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IRCT2015121317254N4 IRCT 2015-12-27 Tehran University of Medical Sciences Effect of green cardamom on improvement of non-alcoholic fatty liver disease 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) 2016-01-21 anticipated 80 Complete https://irct.ir/trial/15918 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 Condition 1: Nonalcoholic fatty liver disease. Condition 2: Overweight or Obesity. Intervention 1: Green cardamom supplementation, 3 gram/day, 3 capsules (1gram)/day with food, for 3 months. Intervention 2: Placebo (bread crumbs) supplementation, 3 gram/day, 3 capsules (1gram)/day with food, for 3 months.
public Gity Sotoudeh
Keshavarz Beulvard, Naderi St, Hojjatdoust alley, No 44
Tehran Iran (Islamic Republic of) +98 21 8895 5742 gsotoodeh@yahoo.com Tehran University of Medical Sciences scientific Gity Sotoudeh
Keshavarz Blv, Naderi St, Hojjatdoust Alley, No 44
Tehran Iran (Islamic Republic of) +98 21 8895 5742 gsotoodeh@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 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. 30 years 60 years Both K76.0 E66 Nonalcoholic fatty liver disease overweight or obesity Treatment - Other Placebo Green cardamom supplementation, 3 gram/day, 3 capsules (1gram)/day with food, for 3 months Placebo (bread crumbs) supplementation, 3 gram/day, 3 capsules (1gram)/day with food, for 3 months 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. 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. Tehran University of Medical Sciences Approved 2015-09-20 Tehran University of Medical Sciences Keshavarz Beulvard, First of Qods Tehran Iran (Islamic Republic of)