liver function dyslipidemia curcuminoids ascorbic acid turmeric amla artichoke HDL ALT
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. healthy Thai people aged 20-70 years, 2. elevated plasma ALT levels (30-200 U/L), 3. no history of liver diseases or jaundice, 4. able to communicate and understand the Thai language, 5. able to consume the herbal blended product or placebo twice daily for 12 weeks, 6. able to decide and sign written informed consent by oneself. 7. (for the block with alcohol consumption habits) over the past 5 years consumed > 7 or 14 standard drinks/ week for females or males respectively, 8. (For the block without alcohol consumption habits) consumed alcohol < 20 g or 30 g for females or males respectively and having metabolic diseases, i.e., obesity, pre-diabetes, dyslipidemia, and insulin resistance
Exclusion criteria
Exclusion criteria: 1. pregnancy lactation or intending to become pregnant, 2. type I diabetes mellitus, 3. cirrhosis, 4. having a history or at risk of hepatitis B or C virus infection, 5. pancreatitis, 6. gout, 7. cardiovascular diseases, 8. kidney diseases, 9. having a history of digestive tract operation, 10. alcohol dependence and abuse, 11. regular intake of vitamin supplements, 12. the use of herbs or supplements with turmeric/curcumin, amla, and artichoke as main ingredients within 2 weeks prior to trial, 13. consume foods with turmeric as the main ingredient regularly (5 times or more per week), 14. allergic to major ingredients (turmeric, amla, artichoke, red grape, mulberry, and beetroot), 15. hemophilia or having a blood clotting disorder, e.g., low platelet, leukemia, 16. use of paracetamol 1-2 days prior to blood collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| liver function markers at 0, 4, 8, 12 weeks after intervention Blood level of ALT, AST,fatigue at 0, 4, 8, 12 weeks after intervention Daily fatigue impact scale and the Rochester fatigue scale,adverse effects at 0, 4, 8, 12 weeks after intervention symptoms of adverse events, vital sign, routine blood chemistry | — |
Secondary
| Measure | Time frame |
|---|---|
| other liver function markers at 0, 4, 8, 12 weeks after intervention blood level of bilirubin, GGT, ALP,lipid profile at 0, 4, 8, 12 weeks after intervention Blood level of HDL. LDL, cholesterol, triglyceride,overall symptoms at 0, 4, 8, 12 weeks after intervention MSAS scale | — |
Countries
Thailand
Contacts
Institute of Nutrition, Mahidol University