NAFLD Clinical Trial
Official title:
The Effects of Choline,Vitamin C, Vitamin E and Ampelopsis Grossedentata Natural Extracts Supplementation on NASH Patients
The global wave of obesity has affected dramatically the incidence of non-alcoholic fatty liver disease (NAFLD) making it the leading cause of liver disease in the western world. NAFLD is considered the hepatic manifestation of metabolic syndrome and is strongly associated with type II diabetes, sleep apnea and cardiovascular disease. Although cardiovascular disease is the leading cause of death in patients with NAFLD, a subset of patients who meet the histological criteria for steatohepatitis have the highest risk for liver-related morbidity and mortality. Reviewing literature, it appears that several pathophysiologic mechanisms related to metabolism, inflammation and fibrosis are deregulated in NAFLD. Choline, Vitamin C, Vitamin E and Ampelopsis Grossedentata natural extracts exhibit high antioxidant activity. In contrast to Vitamin E, which has been extensively studied and has a role as a drug of choice in non-diabetic patients with NAFLD, epidemiological or clinical data for the use of Choline, Vitamin C, Ampelopsis Grossedentata natural extracts or their combination in NAFLD are limited.
The study will be randomized, placebo-controlled and double-blinded in order to avoid a number of systemic errors, such as selection bias and the placebo effect. Patients will be randomly assigned to one of the two categories: (A) a placebo group (B) a Choline - Vitamin C, E and Ampelopsis Grossedentata natural extracts tablets supplementation group (two tablets twice per day). The duration of the intervention will be 12 months. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06101433 -
The Effect of Soy Isoflavones on Non-alcoholic Fatty Liver Disease and the Level of FGF-21 and Fetuin A
|
N/A | |
| Completed |
NCT03289897 -
Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan
|
N/A | |
| Recruiting |
NCT05479721 -
LITMUS Imaging Study
|
||
| Completed |
NCT05527938 -
Web-based Interventions on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Children
|
N/A | |
| Recruiting |
NCT06308757 -
Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis
|
N/A | |
| Completed |
NCT02654977 -
CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy
|
Phase 2 | |
| Completed |
NCT02927184 -
Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
|
Phase 2 | |
| Recruiting |
NCT06047847 -
Determination of Biological Activity of Enriched Serum Following TOTUM-448 Consumption
|
N/A | |
| Active, not recruiting |
NCT03534908 -
Nonalcoholic Fatty Liver Disease and Cardiovascular Disease: the Correlation Analysis and Risk Prediction Model Study
|
||
| Recruiting |
NCT06098417 -
Biomarkers in the Diagnosis and Prognosis of NAFLD
|
||
| Recruiting |
NCT04564391 -
Whey or Casein - Liver Fat Reduction and Metabolic Improvement by Fast vs. Slow Proteins
|
N/A | |
| Not yet recruiting |
NCT05984745 -
Effect of CoQ10 on the Outcome of MAFLD Patients
|
Phase 2 | |
| Recruiting |
NCT02459496 -
Diabetes Nutrition Algorithms in Patients With Overt Diabetes Mellitus
|
N/A | |
| Completed |
NCT01936779 -
Understanding the Role of Dietary Fatty Acids on Liver Fat Metabolism in Humans
|
N/A | |
| Completed |
NCT05844137 -
Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes
|
N/A | |
| Recruiting |
NCT04664036 -
Prevalence, Incidence and Characteristics of NAFLD/NASH in Type 1 Diabetes Mellitus
|
||
| Recruiting |
NCT04976283 -
Effect of Oral Anti-diabetic Medication on Liver Fat in Subjects With Type II Diabetes and Non-alcoholic Fatty Liver
|
Phase 4 | |
| Recruiting |
NCT03587298 -
Use of Shear Wave Elastography to Assess Non-alcoholic Fatty Liver Disease (NAFLD)
|
||
| Completed |
NCT02952170 -
Impact of Weight Loss Surgery in Adolescents With NAFLD
|
N/A | |
| Completed |
NCT05044130 -
Postprandial VLDL-triglyceride Metabolism in Type 2 Diabetes Patients With and Without NAFLD
|
N/A |