroot powder prepared by Pak Shilan Negin Salamat private company located in Chaharmahal and Bakhtiari province, producing all kinds of fruit powder, summer vegetables, and dried vegetables, 7 grams twice a day (14 grams daily) for 12 weeks. (3 months), it is eaten with yogurt, salad, or a meal during lunch and dinner. Control group: Rice powder prepared by Pak Shilan Negin Salamat private company located in Chaharmahal and Bakhtiari province, producing all kinds of fruit powder, summer vegetables, and dried vegetables, 7 grams twice a day (14 grams daily) for 12 weeks (3 months ), it is eaten with yogurt, salad, or a meal during lunch and dinner. 2-hour blood glucose. Timepoint: At the baseline and after 12 weeks. Method of measurement: Enzyme calorimetry method. Fasting blood sugar. Timepoint: At the baseline and after 12 weeks. Method of measurement: Enzyme calorimetry method. Fasting insulin. Timepoint: At the baseline and after 12 weeks. Method of measurement: The enzyme-linked immunosorbent assay. Hemoglobin A1C. Timepoint: At the baseline and after 12 weeks. Method of measurement: Enzyme calorimetry method. Homeostatic model assessment for insulin resistance. Timepoint: At the baseline and after 12 weeks. Method of measurement: Calculated by formula. The quantitative insulin-sensitivity check index. Timepoint: At the baseline and after 12 weeks. Method of measurement: Calculated by formula. Triglyceride. Timepoint: At the baseline and after 12 weeks. Method of measurement: Enzyme calorimetry method. Total cholesterol. Timepoint: At the baseline and after 12 weeks. Method of measurement: Enzyme calorimetry method. Low density lipoprotein. Timepoint: At the baseline and after 12 weeks. Method of measurement: Enzyme calorimetry method. High density lipoprotein. Timepoint: At the baseline and after 12 weeks. Method of measurement: Enzyme calorimetry method. High sensitivity-C Reactive Protein. Timepoint: At the baseline and after 12 weeks. Method of measurement: The enzyme-linked immunosorbent assay. Glutathione. Timepoint: At the baseline and after 12 weeks. Method of measurement: The enzyme-linked immunosorbent assay. Total antioxidant capacity. Timepoint: At the baseline and after 12 weeks. Method of measurement: The enzyme-linked immunosorbent assay. Total oxidative stress. Timepoint: At the baseline and after 12 weeks. Method of measurement: The enzyme-linked immunosorbent assay. Alanine transaminase. Timepoint: At the baseline and after 12 weeks. Method of measurement: Enzyme calorimetry method. Aspartate aminotransferase. Timepoint: At the baseline and after 12 weeks. Method of measurement: Enzyme calorimetry method. Alkaline Phosphatase. Timepoint: At the baseline and after 12 weeks. Method of measurement: Enzyme calorimetry method. Gamma-glutamyltransferase. Timepoint: At the baseline and after 12 weeks. Method of measurement: Enzyme calorimetry method. The Fibrosis-4 score. Timepoint: At the baseline and after 12 weeks. Method of measurement: Calculated by formula. Serum creatinine. Timepoint: At the baseline and after 12 weeks. Method of measurement: Kinetic Jaffe calorimetry. Urine creatinine. Timepoint: At the baseline and after 12 weeks. Method of measurement: Kinetic Jaffe calorimetry. Blood urea nitrogen. Timepoint: At the baseline and after 12 weeks. Method of measurement: Enzyme calorimetry method. Urine microalbumin. Timepoint: At the baseline and after 12 weeks. Method of measurement: The enzyme-linked immunosorbent assay. Esfahan University of Medical Sciences Approved 2022-08-22 Ethics Committee of Isfahan University of Medical Sciences Hezar Jerib Isfahan Isfehan Iran (Islamic Republic of)