Effects of Two Different Exercise Programs and Diet in Obese Subjects With NAFLD

NCT06186869 | Recruiting

• 1 other identifier: AF_001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to estimate the effectiveness of two different exercise programs combined with the Mediterranean diet versus diet alone on inflammatory status in subjects aged 18-65 years with obesity (BMI\>30) and Non-Alcoholic Fatty Liver Disease (NAFLD) (CAP \>248 dB/m).

Conditions

Obesity; NAFLD

Keywords

Obesity; Physical Exercise; systemic inflammation; NAFLD

Outcome Measures

Primary Outcomes (1)

• The effect of diet and exercise on systemic inflammatory status

  To estimate the effect of two exercise programs of different types and intensity combined with a Mediterranean Low Glycaemic Index Diet (LGIMD) compared to diet alone on the systemic inflammation index (SII) and biomarkers related to the inflammatory state: C-reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) were measured after venous blood sampling. Proinflammatory (TNF-alpha; IL-1, IL-6, CK-18) and anti-inflammatory (IL-10) cytokines will be measured using commercially available ELISA tests for each.

  at baseline and day120

Secondary Outcomes (7)

• The effect of diet and exercise on body composition

  At baseline, day 60, and day 120

• The effect of diet and exercise on the gut microbiota

  At baseline and day 120

• The effect of diet and exercise on quality of life

  At baseline and day 120

• The effect of diet and exercise on the fatty acid profile of erythrocyte membranes

  At baseline and day 120

• The effect of diet and exercise on the risk of sarcopenia

  At baseline and day 120

Study Arms (3)

Aerobic Exercise and Mediterranean Diet

ACTIVE COMPARATOR

Subjects randomized and assigned to this intervention group will follow the low glycaemic index Mediterranean diet and simultaneously perform 180 minutes of moderate-intensity aerobic exercise per week for 4 months. Intervention type: aerobic exercise and Mediterranean diet.

Behavioral: Aerobic Exercise and diet intervention

HITT and Mediterranean Diet

ACTIVE COMPARATOR

Subjects randomized and assigned to this intervention group will follow the low glycaemic index Mediterranean diet and simultaneously perform 150 minutes per week of high-intensity interval exercise (HITT) in the gym for 4 months. Intervention type: HIIT and Mediterranean diet.

Behavioral: Hiit and diet intervention

Mediterranean Diet

ACTIVE COMPARATOR

Subjects randomized and assigned to this intervention group will follow the low-glycaemic index Mediterranean diet for 4 months. Intervention type: Mediterranean Diet.

Behavioral: Diet

Interventions

Diet BEHAVIORAL

subjects randomised and assigned to this intervention group will follow the low-glycaemic index Mediterranean diet

Mediterranean Diet

Aerobic Exercise and diet intervention BEHAVIORAL

subjects randomized and assigned to one intervention group, will follow the low glycaemic index Mediterranean diet and simultaneously perform moderate-intensity aerobic exercises

Aerobic Exercise and Mediterranean Diet

Hiit and diet intervention BEHAVIORAL

subjects randomised and assigned to one intervention group, will follow the low glycaemic index Mediterranean diet and simultaneously perform high-intensity interval exercises in the gym

HITT and Mediterranean Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 characterise metabolic syndrome
• Age range 18-65 years, both sexes
• Diagnosis of hepatic steatosis, formulated on the basis of recognised criteria (fibroscan (CAP (controlled attenuation parameter) \> 238 dB/m)).

You may not qualify if:

• Normal and underweight subjects
• Pregnancy or breastfeeding
• Subjects with osteoarticular pathologies that may prevent regular exercise
• Inability to quantify the degree of NAFLD by Fibroscan
• Person not in possession of a medical certificate of fitness for non-competitive physical activity.

Sponsors & Collaborators

• Antonella Bianco: collaborator
• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead
• Isabella Franco: collaborator

Study Sites (1)

IRCCS De Bellis

Castellana Grotte, Bari, 70013, Italy

RECRUITING

Related Publications (9)

• Ye Q, Zou B, Yeo YH, Li J, Huang DQ, Wu Y, Yang H, Liu C, Kam LY, Tan XXE, Chien N, Trinh S, Henry L, Stave CD, Hosaka T, Cheung RC, Nguyen MH. Global prevalence, incidence, and outcomes of non-obese or lean non-alcoholic fatty liver disease: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2020 Aug;5(8):739-752. doi: 10.1016/S2468-1253(20)30077-7. Epub 2020 May 12.

