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The study of effect of total anthocyanin base standardized (cornus mas L.) fruit extract in patients with non-alcoholic fatty liver

The study of effect of total anthocyanin base standardized (cornus mas L.) fruit extract on liver function, tumor necrosis factor a, malondealdehyde and adiponectin in patients with non-alcoholic fatty liver.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180419039359N1
Enrollment
80
Registered
2018-09-30
Start date
2018-12-22
Completion date
Unknown
Last updated
2021-11-29

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

Conditions

non-alcoholic fatty liver. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: Intervention group: Daily intake of total anthocyanin base standardized (cornus mas L.) fruit extract (equal to 320 mg/d anthocyanins) for 12 weeks. Intervention 2: Control group: Dail

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 65 Years

Inclusion criteria

Inclusion criteria: ALT levels more than 30 U / L in men and more than 19 U / L in women Age 25-26 years Diagnosis of the disease by ultrasonography and by a gastroenterologist The patients with grade 1, 2 and 3 fatty liver The consent of subject to participate in the study The patients are from Yazd

Exclusion criteria

Exclusion criteria: The history of diseases including cirrhosis, viral hepatitis, cardiovascular disease, diabetes, Wilson and cancer. Consumption of medications including corticosteroids, nonsteroidal anti-inflammatory drugs, hypoglycemic agents or any medicine that affect blood glucose, tamoxifen, sodium valproate, methotrexate, probiotics, any medicine or supplement that affect liver function, supplements with antioxidant and anti-inflammatory properties (such as vitamin D, vitamin E, omega-3, resveratrol) during 1 month before the study Following a special diet during 1 month before the study Pregnancy and breastfeeding ?lcohol consumption

Design outcomes

Primary

MeasureTime frame
Serum levels of Alanine Aminotransferase (ALT). Timepoint: Before and after the 12-week intervention. Method of measurement: By autoanalyzer.;Serum levels of Aspartate Aminotransaminase (AST). Timepoint: Before and after the 12-week intervention. Method of measurement: By autoanalyzer.;Serum levels of Tumor necrosis factor a (TNF-a). Timepoint: Before and after the 12-week intervention. Method of measurement: By ELISA kit.;Serum levels of Malondealdehyde (MDA). Timepoint: Before and after the 12-week intervention. Method of measurement: By ELISA kit.;Serum levels of adiponectin. Timepoint: Before and after the 12-week intervention. Method of measurement: By ELISA kit.;Serum levels of cytokeratin-18 fragment M30 (CK-18 M30). Timepoint: Before and after the 12-week intervention. Method of measurement: By ELISA kit.;Liver steatosis. Timepoint: Before and after the 12-week intervention. Method of measurement: By ultrasonography.;Liver fibrosis. Timepoint: Before and after the 12-week intervention. Method of measurement: By fibroscan.

Secondary

MeasureTime frame
Fasting blood glucose (FBS). Timepoint: Before and after the 12-week intervention. Method of measurement: By autoanalyzer.;Serum levels of Triglyceride (TG). Timepoint: Before and after the 12-week intervention. Method of measurement: By autoanalyzer.;Serum levels of High-density lipoprotein (HDL). Timepoint: Before and after the 12-week intervention. Method of measurement: By autoanalyzer.;Serum levels of Low-density lipoprotein (LDL). Timepoint: Before and after the 12-week intervention. Method of measurement: By autoanalyzer.;Serum levels of total cholesterol. Timepoint: Before and after the 12-week intervention. Method of measurement: By autoanalyzer.;Serum levels of insulin. Timepoint: Before and after the 12-week intervention. Method of measurement: By ELISA kit.;Insulin resistance. Timepoint: Before and after the 12-week intervention. Method of measurement: By HOMA-IR and QUICKI.;Lipid accumulation product. Timepoint: Before and after the 12-week intervention. Method of measurement: Formula.;Atherogenic index of plasma. Timepoint: Before and after the 12-week intervention. Method of measurement: Formula.;Atherogenic coefficient. Timepoint: Before and after the 12-week intervention. Method of measurement: Formula.;Castelli 1 index. Timepoint: Before and after the 12-week intervention. Method of measurement: Formula.;Castelli 2 index. Timepoint: Before and after the 12-week intervention. Method of measurement: Formula.;TyG index. Timepoint: Before and after the 12-week intervention. Method of measurement: Formula.;Fatty liver index. Timepoint: Before and after the 12-week intervention. Method of measurement: Formula.;Hepatic steatosis index. Timepoint: Before and after the 12-week intervention. Method of measurement: Formula.;Visceral adiposity index. Timepoint: Before and after the 12-week intervention. Method of measurement: Formula.;NAFLD-liver fat score. Timepoint: Before and after the 12-week intervention. Method of measurement: Formula.;Estimated glucose

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZohreh Sadat Sangsefidi

Yazd University of Medical Sciences

sangsefidi.zsadat@gmail.com+98 353820910014

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 2, 2026