Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Complejo Hospitalario de Navarra | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control diet | Placebo Comparator | 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. |
|
| FLiO diet | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control diet | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Body fat at 6 months | Fat mass will be measured by Dual X-ray absorptiometry | Baseline and 6 months |
| Change from 6 month Body fat at 12 months | Fat mass will be measured by Dual X-ray absorptiometry |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| M. Angeles Zulet, PhD | Contact | +34948425600 | 806317 | mazulet@unav.es |
| Itziar Abete, PhD | Contact | +34948425600 | 806357 | iabetego@unav.es |
| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Nutrition Research, University of Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25937862 | Background | 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. | |
| 23968597 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 8, 2020 | |
| Reset | May 28, 2020 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 8, 2020 | May 28, 2020 |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| D007249 | Inflammation |
| D005247 | Feeding Behavior |
| D009043 | Motor Activity |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D044343 | Overnutrition |
Not provided
Not provided
The participants are randomly assigned to Control or FLiO strategy.
Not provided
Not provided
Not provided
|
|
| FLiO diet | Other | 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. |
|
|
| 6 months and 12 months |
| Change from Baseline Body fat at 12 months | Fat mass will be measured by Dual X-ray absorptiometry | Baseline and 12 months |
| Change from Baseline Waist circumference at 6 months | Waist circumference will be measured with a tape measure | Baseline and 6 months |
| Change from 6 month Waist circumference at 12 months | Waist circumference will be measured with a tape measure | 6 months and 12 months |
| Change from Baseline Waist circumference at 12 months | Waist circumference will be measured with a tape measure | Baseline and 12 months |
| Change from Baseline handgrip strength at 6 months | Handgrip strength will be measured with a dynamometer | Baseline and 6 months |
| Change from 6 month handgrip strength at 12 months | Handgrip strength will be measured with a dynamometer | 6 months and 12 months |
| Change from Baseline handgrip strength at 12 months | Handgrip strength will be measured with a dynamometer | Baseline and 12 months |
| Change from Baseline Systolic blood pressure at 6 months | Systolic blood pressure will be measured with a sphygmomanometer | Baseline and 6 months |
| Change from 6 month Systolic blood pressure at 12 months | Systolic blood pressure will be measured with a sphygmomanometer | 6 months and 12 months |
| Change from Baseline Systolic blood pressure at 12 months | Systolic blood pressure will be measured with a sphygmomanometer | Baseline and 12 months |
| Change from Baseline Diastolic blood pressure at 6 months | Diastolic blood pressure will be measured with a sphygmomanometer | Baseline and 6 months |
| Change from 6 month Diastolic blood pressure at 12 months | Diastolic blood pressure will be measured with a sphygmomanometer | 6 months and 12 months |
| Change from Baseline Diastolic blood pressure at 12 months | Diastolic blood pressure will be measured with a sphygmomanometer | Baseline and 12 months |
| Change from Baseline lipid metabolism at 6 months | Serum free fatty acids, triglycerides, total cholesterol, LDL cholesterol and HDL cholesterol concentrations will be measured in a fasting state | Baseline and 6 months |
| Change from 6 month lipid metabolism at 12 months | Serum free fatty acids, triglycerides, total cholesterol, LDL cholesterol and HDL cholesterol concentrations will be measured in a fasting state | 6 months and 12 months |
| Change from Baseline lipid metabolism at 12 months | Serum free fatty acids, triglycerides, total cholesterol, LDL cholesterol and HDL cholesterol concentrations will be measured in a fasting state | Baseline and 12 months |
| Change from Baseline uric acid concentration at 6 months | Serum uric acid will be measured in a fasting state | Baseline and 6 months |
| Change from 6 month uric acid concentration at 12 months | Serum uric acid will be measured in a fasting state | 6 months and 12 months |
| Change from Baseline uric acid concentration at 12 months | Serum uric acid will be measured in a fasting state | Baseline and 12 months |
| Change from Baseline homocysteine concentration at 6 months | Serum homocysteine will be measured in a fasting state | Baseline and 6 months |
