Evaluating the Effect of Synbiotic Supplements on type 2 Diabetes

Evaluating the Effect of Synbiotic Supplements on Hyperglycemia and Insulin Resistance in Patients with Type 2 Diabetes: A Randomized Double-blinded, Clinical Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230212057393N2

Enrollment

194

Registered

2023-04-18

Start date

2023-05-05

Completion date

Unknown

Last updated

2023-05-01

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

Conditions

Diabetes mellitus. Diabetes mellitus without complications

Interventions

Intervention 1: 97 Patients are in the synbiotic Supplements( Familact, zisttakhmir Company) Intervention Group. Patients will receive The supplements twice daily for three months. Intervention 2: nin

Eligibility

Sex/Gender

All

Age

30 Years to 75 Years

Inclusion criteria

Inclusion criteria: All patients in the age group of 30 to 75 years with type 2 diabetes who are diagnosed based on the latest American Diabetes Association(ADA) guidelines.

Exclusion criteria

Exclusion criteria: Pregnant and lactating women Patients receiving hormone therapy, including estrogen and progesterone. Hypothyroidism Patients with kidney disease that have a creatinine level more than two times the upper normal limit. Consumption of any Probiotic, Synbiotic products and Antibiotics in the last three months. Alcohol consumption

Design outcomes

Primary

Measure	Time frame
Hyperglycemia. Timepoint: In the beginning, and after three months. Method of measurement: Test kit for measuring blood sugar.;Insulin Resistance. Timepoint: In the beginning, and after three months. Method of measurement: ELISA Insulin Kit.	—

Secondary

Measure	Time frame
Lipid Profiles. Timepoint: At the Baseline and three months after entering the trial. Method of measurement: Blood test.;Body Mass Index. Timepoint: At the Baseline and three months after entering the Trial. Method of measurement: Scale and Tape Measure.;Systolic and Diastolic Blood Pressure. Timepoint: At the baseline and three months after entering the Trial. Method of measurement: Mercury Sphygmomanometer.;Measure psychological disorder. Timepoint: At the baseline and three months after entering the trial. Method of measurement: The General Health Questionnaire – 28.;Appetite assessment. Timepoint: At the Baseline and every month after entering the trial. Method of measurement: Question by the research team by phone.;Evaluating the stool condition of patients. Timepoint: At the Baseline and every month after entering the trial. Method of measurement: Question by the research team by phone.	—

Measure

Time frame

Lipid Profiles. Timepoint: At the Baseline and three months after entering the trial. Method of measurement: Blood test.;Body Mass Index. Timepoint: At the Baseline and three months after entering the Trial. Method of measurement: Scale and Tape Measure.;Systolic and Diastolic Blood Pressure. Timepoint: At the baseline and three months after entering the Trial. Method of measurement: Mercury Sphygmomanometer.;Measure psychological disorder. Timepoint: At the baseline and three months after entering the trial. Method of measurement: The General Health Questionnaire – 28.;Appetite assessment. Timepoint: At the Baseline and every month after entering the trial. Method of measurement: Question by the research team by phone.;Evaluating the stool condition of patients. Timepoint: At the Baseline and every month after entering the trial. Method of measurement: Question by the research team by phone.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactTaha Ghasemi

Mazandaran University of Medical Sciences

mr.taha.ghasemi@gmail.com+98 913 148 3265

Outcome results

None listed

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