Diabetes Type 2MEDEANCT03380416
Effects of a Portfolio Diet on NAFLD in Type 2 Diabetic Patients
A study testing Portfolio Diet and MUFA Diet in people with Diabetes Type 2 and NAFLD, run by Federico II University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Diabetes Type 2, NAFLD
- What is being tested?
- Portfolio Diet and MUFA Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteItaly
- Study dates
- 4 Apr 2017to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes
- non-alcoholic fatty liver disease (evaluated by US)
- HbA1c <7.5%
- LDL cholesterol <130 mg/dl
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diabetes Type 2, NAFLD
- Being tested
- Portfolio Diet, MUFA Diet
- Medical subject headings
- Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portfolio DietOther
Medium-term (8 weeks ) nutritional intervention
MUFA DietOther
Medium-term (8 weeks ) nutritional intervention used as control
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: MUFA Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fat content
MRI spectroscopy
Measured: Change from Baseline after 8 weeks
Secondary outcomes (11)
Liver functionality
Liver enzymes
Measured: Change from Baseline after 8 weeks
Blood pressure
Measured: Change from Baseline after 8 weeks
Endothelial function
Flow-mediated dilation
Measured: Change from Baseline after 8 weeks
Liver fibrosis
Transient Elastography
Measured: Change from Baseline after 8 weeks
Biochemical parameters
glucose homeostasis (glucose)
Measured: Change from Baseline after 8 weeks
Body composition
bioimpedance analyses (BIA)
Measured: Change from Baseline after 8 weeks
lipids
Measured: Change from Baseline after 8 weeks
subclinical inflammation
elisa
Measured: Change from Baseline after 8 weeks
oxidative stress
urinary isoprostanes
Measured: Change from Baseline after 8 weeks
Biochemical parameters
glucose homeostasis (HbA1c)
Measured: Change from Baseline after 8 weeks
Biochemical parameters
glucose homeostasis (Insulin)
Measured: Change from Baseline after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start4 Apr 2017
- Primary completion7 Mar 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rivellese angela, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380416
- Sponsor's protocol ID
- 16/17
- Acronym
- MEDEA
- Status last verified
- Mar 2020
- First submitted
- 30 Oct 2017
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40471240Della 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.
PubMed 35862001Costabile 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.
PubMed 35631319Della 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.
PubMed 32448788
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medium-term Effects of a Portfolio Diet on Non-alcoholic Fatty Liver Disease in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT03380416
- Acronym / sponsor ID
- MEDEA / 16/17
- Conditions
- Diabetes Type 2, NAFLD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 21 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Portfolio Diet | Experimental | Other: Portfolio DietThe 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 | Active comparator | Other: MUFA DietThe 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) |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- type 2 diabetes
- non-alcoholic fatty liver disease (evaluated by US)
- HbA1c <7.5%
- LDL cholesterol <130 mg/dl
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portfolio DietMedium-term (8 weeks ) nutritional intervention | Other | Portfolio Diet |
| MUFA DietMedium-term (8 weeks ) nutritional intervention used as control | Other | MUFA Diet |
Primary outcome
Liver fat content
Time frame: Change from Baseline after 8 weeks
MRI spectroscopy
11 secondary outcomes
Liver functionality
Time frame: Change from Baseline after 8 weeks
Blood pressure
Time frame: Change from Baseline after 8 weeks
Endothelial function
Time frame: Change from Baseline after 8 weeks
Liver fibrosis
Time frame: Change from Baseline after 8 weeks
Biochemical parameters
Time frame: Change from Baseline after 8 weeks
Body composition
Time frame: Change from Baseline after 8 weeks
lipids
Time frame: Change from Baseline after 8 weeks
subclinical inflammation
Time frame: Change from Baseline after 8 weeks
oxidative stress
Time frame: Change from Baseline after 8 weeks
Biochemical parameters
Time frame: Change from Baseline after 8 weeks
Biochemical parameters
Time frame: Change from Baseline after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Derived from this study: PubMed 40471240Costabile 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.
- Derived from this study: PubMed 35862001Della 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.
- Derived from this study: PubMed 35631319Costabile 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.
- Derived from this study: PubMed 32448788Della 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portfolio Diet and MUFA Diet in people with Diabetes Type 2 and NAFLD, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver fat content (time frame: Change from Baseline after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03380416, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.