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OpenTrials
Completed

NCT Number: NCT03300661

Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine

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.

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Key information

Conditions

Non Alcoholic Fatty Liver Disease Diet Modification Digestive System Diseases Fatty Liver Lifestyle Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

20 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ASST Spedali Civili Brescia

Brescia, 25123, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Weight loss

    Time frame: 12 months

    A reduction of at least 3 Kg

  2. Body Mass Index (BMI) decrease

    Time frame: 12 months

    A dicresae of at least 1Kg/m2

  3. Waist Circumference (WC) decrease

    Time frame: 12 months

    A decrease of at least 1.5 cm

Secondary outcomes

  1. Blood sugar level decrease

    Time frame: 12 months

    A decrease of 6 mg/dL

  2. Blood cholesterol level decrease

    Time frame: 12 months

    A decrease of 9 mg/dL

  3. Blood triglycerides level dicrease

    Time frame: 12 months

    A decrease of 12 mg/dL

Sponsors and collaborators

Lead sponsor

Università degli Studi di Brescia

Other

Registry information

Official study title

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

Acronym: SEELN

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 3, 2017
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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