The Effect of Synbiotics Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Lean and Normal Weight Patients With Nonalcoholic Fatty Liver

Phase 2

• Conditions: Non Alcoholic Steatohepatitis
• Interventions: Dietary Supplement: synbiotic; Dietary Supplement: Placebo

• Registration Number: NCT02530138
• Lead Sponsor: National Nutrition and Food Technology Institute

Brief Summary

Introduction: Currently, Nonalcoholic Fatty Liver Disease (NAFLD) is the most common liver disease in the world. The only approved treatment for it is lifestyle modification and weight loss; however, there is no evidence for patients with normal or low body mass index (BMI).

The aim of this study is to evaluate the efficacy of symbiotic supplementation in NAFLD patients with normal or low BMI.

Methods and analysis: In this randomized, double-blind, placebo-controlled clinical trial protocol, 21 cases and 21 controls will be individually matched based on age and sex. This 42 patients with NAFLD will be supplemented twice daily for 28 wk with either a synbiotic or a placebo capsule. Both groups will be advised to follow an energy balanced diet and physical activity recommendations.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Status Verified: 2015-08
• Study First Submitted: 2015-08-18
• Study First Submitted QC: 2015-08-19
• Last Update Submitted: 2015-08-19
• Study First Posted: 2015-08-20
• Last Update Posted: 2015-08-20
• Primary Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Age of 18 to 70 years
• Body Mass Index (BMI) below 25
• Serum alaninaminotransferase more than 1.5 fold of upper limit of normal range
• Sonographic findings compatible with hepatic steatosis (degree 2 or more)

Exclusion Criteria

• Diabetes
• Taking any kind of antibiotics two weeks before recruitment
• History of alcohol consumption
• pregnancy or lactation
• Professional athletes
• Other liver disease (viral/etc)
• Use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin E
• A history of Hypertension, Cardiovascular disease, Pulmonary disease, Renal disease & Celiac disease; Cirrhosis
• History of Upper GI surgery / Prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty
• Following program to lose weight in recent 3 mo
• A history of hypothyroidism or Cushing's syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Synbiotic	synbiotic	2 synbiotic capsules for 28 weeks
maltodexterin	Placebo	two capsules per day for 28 weeks

Primary Outcome Measures

Name	Time	Method
Alaninaminotransferase (ALT) (UL)	28 weeks	by biochemical method
hepatic steatosis (cap score)	28 weeks	using transient elastography

Secondary Outcome Measures

Name	Time	Method
Body Mass Index (BMI) (kg/m2)	28 weeks	using formula

Trial Locations

Locations (1)

NNFTRI clinic; 🇮🇷 Tehran, Iran, Islamic Republic of