The Effects of Coffee Main Constituents (Caffeine and Chlorogenic Acid) Supplementation on Inflammatory, Metabolic Factors, Hepatic Steatosis and Fibrosis in None- Alcoholic Fatty Liver Patients With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Hepatic steatosis
研究概览
简要总结
The purpose of this study is to investigate the effects of coffee main constituents (caffeine and chlorogenic acid) supplements on inflammatory, metabolic factors, hepatic steatosis and fibrosis in none- alcoholic fatty liver patients with type 2 diabetes. Two hundred patients with fatty liver and type 2 diabetes will be randomly assigned to one of four groups: group 1, caffeine (200 mg/d) plus chlorogenic acid (200 mg/d); group 2, caffeine (200 mg/d) plus placebo; group 3, chlorogenic acid (200 mg/d) plus placebo; group 4, placebo plus placebo. Supplementation will be daily and will supervise for 6 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with type 2 diabetes based on American Diabetes Association (ADA) definition or who only take oral antidiabetic drug.
- •CAPscore >263
排除标准
- •Criteria:
- •Taking any kind of antibiotics two weeks before recruitment;
- •History of alcohol consumption ;
- •pregnancy or lactation;
- •Professional athletes;
- •Other liver disease (viral/etc);
- •High dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs;
- •A history of Cardiovascular disease;
- •Renal disease, Celiac disease, Cirrhosis;
- •History of Upper Gastrointestinal surgery ;
- •A history of hypothyroidism or Cushing's syndrome;
- •History of drug dependence;
- •Body mass index (BMI) ≥35 kg/m2;
- •A restrictive diet or weight change ≥ 5 kg during the 3 months prior to study;
- •Any change in treatment with oral hypoglycemic; anti hypertensive and antilipid agents during the study;
- •Use of weight loss medications
研究组 & 干预措施
caffeine and chlorogeinc acid
caffeine (200 mg) 1 capsule / day for 6 months plus chlorogenic acid (200 mg) 1 capsule / day for 6 months
干预措施: caffeine and chlorogenic acid (Dietary Supplement)
caffeine
caffeine (200 mg) 1 capsule / day for 6 months plus placebo (200) mg 1 capsule / day for 6 months
干预措施: caffeine (Dietary Supplement)
placebo
placebo (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months
干预措施: placebo (Dietary Supplement)
chlorogenic acid
chlorogenic acid (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months
干预措施: chlorogenic acid (Dietary Supplement)
结局指标
主要结局
Hepatic steatosis
时间窗: 6 months
measured by CAP score using Fibroscan
次要结局
- aspartate aminotransferase (ALS)(6 months)
- High sensitive C reactive protein ( hs- CRP)(6 months)
- gut microbiota(3 months)
- Glucose(6 months)
- Glycated hemoglobin (HBA1C)(6 months)
- alanine aminotransferase (ALT)(6 months)
研究者
Dr Azita Hekmatdoost
Dr Azita Hekmatdoost
National Nutrition and Food Technology Institute