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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

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

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230129002
Enrollment
68
Registered
2023-01-29
Start date
2020-09-21
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver function dyslipidemia curcuminoids ascorbic acid turmeric amla artichoke HDL ALT

Interventions

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)
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

Sponsors

Natural Health Food, Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

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

MeasureTime 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

MeasureTime 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

Public ContactDunyaporn Trachootham

Institute of Nutrition, Mahidol University

dunyaporn.tra@mahidol.ac.th66828002380

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026