Influence of a Mediterranean Diet Combined With a Physical Activity Intervention, on NAFLD and Inflammation Parameters.

NCT06275906 | Completed

• 1 other identifier: NAFLD-POS5
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NAFLD; Obesity; IBS

Keywords

NAFLD; Obesity; Mediterranean diet; physical activity; walk

Outcome Measures

Primary Outcomes (4)

• The effect of intervention on CAP value

  To evaluate whether the adoption of one of the two different models of the Mediterranean diet, based on different percentages of carbohydrates and lipids, combined with a moderate-intensity aerobic exercise programme, in patients with obesity and NAFLD can exert favourable effects on the CAP value and the degree of liver fibrosis assessed by Fibroscan after only 3 months. Values considered normal are less than 5.1 kPa (kPascal)

  at Baseline and after 90 days

• The effect of intervention on FLI value

  To evaluate whether the adoption of one of the two different models of the Mediterranean diet, based on different percentages of carbohydrates and lipids, combined with a moderate-intensity aerobic exercise programme, in patients with obesity and NAFLD can exert favourable effects on the FLI value (fatty liver index), based on anthropometric parameters (BMI, abdominal circumference) and blood chemistry (triglycerides and γGT). Values considered normal are less than 30.

  at Baseline and after 90 days

• The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis, nutritional status, inflammatory status and metabolic and cardiovascular risk

  To evaluate whether the adoption of one of two different Mediterranean diet models, based on different percentages of carbohydrates and lipids, combined with a moderate intensity aerobic exercise program, in patients with obesity and NAFLD can exert favorable effects on routine blood chemistry tests parameters, relating to NAFLD, fibrosis, nutritional and inflammatory status, metabolic and cardiovascular risk. The following will be considered: blood sugar, insulin, glycated hemoglobin, triglycerides, total cholesterol, HDL and LDL, transaminases, γGT, creatinine, uric acid, blood count, ferritin, vitamin D, calcemia, IGF-I, TSH, FT3, FT4, proBNP and HOMA INDEX, adipokines (leptin, adiponcetin, RBP-4, resistin, visfatin, chemerin), hepatic growth factors (HGF, Fetuin-A, FGF21, FGF19, PAI-1) and proinflammatory cytokines (C-Reactive Protein, IL-6, IL-8, TNF-α) and anti-inflammatory (IL-4).

  at Baseline and after 90 days

• The effect of the intervention on the integrity of the intestinal barrier

  To evaluate whether the adoption of one of two different Mediterranean diet models, based on different percentages of carbohydrates and lipids, combined with a moderate intensity aerobic exercise program, in patients with obesity and NAFLD can exert favorable effects on the function and integrity of the intestinal barrier assessed by measuring Zonulin, I-FABP, DAO.

  at Baseline and after 90 days

Secondary Outcomes (2)

• The effect of the intervention on the Gastrointestinal Symptoms

  at Baseline and after 90 days

• The effect of the intervention on the Body Composition

  at Baseline and after 90 days

Study Arms (2)

Intervention arm 1

EXPERIMENTAL

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).

Other: Mediterranean diet and moderate intensity physical exercise (outdoor walking).

Intervention arm 2

EXPERIMENTAL

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).

Other: Mediterranean diet and moderate intensity physical exercise (outdoor walking).

Interventions

Mediterranean diet and moderate intensity physical exercise (outdoor walking). OTHER

Mediterranean Diet, based on the different percentage of carbohydrates and lipids, associated with a program of moderate intensity aerobic physical exercise (outdoor walking), in patients with obesity and NAFLD.

Intervention arm 1; Intervention arm 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Normal weight and underweight subjects
• Treatment with any device, pharmacological or otherwise, which can influence hepatic metabolism and, therefore, the presence of steatosis
• Pregnancy or breastfeeding
• Subjects with osteo-articular pathologies that may prevent regular physical exercise

