CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 49 enrolled
Drug / intervention
Portfolio Diet +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03380416
NCT03380416N/ACompleted
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Medium-term Effects of a Portfolio Diet on Non-alcoholic Fatty Liver Disease in Type 2 Diabetic Patients

Federico II University·interventional·Posted Dec 21, 2017·Updated Mar 3, 2020

In Brief

A clinical study evaluating Portfolio Diet and MUFA Diet for Diabetes Type 2 and NAFLD. Completed, enrolled 49 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Type 2, NAFLD
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedDec 21, 2017
Enrollment StartApr 4, 2017
Primary CompletionMar 7, 2019
Study CompletionDec 20, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.5 years ago

Interventions

Portfolio Dietother

Medium-term (8 weeks ) nutritional intervention

MUFA Dietother

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