NAFLD
Conditions
Brief summary
Non-alcoholic fatty liver disease (also called NAFLD) is a disease in which excessive fat accumulates in the liver of a patient without a history of alcohol abuse. Early-stage NAFLD does not usually cause any harm but nonalcoholic steatohepatitis (NASH) can lead to serious liver damage, including fibrosis or cirrhosis. Nearly 25% of the world's population is affected by NAFLD. There are no FDA-approved medications for the treatment of NAFLD currently and although lifestyle modifications with appropriate diet and exercise have been shown to be beneficial, this has been difficult to achieve and sustain for the majority of patients. LivPhcD™ capsule have shown hepatoprotective effects in both animal and human data. This study aims to investigate the effects of LivPhcD™ capsule in hepatocellular lipid content using Fibroscan.
Interventions
DIETARY_SUPPLEMENTPlacebo
Placebo matching LivPhcD cap.
DIETARY_SUPPLEMENT2 cap.LivPhcD/per day
2 caps. LivPhcD cap. after meal, once a day
DIETARY_SUPPLEMENT4 cap.LivPhcD/per day
4 caps. LivPhcD cap. after meal, BID
DIETARY_SUPPLEMENT6 cap.LivPhcD/per day
6 caps. LivPhcD cap. after meal, TID
Sponsors
TCM Biotech International Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female between 20 and 75 years of age. 2. Capable of giving written informed consent and able to effectively communicate with the investigator and study personnel. 3. Has a body mass index (BMI) ≥20 kg/m\^2 and ≤50 kg/m\^2 and stable weight for the past 3 months 4. CAP ≥ 238 db/m 5. Fibro scan (transient elastography) F0\ F3
Exclusion criteria
1. Pregnant or breastfeeding or planning to become pregnant or unwilling to use an acceptable contraceptive method to avoid pregnancy during the study period 2. Type 1 diabetes mellitus. 3. History of other causes of chronic liver disease \[autoimmune, primary biliary cirrhosis, HBV (HBsAg positive) and HCV, Wilson disease, alpha-1-antitrypsin deficiency, hemochromatosis etc. 4. Use of medications that could induce steatosis, such as estrogen or other hormonal replacement therapy, amiodarone, methotrexate, tamoxifen, raloxifene, pharmacological doses of oral glucocorticoids (≥10 mg per day of prednisone or equivalent), or chloroquine. 5. Use of vitamin E (doses ≥800 IU/dy) or pioglitazone or SGLT2 inhibitor or GLP-1 agonists any FDA-approved drug for NASH to be approved during the study. 6. Has significant systemic or major illnesses other than liver disease, ex: recent events (≤6 months before study entry) of congestive heart failure, unstable coronary artery disease, serious COPD, renal failure and need hemodialysis, stroke, transient ischemic attack, or organ transplantation 7. Known alcohol abuse or alcohol use disorder (\>20 g/day for women; \>30 g/day for men) 8. Has the abnormal data including: fasting TG \>400 mg/dL ; ALT or GGT\>5.0 x ULN；Bilirubin \>2 x ULN，unless due to an alternative etiology such as Gilbert's syndrome; INR ≥1.3; Albumin \< LLN; Platelet \<0.95x LLN 9. Subjects with hemoglobin A1c (HbA1c) \>8.5% within 3 months before study entry 10. Plan to have major surgery during the study period (bariatric surgery, biliary diversion surgery) 11. Participation in any other investigational clinical trial within 30 days of entry to this protocol(including drugs, medical devices, novel medical technologies, food, and lifestyle interventions affecting diet, exercise, and circadian rhythm investigational clinical trial.); 12. History of HIV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Liver Fat | 36 weeks | Between group difference in the proportion of patients with ≥ 10% reduction of baseline of liver fat by CAP(Controlled Attenuation Parameter) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Cholesterol | 24 weeks and 36 weeks | Between group difference in mean change or in the proportion of patients of Total Cholesterol |
| Stable in liver fat | 24 weeks and 36 weeks | Between group difference in the proportion of patients with stable of baseline of liver fat by CAP |
| Change in liver fat at least 30% reduction | 24 weeks and 36 weeks | Between group difference in the proportion of patients with ≥ 30% reduction of baseline of liver fat by CAP |
| Change in liver fat at least 1 stage reduction | 24 weeks and 36 weeks | Between group difference in the proportion of patients with 1 stage reduction of baseline of liver fat by CAP |
| Change in liver fat | 24 weeks and 36 weeks | Between group difference in mean change of liver fat by CAP |
| Change in liver fibrosis at least 10% reduction | 24 weeks and 36 weeks | Between group difference in the proportion of patients with ≥ 10% reduction of baseline of liver fibrosis by Fibroscan |
| Change in liver fibrosis at least 1 stage reduction | 24 weeks and 36 weeks | Between group difference in the proportion of patients with 1 stage reduction of baseline of liver fibrosis by Fibroscan |
| Stable in liver fibrosis | 24 weeks and 36 weeks | Between group difference in the proportion of patients with stable reduction of baseline of liver fibrosis by Fibroscan |
| Change in liver fibrosis | 24 weeks and 36 weeks | Between group difference in mean change of FIB-4 |
| Change in ALT | 24 weeks and 36 weeks | Between group difference in mean change or in the proportion of patients of ALT |
| Change in HDL-C | 24 weeks and 36 weeks | Between group difference in mean change or in the proportion of patients of HDL-C |
| Change in GGT | 24 weeks and 36 weeks | Between group difference in mean change or in the proportion of patients of GGT |
| Change in AP | 24 weeks and 36 weeks | Between group difference in mean change or in the proportion of patients of AP |
| Change in Bilirubin | 24 weeks and 36 weeks | Between group difference in mean change or in the proportion of patients of Bilirubin |
| Change in Triglyceride | 24 weeks and 36 weeks | Between group difference in mean change or in the proportion of patients of Triglyceride |
| Change in LDL-C | 24 weeks and 36 weeks | Between group difference in mean change or in the proportion of patients of LDL-C |
| Change in TNF-α | 24 weeks and 36 weeks | Between group difference in mean change or in the proportion of patients of TNF-α |
| Change in C-Reactive Protein | 24 weeks and 36 weeks | Between group difference in mean change or in the proportion of patients of C-Reactive Protein |
| Change in Albumin | 24 weeks and 36 weeks | Between group difference in mean change or in the proportion of patients of Albumin |
| Occurrence of adverse events and serious adverse events | 24 weeks and 36 weeks | Between group difference in the occurrence of adverse events and serious adverse events. |
| Change in AST | 24 weeks and 36 weeks | Between group difference in mean change or in the proportion of patients of AST |
Countries
Taiwan
Contacts
Primary ContactChun-Jen Liu, Ph.D
Backup ContactWen-Chuan Huang, Master
Outcome results
None listed