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
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||February 2016|
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
- Alaninaminotransferase (ALT) (UL) [ Time Frame: 28 weeks ]by biochemical method
- hepatic steatosis (cap score) [ Time Frame: 28 weeks ]using transient elastography
- Body Mass Index (BMI) (kg/m2) [ Time Frame: 28 weeks ]using formula
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
|Contact: Azita Hakmatdost, MD, PhDemail@example.com|
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of, 19435|
|Contact: Azita Hekmatdoost, MD, PhD 9123065084 firstname.lastname@example.org|