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The effect of synbiotic supplementation in the treatment of fatty liver

Investigating the effect of multi-strain synbiotic supplementation on insulin resistance, liver enzymes, inflammatory, and anthropometric indices in diabetic, obese, and overweight patients with non-alcoholic fatty liver disease

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240212060977N1
Enrollment
40
Registered
2024-02-20
Start date
2024-04-13
Completion date
Unknown
Last updated
2024-03-06

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

Conditions

Condition 1: Fatty Liver. Condition 2: Type 2 diabetes mellitus. Fatty (change of) liver, not elsewhere classified Type 2 diabetes mellitus

Interventions

Intervention 1: Intervention group: The intervention in this group includes receiving a synbiotic supplement (produced by Zist Takhmir Company) containing one billion CFU in each capsule of strains of

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Having fatty liver (grade 2 or 3) Having diabetes or prediabetes (fasting blood sugar above 100) Being overweight or obese (BMI greater than 25) Aged 18 or higher from both male and female genders Not taking insulin Not being pregnant or breastfeeding Not suffering from certain diseases, including metabolic, respiratory, and kidney diseases Not taking antibiotics or probiotic or synbiotic supplements in the 3 months before the study

Exclusion criteria

Exclusion criteria: Suffering from certain diseases during study, including respiratory and kidney diseases Taking multivitamins while studying Consumption of less than 80% of prescribed supplements Consumption of other probiotics during the study The need to take antibiotics Getting pregnant Requiring need for insulin

Design outcomes

Primary

MeasureTime frame
Aspartate Aminotransferase. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Standard enzymatic method.

Secondary

MeasureTime frame
Alanine aminotransferase. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Standard enzymatic method.;Fasting blood sugar. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Standard enzymatic method.;Triglyceride. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Standard enzymatic method.;Total cholestrol. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Standard enzymatic method.;Total antioxidant capacity. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Standard enzymatic method.;Low-density lipoprotein. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Standard enzymatic method.;High-density lipoprotein. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Standard enzymatic method.;C-reactive protein. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: ELISA method.;Alkaline Phosphates. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Standard enzymatic method.;Glycated hemoglobin. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Standard enzymatic method.;Fasting insulin. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: ELISA method.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAryan Mohammad Yazdani

Shiraz University of Medical Sciences

Yazdani.2000.a@gmail.com+98 71 3725 1001

Outcome results

None listed

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