Medium-term Effects of a Portfolio Diet on Non-alcoholic Fatty Liver Disease in Type 2 Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Liver fat content
研究概览
简要总结
Patients with type 2 diabetes and non-alcoholic fatty liver disease will be enrolled.
According to a parallel design, the participants will be randomized to a Portfolio diet or a monounsaturated fatty acid (MUFA)-rich diet (used as control) for 8 weeks.
At the beginning and at the end of the trial, the participants will undergo a MRI spectroscopy to evaluate fatty liver content. Moreover, the participants will undergo a test meal resembling the nutritional composition of the assigned diet to evaluate fasting and postprandial metabolic response.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes
- •non-alcoholic fatty liver disease (evaluated by US)
- •HbA1c <7.5%
- •LDL cholesterol <130 mg/dl
排除标准
- •hypoglycemic therapy with sodium-glucose cotransporter (SGLT-2), pioglitazone and glucagon-like peptide (GLP-1) analogues
- •severe liver and kidney failure
- •recent cardiovascular events (prior 6 months)
- •any other acute/chronic disease (anemia, cancer, BPCO)
研究组 & 干预措施
Portfolio Diet
The participants will follow a weight-maintaining diet characterized by whole-grain, polyphenol-rich foods, omega 3- rich foods, MUFA-rich foods (protein 18%/total energy, carbohydrates 41%/total energy, fat 41%/total energy, MUFA 26%/total energy, fiber 24 g/1000Kcal) polyphenols 2715/day, omega-3 2.6 g/day and omega-6 9.6 g/day)
干预措施: Portfolio Diet (Other)
MUFA Diet
The participants will follow a weight-maintaining diet characterized by MUFA-rich food (olive oil) (protein 18%/total energy, carbohydrates 41%/total energy, fat 41%/total energy, MUFA 28%/total energy, fiber 10 g/1000Kcal) polyphenols 376/day, omega-3 1.1 g/day and omega-6 7.4 g/day)
干预措施: MUFA Diet (Other)
结局指标
主要结局
Liver fat content
时间窗: Change from Baseline after 8 weeks
MRI spectroscopy
次要结局
- Biochemical parameters(Change from Baseline after 8 weeks)
- subclinical inflammation(Change from Baseline after 8 weeks)
- Blood pressure(Change from Baseline after 8 weeks)
- Liver functionality(Change from Baseline after 8 weeks)
- Liver fibrosis(Change from Baseline after 8 weeks)
- Body composition(Change from Baseline after 8 weeks)
- Endothelial function(Change from Baseline after 8 weeks)
- oxidative stress(Change from Baseline after 8 weeks)
- lipids(Change from Baseline after 8 weeks)
研究者
rivellese angela
Full Professor
Federico II University