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

Medium-term Effects of a Portfolio Diet on Non-alcoholic Fatty Liver Disease in Type 2 Diabetic Patients

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.

Study Overview

• Status: Completed
• Conditions: NAFLD; Diabetes Type 2
• Intervention / Treatment: Other: Portfolio Diet; Other: MUFA Diet

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Department of Clinical Medicine and Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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)	Other: Portfolio Diet; Medium-term (8 weeks ) nutritional intervention
ACTIVE_COMPARATOR: 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)	Other: MUFA Diet; Medium-term (8 weeks ) nutritional intervention used as control

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver functionality	Liver enzymes	Change from Baseline after 8 weeks
Blood pressure		Change from Baseline after 8 weeks
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

Collaborators and Investigators

• Sponsor: Federico II University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 4, 2017
• Primary Completion (ACTUAL): March 7, 2019
• Study Completion (ACTUAL): December 20, 2019

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (ACTUAL): December 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 16/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No