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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

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ClinicalTrials.gov Identifier: NCT02530138
Recruitment Status : Unknown
Verified August 2015 by Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute.
Recruitment status was:  Recruiting
First Posted : August 20, 2015
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, 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.


Condition or disease Intervention/treatment Phase
Non Alcoholic Steatohepatitis Dietary Supplement: synbiotic Dietary Supplement: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2014
Estimated Primary Completion Date : February 2016


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




Primary Outcome Measures :
  1. Alaninaminotransferase (ALT) (UL) [ Time Frame: 28 weeks ]
    by biochemical method

  2. hepatic steatosis (cap score) [ Time Frame: 28 weeks ]
    using transient elastography


Secondary Outcome Measures :
  1. Body Mass Index (BMI) (kg/m2) [ Time Frame: 28 weeks ]
    using formula



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530138


Contacts
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Contact: Azita Hakmatdost, MD, PhD 9123065084 a_hekmat2000@yahoo.com

Locations
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Iran, Islamic Republic of
NNFTRI clinic Recruiting
Tehran, Iran, Islamic Republic of, 19435
Contact: Azita Hekmatdoost, MD, PhD    9123065084    a_hekmat2000@yahoo.com   
Sponsors and Collaborators
National Nutrition and Food Technology Institute

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Responsible Party: Dr Azita Hekmatdoost, associate prof, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT02530138     History of Changes
Other Study ID Numbers: 563
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases