IRCT2015121317254N4已完成2 期
The effects of green cardamom (Elettaria Cardamomum) supplementation along with lifestyle changes on blood glucose index, lipids, inflammation factors, paraxonase-1, sirtuin-1 and irisin in overweight and obese patients with non-alcoholic fatty liver disease (NAFLD)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 30 years 至 60 years（—）
- 性别
- All
入选标准
- •non-alcohilic fatty liver disease diagnosed by a radiologist and hepatologist using ultrasonography into one of three categories (mild, moderate or severe degree); age 30–60 years old; overwight or obesity (25=BMI<35); informed consent signed and dated by the subject and investigator.
- •Exclusion criteria: history of alcohol consumption at the time of the study or in the past 12 months, based on patient confession; diagnosed pathological conditions affecting the liver such as viral hepatitis, acute or chronic liver failure, cholestasis, liver transplantation, habitual abuse of nonsteroidal anti-inflammatory drugs, antibiotics, anti-secretory drugs cause achlorhydria within 3 months before the study, Corticosteroids, amiodarone, valproate, prednisone, tamoxifen, perhexiline and methotrexate, rapid weight loss, diabetes, heart failure, thyroid disorders, kidney disease, respiratory failure, psychological disorders, hereditary hemochromatosis and Wilson disease, alpha-1 antitrypsin deficiency, autoimmune diseases, celiac disease, use of liver fat inducer and hormonal drugs; acute systemic disease, cystic fibrosis disease, muscular dystrophy, protein malnutrition, history of gastrointestinal surgery, neurological disorders, structural abnormalities of the gastrointestinal tract; the secondary causes of NAFLD, including drugs, surgical procedures, environmental toxins and total parenteral nutrition (TPN); conditions lead to the physical inactivity (disability); uncontrolled hypertension (>90/140 mmHg); any diagnosed malignancy; breast-feeding, pregnancy and or plan for pregnancy in the next 3 months; professional athlete or regular exercise; treatment with statins, antihypertensive and ursodeoxy colic acid, probiotics and multivitamin-mineral and antioxidant supplements during the three months prior to the intervention; surgery for weight loss in the last year and weight loss program for the past three month; different drugs that interact with cardamom, including aspirin, anticoagulants (warfarin, heparin) and antiplatelet (clopidogrel), non-steroidal anti-inflammatory (ibuprofen or naproxen), blood pressure-lowering drugs, CNS depressants (benzodiazepines such as lorazepam or diazepam, barbiturates such as phenobarbital, narcotics such as codeine, some antidepressants and alcohol), anesthetics, antibiotics, anti-cancer agents, anti-cholinergics, anti-fungals, cyproheptadine, diuretics (loop), estrogen, indomethacin, muscarinic agents, pain relievers and prednisolone; taking a multivitamin-mineral and or antioxidants supplement at least twice a week during study; not taking more than 10% of prescription supplements.
排除标准
- 未提供
研究者
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