Effects of a Portfolio Diet on NAFLD in Type 2 Diabetic Patients

Conditions

Diabetes Type 2, NAFLD

Brief summary

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.

Costabile G, Salamone D, Della Pepa G, Testa R, Vitale M, Brancato V, Salvatore M, Soricelli A, Annuzzi G, Rivellese AA, Bozzetto L.

2025-06-05

10.1007/s00125-025-06464-w

Reduction of De Novo Lipogenesis Mediates Beneficial Effects of Isoenergetic Diets on Fatty Liver: Mechanistic Insights from the MEDEA Randomized Clinical Trial

Giuseppina Costabile, Giuseppe Della Pepa, Dominic Salamone, Delia Luongo, Daniele Naviglio et al. (14 authors)

Nutrients2022-05-2328 citations

10.3390/nu14102178

Effects of a multifactorial ecosustainable isocaloric diet on liver fat in patients with type 2 diabetes: randomized clinical trial

Giuseppe Della Pepa, Claudia Vetrani, Valentina Brancato, Marilena Vitale, Serena Monti et al. (17 authors)

BMJ Open Diabetes Research & Care2020-05-0120 citations

10.1136/bmjdrc-2020-001342

Interventions

OTHERPortfolio Diet

Medium-term (8 weeks ) nutritional intervention

OTHERMUFA Diet

Medium-term (8 weeks ) nutritional intervention used as control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

* type 2 diabetes * non-alcoholic fatty liver disease (evaluated by US) * HbA1c \<7.5% * LDL cholesterol \<130 mg/dl

Exclusion criteria

* hypoglycemic therapy with sodium-glucose cotransporter (SGLT-2), pioglitazone and glucagon-like peptide (GLP-1) analogues * severe liver and kidney failure * recent cardiovascular events (prior 6 months) * any other acute/chronic disease (anemia, cancer, BPCO)

Design outcomes

Primary

Measure	Time frame	Description
Liver fat content	Change from Baseline after 8 weeks	MRI spectroscopy

Secondary

Measure	Time frame	Description
Blood pressure	Change from Baseline after 8 weeks	—
Endothelial function	Change from Baseline after 8 weeks	Flow-mediated dilation
Liver fibrosis	Change from Baseline after 8 weeks	Transient Elastography
Biochemical parameters	Change from Baseline after 8 weeks	glucose homeostasis (glucose)
Liver functionality	Change from Baseline after 8 weeks	Liver enzymes
lipids	Change from Baseline after 8 weeks	—
subclinical inflammation	Change from Baseline after 8 weeks	elisa
oxidative stress	Change from Baseline after 8 weeks	urinary isoprostanes
Body composition	Change from Baseline after 8 weeks	bioimpedance analyses (BIA)

Countries

Italy

Outcome results

None listed