Effects of Green Coffee Extract Supplementation on Anthropometric Measurements, Glycemic Control, Blood Pressure, Lipid Profile
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- fasting blood glucose
研究概览
简要总结
Metabolic syndrome (Mets) is an assemblage of risk factors which can increase the risk of developing type 2 diabetes mellitus and cardiovascular disease. Green coffee extract (GCE) is derived from unroasted coffee beans and has substantial amounts of polyphenols primarily chlorogenic acids (CGA). It has been shown that GCE and CGA can exert a positive influence over Mets components including blood pressure, blood glucose, inflammation, oxidative stress, insulin resistance and blood lipids. Up to our knowledge no study has been conducted on humans in the field of GCA influences on Mets patients. Therefore, this study is planned to evaluate GCA supplementation effects on anthropometric measurements, glycemic control, blood pressure, lipid profile in patients with metabolic syndrome.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Waist circumference>102 cm in men and >88 cm in women
- •Fasting blood glucose>100 mg/dL (5.6 mmol /L)
- •Systolic blood pressure>130 mmHg or diastolic blood pressure>85mmHg
- •Triglycerides> 150 mg/dL (1.7 mmol/L)
排除标准
- •Insulin administration
- •Pregnancy and breastfeeding
- •regular consumption of coffee and green tea
研究组 & 干预措施
control
placebo capsules twice per day for 8 weeks have identical appearance to Green coffee extract capsules and contain starch
干预措施: placebo (Dietary Supplement)
intervention
400 mg green coffee extract capsules twice per day for 8 weeks The Green coffee extract is standardised with 45% total chlorogenic acid by HPLC
干预措施: green coffee extract (Dietary Supplement)
结局指标
主要结局
fasting blood glucose
时间窗: 8 weeks
次要结局
- HOMA-IR(8 weeks)
- blood pressure(8 weeks)
- insulin(8 weeks)
- hemoglubin A1c(8 weeks)
- triglyceride(8 weeks)
研究者
Dr Azita Hekmatdoost
Dr Azita Hekmatdoost
National Nutrition and Food Technology Institute