Effects of Two Different Exercise Programs and Diet in Obese Subjects With NAFLD (Obesity_AF)

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Status: Enrolling

Conditions: Obesity; NAFLD

Treatments: Behavioral: Diet; Behavioral: Hiit and diet intervention; Behavioral: Aerobic Exercise and diet intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06186869

AF_001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Aerobic Exercise and Mediterranean Diet

Active Comparator group

Description:

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.

Treatment:

Behavioral: Aerobic Exercise and diet intervention

HITT and Mediterranean Diet

Active Comparator group

Description:

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.

Treatment:

Behavioral: Hiit and diet intervention

Mediterranean Diet

Active Comparator group

Description:

Subjects randomized and assigned to this intervention group will follow the low-glycaemic index Mediterranean diet for 4 months. Intervention type: Mediterranean Diet.

Treatment:

Behavioral: Diet