Effects of Green Coffee Extract Supplementation on Oxidative Stress, Systemic and Vascular Inflammation in Patients With Metabolic Syndrome: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 主要终点
- intercellular adhesion molecule-1 (ICAM-1)
研究概览
简要总结
Metabolic syndrome (Mets) is defined as the collection of risk factors contributing to type 2 diabetes mellitus and cardiovascular disease. Mets is accompanied by oxidative stress and low-grade inflammation. Green coffee is rich in polyphenols called chlorogenic acids (CGA) which possess anti-inflammatory and anti-oxidative characteristics. Thus, we carried out this trial to examine green coffee extract (GCE) effects on oxidative stress, systemic and vascular inflammation in patients having Mets
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
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
- •body mass index of over 25, waist circumference >102 cm in men or >88 cm in women,Fasting blood glucose >100 mg/dL, Triglycerides (TG) > 150 mg/dL, High density lipoprotein cholesterol (HDL-C) <50 in women or <40 in men, Systolic blood pressure (SBP) >130 mmHg and diastolic blood pressure (DBP) >85mmHg
排除标准
- •insulin administration for diabetes control, having hypo- or hyperthyroidism, renal failure or other chronic diseases, regular coffee consumption, pregnancy, breastfeeding, taking estrogen, progesterone, corticosteroids, weight loss supplements and obeying unusual weight loss plans
研究组 & 干预措施
intervention group
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)
placebo group
placebo capsules twice per day for 8 weeks have identical appearance to Green coffee extract capsules and contain starch
干预措施: green coffee extract (Dietary Supplement)
结局指标
主要结局
intercellular adhesion molecule-1 (ICAM-1)
时间窗: 8 weeks
interleukin-6 (IL-6)
时间窗: 8 weeks
high sensitivity C-reactive protein (hs-CRP)
时间窗: 8 weeks
malondialdehyde (MDA)
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
Dr Azita Hekmatdoost
National Nutrition and Food Technology Research Institute
National Nutrition and Food Technology Institute