None
Conditions
Interventions
1. Study setting: Department of Biochemistry and Medicine, Faculty of Medicine, University of Ruhuna.
2. Randomization: Simple randomization using a computer-generated random number table, concealmen
Sponsors
Faculty of Medicine, University of Ruhuna
National Research Council, Sri Lanka (NRC IDG 24-005
Eligibility
Inclusion criteria
Inclusion criteria: - Patients aged between 20 -60 yrs, - Male and female - NAFLD; through mild or moderately elevated liver enzymes (NHANES III criteria-AST >37 IU/L or ALT > 40 IU/L for males and AST or ALT >31 IU/L in females, but not greater than the three times the upper limit of 37/40 IU/L and 31 IU/L respectively) AND -Presence of fatty liver according to the established ultrasound criteria (two out of the following three criteria: increased echogenicity of the liver compared to the kidney and spleen, obliteration of the vascular architecture of the liver, and deep attenuation of the ultrasonic signal -Able to communicate effectively with the study personnel and understand the nature of the study, and be willing to give written informed consent at the enrollment
Exclusion criteria
Exclusion criteria: - Pregnancy, lactation, a history of documented acute or chronic liver disease, including acute hepatitis of any cause, viral hepatitis, autoimmune hepatitis, hemochromatosis, vascular disease of the liver, gastrointestinal surgery, Wilson disease, ?-1antitrypsin deficiency, or any illness with jaundice · Daily alcohol consumption of more than 20 g/day (two 30 mL drinks) throughout life and consumption of any alcohol for the past six months · Chronic illnesses including rheumatoid arthritis, severe osteoarthritis, symptomatic heart failure, type 1 and 2 diabetes mellitus, myocardial infarction within the last 6 months, acromegaly, clinically apparent hypothyroidism, nephrotic syndrome, and chronic kidney disease, stage III and above, hypertension Patients who are on lipid-lowering drugs (statins, omega -3 polyunstaurated fatty acids, etc.) or drugs affecting lipid metabolism (full dose thiazides, corticosteroids, immunosuppressants) · Malignancies · Extreme body habitus (BMI >40 kg/m2), who are on active drug treatment for obesity · Had used antioxidants such as vitamin E, vitamin C, glutathione, alpha tocopherol, or non-prescribed complementary alternative medications (including dietary supplements, megadose vitamins, herbal preparations and special herbal teas) within 30 days before screening. · Patients who are on weight-loss diets during the three months before the study · Individuals who are undernourished · Individuals taking any Western, Ayurvedic, or other medications on long-term basis · Individuals with a positive family history of liver disease, such as hereditary hemochromatosis, Wilson's disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An absolute reduction in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) concentration 2. [Baseline of the intervention, and three months after the intervention] [Screening/at the baseline of the intervention, one month after the intervention, second months after the intervention, three months after the intervention] A change in homeostatic model assessment for insulin resistance (HOMA-IR) [Baseline of the intervention, and three months after the intervention] Grading in fatty liver and hepatic steatosis based on USS [Screening/at the baseline of the intervention, and three months after the intervention ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in the lipid profile [At the baseline of the intervention, and three months after the intervention] Change in anthropometric variables- body mass index, waist circumference [At the baseline of the intervention, one month after the intervention, second months after the intervention, three months after the intervention] Reduction/change in ?-GT, ALP, HbA1c, creatinine [At the baseline of the intervention, one month after the intervention, second months after the intervention, three months after the intervention] Fasting blood glucose level [At the baseline of the intervention, one month after the intervention, second months after the intervention, three months after the intervention] Change in cytokeratin 18, serum total antioxidant status, catalase, GPx, hs-CRP, catalase, malonaldehyde, adiponectin, leptin concentration, TNF-a, IL-6 [At the baseline of the intervention, and three months after the intervention] Change in full blood count parameters [At the baseline of the intervention, one month after the intervention, second months after the intervention, three months after the intervention] | — |
Countries
Sri Lanka
Contacts
Public ContactProf. Anoja Attanayake
Professor
Outcome results
None listed