Effect of Green Coffee Supplementation on Inflammatory Biomarkers in Obese Patients With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- TNF-α (pg/mL)
研究概览
简要总结
The present study aimed to investigate the effect of green coffee bean extract (GCBE) on the inflammatory biomarkers in obese patients with a metabolic syndrome via analyzing some inflammatory biomarkers as resistin, TNF-α, total sialic acid, homocysteine, high sensitivity C-reactive protein (hs-CRP) and anti-inflammatory cytokine, adiponectin
详细描述
160 obese patients supplemented with either GCBE capsules (800 mg) daily or placebo for 6 months and advised to take a balanced diet. Blood samples were collected at baseline and after three months of supplementation
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, Investigator)
盲法说明
double-blind randomised controlled study
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants were enrolled if they were
- •aged 20-60y
- •waist circumference >102 cm in male; 88 cm in female
- •triglycerides ≥150 mg/dL (1.7 mmol/L)
- •HDL-C<40 mg/dL (1.03 mmol/L) in males & <50 mg/dL (1.29 mmol/L) in females
- •systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg.
排除标准
- •liver, kidney, coronary artery disease, type I diabetes, autoimmune diseases, cancer, infection, smoking, recent major surgery, routine coffee consumption, pregnancy or breast-feeding, use of anti-inflammatory drugs, corticosteroids, hormone replacement therapy, weight-loss and anti-hypercholesterolemic medications three months or less prior to enrolment
结局指标
主要结局
TNF-α (pg/mL)
时间窗: six months
Serum Level
Hs-CRP (mg/L)
时间窗: Six months
Serum Level
Adiponectin (µg/mL)
时间窗: six months
Serum Level
Resistin (ng/mL)
时间窗: six months
Serum Level
Homocysteine (µmol/L)
时间窗: six months
Serum Level
次要结局
- LDL-C (mg/dL)(six Months)
- BMI (kg/m2)(six months)
研究者
Naglaa Khedr
Professor of Biochemistry
Tanta University