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IRCT20150815023617N5 IRCT 2020-12-06 Shahid Beheshti University of Medical Sciences Investigation of the effect of concentrated beetroot juice consumption in patients with type 2 diabetes Effect of concentrated beetroot juice consumption on anthropometric measures, glycemic control, lipid profile, blood pressure, plasma systematic and vascular inflammation and oxidative stress, and NF-kB in peripheral blood mononuclear cells in patients with type 2 diabetes: Randomized clinical trial study 2020-10-10 anticipated 70 Complete https://irct.ir/trial/51381 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a simply randomized, controlled, open-labeled trial. Patients will match for gender and age then will be allocated to the beetroot group-group A- (n = 35) and control group- group B- (n = 35) by blocked randomization (using the table of four blocks (A and B). A computer algorithm written in SAS® (Cary, NC) will be used for performing block randomization with randomly selected block sizes of 4. Finally, 18-block will be randomly selected and these blocks will be placed behind each other and 70 sealed envelopes named A and B will be provided. Participants will randomly choose one of these envelopes at the beginning of the study. These envelopes will be referred to individuals respectively for consumption in either order, an a12-week period of daily supplementation with 25 ml concentrated beetroot juice or without any intervention. 3 Diabetes. Intervention 1: Intervention group: A12-week period of daily supplementation with 25 ml concentrated beetroot juice . Concentrated beetroot juice will be prepared by Takdaneh, Inc., Iran, without any additives (contains 17/3 mg nitrate and 0.009 mg nitrite per 25 ml)Patients do not change the medication prescribed to them, during the intervention. Intervention 2: Control group: A12-week period with out any intervention Patients do not change the medication prescribed to them during the intervention. Yes - There is a plan to make this available What will be shared: Only part of the data is shared, such as the original outcome. When: The start of the access period is 12 months after printing the results. To whom: It will be available for researchers working in academic and scientific institutions. Conditions: It will be available for researchers working in academic and scientific institutions. Where to obtain: golbonsohrab@sbmu.ac.ir How to obtain: The communication will be possible through the electronic mail given in the previous section. Comments:
public Golbon Sohrab
No. 7, West Hafezi Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2207 7424 golbonsohrab@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Golbon Sohrab
No. 7, West Hafezi Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2207 7424 golbonsohrab@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) ٰٰٰTendency to cooperate Patients with type 2 diabetes for 1-10 years Age between 35 to70 years old BMI between 20-25 kg/m2 No pregnancy or breast-feeding Patients who are only being treated with oral hypoglycemic agents No alcohol and substance abuse history 35 years 70 years Both Patients who are using insulin Having chronic kidney, liver, or inflammatory diseases Taking multivitamin and herbal supplements in the past 3 months Taking glucocorticoids and nonsteroidal anti-inflammatory drugs Taking of nitrate-containing drugs such as nitroglycerin, isosorbide, nitropress, etc. History of microvascular and macrovascular diseases (such as history of angioplasty, foot vascular surgery) Patients with uncontrolled diabetes (HbA1C more than or equal 8.5%) E08 Diabetes mellitus due to underlying condition Treatment - Other Treatment - Other Intervention group: A12-week period of daily supplementation with 25 ml concentrated beetroot juice . Concentrated beetroot juice will be prepared by Takdaneh, Inc., Iran, without any additives (contains 17/3 mg nitrate and 0.009 mg nitrite per 25 ml)Patients do not change the medication prescribed to them, during the intervention. Control group: A12-week period with out any intervention Patients do not change the medication prescribed to them during the intervention Plasma level of fasting plasma glucose. Timepoint: At the beginning (before the start of the study) and at the end of the study (12 weeks after the start of beet juice consumption). Method of measurement: Measuring by the colorimetric method based on the enzymatic reactions of invertase and glucose oxidase-peroxidase (GOD-POD). HbA1C. Timepoint: At the beginning (before the start of the study) and at the end of the study (12 weeks after the start of beet juice consumption). Method of measurement: Chromatography. HOMA-β: The homeostasis model assessment of pancreatic β-cell function. Timepoint: At the beginning (before the start of the study) and at the end of the study. Method of measurement: Calculating by formula: HOMA-B=20× Insulin (μU/m/glucose(mg/dl) −3.5. HOMA-IR: Homeostatic model assessment of insulin resistance. Timepoint: At the beginning (before the start of the study) and at the end of the study. Method of measurement: Calculating by formula: HOMA-IR=(glucose(mg/dl)× Insulin(μU/ml))/22.5. Anthropometric measures: Weight. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (12 weeks after consuming beet juice). Method of measurement: Using a digital scale. Systolic and diastolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (12 weeks after consuming beet. Method of measurement: Standardized mercury sphygmomanometer. HDL. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (12 weeks after consuming beet). Method of measurement: Photometric enzymatic method. Total -cholesterol. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (12 weeks after consuming beet). Method of measurement: Photometric enzymatic method. LDL-cholesterol. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (12 weeks after consuming beet). Method of measurement: Using the Friedwald formula: LDL=TC −HDL − (TAG/5). Intercellular Adhesion Molecule 1( ICAM-1). Timepoint: At the beginning of the study (before the intervention) and at the end of the study (12 weeks after consuming beet). Method of measurement: ELISA. Interleukin 6. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (12 weeks after consuming beet). Method of measurement: ELISA. High-sensitivity C-reactive protein (hs-CRP). Timepoint: At the beginning of the study (before the intervention) and at the end of the study (12 weeks after consuming beet). Method of measurement: ELISA. Malondialdehyde (MDA). Timepoint: At the beginning of the study (before the intervention) and at the end of the study (12 weeks after consuming beet). Method of measurement: Photometric enzymatic method. Plasma nitrate and nitrite. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (12 weeks after consuming beet). Method of measurement: Griess Colorimetric method. Tumor necrosis factor(TNF-α). Timepoint: At the beginning of the study (before the intervention) and at the end of the study (12 weeks after consuming beet). Method of measurement: ELISA. Nuclear factor-κB (NF-κB). Timepoint: ELISA. Method of measurement: At the beginning of the study (before the intervention) and at the end of the study (12 weeks after consuming beet). Height. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (12 weeks after consuming beet). Method of measurement: Using a Seca portable height gauge. Body mass index. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (12 weeks after consuming beet). Method of measurement: Weight in kilogram / the square of the height in centimeters. Shahid Beheshti University of Medical Sciences Approved 2020-07-25 Ethics committee of Shahid Beheshti University of medical sciences No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town Tehran Tehran Iran (Islamic Republic of)