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FLiO
Non-alcoholic Fatty Liver Disease (NAFLD) in Overweight and Obese People Under Nutritional and Lifestyle Follow-up: a Randomized Controlled Trial
Sponsor study identifier
interventional
120
1 country
1
Study Start
June 2016
Actual (reported)Primary Completion
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2016
Actual (reported)March 31, 2017
Actual (reported)June 12, 2017
Actual (reported)December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change from Baseline Weight at 6 months
Weight will be measured by a digital scale
Baseline and 6 months
Change from 6 month Weight at 12 months
Weight will be measured by a digital scale
6 months and 12 months
Change from Baseline Weight at 12 months
Weight will be measured by a digital scale
Baseline and 12 months
A conventional and balanced diet based on American Heart Association (AHA) guidelines and lifestyle advice to achieve the objective of American Association for the Study of Liver Diseases (AASLD): loss of at least 3-5% of the initial body weight and up to 10% needed to improve necroinflammation.
A mediterranean dietary strategy based on macronutrient distribution (quantity and quality), antioxidant capacity, meal frequency, dietary behaviour and lifestyle advice to achieve the objective of AASLD: loss of at least 3-5% of the initial body weight and up to 10% needed to improve necroinflammation.
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).
Centre for Nutrition Research, University of Navarra
Pamplona, Navarre, 31008, Spain
Abd El-Kader SM, El-Den Ashmawy EM. Non-alcoholic fatty liver disease: The diagnosis and management. World J Hepatol. 2015 Apr 28;7(6):846-58. doi: 10.4254/wjh.v7.i6.846.
de la Iglesia R, Lopez-Legarrea P, Abete I, Bondia-Pons I, Navas-Carretero S, Forga L, Martinez JA, Zulet MA. A new dietary strategy for long-term treatment of the metabolic syndrome is compared with the American Heart Association (AHA) guidelines: the MEtabolic Syndrome REduction in NAvarra (RESMENA) project. Br J Nutr. 2014 Feb;111(4):643-52. doi: 10.1017/S0007114513002778. Epub 2013 Aug 23.
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
First Submitted
March 31, 2017
First Posted
June 12, 2017
Study Start
June 2016
Actual (reported)Primary Completion
Change from Baseline Body fat at 6 months
Baseline and 6 months
Change from 6 month Body fat at 12 months
6 months and 12 months
Change from Baseline Body fat at 12 months
Baseline and 12 months
Change from Baseline Waist circumference at 6 months
Baseline and 6 months
Change from 6 month Waist circumference at 12 months
6 months and 12 months
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.
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de la Iglesia R, Lopez-Legarrea P, Celada P, Sanchez-Muniz FJ, Martinez JA, Zulet MA. Beneficial effects of the RESMENA dietary pattern on oxidative stress in patients suffering from metabolic syndrome with hyperglycemia are associated to dietary TAC and fruit consumption. Int J Mol Sci. 2013 Mar 27;14(4):6903-19. doi: 10.3390/ijms14046903.
Lopez-Legarrea P, de la Iglesia R, Abete I, Bondia-Pons I, Navas-Carretero S, Forga L, Martinez JA, Zulet MA. Short-term role of the dietary total antioxidant capacity in two hypocaloric regimes on obese with metabolic syndrome symptoms: the RESMENA randomized controlled trial. Nutr Metab (Lond). 2013 Feb 13;10(1):22. doi: 10.1186/1743-7075-10-22.
Yasutake K, Kohjima M, Kotoh K, Nakashima M, Nakamuta M, Enjoji M. Dietary habits and behaviors associated with nonalcoholic fatty liver disease. World J Gastroenterol. 2014 Feb 21;20(7):1756-67. doi: 10.3748/wjg.v20.i7.1756.
Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ; American Gastroenterological Association; American Association for the Study of Liver Diseases; American College of Gastroenterologyh. The diagnosis and management of non-alcoholic fatty liver disease: practice guideline by the American Gastroenterological Association, American Association for the Study of Liver Diseases, and American College of Gastroenterology. Gastroenterology. 2012 Jun;142(7):1592-609. doi: 10.1053/j.gastro.2012.04.001. Epub 2012 May 15. No abstract available.
