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IRCT20110510006431N3 IRCT 2018-03-04 Semnan University of Medical Sciences The effect of probiotic on metabolic disorders in subjects with pre-diabetes The effect of probiotic supplementation on glycemic control, cardiometabolic risk factors, and endothelial function in overweight and obese subjects with pre-diabetes 2018-06-22 anticipated 85 Complete https://irct.ir/trial/6883 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will be randomized to receive probiotic or placebo supplementation. Randomization will conduct based on permuted-block randomizations, stratified by gender and BMI. For this purpose, a random number table will be used. Allocation concealment will be performed by a statistician uninformed about the intervention and control groups, Blinding description: The patients and the main investigators will not be aware of the type of intervention received in the two groups. Supplements and placebo will be prepared by the pharmaceutical company outside the research environment in sealed and non-transparent packaging, and will be available to researchers after encoding. Until the end of the study, patients and researchers will not be aware of the content and method of coding supplementation and placebo. 3 prediabetes. Intervention 1: Intervention group: Probiotic supplements will be provided in the form of capsules containing Lactobacillus acidophilus and Bifidobacterium longum in a colony-forming units of 10*9. All participants is this group are asked to take the capsule daily with a glass of water for 12 weeks. Intervention 2: Control group: All participants is this group are asked to take the capsule daily with a glass of water for 12 weeks. Yes - There is a plan to make this available What will be shared: Information on the main outcome and secondary outcomes will be published. When: The start of access period will be after the publication of the results in 1398 To whom: All academic researchers and health professionals Conditions: Not currently set. Where to obtain: Not currently set. How to obtain: Not currently set. Comments:
public Mahdi Shadnoush
Head of Semnan University of Medical Sciences and Health Services, Basij Boulevard, Semnan
Semnan Iran (Islamic Republic of) 35198-99951 +98 23 3344 8998 shadnoush@sbmu.ac.ir Semnan University of Medical Sciences scientific Mahdi Shadnoush
Head of Semnan University of Medical Sciences and Health Services, Basij Boulevard, Semnan
Semnan Iran (Islamic Republic of) 35198-99951 +98 23 3344 8998 shadnoush@sbmu.ac.ir Semnan University of Medical Sciences Iran (Islamic Republic of) Pre-diabetes diagnosis within the last 12 months Age between 35-65 25<BMI<40 kg/m2 35 years 65 years Both Type 1 and 2 diabetes People under treatment with any specific drug protocol including Metformin, Aspirin, OCPs or HRTs, immunosuppressives, and Corticosteroids People treated with antibiotics over the past three months People with digestive disorders, cardiovascular diseases, endocrine disorders, kidney dysfunction and malignancies Pregnant and lactating women, or those planning to become pregnant within the next 12 weeks Smokers, consumers of addictive drugs and alcohol Regular consumption of probiotic foods, or prebiotic and probiotic supplements over the past three months People with major changes in weight, diet and lifestyle over the past three months R73.0 Abnormal glucose tolerance test, Prediabetes Other Placebo Intervention group: Probiotic supplements will be provided in the form of capsules containing Lactobacillus acidophilus and Bifidobacterium longum in a colony-forming units of 10*9. All participants is this group are asked to take the capsule daily with a glass of water for 12 weeks. Control group: All participants is this group are asked to take the capsule daily with a glass of water for 12 weeks. HbA1c. Timepoint: At the beginning and following 12 weeks supplementation. Method of measurement: HPLC method. Fasting serum insulin. Timepoint: The beginning of the study and the end of 12 weeks. Method of measurement: ELISA. HOMA-IR. Timepoint: The beginning of the study and the end of 12 weeks. Method of measurement: Calculation. Fasting serum total cholesterol. Timepoint: The beginning of the study and the end of 12 weeks. Method of measurement: biochemical assay kits. Fasting serum triglyceride. Timepoint: The beginning of the study and the end of 12 weeks. Method of measurement: biochemical assay kits. Fasting serum LDL cholesterol. Timepoint: The beginning of the study and the end of 12 weeks. Method of measurement: biochemical assay kits. Fasting serum HDL cholesterol. Timepoint: The beginning of the study and the end of 12 weeks. Method of measurement: biochemical assay kits. Fasting serum adiponectin. Timepoint: The beginning of the study and the end of 12 weeks. Method of measurement: ELISA. Fasting serum resistin. Timepoint: The beginning of the study and the end of 12 weeks. Method of measurement: ELISA. Fasting serum IL-6. Timepoint: The beginning of the study and the end of 12 weeks. Method of measurement: ELISA. Fasting serum TNF-α. Timepoint: The beginning of the study and the end of 12 weeks. Method of measurement: ELISA. Fasting serum ICAM-1. Timepoint: The beginning of the study and the end of 12 weeks. Method of measurement: ELISA. Fasting serum VCAM-1. Timepoint: The beginning of the study and the end of 12 weeks. Method of measurement: ELISA. Systolic blood pressure. Timepoint: The beginning of the study and the end of 12 weeks. Method of measurement: calibrated blood pressure monitor. Diastolic blood pressure. Timepoint: The beginning of the study and the end of 12 weeks. Method of measurement: calibrated blood pressure monitor. Semnan University of Medical Sciences Approved 2018-02-06 Ethnical Committee of Semnan University of Medical Sciences Head of Semnan University of Medical Sciences and Health Services, Basij Boulevard, Semnan Semnan Semnan Iran (Islamic Republic of)