NCT02940080已完成不适用
Effect of Anthocyanins Extracted From Purple Potatoes on Healthy Study Subjects' Postprandial Glycemia and Insulinemia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Plasma glucose concentration
研究概览
简要总结
A randomized, single-blind cross-over clinical nutrition trial will be conducted. The effects of yellow-fleshed potatoes and yellow-fleshed potatoes supplemented with anthocyanins extracted from purple-fleshed potatoes on healthy men's postprandial glycemia and insulinemia will be compared. Additionally, the postprandial metabolism and metabolites, and the appearance and metabolism of the flavonoids and their metabolites is studied in plasma, urine and feces.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18-45
- •No regular medication
- •No participation in a drug trial or blood donation within 2 months
- •Non-smoker
- •Signs informed consent
- •Body mass index 18.5-27 kg/m2
- •Fasting plasma cholesterol < 5.5 mmol/l
- •Fasting plasma triacylglycerols < 2.6 mmol/l
- •Fasting plasma glucose 4-6 mmol/l
- •blood pressure <140/80 mmHg
- •hemoglobin>130 g/l
- •Fasting plasma alanine amino transferase (ALAT) <60 U/l (normal liver function)
- •Fasting plasma thyroid-stimulating hormone (TSH) 0.4 - 4.5 mU/l (normal thyroid function)
- •Fasting plasma creatinine <118 µmol/l (normal kidney function)
排除标准
- •Regular smoking
- •Alcohol abuse
- •Regular medication
结局指标
主要结局
Plasma glucose concentration
时间窗: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
Plasma insulin concentration
时间窗: 0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min
次要结局
- Concentrations and quality of metabolites and flavonoid color compounds and their metabolites in plasma (NMR and (U)HPLC-MS/MS measurements)(0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min)
- Concentrations and quality of metabolites and flavonoid color compounds and their metabolites in urine (NMR and (U)HPLC-MS/MS measurements)(Before meal, and 0-4h, 4-8h, 8-16h, 16-24 h)
- Concentrations and quality of metabolites and flavonoid color compounds and their metabolites in feces (NMR and (U)HPLC-MS/MS measurements)(before and after meal)
- Area under the glucose concentration curve (AUC)(0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min)
- Area under the insulin concentration curve (AUC)(0min, 20min, 40min, 60min, 90min, 120min, 180min, 240min)
研究者
Kaisa Linderborg
Principal Investigator
University of Turku
研究点 (2)
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