Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06186869

Recruiting nowNot applicableInterventional

What this study is 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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersAccepted

ConditionObesity, NAFLD

Full registry 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.

Treatments and study arms

Aerobic Exercise and diet intervention

Behavioral

subjects 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

Behavioral

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

Diet

Behavioral

subjects randomised and assigned to this intervention group will follow the low-glycaemic index Mediterranean diet

Primary outcomes

The effect of diet and exercise on systemic inflammatory statusat baseline and day120

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

IRCCS De Bellis🇮🇹 Castellana Grotte, Bari, Italy

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Endrit Shahini, MDContact

Email · Call 00390804994249