Efficacy of a Natural Components Mixture in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD) (NUTRAFAST)
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|ClinicalTrials.gov Identifier: NCT02369536|
Recruitment Status : Completed
First Posted : February 24, 2015
Last Update Posted : February 5, 2018
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).
|Condition or disease||Intervention/treatment||Phase|
|Non-alcoholic Fatty Liver Disease||Dietary Supplement: nutraceutical mixture Dietary Supplement: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||127 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Clinical Trial on the Efficacy of a Natural Components Mixture in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)|
|Actual Study Start Date :||August 18, 2015|
|Actual Primary Completion Date :||September 15, 2016|
|Actual Study Completion Date :||September 15, 2016|
Active Comparator: nutraceutical mixture
Lifestyle counseling plus three month administration of nutraceutical mixture (2 soft gelatin capsules of 800 mg per day)
Dietary Supplement: nutraceutical mixture
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)
Placebo Comparator: placebo
Lifestyle counseling plus three month administration of placebo formulation (2 soft gelatin capsules of 800 mg per day)
Dietary Supplement: placebo
Lifestyle counseling, administration of a placebo, containing only choline, at the same low concentration of the active mixture
- change of hematic levels of hepatic enzymes [ Time Frame: before and at the end of treatment (three months) ]ALT, AST and/or γ-GT
- Change of hepatic function [ Time Frame: before and at the end of treatment (three months) ]hematic levels of direct and indirect bilirubin
- Levels of circulating Inflammation markers [ Time Frame: before and at the end of treatment (three months) ]C Reactive Protein (CRP), interleukin (IL)-6, IL-1β, IL-8, IL-10, Receptor for Advanced Glycation End Products (RAGE), Advanced Glycation End Products (AGE), insulin-like growth factor-1 (IGF-1)
- Measures of the haemostatic function [ Time Frame: before and at the end of treatment (three months) ]Factor VII, fibrinogen, thrombin generation with and without thrombomodulin, antithrombin (AT), tissue-type Plasminogen Activator (t-PA), Plasminogen Activator Inhibitor-1(PAI-1), thrombin activatable fibrinolysis inhibitor (TAFI) and activated TAFI (TAFIa), plasmin-antiplasmin complex, plasma fibrinolytic capacity
- Metabolic syndrome parameters [ Time Frame: before and at the end of treatment (three months) ]glycemia, triglycerides, HDL cholesterol, insulin e insulin-resistance (HOMA-IR homeostasis model assessment-estimated insulin resistance), adiponectin
- Apoptosis parameters [ Time Frame: before and at the end of treatment (three months) ]total cytokeratin-18 (M65 antigene), M30 and M65/M65ED, soluble fas and soluble fas ligand
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369536
|Pozzilli, Isernia, Italy, 86077|
|Principal Investigator:||Giovanni de Gaetano, MD PhD||IRCCS Neuromed|