| Change from 6 month homocysteine concentration at 12 months | Serum homocysteine will be measured in a fasting state | 6 months and 12 months |
| Change from Baseline homocysteine concentration at 12 months | Serum homocysteine will be measured in a fasting state | Baseline and 12 months |
| Change from Baseline glucose metabolism at 6 months | Serum glucose levels will be measured in a fasting state | Baseline and 6 months |
| Change from 6 month glucose metabolism at 12 months | Serum glucose levels will be measured in a fasting state | 6 months and 12 months |
| Change from Baseline glucose metabolism at 12 months | Serum glucose levels will be measured in a fasting state | Baseline and 12 months |
| Change from Baseline insulin concentration at 6 months | Serum insulin levels will be measured in a fasting state | Baseline and 6 months |
| Change from 6 month insulin concentration at 12 months | Serum insulin levels will be measured in a fasting state | 6 months and 12 months |
| Change from Baseline insulin concentration at 12 months | Serum insulin levels will be measured in a fasting state | Baseline and 12 months |
| Change from Baseline Hemoglobin A1c concentration at 6 months | Serum Hemoglobin A1c will be measured in a fasting state | Baseline and 6 months |
| Change from 6 month Hemoglobin A1c concentration at 12 months | Serum Hemoglobin A1c will be measured in a fasting state | 6 months and 12 months |
| Change from Baseline Hemoglobin A1c concentration at 12 months | Serum Hemoglobin A1c will be measured in a fasting state | Baseline and 12 months |
| Change from Baseline liver function at 6 months | Serum aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, total bilirubin, direct bilirubin, alkaline phosphatase, creatinine, total protein, albumin, prothrombin will be measured in a fasting state | Baseline and 12 months |
| Change from 6 month liver function at 12 months | Serum aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, total bilirubin, direct bilirubin, alkaline phosphatase, creatinine, total protein, albumin, prothrombin will be measured in a fasting state | 6 months and 12 months |
| Change from Baseline liver function at 12 months | Serum aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, total bilirubin, direct bilirubin, alkaline phosphatase, creatinine, total protein, albumin, prothrombin will be measured in a fasting state | Baseline and 12 months |
| Change from Baseline fibroblast growth factor 21 (FGF21) concentration at 6 months | Plasma FGF21 is a specific biomarker of NAFLD and will be measured in a fasting state | Baseline and 6 months |
| Change from 6 month fibroblast growth factor 21 (FGF21) concentration at 12 months | Plasma FGF21 is a specific biomarker of NAFLD and will be measured in a fasting state | 6 months and 12 months |
| Change from Baseline fibroblast growth factor 21 (FGF21) concentration at 12 months | Plasma FGF21 is a specific biomarker of NAFLD and will be measured in a fasting state | Baseline and 12 months |
| Change from Baseline cytokeratin-18 (CK18) concentration at 6 months | Plasma CK18 is a specific biomarker of NAFLD and will be measured in a fasting state | Baseline and 6 months |
| Change from 6 month cytokeratin-18 (CK18) concentration at 12 months | Plasma CK18 is a specific biomarker of NAFLD and will be measured in a fasting state | 6 months and 12 months |
| Change from Baseline cytokeratin-18 (CK18) concentration at 12 months | Plasma CK18 is a specific biomarker of NAFLD and will be measured in a fasting state | Baseline and 12 months |
| Change from Baseline C-reactive protein (CRP) concentration at 6 months | Plasma CRP will be assessed to determine inflammatory status | Baseline and 6 months |
| Change from 6 month C-reactive protein (CRP) concentration at 12 months | Plasma CRP will be assessed to determine inflammatory status | 6 months and 12 months |
| Change from Baseline C-reactive protein (CRP) concentration at 12 months | Plasma CRP will be assessed to determine inflammatory status | Baseline and 12 months |
| Change from Baseline interleukin 6 (IL-6) concentration at 6 months | Plasma IL-6 will be assessed to determine inflammatory status | Baseline and 6 months |
| Change from 6 month interleukin 6 (IL-6) concentration at 12 months | Plasma IL-6 will be assessed to determine inflammatory status | 6 months and 12 months |
| Change from Baseline interleukin 6 (IL-6) concentration at 12 months | Plasma IL-6 will be assessed to determine inflammatory status | Baseline and 12 months |
| Change from Baseline tumor necrosis factor-α (TNFα) concentration at 6 months | Plasma TNF-alpha will be assessed to determine inflammatory status | Baseline and 6 months |
| Change from 6 month tumor necrosis factor-α (TNFα) concentration at 12 months | Plasma TNF-alpha will be assessed to determine inflammatory status | 6 months and 12 months |
