Effect of Arginine-rich Dietary Protein on Postprandial Metabolism, Inflammation and Endothelial Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Postprandial metabolic, inflammatory and endothelial response
研究概览
简要总结
The main objective is to investigate the postprandial effect of arginine-rich protein (i.e. pea-protein) on metabolic control, inflammation and endothelial function after a high-fat meal in subjects with characteristics of the metabolic syndrome.
详细描述
Arginine is potential interesting considering the metabolic syndrome. Studies so far indicated both long-term effects, as well as acute - postprandial - actions; especially when metabolism is already challenged, e.g. in diabetic patients or after a high-fat meal. If arginine-rich proteins are equally effective is not known. Therefore we are interested in the effect of (arginine rich) protein on postprandial (dys)metabolism, inflammation and endothelial function, within 6 hours after a meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •male gender
- •central obesity: waist circumference ≥94 cm
- •plus any one of the following four factors:
- •raised triglyceride level: ≥1.7 mmol/L;
- •reduced high-density lipoprotein (HDL) cholesterol: <1.03 mmol/L
- •raised blood pressure: systolic blood pressure ≥130 mmHg or diastolic BP ≥85 mmHg or use of blood pressure lowering medication
- •raised fasting plasma glucose ≥ 5.6 mmol/L
- •Additional inclusion criteria:
- •age 45-70 years
- •body weight should be stable for 3 months
- •stable exercise habits during the last 6 months, and not participating in any vigorous exercise program
排除标准
- •tobacco smoking
- •(undiagnosed) diabetes - but not impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) as evaluated by an oral glucose tolerance test at screening
- •active hearth disease, i.e. history of myocardial infarction or angina pectoris
- •following, or have recently followed a (weight-loss) diet
- •drug uses knowing to interfere with the objectives of the study
- •oral corticosteroids, lipid-lowering drugs (statins)
- •allergic to cow milk / dairy products or gluten
- •vegetarians
- •received inoculations within 2 months of starting or planned to during the study
- •donated or intended to donate blood 2 months before till two months after the study
- •abuse of drugs and/or alcohol
- •participation in another biomedical study within 1 month before the first screening visit
- •not agreeable to be informed about possible distorted blood values which could be found by screening
结局指标
主要结局
Postprandial metabolic, inflammatory and endothelial response
时间窗: up to 6 hours
Metabolic: Plasma glucose, insulin and triglyceride levels (T= 0,1,2,3,4,5 and 6 hrs) Inflammatory: C-reactive protein (CRP), Plasminogen activator inhibitor-1 (PAI-1), Tumor necrosis factor-alpha (TNF-a), Interleukin-6 (IL-6), Inter-Cellular Adhesion Molecule-1 (ICAM-1) and Monocyte chemotactic protein-1 (MCP-1) (T=0, 2, 4 and 6 hrs). Endothelial function: Macro vascular regional arterial stiffness by Pulse Wave Analysis (PWA) (T=0, 3 and 6 hrs).
次要结局
- Satiety markers and Oxidative stress(up to 6 hours)