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

NCT03380416 | Completed

• 1 other identifier: 16/17
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Type 2; NAFLD

Outcome Measures

Primary Outcomes (1)

• Liver fat content

  MRI spectroscopy

  Change from Baseline after 8 weeks

Secondary Outcomes (11)

• Liver functionality

  Change from Baseline after 8 weeks

• Blood pressure

  Change from Baseline after 8 weeks

• Endothelial function

  Change from Baseline after 8 weeks

• Liver fibrosis

  Change from Baseline after 8 weeks

• Biochemical parameters

  Change from Baseline after 8 weeks

Study Arms (2)

Portfolio Diet

EXPERIMENTAL

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

MUFA Diet

ACTIVE COMPARATOR

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

Interventions

Portfolio Diet OTHER

Medium-term (8 weeks ) nutritional intervention

Portfolio Diet

MUFA Diet OTHER

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

MUFA Diet

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Clinical Medicine and Surgery

Naples, 80131, Italy

Location

Related Publications (4)

• 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.

  PMID: 40471240 DERIVED

• 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.

  PMID: 35862001 DERIVED

• 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.

  PMID: 35631319 DERIVED

• 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.

  PMID: 32448788 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: December 21, 2017
• Study Start: April 4, 2017
• Primary Completion: March 7, 2019
• Study Completion: December 20, 2019
• Last Updated: March 3, 2020

Record last verified: 2020-03

Locations

IT (1)