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
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Alaninaminotransferase (ALT) (UL)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Alaninaminotransferase (ALT) (UL)
时间窗: 28 weeks
by biochemical method
hepatic steatosis (cap score)
时间窗: 28 weeks
using transient elastography
次要结局
- Body Mass Index (BMI) (kg/m2)(28 weeks)
研究者
Dr Azita Hekmatdoost
associate prof
National Nutrition and Food Technology Institute