Efficacy of a Natural Components Mixture in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)

NCT02369536 | Completed Results

• 1 other identifier: Neuromed-Nutrafast-PON2015
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

NAFLD; nutraceutical mixture

Outcome Measures

Primary Outcomes (3)

• Hematic Levels of Hepatic Enzymes AST

  hematic levels of hepatic enzyme: aspartate aminotransferase (AST)

  before and at the end of treatment (three months)

• Hematic Levels of Hepatic Enzymes ALT

  hematic levels of hepatic enzyme: alanine aminotransferase (ALT)

  before and at the end of treatment (three months)

• 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 Outcomes (5)

• Plasma Levels of Hepatic Enzymes

  before and at the end of treatment (three months)

• Levels of Circulating Inflammation Marker

  before and at the end of treatment (three months)

• Measures of the Haemostatic Function

  before and at the end of treatment (three months)

• Measures of the Haemostatic Function

  before and at the end of treatment (three months)

• Measures of the Haemostatic Function

  before and at the end of treatment (three months)

Study Arms (2)

nutraceutical mixture

ACTIVE COMPARATOR

Lifestyle counseling plus three month administration of nutraceutical mixture (2 soft gelatin capsules of 800 mg per day)

Dietary Supplement: nutraceutical mixture

placebo

PLACEBO COMPARATOR

Lifestyle counseling plus three month administration of placebo formulation (2 soft gelatin capsules of 800 mg per day)

Dietary Supplement: placebo

Interventions

nutraceutical mixture DIETARY_SUPPLEMENT

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)

nutraceutical mixture

placebo DIETARY_SUPPLEMENT

Lifestyle counseling, administration of a placebo, containing only choline, at the same low concentration of the active mixture

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuromed IRCCS: lead

Study Sites (1)

IRCCS Neuromed

Pozzilli, Isernia, 86077, Italy

Location

Related Publications (1)

• 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. No abstract available.

  PMID: 22641309 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. Chiara Cerletti, operative responsible of the trial and corresponding author of the data public
• Organization: IRCCS Neuromed

chiara.cerletti@moli-sani.org

0865915246

Study Officials

• Giovanni de Gaetano, MD PhD

  IRCCS Neuromed

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Department Epidemiology and Prevention

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: February 24, 2015
• Study Start: August 18, 2015
• Primary Completion: September 15, 2016
• Study Completion: September 15, 2016
• Last Updated: January 12, 2022
• Results First Posted: February 15, 2021

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)