| Change from Baseline tumor necrosis factor-α (TNFα) concentration at 12 months | Plasma TNF-alpha will be assessed to determine inflammatory status | Baseline and 12 months |
| Change from Baseline leptin concentration at 6 months | Plasma leptin will be assessed to determine inflammatory status | Baseline and 6 months |
| Change from 6 month leptin concentration at 12 months | Plasma leptin will be assessed to determine inflammatory status | 6 months and 12 months |
| Change from Baseline leptin concentration at 12 months | Plasma leptin will be assessed to determine inflammatory status | Baseline and 12 months |
| Change from Baseline adiponectin concentration at 6 months | Plasma leptin will be assessed to determine inflammatory status | Baseline and 6 months |
| Change from 6 month adiponectin concentration at 12 months | Plasma adiponectin will be assessed to determine inflammatory status | Baseline and 12 months |
| Change from Baseline adiponectin concentration at 12 months | Plasma adiponectin will be assessed to determine inflammatory status | Baseline and 12 months |
| Change from Baseline LDL-oxidized concentration at 6 months | LDL-ox will be assessed to determine oxidative status | Baseline and 6 months |
| Change from 6 month LDL-oxidized concentration at 12 months | LDL-ox will be assessed to determine oxidative status | 6 months and 12 months |
| Change from Baseline LDL-oxidized concentration at 12 months | LDL-ox will be assessed to determine oxidative status | Baseline and 12 months |
| Change from Baseline Malondialdehyde concentration at 6 months | Plasma malondialdehyde will be assessed to determine oxidative status | Baseline and 6 months |
| Change from 6 month Malondialdehyde concentration at 12 months | Plasma malondialdehyde will be assessed to determine oxidative status | 6 months and 12 months |
| Change from Baseline Malondialdehyde concentration at 12 months | Plasma malondialdehyde will be assessed to determine oxidative status | Baseline and 12 months |
| Change from Baseline plasma antioxidant capacity at 6 months | Plasma antioxidant capacity will be assessed by measuring the ferric reducing ability of plasma (FRAP) | Baseline and 6 months |
| Change from 6 month plasma antioxidant capacity at 12 months | Plasma antioxidant capacity will be assessed by measuring the ferric reducing ability of plasma (FRAP) | 6 months and 12 months |
| Change from Baseline plasma antioxidant capacity at 12 months | Plasma antioxidant capacity will be assessed by measuring the ferric reducing ability of plasma (FRAP) | Baseline and 12 months |
| Change from Baseline Hepatic echography at 6 months | Echography will be carried out to analyze liver steatosis | Baseline and 6 months |
| Change from 6 month Hepatic echography at 12 months | Echography will be carried out to analyze liver steatosis | 6 months and 12 months |
| Change from Baseline Hepatic echography at 12 months | Echography will be carried out to analyze liver steatosis | Baseline and 12 months |
| Change from Baseline Hepatic elastography at 6 months | Elastography will be carried out to analyze liver fibrosis | Baseline and 6 months |
| Change from 6 month Hepatic elastography at 12 months | Elastography will be carried out to analyze liver fibrosis | 6 months and 12 months |
| Change from Baseline Hepatic elastography at 12 months | Elastography will be carried out to analyze liver fibrosis | Baseline and 12 months |
| Change from Baseline Hepatic Magnetic Resonance Imaging at 6 months | Magnetic Resonance Imaging will be carried out to analyze liver status | Baseline and 6 months |
| Change from 6 month Hepatic Magnetic Resonance Imaging at 12 months | Magnetic Resonance Imaging will be carried out to analyze liver status | 6 months and 12 months |
| Change from Baseline Hepatic Magnetic Resonance Imaging at 12 months | Magnetic Resonance Imaging will be carried out to analyze liver status | Baseline and 12 months |
| Change from Baseline White blood cell count at 6 months | White blood cell count includes: Leucocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophil, Basophils. | Baseline and 6 months |
| Change from 6 month White blood cell count at 12 months | White blood cell count includes: Leucocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophil, Basophils. | 6 months and 12 months |
| Change from Baseline White blood cell count at 12 months | White blood cell count includes: Leucocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophil, Basophils. | Baseline and 12 months |
| Change from Baseline blood rheological properties at 6 months | Red blood cell count, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red cell distribution width, platelet count, platelet distribution width, mean platelet volume, plateletcrit | Baseline and 6 months |
