Effect of Crocus Sativus (Saffron) and Berberis Vulgaris (Barberry Fruit) on Metabolic Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 732
- 试验地点
- 1
- 主要终点
- Serum LDL cholesterol
研究概览
简要总结
The metabolic syndrome is associated with increased risk of cardiovascular disease and diabetes mellitus. The age-adjusted prevalence of the metabolic syndrome in the United States is 34% for men and 35% for women. Emerging alternative medicine worldwide led investigators to evaluate the efficacy of Crocus sativus (Saffron) and Berberis Vulgaris (barberry fruit) in treatment of metabolic syndrome. Serum total cholesterol, serum LDL cholesterol, serum HDL cholesterol, serum triglyceride, Fasting Blood Sugar and hematocrit measured before and after 45 days of treatment.
详细描述
In a randomized, placebo controlled, single-blind , efficacy trial with three treatment arms the investigators randomly assigned 105 patients with metabolic syndrome to receive barberry juice, saffron juice or placebo tablet.
The aim was to evaluate the efficacy of Crocus sativus (Saffron) and Berberis Vulgaris (barberry fruit) in treatment of metabolic syndrome. The metabolic syndrome (syndrome X, insulin resistance syndrome) consists of a constellation of metabolic abnormalities that confer increased risk of cardiovascular disease (CVD) and diabetes mellitus (DM). The major features of the metabolic syndrome include central obesity hypertriglyceridemia, low HDL cholesterol, hyperglycemia, and hypertension. Based on data from the National Health and Nutrition Examination Survey (NHANES) III, the age-adjusted prevalence of the metabolic syndrome in the United States is 34% for men and 35% for Women. Review of literature revealed anti-inflammatory, radical-scavenging, antioxidant, cytoprotective, beneficial cardiovascular and neural system effects for saffron, potential use for treatment of hypertension, tachycardia and some neuronal disorders, such as epilepsy and convulsion, antihypertensive and vasodilatory activities. Barberry has promising and selective anti-cancer activities, beneficial effects in atherosclerosis, arthritis, coronary heart disease and hepatitis, hypotensive property and to promote immunity, prevention of insulin resistance and related diseases, neuroprotective, hypolipidemic and antioxidant properties for saffron in animal models.
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
- 否
入选标准
- •waist circumference of ≥ 94 cm (males) or ≥ 80 cm (females) plus any two of the following:
- •blood pressure ≥ 130/85 or taking antihypertensive medication,
- •fasting plasma glucose (FPG) > 100 mg/dL,
- •serum triglycerides (TG) > 150 mg/dL,
- •high-density lipoprotein (HDL) < 40 mg/dL in men,and < 50 mg/dL in women-
排除标准
- •using insulin or glucose sensitizing medication
- •preexisting cardiovascular disease
- •psychiatric problems
- •non-compliance of patients
- •not presenting at times determined for treatment and evaluation
研究组 & 干预措施
Saffron
Saffron treatment group received saffron tablets daily for 45 days
干预措施: Saffron tablet (Drug)
Barberry
Barberry group received barberry tablets daily for 45 days
干预措施: Barberry tablet (Drug)
Placebo
Placebo group received placebo tablets daily for 45 days
干预措施: Placebo (Drug)
结局指标
主要结局
Serum LDL cholesterol
时间窗: after 45 days of treatment
Serum LDL cholesterol after 45 days of treatment in three study groups
次要结局
- Serum total cholesterol(after 45 days of treatment)
- serum HDL cholesterol(after 45 days of treatment)
- serum triglyceride(after 45 days of treatment)
- Fasting Blood Sugar(after 45 days of treatment)
- Hematocrit(after 45 days of treatment)
