Evaluation of the Effects of a Low Free Sugar Diet on Lipid Profile, Glycemic Indices, Liver Enzymes, Inflammatory Factors and Hepatic Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- ALT
研究概览
简要总结
To study the effects of a low free sugar diet on lipid profile, glycemic indices, liver enzymes, inflammatory factors and hepatic steatosis and fibrosis in patients with Nonalcoholic fatty liver disease, 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be randomly allocated to receive low free sugar diet or regular diet for 12 weeks; both groups will be advised to adherence the investigators' nutrition recommendation and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes,glycemic indices, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 to 60 years
- •Body Mass Index (BMI) between 25-40
- •Sonographic findings compatible with hepatic steatosis (degree 2 or more)
排除标准
- •Alcohol consumption
- •pregnancy or lactation
- •Other liver disease (viral,cirrhosis,...)
- •Use of drugs such as phenytoin,tamoxifen,lithium
- •A history of Cancer, autoimmune disease,Renal disease & Celiac disease, hypothyroidism or Cushing's syndrome
- •Lack of desire to continue studying
- •Have to use antibiotics with hepatotoxic drugs while studying
- •Non-compliance with diet
结局指标
主要结局
ALT
时间窗: 12 weeks
serum level of Alanine transaminase
LDL-c
时间窗: 12 weeks
serum level of LDL-Cholesterol
GGT
时间窗: 12 weeks
serum level of Gamma glutaminase
TG
时间窗: 12 weeks
serum level of Triglyceride
hs-CRP
时间窗: 12 weeks
Serum level of high-sensitive C-reactive protein
AST
时间窗: 12 weeks
serum level of Aspartate transaminase
HDL-c
时间窗: 12 weeks
serum level of HDL-Cholesterol
Insulin
时间窗: 12 weeks
serum level of Insulin
TNF-a
时间窗: 12 weeks
Serum level of Tumor necrosis factor-a
Liver fibrosis
时间窗: 12 weeks
Liver fibrosis according to fibroscan exam
Total cholesterol
时间窗: 12 weeks
serum level of total cholesterol
FBS
时间窗: 12 weeks
serum level of Fasting blood sugar
NF-kb
时间窗: 12 weeks
Activity of Nuclear factor-B in peripheral monocellular cells
次要结局
未报告次要终点
研究者
Dr Azita Hekmatdoost
principal investigator
National Nutrition and Food Technology Institute