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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Type 2, NAFLD

Intervention / Treatment
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* Other: Portfolio Diet
* Other: MUFA Diet


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Portfolio Diet<br>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<br>* Medium-term (8 weeks ) nutritional intervention<br>|
| Active Comparator: MUFA Diet<br>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<br>* Medium-term (8 weeks ) nutritional intervention used as control<br>|

What is the study measuring?
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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 |