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IRCT20220621055238N1 IRCT 2023-01-08 Iran University of Medical Sciences The effect of yogurt and probiotic supplement on the cognitive function of patients with type 2 diabetes Comparison of the effect of probiotic yogurt with its supplementation on cognitive function, cortisol and serum superoxide dismutase in patients with type 2 diabetes 2021-09-22 anticipated 111 Complete https://irct.ir/trial/64599 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization with six blocks will be used for randomization. According to the determined sample size of 111, 19 blocks of six will be produced using the online site (www.sealedenvelope.com). In order to apply concealment in the randomization process, numbered envelopes containing a random sequence will be used, Blinding description: The people participating in the study, the researchers evaluating the results and the laboratory technicians will not be informed about the type of intervention until the end of the research. For this purpose, normal and probiotic yogurt packages, as well as probiotic supplement and its placebo, will be prepared similar to each other in terms of their appearance and labels, and someone other than the researcher will code them. In addition, the researcher will not know the allocation of the participants in each of the groups during the evaluation of the results. 3 Type 2 diabetes mellitus. Intervention 1: Intervention group: The first intervention group: they receive one probiotic supplement capsule + 200 grams of plain yogurt per day for 12 weeks. Probiotic supplement is produced by Takgene Zist Company. This probiotic product is produced from two groups of bacteria, including Lactobacilli and Bifidobacteria, with a dose of two times ten to the power of eight Colony Forming Units (CFU) per capsule, and lactose and magnesium stearate are used as carriers. Plain yogurt is low-fat and produced by Amol Doosheh Dairy Products company. Yogurt is distributed weekly, which is provided to the participants in packages containing 14 glasses of 100 grams. Each 100 gram package of plain yogurt contains 51% calories, 3.6 grams of protein, 6 grams of carbohydrates and 1.4 grams of fat. Yogurt packages are delivered to the participants by maintaining the cold chain and at a temperature of minus 4 degrees Celsius. The people participating in the study are emphasized to store the yogurts immediately in the refrigerator. Intervention 2: Intervention group: The second intervention group: they will receive 200 grams of probiotic yogurt + one placebo capsule per day for 12 weeks. The probiotic yogurt of the present study is low-fat yogurt and it is produced by Amol Doosheh Dairy Products company. This probiotic product is produced from two groups of bacteria, including Lactobacilli and bifidobacteria, with a dose of two times ten to the power of eight Colony Forming Units (CFU). Yogurt is distributed weekly, which is provided to the participants in packages containing 14 glasses of 100 grams. Each 100 gram package of probiotic yogurt contains 51% calories, 3.6 grams of protein, 6 grams of carbohydrates and 1.4 grams of fat. Yogurt packages are delivered to the participants by maintaining the cold chain and at a temperature of minus 4 degrees Celsius. Participants are emphasized to store the yogurts immediately in the refrigerator. The placebo capsule is produced by Takgene Zist Company, which contains starch and is similar to the probiotic supplement in terms of appearance, color, size, and packaging. Intervention 3: Control group: they will receive 200 grams of plain yogurt + one placebo capsule per day for 12 weeks. Plain yogurt is low-fat and produced by Amol Doosheh Dairy Products company. Yogurt is distributed weekly, which is provided to the participants in packages containing 14 glasses of 100 grams. Each 100 gram package of plain yogurt contains 51% calories, 3.6 grams of protein, 6 grams of carbohydrates and 1.4 grams of fat. Yogurt packages are delivered to the participants by maintaining the cold chain and at a temperature of minus 4 degrees Celsius. Participants are emphasized to store the yogurts immediately in the refrigerator. The placebo capsule is produced by Takgene Zist Company, which contains starch and is similar to the probiotic supplement in terms of appearance, color, size, and packaging. 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 Currently, no decision has been made regarding IDP release.
