Hypoglycemic effects of bittergourd (Momordica charantia L)among prediabetics:An intervention study in Coimbatore
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- It is expected that the consumption of bitter gourd will significantly decrease FPG compared to the placebo. Further, it is expected that the bitter gourd consumption will improve, insulin and HbA1c levels among pre-diabetic participants.
研究概览
简要总结
The study aims to assess the anti-diabetic effects of bitter gourd drink and the study will examine the following criteria: gender, age, physical activity, dietary intake and medical history. Socio-economic and demographic information will also be assessed during the intervention study. Venous blood samples will be taken from participants four times after an overnight fast. FPG, TG, total cholesterol, HDL, and LDL concentrations will be determined by enzymatic methods. HbA1c will be determined by high-performance liquid chromatography. Hypothesis set for the study is bittergourd juice is a hypoglycemic agent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Fasting blood glucose 100 – 125 mg/dl HbA1c between 5.7 – 6.4% Non alcoholics Written consent from the participants.
排除标准
- •Presence of complications & disorders Taking medication High blood pressure (>160/>100) and low blood pressure (<90/<60) Pregnancy/ planning for pregnancy/ breast feeding.
结局指标
主要结局
It is expected that the consumption of bitter gourd will significantly decrease FPG compared to the placebo. Further, it is expected that the bitter gourd consumption will improve, insulin and HbA1c levels among pre-diabetic participants.
时间窗: 6 months
次要结局
- bitter gourd is known to have anti-obesogenic effects, it is expected that there will be no weight gain during bitter gourd consumption or even some weight loss and improvement of BMI and waist-to-hip ratio (WHR). It is expected that Bitter gourd helps to prevent the onset of diabetes among the pre-diabetic participants(22 weeks)