Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine

Open-label, Non-Pharmacological, Intervention Cohort Study Without Control Arm, in Patients With Non Alcoholic Fatty Liver Disease and in Healthy Subjects.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03300661

Acronym

SEELN

Enrollment

100

Registered

2017-10-03

Start date

2017-06-13

Completion date

2019-05-20

Last updated

2019-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet Modification, Lifestyle, Non Alcoholic Fatty Liver Disease

Brief summary

The study is an open-label intervention non pharmacological Cohort Study without control arm in patients with Non Alcoholic Fatty Liver Disease (NAFLD) and in healthy subjects. The intervention in patients with NAFLD is educational, providing personalized suggestions to improve diet and physical activity; the intervention in healthy subjects is educational, providing general suggestions to improve diet and physical activity.

Interventions

BEHAVIORALMediterranean Style

After completion of a Food Frequency Questinnaire (FFQ) and the International Physical Activity Questionnaire (IPAQ), patients enrolled in the study undergo a personalized educational intervention by a registered dietician. During the intervention the dietician advice about the main errors in diet and physical activity (by FFQ and IPAQ) and chooses three aims in diet modification and one aim in physical activity improvement. Patients adherence is assessed by the same dietician every three months, using FFQ and IPAQ, and futher supports are provided. Total intervention lenght is twelve months.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

A single cohort of patients with NAFLD, without control group.

Eligibility

Sex/Gender

ALL

Age

20 Years to 59 Years

Healthy volunteers

Yes

Inclusion criteria

* Presence of Fatty Liver at ultrasonography

Exclusion criteria

* Pregnancy; * Breast Feeding * Cirrhosis or End Stage Liver Disease * Fatty Liver due to Hepatic Diseases other than Non Alcoholic Fatty Liver disease * Concomitant severe clinical condition

Design outcomes

Primary

Measure	Time frame	Description
Weight loss	12 months	A reduction of at least 3 Kg
Body Mass Index (BMI) decrease	12 months	A dicresae of at least 1Kg/m2
Waist Circumference (WC) decrease	12 months	A decrease of at least 1.5 cm

Secondary

Measure	Time frame	Description
Blood sugar level decrease	12 months	A decrease of 6 mg/dL
Blood cholesterol level decrease	12 months	A decrease of 9 mg/dL
Blood triglycerides level dicrease	12 months	A decrease of 12 mg/dL

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026