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

Plain Language Summary

Simplified for easier understanding

This study compares two exercise programs — moderate-intensity outdoor walking (4 sessions per week, 60 minutes each) and high-intensity interval training (HIIT, 3 sessions per week, 50 minutes each) — combined with a low glycaemic index Mediterranean diet, versus diet alone, in adults aged 18–65 with obesity and non-alcoholic fatty liver disease (NAFLD). Researchers are primarily looking at whether these exercise-plus-diet programs reduce inflammation markers in the body, and secondarily whether they improve body composition, physical fitness, gut microbiome, and quality of life over 4 months. Adults with a BMI of 30 or above (or significant abdominal obesity) and ultrasound-confirmed liver fat accumulation are eligible; those with other significant liver, neurological, cardiovascular, or musculoskeletal conditions that would prevent exercise are excluded. Participation involves attending supervised exercise sessions and following a structured dietary plan with guidance from specialized staff. This summary was prepared as patient-facing educational content using AI assistance.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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