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synbiotic in diabetes

Study of the effect of synbiotic supplement on glycemic and lipid profile indices, inflammatory factors, oxidative stress condition and expression of related microRNAs in T2DM patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180624040228N1
Enrollment
72
Registered
2018-07-21
Start date
2018-07-23
Completion date
Unknown
Last updated
2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus. Type 2 diabetes mellitus

Interventions

Intervention 1: Intervention group: The intervention group will receive synbiotic capsules (containing probiotic, fructo-oligosaccharide as prebiotic, lactose, magnesium stearate, talc) containing 50

Sponsors

Yazd University of Medical Sciences
Lead Sponsor
Iran National Science Foundation
Collaborator

Eligibility

Sex/Gender
All
Age
25 Years to 65 Years

Inclusion criteria

Inclusion criteria: Men and women with type 2 diabetes (the minimum elapsed time of diagnosis is 3 months and diabetes treatment is started in person) Age range 25 to 65 years Glycosylated hemoglobin above 6.5% and below 8.5% BMI is between 25 and 35

Exclusion criteria

Exclusion criteria: Using alternative therapies with hormone (Insulin, Corticosteroids) or vitamin supplements Chronic kidney, liver, pulmonary diseases. chronic or acute inflammatory diseases (especially acute Pancreatic inflammation and Endocarditis) Valvular disease of the heart. Irritable Bowel Syndrome. Allergic Diabetes complications (Nephropathy, Cardiomyopathy, Retinopathy, Diabetic foot ulcers) People with low immune system (Autoimmune) Pregnancy, Lactation Use of tobacco and alcohol Probiotic consumption in the last three months Follow the unusual diet up to 1month before the study

Design outcomes

Primary

MeasureTime frame
Expression of microRNA-126. Timepoint: Before and immediately after the intervention. Method of measurement: Real time Polymerase Chain Reaction (PCR).;Experation of microRNA-146a. Timepoint: Before and immediately after the intervention. Method of measurement: Real time Polymerase Chain Reaction (PCR).;Serum levels of interleukin 6. Timepoint: Before and immediately after the intervention. Method of measurement: ELISA kit.;Serum levels of tumor necrosis factor alpha. Timepoint: Before and immediately after the intervention. Method of measurement: ELISA kit.;Serum levels of Malondialdehyde. Timepoint: Before and immediately after the intervention. Method of measurement: ELISA kit.;Serum levels of total antioxidant capacity. Timepoint: Before and immediately after the intervention. Method of measurement: ELISA kit.

Secondary

MeasureTime frame
Triglyceride. Timepoint: Before and immediately after the intervention. Method of measurement: Turbidity test.;Total cholesterol. Timepoint: Before and immediately after the intervention. Method of measurement: Turbidity test.;High-density lipoprotein. Timepoint: Before and immediately after the intervention. Method of measurement: Turbidity test.;Low-density lipoprotein. Timepoint: Before and immediately after the intervention. Method of measurement: Turbidity test.;Fasting Blood Sugar. Timepoint: Before and immediately after the intervention. Method of measurement: Turbidity test.;Glycosylated hemoglobin. Timepoint: Before and immediately after the intervention. Method of measurement: Enzymatic Assay Kit.;Fasting insulin. Timepoint: Before and immediately after the intervention. Method of measurement: ELISA kit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFahime Zeinali

Yazd University of Medical Sciences

fghzeinaly@ssu.ac.ir+98 35 3820 9100

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026