The effects of probiotic and prebiotic supplementation on Non Alcoholic Fatty Liver Disease

Assessing the Effects of probiotic and prebiotic supplementation on serum hepatic enzymes, Insulin resistance, hs-CRP, Lipid profile, leptin and Adiponectin in patients with NAFLD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201410052394N13

Enrollment

105

Registered

2014-12-14

Start date

2014-12-06

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Non alcoholic fatty liver. Other diseases of liver

Interventions

Intervention 1: Intervention group 1: Patients in the group receiving the probiotic supplement, 1 capsule contains a combination of probiotics comprising of five bacterial species ( 5 billion active c

Treatment - Drugs

Placebo

Intervention group 1: Patients in the group receiving the probiotic supplement, 1 capsule contains a combination of probiotics comprising of five bacterial species ( 5 billion active cell, containing

In the placebo group,2 cups of 7.5 g oral powder maltodextrin as probiotic supplement placebo and one capsule containing starch as prebiotic supplement placebo recieve. Used placebo is similar to th

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Willing to participate and signed the consent; Elevated serum levels of liver enzymes( ALT greater than 1.5 times normal); More than one degree of steatosis on ultrasonography in patients; No alcohol abuse (consuming more than 10 grams for women and 20 grams for men) and opium abuse; Body Mass Index equal to or greater than 25 Kg/m2 and equal to or less than 40 Kg/m2; The absence of other acute and chronic diseases and disorders of the liver (hepatitis B, C, ...), cirrhosis, celiac disease, diabetes, hypertension, cardiovascular disease, kidney disease, lung disease; No pregnancy and lactation; Not taking metformin, vitamin E, orso de Oxy-colic acid and weight-loss drugs, hepatotoxic , antibiotics, corticosteroids, NSAIDs and other medications; no history of weight loss surgery in the past year; Failure to lose weight in 3 months; nonsmoking; aged 20-60 years; without the use of supplemental multivitamins, minerals and omega-3 (nutritional supplements); not using the contraceptive pill. Exclusion criteria: Taking antibiotics for over a week during the study period; Personal desire to withdraw from the study; Not consume more than 10% of the capsules at any follow up; Any changes in recommended diet and daily physical activity; being pregnant during the intervention.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
ALT. Timepoint: At baseline, after 12 weeks. Method of measurement: photometric assay.;AST. Timepoint: At baseline, after 12 weeks. Method of measurement: photometric assay.;?GT. Timepoint: At baseline, after 12 weeks. Method of measurement: Enzymatic colorimetric assay.;ALP. Timepoint: At baseline, after 12 weeks. Method of measurement: photometric assay.;Hs-CRP. Timepoint: At baseline, after 12 weeks. Method of measurement: ELISA.;Leptin. Timepoint: At baseline, after 12 weeks. Method of measurement: ELISA.;Adiponectin. Timepoint: At baseline, after 12 weeks. Method of measurement: ELISA.;Insulin. Timepoint: At baseline, after 12 weeks. Method of measurement: ELISA.;HOMA-IR. Timepoint: At baseline, after 12 weeks. Method of measurement: Serum insulin*FBS/405.;QUICKI. Timepoint: At baseline, after 12 weeks. Method of measurement: Calculation.;Fasting Glucose. Timepoint: At baseline, after 12 weeks. Method of measurement: GOD/POD.;TG. Timepoint: At baseline, after 12 weeks. Method of measurement: Enzymatic colorimetric assay.;Cholestrol. Timepoint: At baseline, after 12 weeks. Method of measurement: Enzymatic colorimetric assay.;LDL. Timepoint: At baseline, after 12 weeks. Method of measurement: Calculation.;Blood pressure. Timepoint: At baseline, after 12 weeks. Method of measurement: sphygmomanometer.	—

Measure

Time frame

ALT. Timepoint: At baseline, after 12 weeks. Method of measurement: photometric assay.;AST. Timepoint: At baseline, after 12 weeks. Method of measurement: photometric assay.;?GT. Timepoint: At baseline, after 12 weeks. Method of measurement: Enzymatic colorimetric assay.;ALP. Timepoint: At baseline, after 12 weeks. Method of measurement: photometric assay.;Hs-CRP. Timepoint: At baseline, after 12 weeks. Method of measurement: ELISA.;Leptin. Timepoint: At baseline, after 12 weeks. Method of measurement: ELISA.;Adiponectin. Timepoint: At baseline, after 12 weeks. Method of measurement: ELISA.;Insulin. Timepoint: At baseline, after 12 weeks. Method of measurement: ELISA.;HOMA-IR. Timepoint: At baseline, after 12 weeks. Method of measurement: Serum insulin*FBS/405.;QUICKI. Timepoint: At baseline, after 12 weeks. Method of measurement: Calculation.;Fasting Glucose. Timepoint: At baseline, after 12 weeks. Method of measurement: GOD/POD.;TG. Timepoint: At baseline, after 12 weeks. Method of measurement: Enzymatic colorimetric assay.;Cholestrol. Timepoint: At baseline, after 12 weeks. Method of measurement: Enzymatic colorimetric assay.;LDL. Timepoint: At baseline, after 12 weeks. Method of measurement: Calculation.;Blood pressure. Timepoint: At baseline, after 12 weeks. Method of measurement: sphygmomanometer.

—

Secondary

Measure	Time frame
Body mass index. Timepoint: At baseline, after 12 weeks. Method of measurement: calculation.;WHR. Timepoint: At baseline, after 12 weeks. Method of measurement: calculation.;Percentage body fat. Timepoint: At baseline, after 12 weeks. Method of measurement: BIA.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactVahideh Behrouz

Department of Nutrition, School of public Health, Iran University of Medical Sciences.

vahideh.behrouz@gmail.com+98 21 8862 2806

Outcome results

None listed

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