Dietary Intervention Replacing Carbohydrate With Protein and Fat Has Greater Effect on Peripheral Blood Mononuclear Cell Metabolites Than on Plasma Metabolites in Patients With Prediabetes or Type-2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Lp-PLA2 Activity in Plasma
研究概览
简要总结
This study examined whether dietary-induced reductions in lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in peripheral blood mononuclear cells (PBMC) and plasma affected metabolic profiles in PBMCs and plasma.
详细描述
Eighty nonobese patients (aged 40-70 years) with prediabetes or newly diagnosed type-2 diabetes were randomly assigned to a control group (normal diet with refined rice) or a whole-grain group (replacement of refined rice with whole-grains and legumes). This dietary intervention replaced approximately 7% of carbohydrate-derived energy with approximately 4% of protein-derived energy and approximately 3% of fat-derived energy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects who had IFG (100≤ fasting glucose <126 mg/dL)
- •or newly diagnosed type-2 diabetes (fasting glucose ≥126 mg/dL)
排除标准
- •current and/or past history of cardiovascular disease including angina
- •liver or kidney dysfunction
- •thyroid or pituitary disease
- •pregnancy or lactation
- •taking medications or supplements
结局指标
主要结局
Lp-PLA2 Activity in Plasma
时间窗: Change from baseline in Lp-PLA2 at 12 weeks
Lp-PLA2 Activity in PBMC
时间窗: Change from baseline in Lp-PLA2 at 12 weeks
次要结局
- PBMC metabolites(Change in L-leucine, oleamide, lysoPC (16:0), and lysoPC (18:0))