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Prevention and Reversion of NAFLD in Obese Patients With Metabolic Syndrome by Mediterranean Diet and Physical Activity

NCT04442620 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-06-22

No results posted yet for this study

Summary

This prospective randomized trial evaluates the role of customized dietary and physical activity intervention on the progression of Non-Alcoholic Fatty Liver Disease (NAFLD) in patients with obesity and presenting at least three of the main Metabolic Syndrome traits.

The project proposes a personalized nutritional intervention based on a Mediterranean customized diet which introduces plenty of antioxidant and anti-inflammatory bioactive components, coupled with physical activity promotion to prevent and reverse NAFLD among obese patients with metabolic syndrome. This will be compared with two more dietary strategies including a Mediterranean Diet intervention with seven meals a day and the conventional dietary approach proposed by the American Association for the Study of Liver Diseases (AASLD).

Conditions

  • Non Alcoholic Fatty Liver Disease

Interventions

OTHER

Physical activity and Mediterranean Diet (PA-MD)

Physical Activity plus caloric restricted Mediterranean diet

OTHER

High meal frequency of Mediterranean Diet (HMF-MD)

High meal frequency of unaltered Mediterranean diet

OTHER

Control diet (CD)

Control Diet

Sponsors & Collaborators

  • Fundació La Marató de TV3

    collaborator OTHER

  • University of the Balearic Islands

    lead OTHER

Principal Investigators

  • Josep A Tur, PhD · University of the Balearic Islands

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-26
Primary Completion
2019-11-29
Completion
2021-12-01

Countries

  • Spain

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 NCT04442620 on ClinicalTrials.gov