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Sari Iran (Islamic Republic of) 4816135987 +98 11 3336 1762 marsazaroody@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) 50 to 69 years of age Body mass index equal to and greater than 25 to 40 Blood pressure under control (lower than 140/90 mmHg) in the last two months The score of a brief cognitive screening test (Mini-Cog) lower or equal of 2 Daily consumption of yogurt at least one serving Education level of at least five classes Hb-A1c equal to and less than 8.5 Type 2 diabetes (at least two years) Willingness to cooperate 50 years 69 years Both Immune deficiency diseases Stage three and above of Chronic Kidney Disease (CKD) History of heart attack, congestive heart failure, stent placement Chronic Obstructive Pulmonary Disease (COPD) Stage three and above of fatty liver Inflammatory Bowel Disease (IBD), Irritable Bowel Syndrome (IBS), pernicious anemia and mal-absorption such as celiac disease and chronic pancreatitis Hypothalamic tumor Uncontrolled thyroid disease Parathyroid disease Adrenal disease Gum surgery under the supervision of a dentist Gastrointestinal surgeries Less than two years recovering from cancer Less than 3 months recovering from Covid-19 Neurological diseases such as seizures, mental retardation and stroke Comorbid psychiatric disorder such as Generalized Anxiety Disorder (GAD), depression, schizophrenia, dementia, Parkinson's Diseases, and bipolar Allergy Uncontrolled hypertriglyceridemia Allergy to cow's milk protein lactose intolerance Taking any medication other than oral medications for diabetes, blood pressure, dyslipidemia, aspirin, and levothyroxine in the last two months Taking antibiotics Having a special diet Regular consumption of dietary supplements (equal to or more than 3 times a week) other than vitamin D during the two months before the study alcohol consumption smoking Being pregnant or breastfeeding Participating in other medical studies E11 Type 2 diabetes mellitus Treatment - Other Treatment - Other Placebo Intervention group: The first intervention group: they receive one probiotic supplement capsule + 200 grams of plain yogurt per day for 12 weeks. Probiotic supplement is produced by Takgene Zist Company. This probiotic product is produced from two groups of bacteria, including Lactobacilli and Bifidobacteria, with a dose of two times ten to the power of eight Colony Forming Units (CFU) per capsule, and lactose and magnesium stearate are used as carriers. Plain yogurt is low-fat and produced by Amol Doosheh Dairy Products company. Yogurt is distributed weekly, which is provided to the participants in packages containing 14 glasses of 100 grams. Each 100 gram package of plain yogurt contains 51% calories, 3.6 grams of protein, 6 grams of carbohydrates and 1.4 grams of fat. Yogurt packages are delivered to the participants by maintaining the cold chain and at a temperature of minus 4 degrees Celsius. The people participating in the study are emphasized to store the yogurts immediately in the refrigerator. Intervention group: The second intervention group: they will receive 200 grams of probiotic yogurt + one placebo capsule per day for 12 weeks. The probiotic yogurt of the present study is low-fat yogurt and it is produced by Amol Doosheh Dairy Products company. This probiotic product is produced from two groups of bacteria, including Lactobacilli and bifidobacteria, with a dose of two times ten to the power of eight Colony Forming Units (CFU). Yogurt is distributed weekly, which is provided to the participants in packages containing 14 glasses of 100 grams. Each 100 gram package of probiotic yogurt contains 51% calories, 3.6 grams of protein, 6 grams of carbohydrates and 1.4 grams of fat. Yogurt packages are delivered to the participants by maintaining the cold chain and at a temperature of minus 4 degrees Celsius. Participants are emphasized to store the yogurts immediately in the refrigerator. The placebo capsule is produced by Takgene Zist Company, which contains starch and is similar to the probiotic supplement in terms of appearance, color, size, and packaging. Control group: they will receive 200 grams of plain yogurt + one placebo capsule per day for 12 weeks. Plain yogurt is low-fat and produced by Amol Doosheh Dairy Products company. Yogurt is distributed weekly, which is provided to the participants in packages containing 14 glasses of 100 grams. Each 100 gram package of plain yogurt contains 51% calories, 3.6 grams of protein, 6 grams of carbohydrates and 1.4 grams of fat. Yogurt packages are delivered to the participants by maintaining the cold chain and at a temperature of minus 4 degrees Celsius. Participants are emphasized to store the yogurts immediately in the refrigerator. The placebo capsule is produced by Takgene Zist Company, which contains starch and is similar to the probiotic supplement in terms of appearance, color, size, and packaging. The score of the brief cognitive screening test (Mini-cog). Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (end of week 12). Method of measurement: Mini-cog, a brief cognitive screening test. The score of Stroop color-word. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (end of week 12). Method of measurement: Stroop color-word test. Salivary cortisol. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (end of week 12). Method of measurement: Immunoassay kit. Superoxide Dismutase (SOD). Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (end of week 12). Method of measurement: ELISA kit. Iran University of Medical Sciences Approved 2021-03-14 Ethics committee of Iran University of Medical Sciences Faculty of Health, Iran University of Medical Sciences, Hemat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)