Acute Dose Response Effects of Korean White Ginseng (Panax Ginseng C.A. Meyer) on Cardiovascular Disease Risk Factors in Individuals With Metabolic Syndrome or Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Effect of KWG on vascular and glycemic measures
研究概览
简要总结
The study is a Phase-I like double blind randomized placebo controlled crossover design trial. The objective is to assess the dose response relationship on glycemic and vascular effects of an acutely administered Korean White Ginseng (KWG)(Panax C.A. Meyer) in individuals with metabolic syndrome or type 2 diabetes . Twenty seven subjects with Type 2 Diabetes (Key inclusion criteria: HbA1c ≤8.5%)or metabolic syndrome (Key inclusion criteria: as defined by The US National Cholesterol Education Program Adult Treatment Panel III)will be recruited for the study.
详细描述
This study hypothesizes that KWG will dose dependently lower postprandial area under the curve compared to negative control, as well as will dose dependently decrease postprandial glycemia. It also assumes that use of KWG will dose dependently decrease aortic and brachial blood pressure, aortic augmentation index, and mean arterial pressure, and improve left ventricular ejection duration(ED) and subendocardial viability ratio (SEVR) compared to control. Finally, it expects to notice an effect on subjective satiety levels and have no significant adverse effects compared to control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women
- •18-75 years old
- •BMI 25-35 kg/m2
- •Presence of type 2 diabetes (as defined by HbA1c ≤8.5%),treatment with diet or oral hypoglycemic medication) OR
- •Presence of Metabolic Syndrome as defined by The US National Cholesterol -Education Program Adult Treatment Panel III (NCEP III). As per NCEP III criteria, at least three of the following must be present:
- •central obesity: waist circumference ≥ 102 cm or 40 inches (male), ≥ 88 cm or 36 inches(female)
- •dyslipidemia: TG ≥ 1.7 mmol/L (150 mg/dl);
- •dyslipidemia: HDL-C < 40 mg/dL (male), < 50 mg/dL (female) blood pressure ≥ 130/85 mmHg; fasting plasma glucose ≥ 6.1 mmol/L (110 mg/dl)
排除标准
- •BMI >35 kg/m2
- •Hypertensive (brachial systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg)
- •Pregnant women, or those at risk of pregnancy, or breastfeeding at the time of the study.
- •Women of childbearing age that do not use acceptable method of birth control (ie. abstinence, implants, injectables, oral contraceptives, IUDs etc).
- •Chronic conditions including: liver disease, cancer, heavy alcohol use, bleeding disorders, history of angina, congestive heart failure, coronary revascularization, peripheral vascular disease, retinopathy, kidney disease or coronary/cerebrovascular event; chronic use of medications including blood-thinners, SSRIs, MAO inhibitors, medications affecting NO synthesis (eg. Viagra)
- •Allergy or sensitivity to the placebo (wheat bran), ginseng or gelatin used in the capsules.
- •Use of any ginseng products within three days preceding the study and during the study.
- •Allergies to Panax species, their constituents or to other members of the Araliaceae family.
- •The use of additional NHPs that may affect blood pressure or blood glucose Individuals suffering from glucose-galactose malabsorption syndrome.
结局指标
主要结局
Effect of KWG on vascular and glycemic measures
时间窗: 3 hours
To evaluate the acute dose response effect of KWG on blood glucose Area under the Curve (AUC) compared to controls in individuals with Metabolic syndrome or Type 2 Diabetes To evaluate the acute effect of KWG treatments on arterial stiffness as measured by aortic augmentation index (AIx)
次要结局
- Effect of KWG on vascular and glycemic measures(4 hours)