Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine

NCT03300661 | Completed

• 1 other identifier: Ubrescia
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Alcoholic Fatty Liver Disease; Lifestyle; Diet Modification

Outcome Measures

Primary Outcomes (3)

• Weight loss

  A reduction of at least 3 Kg

  12 months

• Body Mass Index (BMI) decrease

  A dicresae of at least 1Kg/m2

  12 months

• Waist Circumference (WC) decrease

  A decrease of at least 1.5 cm

  12 months

Secondary Outcomes (3)

• Blood sugar level decrease

  12 months

• Blood cholesterol level decrease

  12 months

• Blood triglycerides level dicrease

  12 months

Study Arms (1)

Mediterranean Style

EXPERIMENTAL

Educational intervention with personalized suggestions to improve diet and physical activity

Behavioral: Mediterranean Style

Interventions

Mediterranean Style BEHAVIORAL

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.

Mediterranean Style

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Presence of Fatty Liver at ultrasonography

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi di Brescia: lead

Study Sites (1)

ASST Spedali Civili Brescia

Brescia, 25123, Italy

Location

Related Publications (1)

• Zanini B, Benini F, Marullo M, Simonetto A, Rossi A, Cavagnoli P, Bonalumi A, Marconi S, Pigozzi MG, Gilioli G, Valerio A, Donato F, Castellano M, Ricci C. Mediterranean-Oriented Dietary Intervention Is Effective to Reduce Liver Steatosis in Patients with Nonalcoholic Fatty Liver Disease: Results from an Italian Clinical Trial. Int J Clin Pract. 2024 Jan 25;2024:8861126. doi: 10.1155/2024/8861126. eCollection 2024.

  PMID: 38303926 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Chiara Ricci, MD. PhD

  Università degli Studi di Brescia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 3, 2017
• Study Start: June 13, 2017
• Primary Completion: May 17, 2019
• Study Completion: May 20, 2019
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)