RecruitingNot ApplicableNCT06186869

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

Effects of Two Different Exercise Programs Combined With the Mediterranean Diet on Inflammatory Status in Subjects With Obesity and NAFLD


Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Enrollment

90 participants

Start Date

Oct 2, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria7

  • 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)).
  • 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.

Exclusion Criteria1

  • Normal and underweight subjects

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Interventions

BEHAVIORALAerobic Exercise and diet intervention

subjects randomized and assigned to one intervention group, will follow the low glycaemic index Mediterranean diet and simultaneously perform moderate-intensity aerobic exercises

BEHAVIORALHiit and diet intervention

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

BEHAVIORALDiet

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


Locations(1)

IRCCS De Bellis

Castellana Grotte, Bari, Italy

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NCT06186869


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