Mogna-Pelaez P, Zhang N, Guasch-Ferre M, Milagro FI, Riezu-Boj JI, Herrero JI, Elorz M, Benito-Boillos A, Tobaruela-Resola AL, Marti Del Moral A, Tur JA, Martinez JA, Abete I, Zulet MA. Planetary Health Diet Adherence Improves Weight and Body Composition During Energy Restriction. Obesity (Silver Spring). 2026 Jun;34(6):1265-1276. doi: 10.1002/oby.70215. Epub 2026 May 20.
Tobaruela-Resola AL, Riezu-Boj JI, Milagro FI, Mogna-Pelaez P, Herrero JI, Elorz M, Benito-Boillos A, Tur JA, Martinez JA, Abete I, Zulet MA. Circulating microRNA panels in subjects with metabolic dysfunction-associated steatotic liver disease after following a 2-year dietary intervention. J Endocrinol Invest. 2025 Apr;48(4):987-1003. doi: 10.1007/s40618-024-02499-9. Epub 2024 Nov 16.
Mogna-Pelaez P, Riezu-Boj JI, Milagro FI, Herrero JI, Elorz M, Benito-Boillos A, Tobaruela-Resola AL, Tur JA, Martinez JA, Abete I, Zulet MA. Inflammatory markers as diagnostic and precision nutrition tools for metabolic dysfunction-associated steatotic liver disease: Results from the Fatty Liver in Obesity trial. Clin Nutr. 2024 Jul;43(7):1770-1781. doi: 10.1016/j.clnu.2024.05.042. Epub 2024 May 31.
Marin-Alejandre BA, Cantero I, Perez-Diaz-Del-Campo N, Monreal JI, Elorz M, Herrero JI, Benito-Boillos A, Quiroga J, Martinez-Echeverria A, Uriz-Otano JI, Huarte-Muniesa MP, Tur JA, Martinez JA, Abete I, Zulet MA. Effects of two personalized dietary strategies during a 2-year intervention in subjects with nonalcoholic fatty liver disease: A randomized trial. Liver Int. 2021 Jul;41(7):1532-1544. doi: 10.1111/liv.14818. Epub 2021 Mar 1.
Perez-Diaz-Del-Campo N, Marin-Alejandre BA, Cantero I, Monreal JI, Elorz M, Herrero JI, Benito-Boillos A, Riezu-Boj JI, Milagro FI, Tur JA, Martinez JA, Abete I, Zulet MA. Differential response to a 6-month energy-restricted treatment depending on SH2B1 rs7359397 variant in NAFLD subjects: Fatty Liver in Obesity (FLiO) Study. Eur J Nutr. 2021 Sep;60(6):3043-3057. doi: 10.1007/s00394-020-02476-x. Epub 2021 Jan 20.
Galarregui C, Cantero I, Marin-Alejandre BA, Monreal JI, Elorz M, Benito-Boillos A, Herrero JI, de la O V, Ruiz-Canela M, Hermsdorff HHM, Bressan J, Tur JA, Martinez JA, Zulet MA, Abete I. Dietary intake of specific amino acids and liver status in subjects with nonalcoholic fatty liver disease: fatty liver in obesity (FLiO) study. Eur J Nutr. 2021 Jun;60(4):1769-1780. doi: 10.1007/s00394-020-02370-6. Epub 2020 Aug 28.
Cantero I, Elorz M, Abete I, Marin BA, Herrero JI, Monreal JI, Benito A, Quiroga J, Martinez A, Huarte MP, Uriz-Otano JI, Tur JA, Kearney J, Martinez JA, Zulet MA. Ultrasound/Elastography techniques, lipidomic and blood markers compared to Magnetic Resonance Imaging in non-alcoholic fatty liver disease adults. Int J Med Sci. 2019 Jan 1;16(1):75-83. doi: 10.7150/ijms.28044. eCollection 2019.
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
Clinica Universidad de Navarra, 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
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 12, 2017
Record last verified: 2017-06
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