A Blinded Block-Randomized Placebo-Controlled Trial for Efficacy of a Fruit and Vegetable Juice (red grape, mulberry, beetroot) Mixed with Herbs on Liver Markers and Fatigue symptoms in Healthy Volunteers with Elevated Alanine Aminotransferase (ALT) Levels

Authors
Category Primary study
Registry of TrialsTCTR
Year 2023
INTERVENTION: consuming 2 bottles (100 cc. per bottle) daily (one after breakfast and another after dinner) for 12 weeks,consuming 2 bottles (100 cc. per bottle) daily (one after breakfast and another after dinner) for 12 weeks Experimental Dietary Supplement,Placebo Comparator Dietary Supplement Fruit and Vegetable Juice (red grape, mulberry, beetroot) Mixed with Herbs (turmeric, amla fruit, and artichoke leaf),placebo drink CONDITION: curcuminoids; ascorbic acid; turmeric; amla; artichoke; HDL; ALT liver function dyslipidemia ; curcuminoids; ascorbic acid; turmeric; amla; artichoke; HDL; ALT PRIMARY OUTCOME: 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 OUTCOME: 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 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
Epistemonikos ID: cec4ace764581173321190fac96dcf479d3c0114
First added on: Feb 20, 2024