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NCT Number: NCT06186869

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

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).

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Key information

Conditions

Obesity Behavior Body Weight Digestive System Diseases Fatty Liver Liver Diseases Motor Activity NAFLD Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS De Bellis

Castellana Grotte, Bari, 70013, Italy

Location status: Recruiting

Location contact

Endrit Shahini, MD

CONTACT

[email protected]

00390804994249

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. The effect of diet and exercise on systemic inflammatory status

    Time frame: at 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.

Secondary outcomes

  1. The effect of diet and exercise on body composition

    Time frame: At baseline, day 60, and day 120

    To evaluate whether adopting two exercise programs of different types and intensities combined with an LGIMD versus diet alone in patients with obesity and NAFLD can significantly change body composition assessed by BIA and anthropometric data measurement.

  2. The effect of diet and exercise on the gut microbiota

    Time frame: At baseline and day 120

    To investigate in patients with obesity and NAFLD, whether the adoption of the two programmes of Exercise of different types and intensities associated with an LGIMD compared to diet alone can improve the gut microbiota, in terms of abundances of microbial taxa, by studying, from the data obtained from the 16S, the metabolic pathways of the microbiota and faecal metabolome.

  3. The effect of diet and exercise on quality of life

    Time frame: At baseline and day 120

    To evaluate the improvements in Quality of Life, by filling out specific questionnaires, following the adoption of the two programmes of Exercise of different types and intensities combined with an LGIMD versus diet alone in patients with obesity and NAFLD for 4 months.

    The questionnaire is divided into 8 domains, and each of the 8 summed scores is transformed linearly on a scale from 0 (negative health) to 100 (positive health) to provide a score for each subscale. Each subscale can be used independently. Scores < 50 indicate negative health, and > 51 indicate positive health.

  4. The effect of diet and exercise on the fatty acid profile of erythrocyte membranes

    Time frame: At baseline and day 120

    All human blood samples will be treated with chloroform: methanol (2:1, v/v) and centrifuged. The lower layer, containing fatty acids, will be removed with care, replaced in a new tube, and dried by a centrifugal evaporator. The fatty acid methyl ester (FAME) will be obtained by adding toluene and BF3. Samples will be collected, transferred into a vial, and analyzed by gas chromatography.

  5. The effect of diet and exercise on the risk of sarcopenia

    Time frame: At baseline and day 120

    To evaluate whether the adoption of two exercise programmes of different types and intensities combined with an LGIMD versus diet alone in patients with obesity and NAFLD can reduce the risk of sarcopenia closely related to NAFLD as assessed by measuring muscle mass (via BIA), muscle strength (handgrip test) and physical performance (SHORT PHYSICAL PERFORMANCE BATTERY (SPPB)).

  6. The effect of diet and exercise on the peptides of Integrity Intestinal Barrier

    Time frame: At baseline and day 120

    Zonulin, I-FABP, DAO, and D-lactate assays will be performed using commercially available ELISA assays for each peptide.

  7. The effect of diet and exercise on the Intestinal dysbiosis

    Time frame: At baseline and day 120

    The intestinal dysbiosis will be evaluated by assaying Indole using a colorimetric analytical method as a marker of fermentative dysbiosis, Skatole, a marker of putrefactive dysbiosis, will be assessed using a refined chromatographic method with fluorimetric detection. Both assays will be conducted on a urine sample.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonella Bianco

CONTACT

[email protected]

00390804994653

Endrit Shahini, MD

CONTACT

[email protected]

00390804994249

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Other

Collaborators

  • Antonella Bianco
  • Isabella Franco

Registry information

Official study title

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

Acronym: Obesity_AF

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 2, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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