Effects of Two Different Exercise Programs and Diet in Obese Subjects With NAFLD
NCT ID: NCT06186869
Last Updated: 2025-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2023-10-02
2026-12-23
Brief Summary
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Detailed Description
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The secondary objectives are: to assess whether the adoption of the two exercise programs of different types and intensities associated with an LGIMD compared to diet alone in patients with obesity and NAFLD can significantly modify body composition, inhibiting the risk of sarcopenia, in turn, favored by NAFLD, improve physical efficiency (fitness), understood as cardio-respiratory fitness muscular strength and flexibility, may also lead to improvements regarding the gut microbiota, in terms of abundance of microbial taxa, by studying, starting from the data obtained from the 16S, the metabolic pathways of the microbiota and fecal metabolome, as well as Quality of Life, by filling in specific questionnaires, and the evaluation of the fatty acid profile of erythrocyte membranes.
The two different types of exercise will be: - outdoor walking, understood as a moderate-intensity aerobic exercise, carried out 4 times a week, for a duration of 60 minutes for 4 months; - High-Intensity Interval Training carried out 3 times a week, for a period of 50 minutes at a time for 4 months in a gymnasium affiliated with the organization.
The diet will be the same for all project participants and will follow advice based on the Low Glycaemic Index Mediterranean Diet. All subjects will be followed by specialized personnel regarding both diet and exercise.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Aerobic Exercise and Mediterranean Diet
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.
Aerobic Exercise and diet intervention
subjects randomized and assigned to one intervention group, will follow the low glycaemic index Mediterranean diet and simultaneously perform moderate-intensity aerobic exercises
HITT and Mediterranean Diet
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.
Hiit and diet intervention
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
Mediterranean Diet
Subjects randomized and assigned to this intervention group will follow the low-glycaemic index Mediterranean diet for 4 months. Intervention type: Mediterranean Diet.
Diet
subjects randomised and assigned to this intervention group will follow the low-glycaemic index Mediterranean diet
Interventions
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Aerobic Exercise and diet intervention
subjects randomized and assigned to one intervention group, will follow the low glycaemic index Mediterranean diet and simultaneously perform moderate-intensity aerobic exercises
Hiit and diet intervention
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
Diet
subjects randomised and assigned to this intervention group will follow the low-glycaemic index Mediterranean diet
Eligibility Criteria
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Inclusion Criteria
* 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)).
* 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.
Exclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
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Antonella Bianco
UNKNOWN
Isabella Franco
UNKNOWN
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
OTHER
Responsible Party
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Dr. Endrit Shahini
Dr
Principal Investigators
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Endrit Shahini, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Saverio de Bellis
Locations
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IRCCS De Bellis
Castellana Grotte, Bari, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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AF_001
Identifier Type: -
Identifier Source: org_study_id
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