Ernährungs-Interventions-Fettleber-Studie (Interventional Study on Nutritional Effects on NAFLD)
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- change in liver fat content
研究概览
简要总结
Epidemiological data and studies in animal models suggest, that polyunsatured fatty acids (PUFA) rather than mono-unsatured fatty acids (MUFA) are associated with lower hepatic lipid content (HCL) and may facilitate a decrease of HCL in case of non-alcoholic fatty liver disease (NAFLD).
The investigators therefore conduct an interventional trial in subjects with normal glucose metabolism, but increased HCL, fulfilling criteria for NAFLD.
The study will compare two dietary interventions in parallel design, one containing mainly PUFA (canola oil), one containing only MUFA (olive oil). The intervention of 8 weeks is accomodated by dietary counseling. Metabolic outcome variables will be assessed with MR spectroscopy (liver fat) and euglycemic hepatic clamp (glucose metabolism/insulin sensitivity).
详细描述
Epidemiological data and studies in animal models suggest, that polyunsatured fatty acids (PUFA) rather than mono-unsatured fatty acids (MUFA) are associated with lower hepatic lipid content (HCL) and may facilitate a decrease of HCL in case of non-alcoholic fatty liver disease (NAFLD). A typical source for PUFAs are fish and certain plant oils, a source of almost pure MUFAs is olive oil.
The investigators therefore conduct an interventional trial in subjects with normal glucose metabolism, but increased HCL, fulfilling criteria for NAFLD. The investigation focusses on male participants to avoid sex-related differences in the results.
The study will compare two isocaloric dietary interventions in parallel design, one containing mainly PUFA (canola oil), one containing only MUFA (olive oil). The intervention of 8 weeks is accomodated by dietary counseling (4 sessions). Metabolic outcome variables will be assessed with MR spectroscopy (liver fat), anthropometry (to check for stable weight and body composition) and euglycemic hepatic clamp (glucose metabolism/insulin sensitivity).
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •increased hepatic fat content (NAFLD)
- •BMI between 30 and 35 kg/m²
排除标准
- •severe cardiac, pulmonary or gastrointestinal disorders
- •hepatic disorders other than NAFLD
- •alcoholism
- •medication with metabolic side or main effects (e.g. statins)
研究组 & 干预措施
MUFA
daily intake of 50 g of olive oil over a period of 8 weeks
干预措施: Dietary intervention / counseling (Dietary Supplement)
PUFA
daily intake of 50 g of canola oil (rapeseed oil) over a period of 8 weeks
干预措施: Dietary intervention / counseling (Dietary Supplement)
结局指标
主要结局
change in liver fat content
时间窗: 4 and 8 weeks
change in liver fat content (MR spectroscopy and ultrasound)
change in hepatic insulin sensitivity
时间窗: 8 weeks only
change in hepatic insulin sensitivity (euglycemic hepatic clamp)
次要结局
未报告次要终点
研究者
Prof. Dr. med. Andreas F. H. Pfeiffer
Head of Department of Clinical Nutrition
German Institute of Human Nutrition