Effects of a Portfolio Diet on NAFLD in Type 2 Diabetic Patients
NCT ID: NCT03380416
Last Updated: 2020-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2017-04-04
2019-12-20
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Portfolio Diet
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)
Portfolio Diet
Medium-term (8 weeks ) nutritional intervention
MUFA Diet
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)
MUFA Diet
Medium-term (8 weeks ) nutritional intervention used as control
Interventions
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Portfolio Diet
Medium-term (8 weeks ) nutritional intervention
MUFA Diet
Medium-term (8 weeks ) nutritional intervention used as control
Eligibility Criteria
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Inclusion Criteria
* non-alcoholic fatty liver disease (evaluated by US)
* HbA1c \<7.5%
* LDL cholesterol \<130 mg/dl
Exclusion Criteria
* severe liver and kidney failure
* recent cardiovascular events (prior 6 months)
* any other acute/chronic disease (anemia, cancer, BPCO)
35 Years
75 Years
ALL
No
Sponsors
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Federico II University
OTHER
Responsible Party
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rivellese angela
Full Professor
Locations
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Department of Clinical Medicine and Surgery
Naples, , Italy
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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16/17
Identifier Type: -
Identifier Source: org_study_id
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