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

Not Applicable

Completed

• Conditions: NAFLD; Diabetes Type 2
• Interventions: Other: Portfolio Diet; Other: MUFA Diet

• Registration Number: NCT03380416
• Lead Sponsor: Federico II University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-04
• Study First Submitted: 2017-10-30
• Study First Submitted QC: 2017-12-15
• Study First Posted: 2017-12-21
• Primary Completion: 2019-03-07
• Study Completion: 2019-12-20
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Portfolio Diet	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)
MUFA Diet	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)

Primary Outcome Measures

Name	Time	Method
Liver fat content	Change from Baseline after 8 weeks	MRI spectroscopy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Clinical Medicine and Surgery; 🇮🇹 Naples, Italy