Non-alcoholic Fatty Liver Disease Clinical Trial
— NUTRAFASTOfficial title:
Clinical Trial on the Efficacy of a Natural Components Mixture in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)
Verified date | January 2022 |
Source | Neuromed IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to provide clinical data to support the effectiveness of a mixture of ingredients of natural origin, suitably selected and packaged, in the protection from liver damage, in subjects with NAFLD. Study design: double-blind, randomized, multicentre trial, placebo-controlled on two parallel groups. The study participants are healthy volunteers, since they do not have nor had any liver-related clinical symptom, but simply laboratory (plasma levels greater than normal for at least one of the liver parameters -aspartate aminotransferase AST, alanine aminotransferase ALT or γ -glutamyltranspeptidase γ-GT) or instrumental (ultrasonographic abnormalities of steatosic liver) tests altered as compared to normal ranges. Three months treatment with the nutraceutical mixture or placebo. Outcomes tested before and at the end of treatment - 3 months).
Status | Completed |
Enrollment | 126 |
Est. completion date | September 15, 2016 |
Est. primary completion date | September 15, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - subjects with non alcoholic fatty liver disease (NAFLD) - presenting ultrasonographic abnormalities of steatosic liver (hyperechogenic parenchyma) - with plasma levels greater than normal (ranges of each recruiting center) for at least one of the following parameters (aspartate aminotransferase AST, alanine aminotransferase ALT, ? -glutamyltranspeptidase ?-GT). Exclusion Criteria: - history of alcohol abuse - use of drugs associated with the development of hepatic steatosis - malnutrition - alcoholic chronic liver disease - chronic liver disease of different etiology (autoimmune disease, primary biliary cirrhosis, primary sclerosing cholangitis, hereditary hemochromatosis, Wilson's disease, deficits of alpha-1 antitrypsin, celiac disease) - severe renal, cardiac or respiratory insufficiency - malignant tumors - intolerance to any component of the active ingredients of the formulation - women who are pregnant or have planned the pregnancy within three months and women who are breast-feeding. |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Neuromed | Pozzilli | Isernia |
Lead Sponsor | Collaborator |
---|---|
Neuromed IRCCS |
Italy,
Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ; American Association for the Study of Liver Diseases; American College of Gastroenterology; American Gastroenterological Association. The diagnosis and management of non-alcoholic fatty liver disease: Practice guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Am J Gastroenterol. 2012 Jun;107(6):811-26. doi: 10.1038/ajg.2012.128. Erratum in: Am J Gastroenterol. 2012 Oct;107(10):1598. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hematic Levels of Hepatic Enzymes AST | hematic levels of hepatic enzyme: aspartate aminotransferase (AST) | before and at the end of treatment (three months) | |
Primary | Hematic Levels of Hepatic Enzymes ALT | hematic levels of hepatic enzyme: alanine aminotransferase (ALT) | before and at the end of treatment (three months) | |
Primary | Hematic Levels of Hepatic Enzymes GGT | hematic levels of hepatic enzyme: gamma-glutamyl transpeptidase (GGT) | before and at the end of treatment (three months) | |
Secondary | Plasma Levels of Hepatic Enzymes | hematic levels of direct bilirubin | before and at the end of treatment (three months) | |
Secondary | Levels of Circulating Inflammation Marker | Levels of circulating Inflammation marker: C Reactive Protein (CRP) | before and at the end of treatment (three months) | |
Secondary | Measures of the Haemostatic Function | Tissue-type Plasminogen Activator (t-PA) levels in plasma | before and at the end of treatment (three months) | |
Secondary | Measures of the Haemostatic Function | Plasminogen Activator Inihibitor (PAI-1) levels in plasma | before and at the end of treatment (three months) | |
Secondary | Measures of the Haemostatic Function | Thrombin activatable fibrinolysis inhibitor (TAFI) levels in plasma | before and at the end of treatment (three months) |
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