Clinical trial NCT03183193: Fatty Liver in Obesity: Long-lifestyle Follow-up (FLiO)
Official title: Non-alcoholic Fatty Liver Disease (NAFLD) in Overweight and Obese People Under Nutritional and Lifestyle Follow-up: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Obese
Overweight
Keywords: NAFLD
NASH
Obesity
AASLD
AHA
Energy-restricted diet
Lifestyle intervention
Mediterranean diet
Weight loss
Liver damage
Inflammation
Oxidative stress
Microbiota composition
Eating behaviour
Satiety
Physical activity
Sedentary behaviours
Sleep quality
Sleep duration
Psychological factors
Nutrigenomics
Nutrigenetics
Transcriptomics
Epigenetics
Metabolomics
miRNAs
Lipidomics
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Complejo Hospitalario de Navarra
First posted: 2017-06-12
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants are randomly assigned to Control or FLiO strategy.
Primary purpose: TREATMENT

Brief 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.

Detailed description: This project is framed within the promotion of health and lifestyles and, specifically, in liver disorder linked to obesity (FLiO: Fatty Liver in Obesity).

The investigation addresses a randomized, parallel, long-term personalized nutritional intervention with two strategies: 1) Control diet based on American Heart Association (AHA); 2) Fatty Liver in Obesity (FLiO) diet based on previous results (RESMENA project).The diet is based on macronutrient distribution, quality and quantity, and is characterized by a low glycemic load, high adherence to the Mediterranean diet and a high antioxidant capacity, with the inclusion of anti-inflammatory foods. It also takes into account the distribution of food throughout the day, number of meals, portion sizes, timing of meal, individual needs, dietary behavior (behavioral therapy: eat slowly, teach what to buy, what to eat, when to eat). The participants are instructed to follow this strategy. This strategy (RESMENA) was even more effective than AHA after 6 months follow-up, in terms of significant reduction of abdominal fat and blood glucose level. In addition, this diet had beneficial effects for participants who were obese and had values of altered glucose, reducing significantly in RESMENA participants LDL-oxidized marker. These results are very important to apply in the present investigation since that patients with NAFLD are commonly insulin resistant.

Both strategies were designed within a hypocaloric dietary pattern (-30%) in order to achieve the American Association for the Study of Liver Diseases (AASLD) recommendations for the management of non-alcoholic liver disease (loss of at least 3-5% of body weight appears necessary to improve steatosis, but a greater weight loss, up to 10%, may be needed to improve necroinflammation). At this time the participants are individually supervised and encouraged to follow with the dietary planning instructions assigned. Furthermore, at baseline, 6, 12 and 24 months anticipated variables are obtained. Both dietary groups receive routine control (weight, body composition, strategy adherence) and dietary advice daily by phone (if they need help) and face to face at the time of routine control.

In order to get a integral lifestyle intervention, all participants will be encouraged to follow a healthy lifestyle. Thus, physical activity will be recorded in each dietary group.

The specific tasks:

1. To recruit and select patients with the adequate characteristics to validate the conclusions reached.
2. To develop and adequately transmit to each patient a personalized strategy according to the group randomly assigned ( AASLD vs FLiO strategy).
3. To check the degree of adherence to the strategy set by regular monitoring: semiquantitative questionnaires of food consumption frequency, pedometers, accelerometers, weight control, satiety.
4. To assess the effect of each strategy on body composition (weight, waist circumference, body fat, muscle mass, bone mineral density), physical status, general biochemistry (lipid profile, glycaemic profile, albumin, blood count, transaminases), specific biomarkers/metabolites in blood or urine (inflammation, oxidative stress, liver damage, appetite, psychological status), quality of life and related factors (anxiety, depression and sleep).
5. To check the evolution of the liver damage, using non-invasive techniques (ultrasound, elastography and magnetic resonance imaging (MRI), metabolomics analysis) and calculating different validated liver scores from the data obtained with each strategy.
6. To compare the effectiveness of strategies, considering not only the ability to decrease body fat, but also other risk factors present in the NAFLD patient such as insulin resistance and cardiovascular risk, which will result in improvement of liver damage.
7. To analyze SNPs (DNA from oral epithelial cells) and the association with NAFLD (diagnosis and response to the strategies).
8. To study gene expression (mRNAs) and microRNAs in white blood cells for identifying biomarkers of diagnosis and response to dietary strategy.
9. To analyze gene DNA methylation patterns in white blood cells for identifying biomarkers of diagnosis and response to dietary strategy.
10. To describe the intestinal microbiota composition by 16s sequencing at baseline and after nutritional intervention for diagnosis and response.

