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).
The main objective of the study is to estimate the effect of two exercise programs of different type and intensity combined with a Low Glycaemic Index Mediterranean Diet (LGIMD) compared to diet alone on the systemic inflammation index (SII) and biomarkers related to the inflammatory state: TNF-alpha; IL-1, IL-6, IL-10, CK-18, PCR and VES, in patients with obesity and NAFLD aged 18-65 years after a 4-month intervention. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
subjects randomized and assigned to one intervention group, will follow the low glycaemic index Mediterranean diet and simultaneously perform moderate-intensity aerobic exercises
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
subjects randomised and assigned to this intervention group will follow the low-glycaemic index Mediterranean diet
IRCCS De Bellis
Castellana Grotte, Bari, Italy
RECRUITINGThe 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.
Time frame: at baseline and day120
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.
Time frame: At baseline, day 60, and day 120
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.
Time frame: At baseline and day 120
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.
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Time frame: At baseline and day 120
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.
Time frame: At baseline and day 120
The effect of diet and exercise on the risk of sarcopenia
To evaluate whether the adoption of two exercise programmes of different types and intensities combined with an LGIMD versus diet alone in patients with obesity and NAFLD can reduce the risk of sarcopenia closely related to NAFLD as assessed by measuring muscle mass (via BIA), muscle strength (handgrip test) and physical performance (SHORT PHYSICAL PERFORMANCE BATTERY (SPPB)).
Time frame: At baseline and day 120
The effect of diet and exercise on the peptides of Integrity Intestinal Barrier
Zonulin, I-FABP, DAO, and D-lactate assays will be performed using commercially available ELISA assays for each peptide.
Time frame: At baseline and day 120
The effect of diet and exercise on the Intestinal dysbiosis
The intestinal dysbiosis will be evaluated by assaying Indole using a colorimetric analytical method as a marker of fermentative dysbiosis, Skatole, a marker of putrefactive dysbiosis, will be assessed using a refined chromatographic method with fluorimetric detection. Both assays will be conducted on a urine sample.
Time frame: At baseline and day 120