N/A
N=126
Efficacy of a Natural Components Mixture in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)
Non-alcoholic Fatty Liver Disease
Bottom Line
View on ClinicalTrials.gov: NCT02369536 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Hematic Levels of Hepatic Enzymes AST — 35.4; 37.5; 31.6; 31.2 IU/L — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- nutraceutical mixture (Dietary_supplement); placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Neuromed IRCCS
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hematic Levels of Hepatic Enzymes AST |
35.4; 37.5; 31.6; 31.2 | <0.05 sig |
| PRIMARY Hematic Levels of Hepatic Enzymes ALT |
45.5; 48.3; 43.8; 40.0 | — |
| PRIMARY Hematic Levels of Hepatic Enzymes GGT |
101.4; 98.5; 87.2; 75.6 | — |
| SECONDARY Plasma Levels of Hepatic Enzymes |
2.05; 2.74; 2.22; 2.39 | <0.05 sig |
| SECONDARY Levels of Circulating Inflammation Marker |
21.0; 28.3; 17.1; 24.0 | — |
| SECONDARY Measures of the Haemostatic Function |
105; 100; 104; 99 | — |
| SECONDARY Measures of the Haemostatic Function |
105; 100; 104; 99 | — |
| SECONDARY Measures of the Haemostatic Function |
105; 100; 104; 99 | — |
Summary
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).
Eligibility Criteria
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, γ -glutamyltranspeptidase γ-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.
Data sourced from ClinicalTrials.gov (NCT02369536). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.