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
NCT ID: NCT02530138
Last Updated: 2015-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
42 participants
INTERVENTIONAL
2014-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Synbiotic
2 synbiotic capsules for 28 weeks
synbiotic
2 symbiotics capsules per day for 28 weeks
maltodexterin
two capsules per day for 28 weeks
Placebo
2 placebo capsules per day for 28 weeks
Interventions
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synbiotic
2 symbiotics capsules per day for 28 weeks
Placebo
2 placebo capsules per day for 28 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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National Nutrition and Food Technology Institute
OTHER
Responsible Party
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Dr Azita Hekmatdoost
associate prof
Locations
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NNFTRI clinic
Tehran, Tehran Province, Iran
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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563
Identifier Type: -
Identifier Source: org_study_id
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