ObesityObesity_AFNCT06186869
Effects of Two Different Exercise Programs and Diet in Obese Subjects With NAFLD
A study testing Aerobic Exercise and diet intervention, Hiit and diet intervention and Diet in people with Obesity and NAFLD, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Aerobic Exercise and diet intervention, Hiit and diet intervention and Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 2 Oct 2023to 23 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS De Bellis
Castellana Grotte, Bari, 70013
Endrit Shahini, MD, 00390804994249, endrit.shahini@irccsdebellis.it
About this study
Official title: Effects of Two Different Exercise Programs Combined With the Mediterranean Diet on Inflammatory Status in Subjects With Obesity and 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).
Read the detailed 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.
- Being tested
- Aerobic Exercise and diet intervention, Hiit and diet intervention, Diet
- Keywords
- Obesity, Physical Exercise, systemic inflammation, NAFLD
- Medical subject headings
- Obesity, Non-alcoholic Fatty Liver Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise and diet interventionBehavioural
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 interventionBehavioural
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
DietBehavioural
subjects randomised and assigned to this intervention group will follow the low-glycaemic index Mediterranean diet
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise and Mediterranean Diet | Active comparator | 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. Receives: Behavioral: Aerobic Exercise and diet intervention |
| HITT and Mediterranean Diet | Active comparator | 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. Receives: Behavioral: Hiit and diet intervention |
| Mediterranean Diet | Active comparator | Subjects randomized and assigned to this intervention group will follow the low-glycaemic index Mediterranean diet for 4 months. Intervention type: Mediterranean Diet. Receives: Behavioral: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of diet and exercise on systemic inflammatory status
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.
Measured: at baseline and day120
Secondary outcomes (7)
The effect of diet and exercise on body composition
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.
Measured: At baseline, day 60, and day 120
The effect of diet and exercise on the gut microbiota
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.
Measured: At baseline and day 120
The effect of diet and exercise on quality of life
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.
Measured: At baseline and day 120
The effect of diet and exercise on the fatty acid profile of erythrocyte membranes
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.
Measured: At baseline and day 120
The effect of diet and exercise on the risk of sarcopenia
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)).
Measured: At baseline and day 120
The effect of diet and exercise on the peptides of Integrity Intestinal Barrier
Zonulin, I-FABP, DAO, and D-lactate assays will be performed using commercially available ELISA assays for each peptide.
Measured: At baseline and day 120
The effect of diet and exercise on the Intestinal dysbiosis
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.
Measured: At baseline and day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start2 Oct 2023
- Primary completion15 Dec 2025
- Study completion23 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Collaborators
- Antonella Bianco, Isabella Franco
- Responsible party
- Principal investigator, Dr. Endrit Shahini, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Investigators
- Endrit Shahini, MD, Principal investigator, IRCCS Saverio de Bellis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186869
- Sponsor's protocol ID
- AF_001
- Acronym
- Obesity_AF
- Status last verified
- Mar 2026
- First submitted
- 9 Nov 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ye Q, Zou B, Yeo YH, Li J, Huang DQ, Wu Y, Yang H, Liu C, Kam LY, Tan XXE, Chien N, Trinh S, Henry L, Stave CD, Hosaka T, Cheung RC, Nguyen MH. Global prevalence, incidence, and outcomes of non-obese or lean non-alcoholic fatty liver disease: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2020 Aug;5(8):739-752. doi: 10.1016/S2468-1253(20)30077-7. Epub 2020 May 12.
PubMed 32413340Miryan M, Darbandi M, Moradi M, Najafi F, Soleimani D, Pasdar Y. Relationship between the Mediterranean diet and risk of hepatic fibrosis in patients with non-alcoholic fatty liver disease: A cross-sectional analysis of the RaNCD cohort. Front Nutr. 2023 Feb 22;10:1062008. doi: 10.3389/fnut.2023.1062008. eCollection 2023.
PubMed 36908910Sanyal AJ, Anstee QM, Trauner M, Lawitz EJ, Abdelmalek MF, Ding D, Han L, Jia C, Huss RS, Chung C, Wong VW, Okanoue T, Romero-Gomez M, Muir AJ, Afdhal NH, Bosch J, Goodman Z, Harrison SA, Younossi ZM, Myers RP. Cirrhosis regression is associated with improved clinical outcomes in patients with nonalcoholic steatohepatitis. Hepatology. 2022 May;75(5):1235-1246. doi: 10.1002/hep.32204. Epub 2022 Feb 7.
PubMed 34662449Misciagna G, Del Pilar Diaz M, Caramia DV, Bonfiglio C, Franco I, Noviello MR, Chiloiro M, Abbrescia DI, Mirizzi A, Tanzi M, Caruso MG, Correale M, Reddavide R, Inguaggiato R, Cisternino AM, Osella AR. Effect of a Low Glycemic Index Mediterranean Diet on Non-Alcoholic Fatty Liver Disease. A Randomized Controlled Clinici Trial. J Nutr Health Aging. 2017;21(4):404-412. doi: 10.1007/s12603-016-0809-8.
