Clinical Trial Details
| Trial ID: | L0871 |
| Source ID: | JPRN-UMIN000018361 |
| Associated Drug: | Catechin beverage |
| Title: | Efficacy and safety of high dose catechin-contained green tea in patients with NAFLD |
| Acronym: | -- |
| Status: | Recruiting |
| Study Results: | No Results Available |
| Results: | -- |
| Conditions: | Nonalcoholic fatty liver disease (NAFLD) |
| Interventions: | Catechin beverage (containing 540 mg of catechins/350mL) 1 bottle per day for 48 weeks.<br>Control beverage (containing 0 mg of catechins/350mL) 1 bottle per day for 48 weeks. |
| Outcome Measures: | Change in serum ALT levels-Hepatic histological improvement in nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS)<br>-NASH diagnosis:<br>Change from definite or indeterminate NASH to not-NASH<br>-Change in hepatic fat intensity and abdominal fat area determined by CT<br>-Change in fibrosis: <br>Serum collagen4-7S, P-3-P, hyaluronic acid<br>Intensity of fibrosis and steatosis determined by fibroscan<br>-Change in fasting glucose, insulin, HbA1c, glycated albumin, hsCRP<br>-Change in fasting markers of insulin resistance (HOMA-IR)<br>-Change in waist circumference, body weight, body mass index, body fat ratio, body fat mass, abdominal visceral fat area, and abdominal subcutaneous fat area<br>-Changes in lipid metabolism (T-chol, LDL-c, TG, FFA, RLP-Cho, oxidized LDL, sdLDL and fatty acid fraction)<br>circumference, basal metabolism, and blood pressure<br>-Change in AST and gamma-glutamyl transpeptidase (GGT)<br>-Change in cytokine and oxidative stress marker (EC-SOD, 8-isoprostanes, 8-OHdG, IL-1beta, G-CCF, TNFR, IL-6, IL-10)<br>-Change in gene sets in liver and plasma determined by DNA chip<br>-Changes in metabolites in plasma and liver by metabolome analysis<br>-Adverse effects |
| Sponsor/Collaborators: | Kanazawa University Department of Disease Control and Homeostasis |
| Gender: | All |
| Age: | 18years-oldNot applicable |
| Phases: | Not selected |
| Enrollment: | 40 |
| Study Type: | Interventional |
| Study Designs: | Parallel Randomized |
| Start Date: | 21/07/2015 |
| Completion Date: | -- |
| Results First Posted: | -- |
| Last Update Posted: | 2 April 2019 |
| Locations: | Japan |
| URL: | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021258 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D063 | Catechin-contained green tea | Herbal medicine | -- | -- | -- | Under clinical trials | Details |
| D018 | Aspirin | Chemical drug | DB00945 | AKR1C1 inhibitor; PCNA downregulator | Enhance lipid metabolism | Under clinical trials | Details |
| D182 | Insulin | Biological drug | DB00030 | INSR agonist; CPE modulator&product of | -- | Under clinical trials | Details |
| D328 | Serine | Chemical drug | DB00133 | SRR | Improve insulin resistance | Under clinical trials | Details |