| Change from 6 month blood rheological properties at 12 months | Red blood cell count, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red cell distribution width, platelet count, platelet distribution width, mean platelet volume, plateletcrit | 6 months and 12 months |
| Change from Baseline blood rheological properties at 12 months | Red blood cell count, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red cell distribution width, platelet count, platelet distribution width, mean platelet volume, plateletcrit | Baseline and 12 months |
| Change from Baseline Physical activity level at 6 months | Physical activity will be assessed by accelerometers | Baseline and 6 months |
| Change from 6 months Physical activity level at 12 months | Physical activity will be assessed accelerometers | 6 months and 12 months |
| Change from Baseline Physical activity level at 12 months | Physical activity will be assessed by accelerometers | Baseline and 12 months |
| Change from Baseline Minnesota Physical Activity test at 6 months | Physical activity assessed by Minnesota Physical Activity test | Baseline and 6 months |
| Change from 6 month Minnesota Physical Activity test at 12 months | Physical activity assessed by Minnesota Physical Activity test | 6 months and 12 months |
| Change from Baseline Minnesota Physical Activity test at 12 months | Physical activity assessed by Minnesota Physical Activity test | Baseline and 12 months |
| Change from Baseline number of steps at 6 months | Physical activity assessed by Pedometers | Baseline and 6 months |
| Change from 6 month number of steps at 12 months | Physical activity assessed by Pedometers | 6 months and 12 months |
| Change from Baseline number of steps at 12 months | Physical activity assessed by Pedometers | Baseline and 12 months |
| Change from Baseline chair test at 6 months | Physical activity assessed by the chair test | Baseline and 6 months |
| Change from 6 month chair test at 12 months | Physical activity assessed by the chair test | 6 months and 12 months |
| Change from Baseline chair test at 12 months | Physical activity assessed by the chair test | Baseline and 12 months |
| Change from Baseline sleep quality at 6 months | Sleep information will be assessed by the Pittsburgh Sleep Quality Index | Baseline and 12 months |
| Change from 6 month sleep quality at 12 months | Sleep information will be assessed by the Pittsburgh Sleep Quality Index | 6 months and 12 months |
| Change from Baseline sleep quality at 12 months | Sleep information will be assessed by the Pittsburgh Sleep Quality Index | Baseline and 12 months |
| Change from Baseline Depressive symptoms at 6 months | Depressive symptoms will be assessed by the Beck Depression Inventory (BDI) | Baseline and 6 months |
| Change from 6 month Depressive symptoms at 12 months | Depressive symptoms will be assessed by the Beck Depression Inventory (BDI) | 6 months and 12 months |
| Change from Baseline Depressive symptoms at 12 months | Depressive symptoms will be assessed by the Beck Depression Inventory (BDI) | Baseline and 12 months |
| Change from Baseline Anxiety symptoms at 6 months | Anxiety symptoms will be assessed by State Anxiety test (STAI) | Baseline and 6 months |
| Change from 6 month Anxiety symptoms at 12 months | Anxiety symptoms will be assessed by State Anxiety test (STAI) | 6 months and 12 months |
| Change from Baseline Anxiety symptoms at 12 months | Anxiety symptoms will be assessed by State Anxiety test (STAI) | Baseline and 12 months |
| Single Nucleotide polymorphisms (SNPs) | Single nucleotide polymorphisms will be determined by Genomic DNA from oral epithelial cells | Baseline |
| Change from Baseline DNA methylation at 6 months | Epigenetics will be assessed by changes in DNA methylation of genes related with NAFLD development | Baseline and 6 months |
| Change from 6 month DNA methylation at 12 months | Epigenetics will be assessed by changes in DNA methylation of genes related with NAFLD development | 6 months and 12 months |
| Change from Baseline DNA methylation at 12 months | Epigenetics will be assessed by changes in DNA methylation of genes related with NAFLD development | Baseline and 12 months |
| Change from Baseline microRNAs at 6 months | Transcriptomic will be assessed by changes in miRNAs | Baseline and 6 months |
| Change from 6 month microRNAs at 12 months | Transcriptomic will be assessed by changes in miRNAs | 6 months and 12 months |
| Change from Baseline microRNAs at 12 months | Transcriptomic will be assessed by changes in miRNAs | Baseline and 12 months |
| Change from Baseline Gut microbiota composition at 6 months | Gut microbiota composition will be analyzed | Baseline and 6 months |
