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

Non Alcoholic Steatohepatitis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02530138
• Other study ID #: 563
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: August 18, 2015
• Last updated: August 19, 2015
• Start date: August 2014

Study information

• Verified date: August 2015
• Source: National Nutrition and Food Technology Institute
• Contact: Azita Hakmatdost, MD, PhD
• Phone: 9123065084
• Email: a_hekmat2000[@]yahoo.com
• Is FDA regulated: No
• Health authority: IRAN: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Non Alcoholic Steatohepatitis

Intervention

Dietary Supplement:
• synbiotic
2 symbiotics capsules per day for 28 weeks
• Placebo
2 placebo capsules per day for 28 weeks

Locations

Country	Name	City	State
Iran, Islamic Republic of	NNFTRI clinic	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alaninaminotransferase (ALT) (UL)	by biochemical method	28 weeks	No
Primary	hepatic steatosis (cap score)	using transient elastography	28 weeks	No
Secondary	Body Mass Index (BMI) (kg/m2)	using formula	28 weeks	No