About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)).
Disqualifiers
Normal and underweight subjects
Presence of any pathology that may influence the presence of steatosis apart from pathologies that are inclusion criteria, neurological and psychiatric pathologies, gastrointestinal, oncological and cardiovascular diseases
Pregnancy or breastfeeding
Subjects with osteoarticular pathologies that may prevent regular exercise
Trial design
Parallel
Treatments tested in this trial
Aerobic Exercise and diet intervention
Behavioralsubjects 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
Behavioralsubjects 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
Behavioralsubjects randomised and assigned to this intervention group will follow the low-glycaemic index Mediterranean diet
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
The effect of diet and exercise on body composition
To evaluate whether adopting two exercise programs of different types and intensities combined with an LGIMD versus diet alone in patients with obesity and NAFLD can significantly change body composition assessed by BIA and anthropometric data measurement.
The effect of diet and exercise on the gut microbiota
To investigate in patients with obesity and NAFLD, whether the adoption of the two programmes of Exercise of different types and intensities associated with an LGIMD compared to diet alone can improve the gut microbiota, in terms of abundances of microbial taxa, by studying, from the data obtained from the 16S, the metabolic pathways of the microbiota and faecal metabolome.
The effect of diet and exercise on quality of life
To evaluate the improvements in Quality of Life, by filling out specific questionnaires, following the adoption of the two programmes of Exercise of different types and intensities combined with an LGIMD versus diet alone in patients with obesity and NAFLD for 4 months. The questionnaire is divided into 8 domains, and each of the 8 summed scores is transformed linearly on a scale from 0 (negative health) to 100 (positive health) to provide a score for each subscale. Each subscale can be used independently. Scores \< 50 indicate negative health, and \> 51 indicate positive health.
The effect of diet and exercise on the fatty acid profile of erythrocyte membranes
All human blood samples will be treated with chloroform: methanol (2:1, v/v) and centrifuged. The lower layer, containing fatty acids, will be removed with care, replaced in a new tube, and dried by a centrifugal evaporator. The fatty acid methyl ester (FAME) will be obtained by adding toluene and BF3. Samples will be collected, transferred into a vial, and analyzed by gas chromatography.
Sponsors and contacts
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Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Lead sponsor
Antonella Bianco
Collaborator
Isabella Franco
Collaborator