Non-alcoholic fatty liver disease
Conditions
Interventions
Study setting: Department of Biochemistry and Medicine, Faculty of Medicine, University of Ruhuna, Sri Lanka.
Details of the interventional product: Oral capsules containing freeze-dried material of a
Sponsors
Faculty of Medicine, University of Ruhuna Sri Lanka
Eligibility
Inclusion criteria
Inclusion criteria: • Healthy subjects as defined by medical history, anthropometry, examination -including systolic and diastolic blood pressure and baseline electrocardiography, hematological and biochemical investigations indicating normal liver and kidney function (BMI of < 23 kg/m2 will be considered as normal healthy weight based on WHO cut-off for Asian population, baseline investigations include full blood count, fasting plasma glucose (FPG), lipid profile, renal function test-serum creatinine, serum liver enzymes (ALT, AST, ALP, Gamma-glutamyl transferase (Gamma-GT), total bilirubin, and electrocardiogram (ECG). • Males and females age 18–60 years • Currently not on any medicines including nutritional supplements, herbal and/or Ayurvedic medicines.
Exclusion criteria
Exclusion criteria: • Patients with any documented chronic illness, liver disease, and abnormal/ baseline values in the liver, renal function tests or blood counts • Individuals with a family history of liver disease • Female volunteers who are pregnant, lactating, or not willing to use an effective form of birth control during the period of study • Alcohol users or any alcohol intake for the past six months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematological parameters - parameters that are expected to be monitored: RBC, Hb, PCV, MCV, MCH, MCHC, PLT, and WBC. [At baseline and monthly for a period of 3 months] Liver function -ALT, AST, ALP, gamma-GT, total bilirubin [At baseline and monthly for a period of 3 months] Renal function -serum creatinine [ At baseline and monthly for a period of 3 months] Percentage of participants who experienced serious adverse events such as death, inpatient hospitalization, major change in hematological or biochemical parameters monitored (severe anemia, leucopenia or thrombocytopenia or biochemical evidence of acute kidney or liver injury), ECG evidence of myocardial injury, any disability or permanent damage, requires interventions to prevent permanent impairment or damage [Monitored throughout the trial period ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipid profile (TC, TG, VLDL-C, HDL-C, LDL-C) [At baseline and after a period of 3 months] Change in anthropometric variables (Height, weight, BMI) [ At baseline and monthly for a period of 3 months] Blood pressure and fasting plasma glucose concentration [ At baseline and monthly for a period of 3 months] ECG evidence of myocardial ischemia such as ST segment changes. [ At baseline and after a period of 3 months] | — |
Countries
Sri Lanka
Contacts
Public ContactProf. Anoja Attanayake
Professor in Biochemistry
Outcome results
None listed