Eligibility criteria: Inclusion Criteria:

* Overweight or obese
* Diagnosis of NAFLD
* Age: 30-80 years
* Female / Male

Exclusion Criteria:

* Known liver disease (other than NAFLD)
* Abuse of alcohol (\>21 and \>14 units of alcohol a week for men and women, respectively, eg 1 unit = 125 mL of wine);
* Drug treatments: immunosuppressants, cytotoxic agents, systemic corticosteroids, agents potentially causing fatty liver disease or abnormal liver tests or weight modifiers
* Active cancer or a history of malignancy in the last 5 years
* Problems of massive edemas
* Obesity known endocrine origin (except treated hypothyroidism)
* Surgical procedure for weight loss
* ≥ 3kg weight loss in the last 3 months
* Severe psychiatric disorders
* Lack of autonomy or inability to follow the diet (including food allergies or intolerances) or/and lifestyle recommendations as well as to follow scheduled visits.
* Consumption of any type of food supplements (antioxidants, prebiotics, probiotics, etc.)

Primary outcomes:
measure: Change from Baseline Weight at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month Weight at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline Weight at 12 months
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change from Baseline Body fat at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month Body fat at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline Body fat at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Waist circumference at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month Waist circumference at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline Waist circumference at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline handgrip strength at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month handgrip strength at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline handgrip strength at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Systolic blood pressure at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month Systolic blood pressure at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline Systolic blood pressure at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Diastolic blood pressure at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month Diastolic blood pressure at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline Diastolic blood pressure at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline lipid metabolism at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month lipid metabolism at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline lipid metabolism at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline uric acid concentration at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month uric acid concentration at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline uric acid concentration at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline homocysteine concentration at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month homocysteine concentration at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline homocysteine concentration at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline glucose metabolism at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month glucose metabolism at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline glucose metabolism at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline insulin concentration at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month insulin concentration at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline insulin concentration at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Hemoglobin A1c concentration at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month Hemoglobin A1c concentration at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline Hemoglobin A1c concentration at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline liver function at 6 months
timeFrame: Baseline and 12 months
measure: Change from 6 month liver function at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline liver function at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline fibroblast growth factor 21 (FGF21) concentration at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month fibroblast growth factor 21 (FGF21) concentration at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline fibroblast growth factor 21 (FGF21) concentration at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline cytokeratin-18 (CK18) concentration at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month cytokeratin-18 (CK18) concentration at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline cytokeratin-18 (CK18) concentration at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline C-reactive protein (CRP) concentration at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month C-reactive protein (CRP) concentration at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline C-reactive protein (CRP) concentration at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline interleukin 6 (IL-6) concentration at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month interleukin 6 (IL-6) concentration at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline interleukin 6 (IL-6) concentration at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline tumor necrosis factor-α (TNFα) concentration at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month tumor necrosis factor-α (TNFα) concentration at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline tumor necrosis factor-α (TNFα) concentration at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline leptin concentration at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month leptin concentration at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline leptin concentration at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline adiponectin concentration at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month adiponectin concentration at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline adiponectin concentration at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline LDL-oxidized concentration at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month LDL-oxidized concentration at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline LDL-oxidized concentration at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Malondialdehyde concentration at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month Malondialdehyde concentration at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline Malondialdehyde concentration at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline plasma antioxidant capacity at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month plasma antioxidant capacity at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline plasma antioxidant capacity at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Hepatic echography at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month Hepatic echography at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline Hepatic echography at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Hepatic elastography at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month Hepatic elastography at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline Hepatic elastography at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Hepatic Magnetic Resonance Imaging at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month Hepatic Magnetic Resonance Imaging at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline Hepatic Magnetic Resonance Imaging at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline White blood cell count at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month White blood cell count at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline White blood cell count at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline blood rheological properties at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month blood rheological properties at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline blood rheological properties at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Physical activity level at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 months Physical activity level at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline Physical activity level at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Minnesota Physical Activity test at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month Minnesota Physical Activity test at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline Minnesota Physical Activity test at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline number of steps at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month number of steps at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline number of steps at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline chair test at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month chair test at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline chair test at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline sleep quality at 6 months
