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

Sponsor

National Nutrition and Food Technology Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT02530138

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Alcoholic Steatohepatitis	Dietary Supplement: synbiotic Dietary Supplement: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Aug 1, 2014

Anticipated Primary Completion Date :

Feb 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Alaninaminotransferase (ALT) (UL) [28 weeks]
by biochemical method
hepatic steatosis (cap score) [28 weeks]
using transient elastography

Secondary Outcome Measures

Body Mass Index (BMI) (kg/m2) [28 weeks]
using formula

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NNFTRI clinic	Tehran		Iran, Islamic Republic of	19435

Sponsors and Collaborators

National Nutrition and Food Technology Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Azita Hekmatdoost, associate prof, National Nutrition and Food Technology Institute

ClinicalTrials.gov Identifier:

NCT02530138

Other Study ID Numbers:

First Posted:

Aug 20, 2015

Last Update Posted:

Aug 20, 2015

Last Verified:

Aug 1, 2015

Additional relevant MeSH terms:

Fatty Liver

Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Aug 20, 2015