Prospective Histopathologic Evaluation of Diet and Exercise in Patients With Non-Alcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis)
研究概览
简要总结
Moderate exercise with a low fat and/or a moderate fat with low processed carbohydrate diet will have a greater effect on slowing disease progression and reversing hepatic steatosis and/or necro-inflammation in the liver of adult patients with NAFLD and NASH when compared to a regular healthy diet alone.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 yrs
- •DEERS eligible (DoD beneficiary)
- •All participants must plan to be in the area for at least nine months
- •Liver biopsy confirmed NAFLD/NASH (NAS Score evaluating steatosis, lobular inflammation and hepatocyte ballooning) within the past 6 months
排除标准
- •Alcohol consumption > 20 g/d or history of alcohol abuse
- •Hepatitis A, B, C
- •Chronic liver disease of any other etiology
- •Fatty acid oxidation disorder (Inborn errors of metabolism)
- •Insulin therapy regime for treatment of diabetes
- •Pregnancy
研究组 & 干预措施
A (Std of Care)
Standard of Care/Control, including Lifestyle Advice (attend a basic healthy nutrition class as well as follow up appointments with GI MD).
干预措施: Mod Fat/Low Processed Carb Diet and Moderate Exercise (Behavioral)
B (Low Fat)
Standard of Care, plus Low Fat Diet and Moderate Exercise
干预措施: Mod Fat/Low Processed Carb Diet and Moderate Exercise (Behavioral)
B (Low Fat)
Standard of Care, plus Low Fat Diet and Moderate Exercise
干预措施: Low Fat Diet and Moderate Exercise (Behavioral)
C (Mod Fat)
Standard of Care, plus Moderate Fat/Low Processed Carbohydrate Diet and Moderate Exercise
干预措施: Mod Fat/Low Processed Carb Diet and Moderate Exercise (Behavioral)
D (Exercise only)
Standard of Care plus Moderate Exercise only
干预措施: Mod Fat/Low Processed Carb Diet and Moderate Exercise (Behavioral)
D (Exercise only)
Standard of Care plus Moderate Exercise only
干预措施: Moderate Exercise Only (Behavioral)
结局指标
主要结局
NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis)
时间窗: 6 months
次要结局
- Insulin resistance (IR)(6 months)
研究者
Renee E. Cole
Director, US Military Dietetic Internship Consortium
San Antonio Military Medical Center