Nonalcoholic steatohepatitis (NASH). Nonalcoholic steatohepatitis (NASH)
Conditions
Interventions
Intervention 1: intervention: 2 protexin capsules for 7 months. Intervention 2: control: 2 placebo capsule (Maltodexterin) for 7 months.
Treatment - Drugs
Placebo
intervention: 2 protexin capsules for 7 months
control: 2 placebo capsule (Maltodexterin) for 7 months
Sponsors
National Nutrition and Food Technology Research Institute (NNFTRI)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Age of 18 years and older; BMI between 25-40; Abnormal serum transferase (ALT & AST more than 1.5 fold of normal range); Sonographic findings compatible with hepatic steatosis (degree 2 or more). Exclusion criteria: Diabetes; Using antibiotic 2 weeks before recruitment to the study; A history of alcohol consumption; Pregnancy & Breast feeding, Professional athletes; Liver disease (viral/etc); Use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin E; A history of Hypertension, Cardiovascular disease, Pulmonary disease, Renal disease & Celiac disease; Cirrhosis; Medications causing NAS; Upper GI surgery / Prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty, following program to lose weight in recent 3 mo;-A history of hypothyroidism or Cushing’s syndrome.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALT, AST, GGT. Timepoint: at the beginning and at the last. Method of measurement: Biochemistry.;Hs-CRP, TNF-a. Timepoint: at the beginning and at the last. Method of measurement: ELISA & Nephlometer.;Liver fibrosis. Timepoint: at the beginning and at the last. Method of measurement: Fibroscan.;FBS. Timepoint: at the beginning and at the last. Method of measurement: Biochemistry.;Cholestrol, TG, LDL-c, HDL-c. Timepoint: at the beginning and at the last. Method of measurement: Biochemistry. | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight and BMI. Timepoint: at weeks: 0, 14, 28. Method of measurement: Weight will be measured by Secca scale , BMI by formula.;Waist circumference, hip circumfereance. Timepoint: at weeks: 0, 14, 28. Method of measurement: non stretch meter.;Insulin. Timepoint: at weeks: 0, 14, 28. Method of measurement: ELISA.;Insulin resistance. Timepoint: at weeks: 0, 28. Method of measurement: formula. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Azita Hekmatdoost
National Nutrition and Food Technology Research Institute (NNFTRI)
Outcome results
None listed