The Metabolic Effects of Cynara Supplementation in Overweight and Obese Class I Subjects With Newly Detected Impaired Fasting Glycaemia: a Double-blind, Placebo-controlled, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Changes on glycemia
研究概览
简要总结
Impaired fasting glucose (IFG) is a condition that precedes diabetes and increases the risk of developing it. Studies support the hypoglycemic effect of Cynara cardunculus (Cs) extracts due to the content of chlorogenic acid, which is a potent inhibitor of glucose 6-phosphate translocase and of dicaffeoylquinic acid derivatives that modulate the activity of alpha-glucosidase. Given this background, we investigated whether a new highly standardized Cs extract could improve glycaemic control, insulin sensitivity and other metabolic parameters (total, HDL and LDL cholesterol, Triglycerides, ApoB, ApoA, waist circumference, Visceral adipose tissue by DXA) in overweight subjects with newly diagnosed IFG.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •without history of cardiovascular disease (CVD),
- •not taking any medication likely to affect glucose or lipid metabolism (oral hypoglycemic agents and statins)
- •free of overt liver, renal and thyroid disease
排除标准
- •drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)
研究组 & 干预措施
Intervention Group
干预措施: 500 mg of artichoke extract (Dietary Supplement)
Control Group
干预措施: Placebo (Other)
结局指标
主要结局
Changes on glycemia
时间窗: Day 0, after 1 month and after 2 months
次要结局
- Changes on VAT (g), lean and fat mass (g)(Day 0, after 1 month)
- Changes on glycated hemoglobin (%)(Day 0, after 1 month and after 2 months)
- Changes on insulin (mcU/ml) and HOMA index(Day 0, after 1 month and after 2 months)
- Changes on total cholesterol (mg/dl), HDL (mg/dl), total cholesterol/HLD, LDL (mg/dl), LDL/HDL, triglycerides (mg/dl), ApoA (mg/dl), ApoB (mg/dl), ApoB/ApoA, creatinine (mg/dl)(Day 0, after 1 month and after 2 months)
- Changes on AST (UI/l), ALT (UI/l), GGT (U/l)(Day 0, after 1 month and after 2 months)
- Changes on A1c-Derived Average Glucose (mmol/l)(Day 0, after 1 month and after 2 months)
- Changes on maximum blood pressure (mmHg), minimum blood pressure (mmHg)(Day 0, after 1 month)
- Changes on waist circumference (cm)(Day 0, after 1 month)