Clinical trial NCT06186869: Effects of Two Different Exercise Programs and Diet in Obese Subjects With NAFLD
Official title: Effects of Two Different Exercise Programs Combined With the Mediterranean Diet on Inflammatory Status in Subjects With Obesity and NAFLD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
NAFLD
Keywords: Obesity
Physical Exercise
systemic inflammation
NAFLD
Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor class: OTHER
Collaborators: name: Antonella Bianco
name: Isabella Franco
First posted: 2024-01-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: 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.

Eligibility criteria: 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 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)).

Exclusion Criteria:

* 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
* Inability to quantify the degree of NAFLD by Fibroscan
* Person not in possession of a medical certificate of fitness for non-competitive physical activity.

Primary outcomes:
measure: The effect of diet and exercise on systemic inflammatory status
timeFrame: at baseline and day120
Secondary outcomes:
measure: The effect of diet and exercise on body composition
timeFrame: At baseline, day 60, and day 120
measure: The effect of diet and exercise on the gut microbiota
timeFrame: At baseline and day 120
measure: The effect of diet and exercise on quality of life
timeFrame: At baseline and day 120
measure: The effect of diet and exercise on the fatty acid profile of erythrocyte membranes
timeFrame: At baseline and day 120
measure: The effect of diet and exercise on the risk of sarcopenia
timeFrame: At baseline and day 120
measure: The effect of diet and exercise on the peptides of Integrity Intestinal Barrier
timeFrame: At baseline and day 120
measure: The effect of diet and exercise on the Intestinal dysbiosis
timeFrame: At baseline and day 120
Other outcomes:
Locations:
city: Castellana Grotte
country: Italy
facility: IRCCS De Bellis
state: Bari
Study officials:
affiliation: IRCCS Saverio de Bellis
name: Endrit Shahini, MD
role: PRINCIPAL_INVESTIGATOR
References:
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