Sponsors & Collaborators

• Pesole Pasqua Letizia: collaborator
• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead
• Russo Francesco: collaborator
• Coletta Sergio: collaborator
• Stabile Dolores: collaborator
• Riezzo Giuseppe: collaborator
• Cozzolongo Raffaele: collaborator
• Shahini Endrit: collaborator
• Zappimbulso Marianna: collaborator
• Giannuzzi Vito: collaborator
• De Nucci Sara: collaborator
• Rinaldi Roberta: collaborator
• Sila Annamaria: collaborator
• Tatoli Rossella: collaborator
• Cerabino Nicole: collaborator
• Donghia Rossella: collaborator
• Franco Isabella: collaborator
• Bianco Antonella: collaborator
• Curci Ritanna: collaborator
• Bagnato Claudia Beatrice: collaborator
• Sciarra Sabrina: collaborator
• Prospero Laura: collaborator
• Serino Grazia: collaborator
• Scalavino Viviana: collaborator
• Piccinno Emanuele: collaborator
• Ancona Anna: collaborator
• D'Attoma Benedetta: collaborator
• Ignazzi Antonia: collaborator

Study Sites (1)

Irccs Saverio de Bellis

Castellana Grotte, BARI, 70013, Italy

Location

Related Publications (7)

• Younossi ZM, Golabi P, Paik JM, Henry A, Van Dongen C, Henry L. The global epidemiology of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH): a systematic review. Hepatology. 2023 Apr 1;77(4):1335-1347. doi: 10.1097/HEP.0000000000000004. Epub 2023 Jan 3.

  PMID: 36626630 BACKGROUND

• Younossi Z, Anstee QM, Marietti M, Hardy T, Henry L, Eslam M, George J, Bugianesi E. Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention. Nat Rev Gastroenterol Hepatol. 2018 Jan;15(1):11-20. doi: 10.1038/nrgastro.2017.109. Epub 2017 Sep 20.

  PMID: 28930295 BACKGROUND

• Haigh L, Kirk C, El Gendy K, Gallacher J, Errington L, Mathers JC, Anstee QM. The effectiveness and acceptability of Mediterranean diet and calorie restriction in non-alcoholic fatty liver disease (NAFLD): A systematic review and meta-analysis. Clin Nutr. 2022 Sep;41(9):1913-1931. doi: 10.1016/j.clnu.2022.06.037. Epub 2022 Jul 2.

  PMID: 35947894 BACKGROUND

• Baker CJ, Martinez-Huenchullan SF, D'Souza M, Xu Y, Li M, Bi Y, Johnson NA, Twigg SM. Effect of exercise on hepatic steatosis: Are benefits seen without dietary intervention? A systematic review and meta-analysis. J Diabetes. 2021 Jan;13(1):63-77. doi: 10.1111/1753-0407.13086. Epub 2020 Aug 11.

  PMID: 32667128 BACKGROUND

• Wu S, Yuan C, Yang Z, Liu S, Zhang Q, Zhang S, Zhu S. Non-alcoholic fatty liver is associated with increased risk of irritable bowel syndrome: a prospective cohort study. BMC Med. 2022 Aug 22;20(1):262. doi: 10.1186/s12916-022-02460-8.

  PMID: 35989356 BACKGROUND

• Kawaguchi T, Takahashi H, Gerber LH. Clinics in Liver Disease: Update on Nonalcoholic Steatohepatitis: Sarcopenia and Nonalcoholic Fatty Liver Disease. Clin Liver Dis. 2023 May;27(2):275-286. doi: 10.1016/j.cld.2023.01.005. Epub 2023 Feb 26.

  PMID: 37024207 BACKGROUND

• Martin-Rincon M, Perez-Valera M, Morales-Alamo D, Perez-Suarez I, Dorado C, Gonzalez-Henriquez JJ, Juan-Habib JW, Quintana-Garcia C, Galvan-Alvarez V, Pedrianes-Martin PB, Acosta C, Curtelin D, Calbet JAL, de Pablos-Velasco P. Resting Energy Expenditure and Body Composition in Overweight Men and Women Living in a Temperate Climate. J Clin Med. 2020 Jan 11;9(1):203. doi: 10.3390/jcm9010203.

  PMID: 31940840 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity; Motor Activity

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., MD

Model Details: The study evaluates the effects of two different Mediterranean Diet models, based on different percentages of macronutrients, on NAFLD and Metabolic Risk. The Mediterranean Diet is associated with a program of moderate intensity aerobic physical exercise (walking) carried out 3 times a week for 3 months.

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 23, 2024
• Study Start: March 19, 2024
• Primary Completion: April 8, 2025
• Study Completion: April 8, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

IT (1)