Efficacy and safety of high dose catechin-contained green tea in patients with NAFLD

Efficacy and safety of high dose catechin-contained green tea in patients with NAFLD - Green tea in NAFLD treatment

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018361

Enrollment

Registered

2015-07-21

Start date

2015-07-21

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Nonalcoholic fatty liver disease (NAFLD)

Interventions

Catechin beverage (containing 540 mg of catechins/350mL) 1 bottle per day for 48 weeks. Control beverage (containing 0 mg of catechins/350mL) 1 bottle per day for 48 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects who are 1) 18 years of age or older as of the initial screening interview and provision of consent 2) are histologically diagnosed as NAFLD by liver biopsy within 5 years at time of consent 3) have ALT 30 and higher 4) have alcohol intake 30 gram and less for male, and 20 gram and less for female

Exclusion criteria

Exclusion criteria: Subjects who 1) are infected with HBV or HCV 2) have alcohol intake more than 30 for male, and more than 20 gram for female 3) have malignant tumor including hepatocellular carcinoma

Design outcomes

Primary

Measure	Time frame
Change in serum ALT levels	—

Secondary

Measure	Time frame
-Hepatic histological improvement in nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) -NASH diagnosis: Change from definite or indeterminate NASH to not-NASH -Change in hepatic fat intensity and abdominal fat area determined by CT -Change in fibrosis: Serum collagen4-7S, P-3-P, hyaluronic acid Intensity of fibrosis and steatosis determined by fibroscan -Change in fasting glucose, insulin, HbA1c, glycated albumin, hsCRP -Change in fasting markers of insulin resistance (HOMA-IR) -Change in waist circumference, body weight, body mass index, body fat ratio, body fat mass, abdominal visceral fat area, and abdominal subcutaneous fat area -Changes in lipid metabolism (T-chol, LDL-c, TG, FFA, RLP-Cho, oxidized LDL, sdLDL and fatty acid fraction) circumference, basal metabolism, and blood pressure -Change in AST and gamma-glutamyl transpeptidase (GGT) -Change in cytokine and oxidative stress marker (EC-SOD, 8-isoprostanes, 8-OHdG, IL-1beta, G-CCF, TNFR, IL-6, IL-10) -Change in gene sets in liver and plasma determined by DNA chip -Changes in metabolites in plasma and liver by metabolome analysis -Adverse effects	—

Measure

Time frame

-Hepatic histological improvement in nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) -NASH diagnosis: Change from definite or indeterminate NASH to not-NASH -Change in hepatic fat intensity and abdominal fat area determined by CT -Change in fibrosis: Serum collagen4-7S, P-3-P, hyaluronic acid Intensity of fibrosis and steatosis determined by fibroscan -Change in fasting glucose, insulin, HbA1c, glycated albumin, hsCRP -Change in fasting markers of insulin resistance (HOMA-IR) -Change in waist circumference, body weight, body mass index, body fat ratio, body fat mass, abdominal visceral fat area, and abdominal subcutaneous fat area -Changes in lipid metabolism (T-chol, LDL-c, TG, FFA, RLP-Cho, oxidized LDL, sdLDL and fatty acid fraction) circumference, basal metabolism, and blood pressure -Change in AST and gamma-glutamyl transpeptidase (GGT) -Change in cytokine and oxidative stress marker (EC-SOD, 8-isoprostanes, 8-OHdG, IL-1beta, G-CCF, TNFR, IL-6, IL-10) -Change in gene sets in liver and plasma determined by DNA chip -Changes in metabolites in plasma and liver by metabolome analysis -Adverse effects

—

Countries

Japan

Contacts

Public ContactTsuguhito Ota

Kanazawa University Department of Medicine

tota@staff.kanazawa-u.ac.jp076-265-2234

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026