NCT04442620: FLIPAN

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

Status unknown NA Last updated 22 June 2020

What this trial tests

NA trial testing Physical activity and Mediterranean Diet (PA-MD) in Non Alcoholic Fatty Liver Disease in 150 participants. Status unknown.

Timeline

26 October 2017

Primary endpoint
29 November 2019

1 December 2021

Quick facts

Lead sponsor	University of the Balearic Islands
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	150
Start date	26 October 2017
Primary completion	29 November 2019
Estimated completion	1 December 2021
Sites	1 location across Spain

Drugs / interventions tested

• Physical activity and Mediterranean Diet (PA-MD)
• High meal frequency of Mediterranean Diet (HMF-MD)
• Control diet (CD)

Conditions studied

• Non Alcoholic Fatty Liver Disease — all drugs for Non Alcoholic Fatty Liver Disease →

Sponsor

University of the Balearic Islands

Who can join

Adults 40 to 60, any sex, with Non Alcoholic Fatty Liver Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Oxidative Stress and Pro-Inflammatory Status in Patients with Non-Alcoholic Fatty Liver Disease.
   Monserrat-Mesquida M, Quetglas-Llabrés M, Abbate M, Montemayor S, et al · · 2020 · cited 76× · PMID 32824349 · DOI 10.3390/antiox9080759
2. Adherence to Mediterranean Diet and NAFLD in Patients with Metabolic Syndrome: The FLIPAN Study.
   Montemayor S, Mascaró CM, Ugarriza L, Casares M, et al · · 2022 · cited 61× · PMID 35956364 · DOI 10.3390/nu14153186
3. Effect of Dietary and Lifestyle Interventions on the Amelioration of NAFLD in Patients with Metabolic Syndrome: The FLIPAN Study.
   Montemayor S, Bouzas C, Mascaró CM, Casares M, et al · · 2022 · cited 43× · PMID 35684022 · DOI 10.3390/nu14112223
4. Effect of a Six-Month Lifestyle Intervention on the Physical Activity and Fitness Status of Adults with NAFLD and Metabolic Syndrome.
   Mascaró CM, Bouzas C, Montemayor S, Casares M, et al · · 2022 · cited 35× · PMID 35565780 · DOI 10.3390/nu14091813
5. Lifestyle modifications for nonalcohol-related fatty liver disease: a network meta-analysis.
   Buzzetti E, Linden A, Best LM, Madden AM, et al · · 2021 · cited 28× · PMID 34114650 · DOI 10.1002/14651858.cd013156.pub2
6. Energy Expenditure Improved Risk Factors Associated with Renal Function Loss in NAFLD and MetS Patients.
   Abbate M, Mascaró CM, Montemayor S, Barbería-Latasa M, et al · · 2021 · cited 21× · PMID 33672073 · DOI 10.3390/nu13020629
7. Increased Adherence to the Mediterranean Diet after Lifestyle Intervention Improves Oxidative and Inflammatory Status in Patients with Non-Alcoholic Fatty Liver Disease.
   Monserrat-Mesquida M, Quetglas-Llabrés M, Bouzas C, Montemayor S, et al · · 2022 · cited 19× · PMID 35892642 · DOI 10.3390/antiox11081440
8. Mediterranean Diet Improves Plasma Biomarkers Related to Oxidative Stress and Inflammatory Process in Patients with Non-Alcoholic Fatty Liver Disease.
   Quetglas-Llabrés MM, Monserrat-Mesquida M, Bouzas C, Llompart I, et al · · 2023 · cited 18× · PMID 37107208 · DOI 10.3390/antiox12040833