PubMed 28346567Franco I, Bianco A, Diaz MDP, Bonfiglio C, Chiloiro M, Pou SA, Becaria Coquet J, Mirizzi A, Nitti A, Campanella A, Leone CM, Caruso MG, Correale M, Osella AR. Effectiveness of two physical activity programs on non-alcoholic fatty liver disease. a randomized controlled clinical trial. Rev Fac Cien Med Univ Nac Cordoba. 2019 Feb 27;76(1):26-36. doi: 10.31053/1853.0605.v76.n1.21638.
PubMed 30882339Franco I, Bianco A, Mirizzi A, Campanella A, Bonfiglio C, Sorino P, Notarnicola M, Tutino V, Cozzolongo R, Giannuzzi V, Aballay LR, Buongiorno C, Bruno I, Osella AR. Physical Activity and Low Glycemic Index Mediterranean Diet: Main and Modification Effects on NAFLD Score. Results from a Randomized Clinical Trial. Nutrients. 2020 Dec 28;13(1):66. doi: 10.3390/nu13010066.
PubMed 33379253Calabrese FM, Disciglio V, Franco I, Sorino P, Bonfiglio C, Bianco A, Campanella A, Lippolis T, Pesole PL, Polignano M, Vacca M, Caponio GR, Giannelli G, De Angelis M, Osella AR. A Low Glycemic Index Mediterranean Diet Combined with Aerobic Physical Activity Rearranges the Gut Microbiota Signature in NAFLD Patients. Nutrients. 2022 Apr 23;14(9):1773. doi: 10.3390/nu14091773.
PubMed 35565740Bianco A, Franco I, Curci R, Bonfiglio C, Campanella A, Mirizzi A, Fucilli F, Di Giovanni G, Giampaolo N, Pesole PL, Osella AR. Diet and Exercise Exert a Differential Effect on Glucose Metabolism Markers According to the Degree of NAFLD Severity. Nutrients. 2023 May 10;15(10):2252. doi: 10.3390/nu15102252.
PubMed 37242135Xu M, Chen R, Liu L, Liu X, Hou J, Liao J, Zhang P, Huang J, Lu L, Chen L, Fan M, Chen X, Zhu X, Liu B, Hu P. Systemic immune-inflammation index and incident cardiovascular diseases among middle-aged and elderly Chinese adults: The Dongfeng-Tongji cohort study. Atherosclerosis. 2021 Apr;323:20-29. doi: 10.1016/j.atherosclerosis.2021.02.012. Epub 2021 Feb 20.
PubMed 33773161
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Different Exercise Programs Combined With the Mediterranean Diet on Inflammatory Status in Subjects With Obesity and NAFLD
- ClinicalTrials.gov ID
- NCT06186869
- Acronym / sponsor ID
- Obesity_AF / AF_001
- Keywords
- Obesity, Physical Exercise, systemic inflammation, NAFLD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Collaborators
- Antonella Bianco, Isabella Franco
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 23 Dec 2026 (estimated)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise and Mediterranean Diet | Active comparator | Behavioral: Aerobic Exercise and diet interventionSubjects 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. |
| HITT and Mediterranean Diet | Active comparator | Behavioral: Hiit and diet interventionSubjects 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. |
| Mediterranean Diet | Active comparator | Behavioral: DietSubjects randomized and assigned to this intervention group will follow the low-glycaemic index Mediterranean diet for 4 months. Intervention type: Mediterranean Diet. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise and diet interventionsubjects randomized and assigned to one intervention group, will follow the low glycaemic index Mediterranean diet and simultaneously perform moderate-intensity aerobic exercises | Behavioural | Aerobic Exercise and Mediterranean Diet |
| Hiit and diet interventionsubjects 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 | Behavioural | HITT and Mediterranean Diet |
| Dietsubjects randomised and assigned to this intervention group will follow the low-glycaemic index Mediterranean diet | Behavioural | Mediterranean Diet |
Primary outcome
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.
7 secondary outcomes
The effect of diet and exercise on body composition
Time frame: At baseline, day 60, and day 120
The effect of diet and exercise on the gut microbiota
Time frame: At baseline and day 120
The effect of diet and exercise on quality of life
Time frame: At baseline and day 120
The effect of diet and exercise on the fatty acid profile of erythrocyte membranes
Time frame: At baseline and day 120
The effect of diet and exercise on the risk of sarcopenia
Time frame: At baseline and day 120
The effect of diet and exercise on the peptides of Integrity Intestinal Barrier
Time frame: At baseline and day 120
The effect of diet and exercise on the Intestinal dysbiosis
Time frame: At baseline and day 120
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Results publication: PubMed 32413340Ye Q, Zou B, Yeo YH, Li J, Huang DQ, Wu Y, Yang H, Liu C, Kam LY, Tan XXE, Chien N, Trinh S, Henry L, Stave CD, Hosaka T, Cheung RC, Nguyen MH. Global prevalence, incidence, and outcomes of non-obese or lean non-alcoholic fatty liver disease: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2020 Aug;5(8):739-752. doi: 10.1016/S2468-1253(20)30077-7. Epub 2020 May 12.