| Change from 6 month Gut microbiota composition at 12 month | Gut microbiota composition will be analyzed | 6 months and 12 months |
| Change from Baseline Gut microbiota composition at 12 month | Gut microbiota composition will be analyzed | Baseline and 12 months |
| Change from Baseline metabolites composition of urine at 6 months | Metabolites composition of urine will be analyzed | Baseline and 6 months |
| Change from 6 month metabolites composition of urine at 12 months | Metabolites composition of urine will be analyzed | 6 months and 12 months |
| Change from Baseline metabolites composition of urine at 12 months | Metabolites composition of urine will be analyzed | Baseline and 12 months |
| Change from Baseline metabolites composition of serum at 6 months | Metabolites composition of serum will be analyzed | Baseline and 6 months |
| Change from 6 month metabolites composition of serum at 12 months | Metabolites composition of serum will be analyzed | 6 months and 12 months |
| Change from Baseline metabolites composition of serum at 12 months | Metabolites composition of serum will be analyzed | Baseline and 12 months |
| Change from Baseline dietary intake at 6 months | Dietary intake will be assessed by means of food frequency questionnaire | Baseline and 6 months |
| Change from 6 month dietary intake at 12 months | Dietary intake will be assessed by means of food frequency questionnaire | 6 months and 12 months |
| Change from Baseline dietary intake at 12 months | Dietary intake will be assessed by means of food frequency questionnaire | Baseline and 12 months |
| Assessment of dietary adherence at Baseline | Dietary adherence will be assessed by means of 3 day weighed food records | Baseline |
| Assessment of dietary adherence at 6 months | Dietary adherence will be assessed by means of 3 day weighed food records | 6 months |
| Assessment of dietary adherence at 12 months | Dietary adherence will be assessed by means of 3 day weighed food records | 12 months |
| Change from Baseline satiety index at 6 months | Satiety index/appetite will be assessed by using the 100 mm Visual Analogue Scale | Baseline and 6 months |
| Change from 6 month satiety index at 12 months | Satiety index/appetite will be assessed by using the 100 mm Visual Analogue Scale | 6 months and 12 months |
| Change from Baseline satiety index at 12 months | Satiety index/appetite will be assessed by using the 100 mm Visual Analogue Scale | Baseline and 12 months |
| Change from Baseline life quality index at 6 months | Life quality index will be assessed by means of the Short Form 36 (SF-36) questionnaire | Baseline and 6 months |
| Change from 6 month life quality index at 12 months | Life quality index will be assessed by means of the Short Form 36 (SF-36) questionnaire | 6 months and 12 months |
| Change from Baseline life quality index at 12 months | Life quality index will be assessed by means of the Short Form 36 (SF-36) questionnaire | Baseline and 12 months |
| Change from Baseline Ghrelin concentration at 6 months | Serum Active Ghrelin will be determined to assess satiety | Baseline and 6 months |
| Change from 6 month Ghrelin concentration at 12 months | Serum Active Ghrelin will be determined to assess satiety | 6 months and 12 months |
| Change from Baseline Ghrelin concentration at 12 months | Serum Active Ghrelin will be determined to assess satiety | Baseline and 12 months |
| Change from Baseline glucagon-like peptide-1 (GLP-1) concentration at 6 months | Serum active glucagon-like peptide-1 will be determined to assess satiety | Baseline and 6 months |
| Change from 6 month glucagon-like peptide-1 (GLP-1) concentration at 12 months | Serum active glucagon-like peptide-1 will be determined to assess satiety | 6 months and 12 months |
| Change from Baseline glucagon-like peptide-1 (GLP-1) concentration at 12 months | Serum active glucagon-like peptide-1 will be determined to assess satiety | Baseline and 12 months |
| Change from Baseline Dopamine concentration at 6 months | Peripheral Dopamine concentration will be analysed using high-performance liquid chromatography (HPLC) | Baseline and 6 months |
| Change from 6 month Dopamine concentration at 12 months | Peripheral Dopamine concentration will be analysed using high-performance liquid chromatography (HPLC) | 6 months and 12 months |
| Change from Baseline Dopamine concentration at 12 months | Peripheral Dopamine concentration will be analysed using high-performance liquid chromatography (HPLC) | Baseline and 12 months |
| Change from Baseline Dopac concentration at 6 months | Peripheral Dopac concentration will be analysed using high-performance liquid chromatography (HPLC) | Baseline and 6 months |
