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IRCT20220226054125N1 IRCT 2022-07-30 Yazd University of Medical Sciences Effect of probiotic yogurt consumption on glycemic control and lipid profile in patients with type 2 diabetes mellitus: A double-blind randomized controlled trial Effect of probiotic yogurt consumption on glycemic control and lipid profile in patients with type 2 diabetes mellitus: A double-blind randomized controlled trial 2019-04-04 anticipated 80 Complete https://irct.ir/trial/62304 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Crossover, Purpose: Screening, Randomization description: The initial selection of patients in this study is available and will then be randomly assigned to two groups: Based on the inclusion criteria and with the help of a random number table, an Excel list of 300 patients with a file is prepared. The researchers will then establish a list of telephone contacts with the patients in order, and each patient who meets the inclusion and exclusion criteria will be included in the study. This will continue until the desired sample size (80 people) is reached. All study samples are explained about the objectives of the study and they are told that they will be included in one of the study groups (test or control). The studied samples are then asked to go to the diabetes clinic and complete the informed consent form to participate in the study. How to randomize: Using the RANDBETWEEN command in Excel software, 40 people are randomly assigned in the test group and 40 people in the control group, Blinding description: This study is designed as a three-way blind. In the first stage, the patient does not know in which group (test or control) he is. People who do blood sampling, not data analysts, do not know what group each person is in (test or control). In this three-blind randomized controlled clinical trial, 80 type 2 diabetic patients with high blood sugar above 100 mg / dL are divided into two groups. The experimental group received 200 g of probiotic yogurt containing Lactobacillus acidophilus and Bifidobacterium lactis daily and the control group received 200 g of normal yogurt daily (lunch and dinner) for 3 months. Anthropometric indices, blood glucose and serum lipid levels are measured at the beginning and end of the study. 3 Effect of probiotic yogurt consumption on glycemic control and lipid profile in patients with type 2 diabetes mellitus. Intervention 1: The subjects of the test group receive 200 grams of probiotic yogurt containing Lactobacillus acidophilus and Bifidobacterium lactis daily for three months. Intervention 2: People in the control group will receive 200 grams of regular yogurt daily (lunch and dinner) for 3 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the confidentiality of patients' personal information
public Ali Salari Sharif
Safaieh Bouali St. Nursing and Midwifery Research Center
Yazd Iran (Islamic Republic of) 8916877443 +98 35 3824 1755 microb.5656@gmail.com Yazd University of Medical Sciences scientific Ali Salarisharif
School of Nursing and Midwifery, in front of Reproductive and Infertility Research Institute, Bouali Alley, Timsar Fallahi St, Safaieh, Yazd
Yazd Iran (Islamic Republic of) 8916877443 +98 35 3824 1755 microb.5656@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) The inclusion criteria included patients with T2DM low density lipoprotein-cholesterol (LDL-c) equal to or greater than 100 mg/dl age between 30-60 years taking metformin and Gli Banglamide tables with correct gastrointestinal function according to patient not taking blood lipid lowering drugs 30 years 60 years Both The inclusion criteria included patients with T2DM low density Lipoprotein-cholesterol (LDL-c) equal to or greater than 100 mg/dl age between 30-60 years taking metformin and Gli Banglamide tables with correct gastrointestinal function according to patient not taking blood lipid lowering drugs E08 Diabetes mellitus due to underlying condition Treatment - Drugs Placebo The subjects of the test group receive 200 grams of probiotic yogurt containing Lactobacillus acidophilus and Bifidobacterium lactis daily for three months. People in the control group will receive 200 grams of regular yogurt daily (lunch and dinner) for 3 months Blood sugar. Timepoint: Before and after study. Method of measurement: Using Pars Azmoun commercial kits. Hemoglobin A1c. Timepoint: Before and after study. Method of measurement: Using Pars Azmoun commercial kits. Cholesterol and Triglyceride. Timepoint: Before and after study. Method of measurement: By photometric method using Pars Azmoun commercial kits. HDL. Timepoint: Before and after study. Method of measurement: By photometric method using Pars Azmoun commercial kits. LDL. Timepoint: Before and after study. Method of measurement: By photometric method using Pars Azmoun commercial kits. Vice Chancellor for Research and Technology, Shahid Sadoughi University of Medical Sciences, Yazd Approved 2014-11-26 IR.SSU.REC Yazd Diabetic Research Center, at the end of the Art hall alley, Bahnar Square towards Azadi Square, Shahid Sadoughi Blvd, Yazd,Iran Yazd Yazd Iran (Islamic Republic of)