Effect of green cardamom on improvement of non-alcoholic fatty liver disease
- Conditions
- Condition 1: Nonalcoholic fatty liver disease. Condition 2: Overweight or Obesity.Nonalcoholic fatty liver diseaseoverweight or obesity
- Registration Number
- IRCT2015121317254N4
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 80
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.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum Irisin. Timepoint: Before and after intervention. Method of measurement: Elisa kit.;Serum Sirtuin1. Timepoint: Before and after intervention. Method of measurement: Elisa kit.;Serum Paraxonase-1. Timepoint: Before and after intervention. Method of measurement: Elisa kit.
- Secondary Outcome Measures
Name Time Method Serum TNF-a, IL-6 and hs-CRP. Timepoint: Before and after intervention. Method of measurement: Elisa Kit.;FBS, FPI. Timepoint: Before and after intervention. Method of measurement: Kit.;SBP, DBP. Timepoint: Before and after intervention. Method of measurement: mmhg by mercury manometer?.;Serum TG, TC, LDL and HDL. Timepoint: Before and after intervention. Method of measurement: Kit.