| Change from 6 month Dopac concentration at 12 months | Peripheral Dopac concentration will be analysed using high-performance liquid chromatography (HPLC) | 6 months and 12 months |
| Change from Baseline Dopac concentration at 12 months | Peripheral Dopac concentration will be analysed using high-performance liquid chromatography (HPLC) | Baseline and 12 months |
| Change from Baseline Serotonin (5-HT) concentration at 6 months | Peripheral Serotonin concentration will be analysed using high-performance liquid chromatography (HPLC) | Baseline and 6 months |
| Change from 6 month Serotonin (5-HT) concentration at 12 months | Peripheral Serotonin concentration will be analysed using high-performance liquid chromatography (HPLC) | 6 months and 12 months |
| Change from Baseline Serotonin (5-HT) concentration at 12 months | Peripheral Serotonin concentration will be analysed using high-performance liquid chromatography (HPLC) | Baseline and 12 months |
| Change from Baseline Noradrenaline concentration at 6 months | Peripheral Noradrenaline concentration will be analysed using high-performance liquid chromatography (HPLC) | Baseline and 6 months |
| Change from 6 month Noradrenaline concentration at 12 months | Peripheral Noradrenaline concentration will be analysed using high-performance liquid chromatography (HPLC) | 6 months and 12 months |
| Change from Baseline Noradrenaline concentration at 12 months | Peripheral Noradrenaline concentration will be analysed using high-performance liquid chromatography (HPLC) | Baseline and 12 months |
| Change from Baseline 5-hydroxyindoleacetic acetic (5-HIAAC) concentration at 6 months | Peripheral 5-hydroxyindoleacetic acetic concentration will be analysed using high-performance liquid chromatography (HPLC) | Baseline and 6 months |
| Change from 6 month 5-hydroxyindoleacetic acetic (5-HIAAC) concentration at 12 months | Peripheral 5-hydroxyindoleacetic acetic concentration will be analysed using high-performance liquid chromatography (HPLC) | 6 months and 12 months |
| Change from Baseline 5-hydroxyindoleacetic acetic (5-HIAAC) concentration at 12 months | Peripheral 5-hydroxyindoleacetic acetic concentration will be analysed using high-performance liquid chromatography (HPLC) | Baseline and 12 months |
| Study Director |
| Itziar Abete, PhD | Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III, Madrid, Spain | Study Director |
| 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 | Study Chair |
| J. Ignacio Riezu, PhD | Centre for Nutrition Research, University of Navarra. | Study Chair |
| Mariana Elorz, MD | Clínica Universidad de Navarra | Study Chair |
| J. Ignacio Herrero, PhD | Clinica Universidad de Navarra | Study Chair |
| Jorge Quiroga, PhD | Clinica Universidad de Navarra | Study Chair |
| Alberto Benito, PhD | Clinica Universidad de Navarra | Study Chair |
| Carmen Fuertes | Clinica Universidad de Navarra | Study Chair |
| Santiago Navas, PhD | Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III, Madrid, Spain | Study Chair |
| Eva Almirón, PhD | Centre for Nutrition Research, University of Navarra. | Study Chair |
| Berta Araceli Marín | University of Navarra | Study Chair |
| Irene Cantero | University of Navarra | Study Chair |
| Maria Vanessa Bullon | University of Navarra | Study Chair |
| Blanca Martínez de Morentín, MD | University of Navarra | Study Chair |
| Salomé Pérez | University of Navarra | Study Chair |
| Veronica Ciaurriz | University of Navarra | Study Chair |
| Ana Martínez, MD | Complejo Hospitalario de Navarra | Study Chair |
| Juan Uriz, PhD | Complejo Hospitalario de Navarra | Study Chair |
| María Pilar Huarte, PhD | Complejo Hospitalario de Navarra | Study Chair |
| J. Ignacio Monreal, MD, PhD | Clinica Universidad de Navarra | Study Chair |
| 23535332 | Background | 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. |
| 23406163 | Background | 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. |
| 24587653 | Background | 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. |
| 22656328 | Result | 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. |
| 42159409 | Derived | 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. |
| 39549213 | Derived | 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. |
| 38861890 | Derived | 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. |
| 33550706 | Derived | 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. |
| 33474638 | Derived | 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. |
| 32857176 | Derived | 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. |
| 30662331 | Derived | 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. |
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D010335 | Pathologic Processes |
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |