Fatty Liver in Obesity: Long-lifestyle Follow-up (FLiO)

Summary

Non-alcoholic fatty liver disease (NAFLD) is a condition of excessive hepatic lipid accumulation in subjects that consume less than 20g ethanol per day, without other known causes as drugs consumption or toxins exposure. In Western countries, the rate of this disease lies about 30% in the general adult population. The process of developing NAFLD can start from simple steatosis to non-alcoholic steatohepatitis (NASH), which eventually can lead to cirrhosis and hepatocellular carcinoma in the absence of alcohol abuse. Liver biopsy is considered the "gold standard" of steatosis, fibrosis and cirrhosis. However, it is rarely performed because it is an invasive procedure and investigators are focusing in the application of non-invasive liver damage scores for diagnosis.

The pathogenesis of NAFLD is multifactorial and triggered by environmental factors such as unbalanced diets and overnutrition as well as by lack of physical activity in the context of a genetic predisposition. Nowadays, the treatment of NAFLD is based on diet and lifestyle modifications. Weight loss, exercise and healthy eating habits are the main tools to fight NAFLD. Nevertheless, there is no a well characterized dietary pattern and further studies are necessary.

With this background, the general aim of this project is to increase the knowledge on the influence of nutritional/lifestyle interventions in obese patients with NAFLD, as well as contribute to identify non-invasive biomarkers/scores to early diagnosis of this pathology in future obese people.

Conditions

• Non-Alcoholic Fatty Liver Disease
• Obese
• Overweight

Interventions

OTHER

Control diet

The participants follow a conventional and balanced distribution of macronutrients (30% fat, 15% protein, 55% carbohydrates), adequate fiber (25-30 g/day) and dietary cholesterol (\<250 mg/day) intake according to AHA guidelines. This strategy was included within a personalized energy-restricted diet (-30% individual needs) under healthy lifestyle advice in order to achieve the objectives of AASLD (loss of at least 3-5% of the initial body weight and up to 10% needed to improve necroinflammation).

OTHER

FLiO diet

The participants follow a strategy based on a distribution of macronutrients 30-35% lipid (extra virgin olive oil and fatty acids Ω3 in detriment of saturated, trans and cholesterol)/ protein 25% (vegetable against animal)/carbohydrates 40-45% (low glycaemic index, fiber 30-35 g/day); high adherence to the Mediterranean diet and natural antioxidants; meal frequency of 7 meals/day; size/composition of the ration suitable for each moment; including traditional foods with no additional economic cost that will allow diet adherence without abandonment; avoid inappropriate mealtimes and the eating manners as the eating rate. The participants are instructed to follow this strategy within a personalized energy-restricted diet (-30%) and under healthy lifestyle advice to achieve AASLD objectives.

Sponsors & Collaborators

• Complejo Hospitalario de Navarra

  collaborator OTHER

• Clinica Universidad de Navarra, Universidad de Navarra

  lead OTHER

Principal Investigators

• M. Angeles Zulet, PhD · Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III, Madrid, Spain

• J. Alfredo Martínez, MD, PhD · Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III, Madrid, Spain

• Itziar Abete, PhD · Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III, Madrid, Spain

• Fermín I Milagro, PhD · Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III, Madrid, Spain

• J. Ignacio Riezu, PhD · Centre for Nutrition Research, University of Navarra.

• Mariana Elorz, MD · Clínica Universidad de Navarra

• J. Ignacio Herrero, PhD · Clinica Universidad de Navarra

• Jorge Quiroga, PhD · Clinica Universidad de Navarra

• Alberto Benito, PhD · Clinica Universidad de Navarra

• Carmen Fuertes · Clinica Universidad de Navarra

• Santiago Navas, PhD · Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III, Madrid, Spain

• Eva Almirón, PhD · Centre for Nutrition Research, University of Navarra.

• Berta Araceli Marín · University of Navarra

• Irene Cantero · University of Navarra

• Maria Vanessa Bullon · University of Navarra

• Blanca Martínez de Morentín, MD · University of Navarra

• Salomé Pérez · University of Navarra

• Veronica Ciaurriz · University of Navarra

• Ana Martínez, MD · Complejo Hospitalario de Navarra

• Juan Uriz, PhD · Complejo Hospitalario de Navarra

• María Pilar Huarte, PhD · Complejo Hospitalario de Navarra

• J. Ignacio Monreal, MD, PhD · Clinica Universidad de Navarra

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2017-12-31

Completion

2019-12-31

Countries

• Spain

Study Locations