- Results publication: PubMed 36908910Miryan M, Darbandi M, Moradi M, Najafi F, Soleimani D, Pasdar Y. Relationship between the Mediterranean diet and risk of hepatic fibrosis in patients with non-alcoholic fatty liver disease: A cross-sectional analysis of the RaNCD cohort. Front Nutr. 2023 Feb 22;10:1062008. doi: 10.3389/fnut.2023.1062008. eCollection 2023.
- Results publication: PubMed 34662449Sanyal AJ, Anstee QM, Trauner M, Lawitz EJ, Abdelmalek MF, Ding D, Han L, Jia C, Huss RS, Chung C, Wong VW, Okanoue T, Romero-Gomez M, Muir AJ, Afdhal NH, Bosch J, Goodman Z, Harrison SA, Younossi ZM, Myers RP. Cirrhosis regression is associated with improved clinical outcomes in patients with nonalcoholic steatohepatitis. Hepatology. 2022 May;75(5):1235-1246. doi: 10.1002/hep.32204. Epub 2022 Feb 7.
- Results publication: PubMed 28346567Misciagna G, Del Pilar Diaz M, Caramia DV, Bonfiglio C, Franco I, Noviello MR, Chiloiro M, Abbrescia DI, Mirizzi A, Tanzi M, Caruso MG, Correale M, Reddavide R, Inguaggiato R, Cisternino AM, Osella AR. Effect of a Low Glycemic Index Mediterranean Diet on Non-Alcoholic Fatty Liver Disease. A Randomized Controlled Clinici Trial. J Nutr Health Aging. 2017;21(4):404-412. doi: 10.1007/s12603-016-0809-8.
- Results publication: PubMed 30882339Franco I, Bianco A, Diaz MDP, Bonfiglio C, Chiloiro M, Pou SA, Becaria Coquet J, Mirizzi A, Nitti A, Campanella A, Leone CM, Caruso MG, Correale M, Osella AR. Effectiveness of two physical activity programs on non-alcoholic fatty liver disease. a randomized controlled clinical trial. Rev Fac Cien Med Univ Nac Cordoba. 2019 Feb 27;76(1):26-36. doi: 10.31053/1853.0605.v76.n1.21638.
- Results publication: PubMed 33379253Franco I, Bianco A, Mirizzi A, Campanella A, Bonfiglio C, Sorino P, Notarnicola M, Tutino V, Cozzolongo R, Giannuzzi V, Aballay LR, Buongiorno C, Bruno I, Osella AR. Physical Activity and Low Glycemic Index Mediterranean Diet: Main and Modification Effects on NAFLD Score. Results from a Randomized Clinical Trial. Nutrients. 2020 Dec 28;13(1):66. doi: 10.3390/nu13010066.
- Results publication: PubMed 35565740Calabrese FM, Disciglio V, Franco I, Sorino P, Bonfiglio C, Bianco A, Campanella A, Lippolis T, Pesole PL, Polignano M, Vacca M, Caponio GR, Giannelli G, De Angelis M, Osella AR. A Low Glycemic Index Mediterranean Diet Combined with Aerobic Physical Activity Rearranges the Gut Microbiota Signature in NAFLD Patients. Nutrients. 2022 Apr 23;14(9):1773. doi: 10.3390/nu14091773.
- Results publication: PubMed 37242135Bianco A, Franco I, Curci R, Bonfiglio C, Campanella A, Mirizzi A, Fucilli F, Di Giovanni G, Giampaolo N, Pesole PL, Osella AR. Diet and Exercise Exert a Differential Effect on Glucose Metabolism Markers According to the Degree of NAFLD Severity. Nutrients. 2023 May 10;15(10):2252. doi: 10.3390/nu15102252.
- Results publication: PubMed 33773161Xu M, Chen R, Liu L, Liu X, Hou J, Liao J, Zhang P, Huang J, Lu L, Chen L, Fan M, Chen X, Zhu X, Liu B, Hu P. Systemic immune-inflammation index and incident cardiovascular diseases among middle-aged and elderly Chinese adults: The Dongfeng-Tongji cohort study. Atherosclerosis. 2021 Apr;323:20-29. doi: 10.1016/j.atherosclerosis.2021.02.012. Epub 2021 Feb 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Endrit Shahini, MD principal investigator
IRCCS Saverio de Bellis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and diet intervention, Hiit and diet intervention and Diet in people with Obesity and NAFLD, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Endrit Shahini, MD (00390804994249, endrit.shahini@irccsdebellis.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of diet and exercise on systemic inflammatory status (time frame: at baseline and day120). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06186869, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.