Obesity Clinical Trial
— NAFLD-POS5Official title:
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
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | April 8, 2026 |
Est. primary completion date | April 8, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: - Normal weight and underweight subjects - Presence of any pathology that could influence the presence of steatosis apart from the pathologies that represent inclusion criteria - 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Irccs Saverio de Bellis | Castellana Grotte | Bari |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis | Ancona Anna, Bagnato Claudia Beatrice, Bianco Antonella, Cerabino Nicole, Coletta Sergio, Cozzolongo Raffaele, Curci Ritanna, D'Attoma Benedetta, De Nucci Sara, Donghia Rossella, Franco Isabella, Giannuzzi Vito, Ignazzi Antonia, Pesole Pasqua Letizia, Piccinno Emanuele, Prospero Laura, Riezzo Giuseppe, Rinaldi Roberta, Russo Francesco, Scalavino Viviana, Sciarra Sabrina, Serino Grazia, Shahini Endrit, Sila Annamaria, Stabile Dolores, Tatoli Rossella, Zappimbulso Marianna |
Italy,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 ?GT).
Values considered normal are less than 30. |
at Baseline and after 90 days | |
Primary | 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, ?GT, 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-a) and anti-inflammatory (IL-4). |
at Baseline and after 90 days | |
Primary | 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 | The effect of the intervention on the Gastrointestinal Symptoms | 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 GI symptoms (IBS or functional dyspepsia or functional bloating) | at Baseline and after 90 days | |
Secondary | The effect of the intervention on the Body Composition | 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 body composition measured by BIA and anthropometric parameters. | at Baseline and after 90 days |
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