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

Federico II University

Status: Completed

Conditions: NAFLD; Diabetes Type 2

Treatments: Other: Portfolio Diet; Other: MUFA Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03380416

16/17

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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49 participants in 2 patient groups

Portfolio Diet

Experimental group

Description:

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)

Treatment:

Other: Portfolio Diet

MUFA Diet

Active Comparator group

Description:

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)

Treatment:

Other: MUFA Diet