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

August 19, 2015 updated by: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Synbiotic
2 synbiotic capsules for 28 weeks
Dietary supplement: synbiotic
2 symbiotics capsules per day for 28 weeks
Placebo Comparator: maltodexterin
two capsules per day for 28 weeks
Dietary supplement: Placebo
2 placebo capsules per day for 28 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alaninaminotransferase (ALT) (UL)
Time Frame: 28 weeks
by biochemical method
28 weeks
hepatic steatosis (cap score)
Time Frame: 28 weeks
using transient elastography
28 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index (BMI) (kg/m2)
Time Frame: 28 weeks
using formula
28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Nutrition and Food Technology Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

August 18, 2015

First Submitted That Met QC Criteria

August 19, 2015

First Posted (Estimate)

August 20, 2015

Study Record Updates

Last Update Posted (Estimate)

August 20, 2015

Last Update Submitted That Met QC Criteria

August 19, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 563

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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