Effect of Amla Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Diastolic Blood Pressure (DBP)
研究概览
简要总结
Amla has demonstrated promising effects in the treatment of obesity, dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings show that Amla has an excellent potential for the prevention and treatment of metabolic syndrome.
详细描述
A randomized, double-blind, placebo-controlled clinical trial will be conducted in 28 patients, 30-59 years old, with diagnosis of Metabolic Syndrome according with modified International Diabetes Federation criteria. Patients will be randomly assigned to receive Amla (500mg) or homologated placebo orally twice daily, for 90 days. Before and after the intervention, the components of Metabolic Syndrome will be evaluated, waist circumference, blood pressure, levels of fasting glucose, triglycerides, cholesterol high density lipoprotein (C-HDL), total insulin secretion (Insulinogenic index), first phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Pregnancy or breast-feeding
- •Known allergy to Amla or placebo
- •History of hepatic, kidney or thyroid disease
- •Drugs or supplements consumption with proven properties that modify the behavior of the Metabolic Syndrome
研究组 & 干预措施
Amla (Emblica Officinalis)
1000 mg dose per day. Two capsules of 500 mg, one in the morning before breakfast and the other before dinner during 90 days.
干预措施: Amla (Drug)
Placebo
1000 mg dose per day. Two capsules of 500 mg, one in the morning before breakfast and the other before dinner during 90 days
干预措施: Placebo (Drug)
结局指标
主要结局
Diastolic Blood Pressure (DBP)
时间窗: 90 days
The DBP will be evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures will be considered as the value of DBP. The value will be expressed on mmHg.
Waist Circumference (WC)
时间窗: 90 days
The WC will be evaluated after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest. The value will be expressed in centimeters.
Triglycerides (TGs)
时间窗: 90 days
The blood sample for determining of TGs, will be taken after an overnight fast and with a spectrophotometry method. The value will be expressed on mmol/L.
Fasting Plasma Glucose (FPG)
时间窗: 90 days
The blood sample for determining of FPG, will be taken after an overnight fast and with a spectrophotometry method. The value will be expressed on mmol/L.
Systolic Blood Pressure (SBP)
时间窗: 90 days
The SBP will be evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures will be considered as the value of SBP. The value will be expressed on mmHg.
High-density Lipoprotein Cholesterol (HDL-C)
时间窗: 90 days
The blood sample for determining of HDL-C, will be taken after an overnight fast with a colorimetric method. The value will be expressed on mmol/L.
次要结局
未报告次要终点
研究者
Esperanza Martínez-Abundis
Researcher Professor
University of Guadalajara