At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Trial on the Efficacy of a Natural Components Mixture in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)
In Brief
A clinical study evaluating nutraceutical mixture and placebo for Non-alcoholic Fatty Liver Disease. Completed, enrolled 126 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
Lifestyle counseling, administration of a nutraceutical mixture: fish oil 70% DHA (docosahexaenoic acid), phosphatidylcholine concentrated in sunflower oil, silymarin, choline bitartrate, curcumin, D-α-tocopherol; choline (82,5 mg, corresponding to 15% of the average intake of 550 mg per day in an adult man)
Lifestyle counseling, administration of a placebo, containing only choline, at the same low concentration of the active mixture