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Patients with type 2 diabetes and non-alcoholic fatty liver disease will be enrolled.
According to a parallel design, the participants will be randomized to a Portfolio diet or a monounsaturated fatty acid (MUFA)-rich diet (used as control) for 8 weeks.
At the beginning and at the end of the trial, the participants will undergo a MRI spectroscopy to evaluate fatty liver content. Moreover, the participants will undergo a test meal resembling the nutritional composition of the assigned diet to evaluate fasting and postprandial metabolic response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Portfolio Diet | Experimental | The participants will follow a weight-maintaining diet characterized by whole-grain, polyphenol-rich foods, omega 3- rich foods, MUFA-rich foods (protein 18%/total energy, carbohydrates 41%/total energy, fat 41%/total energy, MUFA 26%/total energy, fiber 24 g/1000Kcal) polyphenols 2715/day, omega-3 2.6 g/day and omega-6 9.6 g/day) |
|
| MUFA Diet | Active Comparator | The participants will follow a weight-maintaining diet characterized by MUFA-rich food (olive oil) (protein 18%/total energy, carbohydrates 41%/total energy, fat 41%/total energy, MUFA 28%/total energy, fiber 10 g/1000Kcal) polyphenols 376/day, omega-3 1.1 g/day and omega-6 7.4 g/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portfolio Diet | Other | Medium-term (8 weeks ) nutritional intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Liver fat content | MRI spectroscopy | Change from Baseline after 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Liver functionality | Liver enzymes | Change from Baseline after 8 weeks |
| Blood pressure | Change from Baseline after 8 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Medicine and Surgery | Naples | 80131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40471240 | Derived | Costabile G, Salamone D, Della Pepa G, Testa R, Vitale M, Brancato V, Salvatore M, Soricelli A, Annuzzi G, Rivellese AA, Bozzetto L. ApoC-III and ectopic fat accumulation in individuals with type 2 diabetes: an exploratory analysis from the MEDEA randomised controlled study. Diabetologia. 2025 Sep;68(9):2036-2041. doi: 10.1007/s00125-025-06464-w. Epub 2025 Jun 5. | |
| 35862001 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| MUFA Diet |
| Other |
Medium-term (8 weeks ) nutritional intervention used as control |
|
| Endothelial function |
Flow-mediated dilation |
| Change from Baseline after 8 weeks |
| Liver fibrosis | Transient Elastography | Change from Baseline after 8 weeks |
| Biochemical parameters | glucose homeostasis (glucose) | Change from Baseline after 8 weeks |
| Body composition | bioimpedance analyses (BIA) | Change from Baseline after 8 weeks |
| lipids | Change from Baseline after 8 weeks |
| subclinical inflammation | elisa | Change from Baseline after 8 weeks |
| oxidative stress | urinary isoprostanes | Change from Baseline after 8 weeks |
| Biochemical parameters | glucose homeostasis (HbA1c) | Change from Baseline after 8 weeks |
| Biochemical parameters | glucose homeostasis (Insulin) | Change from Baseline after 8 weeks |
| Della Pepa G, Brancato V, Costabile G, Salamone D, Corrado A, Vitale M, Cavaliere C, Mancini M, Salvatore M, Luongo D, Riccardi G, Rivellese AA, Annuzzi G, Bozzetto L. An Isoenergetic Multifactorial Diet Reduces Pancreatic Fat and Increases Postprandial Insulin Response in Patients With Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2022 Sep 1;45(9):1935-1942. doi: 10.2337/dc22-0605. |
| 35631319 | Derived | Costabile G, Della Pepa G, Salamone D, Luongo D, Naviglio D, Brancato V, Cavaliere C, Salvatore M, Cipriano P, Vitale M, Corrado A, Rivellese AA, Annuzzi G, Bozzetto L. Reduction of De Novo Lipogenesis Mediates Beneficial Effects of Isoenergetic Diets on Fatty Liver: Mechanistic Insights from the MEDEA Randomized Clinical Trial. Nutrients. 2022 May 23;14(10):2178. doi: 10.3390/nu14102178. |
| 32448788 | Derived | Della Pepa G, Vetrani C, Brancato V, Vitale M, Monti S, Annuzzi G, Lombardi G, Izzo A, Tommasone M, Cipriano P, Clemente G, Mirabelli P, Mancini M, Salvatore M, Riccardi G, Rivellese AA, Bozzetto L. Effects of a multifactorial ecosustainable isocaloric diet on liver fat in patients with type 2 diabetes: randomized clinical trial. BMJ Open Diabetes Res Care. 2020 May;8(1):e001342. doi: 10.1136/bmjdrc-2020-001342. |
| D004700 | Endocrine System Diseases |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |