Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT04442620
Status:
UNKNOWN
Last Update Posted:
2020-06-22
First Post:
2020-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention and Reversion of NAFLD in Obese Patients With Metabolic Syndrome by Mediterranean Diet and Physical Activity
Sponsor:
University of the Balearic Islands
Organization:
Study Overview
Official Title:
Prevention and Reversion of Non-Alcoholic Fatty Liver Disease in Obese Patients With Metabolic Syndrome by Mediterranean Diet and Physical Activity
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLIPAN
Brief 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).
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).
Detailed Description:
There is currently no licensed pharmacological treatment for reversing Non-Alcoholic Fatty Liver Disease (NAFLD), this is why nutritional and lifestyle strategies are pivotal to ameliorate risk factors and prevent disease progression. Weight loss achieved by a weight loss diet and exercise is certainly the principal treatment for the amelioration of fatty liver, nevertheless quality of diet composition could also play a crucial role. Since oxidative stress and inflammation have been cited among the mechanisms involved in NAFLD, foods containing antioxidant and anti-inflammatory bioactive components should be considered when designing a nutritionally sound diet. The Mediterranean Diet, naturally rich in antioxidants and antinflammatory foods, together with personalised physical activity could have a variety of positive health effects, including the slowing down of degenerative diseases such as liver steatosis.
The present study aims to compare and evaluate the efficacy of three interventions on the pathophysiological mechanisms that may affect changes in liver fat deposits and progression of NAFLD in patients with obesity and presenting at least three of the main Metabolic Syndrome traits.
The first intervention group receives a caloric restricted Mediterranean Diet coupled with physical activity (delivered through guided gym classes); the second group receives a caloric restricted Mediterranean Diet distributed over 7 meals and advise to walk 10.000 steps a day; the third group receives the conventional diet proposed by the American Association for the Study of Liver Diseases (AASLD) and advise to walk 10.000 steps a day.
The present study aims to compare and evaluate the efficacy of three interventions on the pathophysiological mechanisms that may affect changes in liver fat deposits and progression of NAFLD in patients with obesity and presenting at least three of the main Metabolic Syndrome traits.
The first intervention group receives a caloric restricted Mediterranean Diet coupled with physical activity (delivered through guided gym classes); the second group receives a caloric restricted Mediterranean Diet distributed over 7 meals and advise to walk 10.000 steps a day; the third group receives the conventional diet proposed by the American Association for the Study of Liver Diseases (AASLD) and advise to walk 10.000 steps a day.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: