prediabetes. Abnormal glucose tolerance test, Prediabetes
Conditions
Interventions
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. Al
Sponsors
Semnan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
35 Years to 65 Years
Inclusion criteria
Inclusion criteria: Pre-diabetes diagnosis within the last 12 months Age between 35-65 25<BMI<40 kg/m2
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c. Timepoint: At the beginning and following 12 weeks supplementation. Method of measurement: HPLC method. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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-a. 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahdi Shadnoush
Semnan University of Medical Sciences
Outcome results
None listed