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

NCT02369536 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2022-01-12

Study results available
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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

Interventions

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)

DIETARY_SUPPLEMENT

placebo

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

Sponsors & Collaborators

  • Neuromed IRCCS

    lead OTHER

Principal Investigators

  • Giovanni de Gaetano, MD PhD · IRCCS Neuromed

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-18
Primary Completion
2016-09-15
Completion
2016-09-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02369536 on ClinicalTrials.gov