Influence of a Different Percentage of Nutrients on the Effects of a Low-calorie Mediterranean Diet Associated With Physical Exercise on the Parameters of Steatosis, Intestinal Function and Metabolic Risk in Patients With Obesity and NAFLD

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The study in question is an interventional study with nutritional intervention. The aim of the study is to evaluate whether the adoption of two different models of Mediterranean Diet, based on the different percentage of carbohydrates and lipids, associated with a program of moderate intensity aerobic physical exercise, in patients with obesity and NAFLD can exercise, after only 3 months, effects on: * specific aspects associated with NAFLD, such as the degree of hepatic steatosis and fibrosis; * circulating levels of molecules correlated with the degree of generalized and hepatic inflammation and the blood concentrations of metabolic and cardiovascular risk factors associated with abdominal obesity; * intestinal barrier; * body composition; * intestinal microbiota; * symptoms of IBS (irritable bowel syndrome) in patients with NAFLD.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• BMI ≥ 30 Kg/m2 or an abdominal circumference (waist) \> 94 cm in men and \> 80 cm in women (IDF criteria for the definition of abdominal obesity) with or without the characteristics that characterize metabolic syndrome

• Age range between 18 and 60 years, both sexes

• Diagnosis of hepatic steatosis, formulated on the basis of recognized criteria (fibroscan \[CAP (controlled attenuation parameter) \> 238 dB/m\], FLI).

Locations
Other Locations
Italy
Irccs Saverio de Bellis
RECRUITING
Castellana Grotte
Contact Information
Primary
Giovanni De PErgola, MD
giovanni.depergola@irccsdebellis.it
0804994653
Time Frame
Start Date: 2024-03-19
Estimated Completion Date: 2026-04-08
Participants
Target number of participants: 60
Treatments
Experimental: Intervention arm 1
The 1st arm involves a low-calorie diet, which respects the criteria of the Mediterranean diet, with the following macronutrient percentage: carbohydrates 50% of total calories, lipids 30% of total calories, proteins 20% of total calories.~The dietary intervention will be combined with moderate intensity exercise (outdoor walking).
Experimental: Intervention arm 2
The 2nd arm involves a low-calorie diet, which respects the criteria of the Mediterranean diet, with the following percentage of macronutrients: carbohydrates 30% of total calories, lipids 50% of total calories, proteins 20% of total calories.~The dietary intervention will be combined with moderate intensity exercise (outdoor walking).
Sponsors
Collaborators: Ignazzi Antonia, Cozzolongo Raffaele, Sila Annamaria, Coletta Sergio, Serino Grazia, Pesole Pasqua Letizia, Tatoli Rossella, Rinaldi Roberta, Franco Isabella, D'Attoma Benedetta, De Nucci Sara, Piccinno Emanuele, Bianco Antonella, Prospero Laura, Ancona Anna, Riezzo Giuseppe, Stabile Dolores, Shahini Endrit, Scalavino Viviana, Curci Ritanna, Giannuzzi Vito, Sciarra Sabrina, Cerabino Nicole, Zappimbulso Marianna, Bagnato Claudia Beatrice, Donghia Rossella, Russo Francesco
Leads: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

This content was sourced from clinicaltrials.gov

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