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

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ClinicalTrials.gov Identifier: NCT03380416
Recruitment Status : Recruiting
First Posted : December 21, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
rivellese angela, 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.


Condition or disease Intervention/treatment Phase
Diabetes Type 2 NAFLD Other: Portfolio Diet Other: MUFA Diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Medium-term Effects of a Portfolio Diet on Non-alcoholic Fatty Liver Disease in Type 2 Diabetic Patients
Actual Study Start Date : April 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019


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




Primary Outcome Measures :
  1. Liver fat content [ Time Frame: Change from Baseline after 8 weeks ]
    MRI spectroscopy


Secondary Outcome Measures :
  1. Liver functionality [ Time Frame: Change from Baseline after 8 weeks ]
    Liver enzymes

  2. Blood pressure [ Time Frame: Change from Baseline after 8 weeks ]
  3. Endothelial function [ Time Frame: Change from Baseline after 8 weeks ]
    Flow-mediated dilation

  4. Liver fibrosis [ Time Frame: Change from Baseline after 8 weeks ]
    Transient Elastography

  5. Biochemical parameters [ Time Frame: Change from Baseline after 8 weeks ]
    glucose homeostasis (glucose)

  6. Body composition [ Time Frame: Change from Baseline after 8 weeks ]
    bioimpedance analyses (BIA)

  7. lipids [ Time Frame: Change from Baseline after 8 weeks ]
  8. subclinical inflammation [ Time Frame: Change from Baseline after 8 weeks ]
    elisa

  9. oxidative stress [ Time Frame: Change from Baseline after 8 weeks ]
    urinary isoprostanes

  10. Biochemical parameters [ Time Frame: Change from Baseline after 8 weeks ]
    glucose homeostasis (HbA1c)

  11. Biochemical parameters [ Time Frame: Change from Baseline after 8 weeks ]
    glucose homeostasis (Insulin)



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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380416


Locations
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Italy
Department of Clinical Medicine and Surgery Recruiting
Naples, Italy, 80131
Contact: Angela A Rivellese    +39 0817462154    rivelles@unina.it   
Sponsors and Collaborators
Federico II University

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Responsible Party: rivellese angela, Full Professor, Federico II University
ClinicalTrials.gov Identifier: NCT03380416     History of Changes
Other Study ID Numbers: 16/17
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Non-alcoholic Fatty Liver Disease
Diabetes Mellitus, Type 2
Fatty Liver
Liver Diseases
Digestive System Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases