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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
Sponsor:
Information provided by (Responsible Party):
Giovanni de Gaetano, Neuromed IRCCS

Brief 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).


Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Dietary Supplement: nutraceutical mixture Dietary Supplement: placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. change of hematic levels of hepatic enzymes [ Time Frame: before and at the end of treatment (three months) ]
    ALT, AST and/or γ-GT


Secondary Outcome Measures :
  1. Change of hepatic function [ Time Frame: before and at the end of treatment (three months) ]
    hematic levels of direct and indirect bilirubin

  2. 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)

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Locations
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Italy
IRCCS Neuromed
Pozzilli, Isernia, Italy, 86077
Sponsors and Collaborators
Neuromed IRCCS
Investigators
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Principal Investigator: Giovanni de Gaetano, MD PhD IRCCS Neuromed

Publications:
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Responsible Party: Giovanni de Gaetano, Head, Department Epidemiology and Prevention, Neuromed IRCCS
ClinicalTrials.gov Identifier: NCT02369536     History of Changes
Other Study ID Numbers: Neuromed-Nutrafast-PON2015
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Giovanni de Gaetano, Neuromed IRCCS:
NAFLD
nutraceutical mixture

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases