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

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ClinicalTrials.gov Identifier: NCT03183193
Recruitment Status : Unknown
Verified June 2017 by Marian Zulet, University of Navarra.
Recruitment status was:  Recruiting
First Posted : June 12, 2017
Last Update Posted : June 12, 2017
Sponsor:
Collaborator:
Complejo Hospitalario de Navarra
Information provided by (Responsible Party):
Marian Zulet, University of Navarra

Tracking Information
First Submitted Date  ICMJE March 31, 2017
First Posted Date  ICMJE June 12, 2017
Last Update Posted Date June 12, 2017
Actual Study Start Date  ICMJE June 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2017)
  • Change from Baseline Weight at 6 months [ Time Frame: Baseline and 6 months ]
    Weight will be measured by a digital scale
  • Change from 6 month Weight at 12 months [ Time Frame: 6 months and 12 months ]
    Weight will be measured by a digital scale
  • Change from Baseline Weight at 12 months [ Time Frame: Baseline and 12 months ]
    Weight will be measured by a digital scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2017)
  • Change from Baseline Body fat at 6 months [ Time Frame: Baseline and 6 months ]
    Fat mass will be measured by Dual X-ray absorptiometry
  • Change from 6 month Body fat at 12 months [ Time Frame: 6 months and 12 months ]
    Fat mass will be measured by Dual X-ray absorptiometry
  • Change from Baseline Body fat at 12 months [ Time Frame: Baseline and 12 months ]
    Fat mass will be measured by Dual X-ray absorptiometry
  • Change from Baseline Waist circumference at 6 months [ Time Frame: Baseline and 6 months ]
    Waist circumference will be measured with a tape measure
  • Change from 6 month Waist circumference at 12 months [ Time Frame: 6 months and 12 months ]
    Waist circumference will be measured with a tape measure
  • Change from Baseline Waist circumference at 12 months [ Time Frame: Baseline and 12 months ]
    Waist circumference will be measured with a tape measure
  • Change from Baseline handgrip strength at 6 months [ Time Frame: Baseline and 6 months ]
    Handgrip strength will be measured with a dynamometer
  • Change from 6 month handgrip strength at 12 months [ Time Frame: 6 months and 12 months ]
    Handgrip strength will be measured with a dynamometer
  • Change from Baseline handgrip strength at 12 months [ Time Frame: Baseline and 12 months ]
    Handgrip strength will be measured with a dynamometer
  • Change from Baseline Systolic blood pressure at 6 months [ Time Frame: Baseline and 6 months ]
    Systolic blood pressure will be measured with a sphygmomanometer
  • Change from 6 month Systolic blood pressure at 12 months [ Time Frame: 6 months and 12 months ]
    Systolic blood pressure will be measured with a sphygmomanometer
  • Change from Baseline Systolic blood pressure at 12 months [ Time Frame: Baseline and 12 months ]
    Systolic blood pressure will be measured with a sphygmomanometer
  • Change from Baseline Diastolic blood pressure at 6 months [ Time Frame: Baseline and 6 months ]
    Diastolic blood pressure will be measured with a sphygmomanometer
  • Change from 6 month Diastolic blood pressure at 12 months [ Time Frame: 6 months and 12 months ]
    Diastolic blood pressure will be measured with a sphygmomanometer
  • Change from Baseline Diastolic blood pressure at 12 months [ Time Frame: Baseline and 12 months ]
    Diastolic blood pressure will be measured with a sphygmomanometer
  • Change from Baseline lipid metabolism at 6 months [ Time Frame: Baseline and 6 months ]
    Serum free fatty acids, triglycerides, total cholesterol, LDL cholesterol and HDL cholesterol concentrations will be measured in a fasting state
  • Change from 6 month lipid metabolism at 12 months [ Time Frame: 6 months and 12 months ]
    Serum free fatty acids, triglycerides, total cholesterol, LDL cholesterol and HDL cholesterol concentrations will be measured in a fasting state
  • Change from Baseline lipid metabolism at 12 months [ Time Frame: Baseline and 12 months ]
    Serum free fatty acids, triglycerides, total cholesterol, LDL cholesterol and HDL cholesterol concentrations will be measured in a fasting state
  • Change from Baseline uric acid concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Serum uric acid will be measured in a fasting state
  • Change from 6 month uric acid concentration at 12 months [ Time Frame: 6 months and 12 months ]
    Serum uric acid will be measured in a fasting state
  • Change from Baseline uric acid concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Serum uric acid will be measured in a fasting state
  • Change from Baseline homocysteine concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Serum homocysteine will be measured in a fasting state
  • Change from 6 month homocysteine concentration at 12 months [ Time Frame: 6 months and 12 months ]
    Serum homocysteine will be measured in a fasting state
  • Change from Baseline homocysteine concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Serum homocysteine will be measured in a fasting state
  • Change from Baseline glucose metabolism at 6 months [ Time Frame: Baseline and 6 months ]
    Serum glucose levels will be measured in a fasting state
  • Change from 6 month glucose metabolism at 12 months [ Time Frame: 6 months and 12 months ]
    Serum glucose levels will be measured in a fasting state
  • Change from Baseline glucose metabolism at 12 months [ Time Frame: Baseline and 12 months ]
    Serum glucose levels will be measured in a fasting state
  • Change from Baseline insulin concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Serum insulin levels will be measured in a fasting state
  • Change from 6 month insulin concentration at 12 months [ Time Frame: 6 months and 12 months ]
    Serum insulin levels will be measured in a fasting state
  • Change from Baseline insulin concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Serum insulin levels will be measured in a fasting state
  • Change from Baseline Hemoglobin A1c concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Serum Hemoglobin A1c will be measured in a fasting state
  • Change from 6 month Hemoglobin A1c concentration at 12 months [ Time Frame: 6 months and 12 months ]
    Serum Hemoglobin A1c will be measured in a fasting state
  • Change from Baseline Hemoglobin A1c concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Serum Hemoglobin A1c will be measured in a fasting state
  • Change from Baseline liver function at 6 months [ Time Frame: Baseline and 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
  • Change from 6 month liver function at 12 months [ Time Frame: 6 months and 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
  • Change from Baseline liver function at 12 months [ Time Frame: Baseline and 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
  • Change from Baseline fibroblast growth factor 21 (FGF21) concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Plasma FGF21 is a specific biomarker of NAFLD and will be measured in a fasting state
  • Change from 6 month fibroblast growth factor 21 (FGF21) concentration at 12 months [ Time Frame: 6 months and 12 months ]
    Plasma FGF21 is a specific biomarker of NAFLD and will be measured in a fasting state
  • Change from Baseline fibroblast growth factor 21 (FGF21) concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Plasma FGF21 is a specific biomarker of NAFLD and will be measured in a fasting state
  • Change from Baseline cytokeratin-18 (CK18) concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Plasma CK18 is a specific biomarker of NAFLD and will be measured in a fasting state
  • Change from 6 month cytokeratin-18 (CK18) concentration at 12 months [ Time Frame: 6 months and 12 months ]
    Plasma CK18 is a specific biomarker of NAFLD and will be measured in a fasting state
  • Change from Baseline cytokeratin-18 (CK18) concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Plasma CK18 is a specific biomarker of NAFLD and will be measured in a fasting state
  • Change from Baseline C-reactive protein (CRP) concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Plasma CRP will be assessed to determine inflammatory status
  • Change from 6 month C-reactive protein (CRP) concentration at 12 months [ Time Frame: 6 months and 12 months ]
    Plasma CRP will be assessed to determine inflammatory status
  • Change from Baseline C-reactive protein (CRP) concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Plasma CRP will be assessed to determine inflammatory status
  • Change from Baseline interleukin 6 (IL-6) concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Plasma IL-6 will be assessed to determine inflammatory status
  • Change from 6 month interleukin 6 (IL-6) concentration at 12 months [ Time Frame: 6 months and 12 months ]
    Plasma IL-6 will be assessed to determine inflammatory status
  • Change from Baseline interleukin 6 (IL-6) concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Plasma IL-6 will be assessed to determine inflammatory status
  • Change from Baseline tumor necrosis factor-α (TNFα) concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Plasma TNF-alpha will be assessed to determine inflammatory status
  • Change from 6 month tumor necrosis factor-α (TNFα) concentration at 12 months [ Time Frame: 6 months and 12 months ]
    Plasma TNF-alpha will be assessed to determine inflammatory status
  • Change from Baseline tumor necrosis factor-α (TNFα) concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Plasma TNF-alpha will be assessed to determine inflammatory status
  • Change from Baseline leptin concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Plasma leptin will be assessed to determine inflammatory status
  • Change from 6 month leptin concentration at 12 months [ Time Frame: 6 months and 12 months ]
    Plasma leptin will be assessed to determine inflammatory status
  • Change from Baseline leptin concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Plasma leptin will be assessed to determine inflammatory status
  • Change from Baseline adiponectin concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Plasma leptin will be assessed to determine inflammatory status
  • Change from 6 month adiponectin concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Plasma adiponectin will be assessed to determine inflammatory status
  • Change from Baseline adiponectin concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Plasma adiponectin will be assessed to determine inflammatory status
  • Change from Baseline LDL-oxidized concentration at 6 months [ Time Frame: Baseline and 6 months ]
    LDL-ox will be assessed to determine oxidative status
  • Change from 6 month LDL-oxidized concentration at 12 months [ Time Frame: 6 months and 12 months ]
    LDL-ox will be assessed to determine oxidative status
  • Change from Baseline LDL-oxidized concentration at 12 months [ Time Frame: Baseline and 12 months ]
    LDL-ox will be assessed to determine oxidative status
  • Change from Baseline Malondialdehyde concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Plasma malondialdehyde will be assessed to determine oxidative status
