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IRCT20110314006065N4 IRCT 2022-02-21 Tehran University of Medical Sciences The effects of bread containing Fenugreek on health of patients with type 2 diabetes mellitus The effects of bread containing Fenugreek and Cinnamon on anthropometric indices, glycemic status and lipid profile in patients with type 2 diabetes mellitus 2021-12-23 anticipated 90 Complete https://irct.ir/trial/59649 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided (six random blocks) into three groups of 30. One group eats toast containing fenugreek and cinnamon, the second group eats placebo toast (containing wheat flour) and the third group eats common breads. Randomization is done using an online system (https://www.sealedenvelope.com/). After randomization, each patient is given a code that is identified during the study. The random number is assigned sequentially. Randomization is not visible to those conducting the study and is provided in matte and sealed envelopes with consecutive numbers. The envelope is opened after patients sign the informed consent form and meet the eligibility criteria, Blinding description: Envelopes containing fortified bread and not fortified toast will be exactly the same in shape, color and size of packaging and will be stored in dark packaging. The packages will be named A and B, and the researcher does not know which bread each group uses. 2 Type 2 diebetes. Intervention 1: Intervention group: Group consumes a toast containing fenugreek and cinnamon. Baked bread will replace 4 units of common bread and the study will continue for 8 weeks. Carbohydrates will be considered for all three study groups, taking into account 55% of carbohydrates consumed daily. Intervention 2: Intervention group: The second group consumes placebo toast (containing wheat flour). Baked bread will replace 4 units of common bread and the study will continue for 8 weeks. Carbohydrates will be considered for all three study groups, taking into account 55% of carbohydrates consumed daily. Intervention 3: Control group: Control group: Consume common breads. .study will continue for 8 weeks. Carbohydrates will be considered for all three study groups, taking into account 55% of carbohydrates consumed daily. 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 It is not clear release schedule.
public Nazli Namazi
Endocrinology & Metabolism Research Institute, Shariati Hospital, North Kargar Avenue
Tehran Iran (Islamic Republic of) 1411713137 +98 919 241 4658 nazli.namazi@yahoo.com Tehran University of Medical Sciences scientific Nazli Namazi
Endocrinology & Metabolism Research Institute, Shariati Hospital, North Kargar Avenue
Tehran Iran (Islamic Republic of) 1411713137 +98 919 241 4658 nazli.namazi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with type 2 diabetes (fasting blood sugar less than or equal to 126 Milligrams in deciliter and two-hour blood sugar greater than or equal to 200 Milligrams in deciliter) Receiving blood sugar lowering drugs HbA1c more than 10% Body mass index less than 40 kilogram in square meter 20 years 50 years Both Insulin or liraglutide injection Type 1 diabetes History of chronic liver and kidney disease, diabetic foot ulcer, various malignancies, rheumatic and infectious diseases • Take any herbal medicine or herbal medicine to control blood sugar at present History of any allergies to herbs Pregnant or lactating women E08 Diabetes mellitus due to underlying condition Treatment - Other Treatment - Other Placebo Intervention group: Group consumes a toast containing fenugreek and cinnamon. Baked bread will replace 4 units of common bread and the study will continue for 8 weeks. Carbohydrates will be considered for all three study groups, taking into account 55% of carbohydrates consumed daily. Intervention group: The second group consumes placebo toast (containing wheat flour). Baked bread will replace 4 units of common bread and the study will continue for 8 weeks. Carbohydrates will be considered for all three study groups, taking into account 55% of carbohydrates consumed daily. Control group: Control group: Consume common breads. .study will continue for 8 weeks. Carbohydrates will be considered for all three study groups, taking into account 55% of carbohydrates consumed daily. Fasting blood sugar. Timepoint: Baseline, after 8 weeks of the intervention (At the end of the intervention). Method of measurement: Autoanalyzer. HbA1c. Timepoint: Baseline, after 8 weeks of the intervention (At the end of the intervention). Method of measurement: En Chromatography. Weight. Timepoint: Baseline, after 8 weeks of the intervention (At the end of the intervention). Method of measurement: Scales. Total cholesterol. Timepoint: Baseline, after 8 weeks of the intervention (At the end of the intervention). Method of measurement: Autoanalyzer. Tehran University of Medical Sciences Approved 2021-05-09 Ethics committee of Endocrinology & Metabolism Research Institute Endocrinology & Metabolism Research Institute, Shariati Hospital, North Kargar Avenue Tehran Tehran Iran (Islamic Republic of)