timeFrame: Baseline and 12 months
measure: Change from 6 month sleep quality at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline sleep quality at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Depressive symptoms at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month Depressive symptoms at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline Depressive symptoms at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Anxiety symptoms at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month Anxiety symptoms at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline Anxiety symptoms at 12 months
timeFrame: Baseline and 12 months
measure: Single Nucleotide polymorphisms (SNPs)
timeFrame: Baseline
measure: Change from Baseline DNA methylation at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month DNA methylation at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline DNA methylation at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline microRNAs at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month microRNAs at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline microRNAs at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Gut microbiota composition at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month Gut microbiota composition at 12 month
timeFrame: 6 months and 12 months
measure: Change from Baseline Gut microbiota composition at 12 month
timeFrame: Baseline and 12 months
measure: Change from Baseline metabolites composition of urine at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month metabolites composition of urine at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline metabolites composition of urine at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline metabolites composition of serum at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month metabolites composition of serum at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline metabolites composition of serum at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline dietary intake at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month dietary intake at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline dietary intake at 12 months
timeFrame: Baseline and 12 months
measure: Assessment of dietary adherence at Baseline
timeFrame: Baseline
measure: Assessment of dietary adherence at 6 months
timeFrame: 6 months
measure: Assessment of dietary adherence at 12 months
timeFrame: 12 months
measure: Change from Baseline satiety index at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month satiety index at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline satiety index at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline life quality index at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month life quality index at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline life quality index at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Ghrelin concentration at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month Ghrelin concentration at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline Ghrelin concentration at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline glucagon-like peptide-1 (GLP-1) concentration at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month glucagon-like peptide-1 (GLP-1) concentration at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline glucagon-like peptide-1 (GLP-1) concentration at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Dopamine concentration at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month Dopamine concentration at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline Dopamine concentration at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Dopac concentration at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month Dopac concentration at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline Dopac concentration at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Serotonin (5-HT) concentration at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month Serotonin (5-HT) concentration at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline Serotonin (5-HT) concentration at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Noradrenaline concentration at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month Noradrenaline concentration at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline Noradrenaline concentration at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline 5-hydroxyindoleacetic acetic (5-HIAAC) concentration at 6 months
timeFrame: Baseline and 6 months
measure: Change from 6 month 5-hydroxyindoleacetic acetic (5-HIAAC) concentration at 12 months
timeFrame: 6 months and 12 months
measure: Change from Baseline 5-hydroxyindoleacetic acetic (5-HIAAC) concentration at 12 months
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Centre for Nutrition Research, University of Navarra
state: Navarra
Study officials:
affiliation: Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III, Madrid, Spain
name: M. Angeles Zulet, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III, Madrid, Spain
name: J. Alfredo Martínez, MD, PhD
role: STUDY_DIRECTOR
affiliation: Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III, Madrid, Spain
name: Itziar Abete, PhD
role: STUDY_DIRECTOR
affiliation: Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III, Madrid, Spain
name: Fermín I Milagro, PhD
role: STUDY_CHAIR
affiliation: Centre for Nutrition Research, University of Navarra.
name: J. Ignacio Riezu, PhD
role: STUDY_CHAIR
affiliation: Clínica Universidad de Navarra
name: Mariana Elorz, MD
role: STUDY_CHAIR
affiliation: Clinica Universidad de Navarra
name: J. Ignacio Herrero, PhD
role: STUDY_CHAIR
affiliation: Clinica Universidad de Navarra
name: Jorge Quiroga, PhD
role: STUDY_CHAIR
affiliation: Clinica Universidad de Navarra
name: Alberto Benito, PhD
role: STUDY_CHAIR
affiliation: Clinica Universidad de Navarra
name: Carmen Fuertes
role: STUDY_CHAIR
affiliation: Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III, Madrid, Spain
name: Santiago Navas, PhD
role: STUDY_CHAIR
affiliation: Centre for Nutrition Research, University of Navarra.
name: Eva Almirón, PhD
role: STUDY_CHAIR
affiliation: University of Navarra
name: Berta Araceli Marín
role: STUDY_CHAIR
affiliation: University of Navarra
name: Irene Cantero
role: STUDY_CHAIR
affiliation: University of Navarra
name: Maria Vanessa Bullon
role: STUDY_CHAIR
affiliation: University of Navarra
name: Blanca Martínez de Morentín, MD
role: STUDY_CHAIR
affiliation: University of Navarra
name: Salomé Pérez
role: STUDY_CHAIR
affiliation: University of Navarra
name: Veronica Ciaurriz
role: STUDY_CHAIR
affiliation: Complejo Hospitalario de Navarra
name: Ana Martínez, MD
role: STUDY_CHAIR
affiliation: Complejo Hospitalario de Navarra
name: Juan Uriz, PhD
role: STUDY_CHAIR
affiliation: Complejo Hospitalario de Navarra
name: María Pilar Huarte, PhD
role: STUDY_CHAIR
affiliation: Clinica Universidad de Navarra
name: J. Ignacio Monreal, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.