  PMID: 32413340 RESULT

• Miryan M, Darbandi M, Moradi M, Najafi F, Soleimani D, Pasdar Y. Relationship between the Mediterranean diet and risk of hepatic fibrosis in patients with non-alcoholic fatty liver disease: A cross-sectional analysis of the RaNCD cohort. Front Nutr. 2023 Feb 22;10:1062008. doi: 10.3389/fnut.2023.1062008. eCollection 2023.

  PMID: 36908910 RESULT

• Sanyal AJ, Anstee QM, Trauner M, Lawitz EJ, Abdelmalek MF, Ding D, Han L, Jia C, Huss RS, Chung C, Wong VW, Okanoue T, Romero-Gomez M, Muir AJ, Afdhal NH, Bosch J, Goodman Z, Harrison SA, Younossi ZM, Myers RP. Cirrhosis regression is associated with improved clinical outcomes in patients with nonalcoholic steatohepatitis. Hepatology. 2022 May;75(5):1235-1246. doi: 10.1002/hep.32204. Epub 2022 Feb 7.

  PMID: 34662449 RESULT

• Misciagna G, Del Pilar Diaz M, Caramia DV, Bonfiglio C, Franco I, Noviello MR, Chiloiro M, Abbrescia DI, Mirizzi A, Tanzi M, Caruso MG, Correale M, Reddavide R, Inguaggiato R, Cisternino AM, Osella AR. Effect of a Low Glycemic Index Mediterranean Diet on Non-Alcoholic Fatty Liver Disease. A Randomized Controlled Clinici Trial. J Nutr Health Aging. 2017;21(4):404-412. doi: 10.1007/s12603-016-0809-8.

  PMID: 28346567 RESULT

• Franco I, Bianco A, Diaz MDP, Bonfiglio C, Chiloiro M, Pou SA, Becaria Coquet J, Mirizzi A, Nitti A, Campanella A, Leone CM, Caruso MG, Correale M, Osella AR. Effectiveness of two physical activity programs on non-alcoholic fatty liver disease. a randomized controlled clinical trial. Rev Fac Cien Med Univ Nac Cordoba. 2019 Feb 27;76(1):26-36. doi: 10.31053/1853.0605.v76.n1.21638.

  PMID: 30882339 RESULT

• Franco I, Bianco A, Mirizzi A, Campanella A, Bonfiglio C, Sorino P, Notarnicola M, Tutino V, Cozzolongo R, Giannuzzi V, Aballay LR, Buongiorno C, Bruno I, Osella AR. Physical Activity and Low Glycemic Index Mediterranean Diet: Main and Modification Effects on NAFLD Score. Results from a Randomized Clinical Trial. Nutrients. 2020 Dec 28;13(1):66. doi: 10.3390/nu13010066.

  PMID: 33379253 RESULT

• Calabrese FM, Disciglio V, Franco I, Sorino P, Bonfiglio C, Bianco A, Campanella A, Lippolis T, Pesole PL, Polignano M, Vacca M, Caponio GR, Giannelli G, De Angelis M, Osella AR. A Low Glycemic Index Mediterranean Diet Combined with Aerobic Physical Activity Rearranges the Gut Microbiota Signature in NAFLD Patients. Nutrients. 2022 Apr 23;14(9):1773. doi: 10.3390/nu14091773.

  PMID: 35565740 RESULT

• Bianco A, Franco I, Curci R, Bonfiglio C, Campanella A, Mirizzi A, Fucilli F, Di Giovanni G, Giampaolo N, Pesole PL, Osella AR. Diet and Exercise Exert a Differential Effect on Glucose Metabolism Markers According to the Degree of NAFLD Severity. Nutrients. 2023 May 10;15(10):2252. doi: 10.3390/nu15102252.

  PMID: 37242135 RESULT

• Xu M, Chen R, Liu L, Liu X, Hou J, Liao J, Zhang P, Huang J, Lu L, Chen L, Fan M, Chen X, Zhu X, Liu B, Hu P. Systemic immune-inflammation index and incident cardiovascular diseases among middle-aged and elderly Chinese adults: The Dongfeng-Tongji cohort study. Atherosclerosis. 2021 Apr;323:20-29. doi: 10.1016/j.atherosclerosis.2021.02.012. Epub 2021 Feb 20.

  PMID: 33773161 RESULT

MeSH Terms

Conditions

Obesity; Non-alcoholic Fatty Liver Disease; Motor Activity

Interventions

Exercise; Diet

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Endrit Shahini, MD

  IRCCS Saverio de Bellis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Endrit Shahini, MD

CONTACT

00390804994249; endrit.shahini@irccsdebellis.it

Antonella Bianco

CONTACT

00390804994653; antonella.bianco@irccsdebellis.it

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: Dr

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: January 2, 2024
• Study Start: October 2, 2023
• Primary Completion: December 15, 2025
• Study Completion (Estimated): December 23, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

IT (1)