  • Change from 6 month Malondialdehyde concentration at 12 months [ Time Frame: 6 months and 12 months ]
    Plasma malondialdehyde will be assessed to determine oxidative status
  • Change from Baseline Malondialdehyde concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Plasma malondialdehyde will be assessed to determine oxidative status
  • Change from Baseline plasma antioxidant capacity at 6 months [ Time Frame: Baseline and 6 months ]
    Plasma antioxidant capacity will be assessed by measuring the ferric reducing ability of plasma (FRAP)
  • Change from 6 month plasma antioxidant capacity at 12 months [ Time Frame: 6 months and 12 months ]
    Plasma antioxidant capacity will be assessed by measuring the ferric reducing ability of plasma (FRAP)
  • Change from Baseline plasma antioxidant capacity at 12 months [ Time Frame: Baseline and 12 months ]
    Plasma antioxidant capacity will be assessed by measuring the ferric reducing ability of plasma (FRAP)
  • Change from Baseline Hepatic echography at 6 months [ Time Frame: Baseline and 6 months ]
    Echography will be carried out to analyze liver steatosis
  • Change from 6 month Hepatic echography at 12 months [ Time Frame: 6 months and 12 months ]
    Echography will be carried out to analyze liver steatosis
  • Change from Baseline Hepatic echography at 12 months [ Time Frame: Baseline and 12 months ]
    Echography will be carried out to analyze liver steatosis
  • Change from Baseline Hepatic elastography at 6 months [ Time Frame: Baseline and 6 months ]
    Elastography will be carried out to analyze liver fibrosis
  • Change from 6 month Hepatic elastography at 12 months [ Time Frame: 6 months and 12 months ]
    Elastography will be carried out to analyze liver fibrosis
  • Change from Baseline Hepatic elastography at 12 months [ Time Frame: Baseline and 12 months ]
    Elastography will be carried out to analyze liver fibrosis
  • Change from Baseline Hepatic Magnetic Resonance Imaging at 6 months [ Time Frame: Baseline and 6 months ]
    Magnetic Resonance Imaging will be carried out to analyze liver status
  • Change from 6 month Hepatic Magnetic Resonance Imaging at 12 months [ Time Frame: 6 months and 12 months ]
    Magnetic Resonance Imaging will be carried out to analyze liver status
  • Change from Baseline Hepatic Magnetic Resonance Imaging at 12 months [ Time Frame: Baseline and 12 months ]
    Magnetic Resonance Imaging will be carried out to analyze liver status
  • Change from Baseline White blood cell count at 6 months [ Time Frame: Baseline and 6 months ]
    White blood cell count includes: Leucocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophil, Basophils.
  • Change from 6 month White blood cell count at 12 months [ Time Frame: 6 months and 12 months ]
    White blood cell count includes: Leucocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophil, Basophils.
  • Change from Baseline White blood cell count at 12 months [ Time Frame: Baseline and 12 months ]
    White blood cell count includes: Leucocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophil, Basophils.
  • Change from Baseline blood rheological properties at 6 months [ Time Frame: Baseline and 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
  • Change from 6 month blood rheological properties at 12 months [ Time Frame: 6 months and 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
  • Change from Baseline blood rheological properties at 12 months [ Time Frame: Baseline and 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
  • Change from Baseline Physical activity level at 6 months [ Time Frame: Baseline and 6 months ]
    Physical activity will be assessed by accelerometers
  • Change from 6 months Physical activity level at 12 months [ Time Frame: 6 months and 12 months ]
    Physical activity will be assessed accelerometers
  • Change from Baseline Physical activity level at 12 months [ Time Frame: Baseline and 12 months ]
    Physical activity will be assessed by accelerometers
  • Change from Baseline Minnesota Physical Activity test at 6 months [ Time Frame: Baseline and 6 months ]
    Physical activity assessed by Minnesota Physical Activity test
  • Change from 6 month Minnesota Physical Activity test at 12 months [ Time Frame: 6 months and 12 months ]
    Physical activity assessed by Minnesota Physical Activity test
  • Change from Baseline Minnesota Physical Activity test at 12 months [ Time Frame: Baseline and 12 months ]
    Physical activity assessed by Minnesota Physical Activity test
  • Change from Baseline number of steps at 6 months [ Time Frame: Baseline and 6 months ]
    Physical activity assessed by Pedometers
  • Change from 6 month number of steps at 12 months [ Time Frame: 6 months and 12 months ]
    Physical activity assessed by Pedometers
  • Change from Baseline number of steps at 12 months [ Time Frame: Baseline and 12 months ]
    Physical activity assessed by Pedometers
  • Change from Baseline chair test at 6 months [ Time Frame: Baseline and 6 months ]
    Physical activity assessed by the chair test
  • Change from 6 month chair test at 12 months [ Time Frame: 6 months and 12 months ]
    Physical activity assessed by the chair test
  • Change from Baseline chair test at 12 months [ Time Frame: Baseline and 12 months ]
    Physical activity assessed by the chair test
  • Change from Baseline sleep quality at 6 months [ Time Frame: Baseline and 12 months ]
    Sleep information will be assessed by the Pittsburgh Sleep Quality Index
  • Change from 6 month sleep quality at 12 months [ Time Frame: 6 months and 12 months ]
    Sleep information will be assessed by the Pittsburgh Sleep Quality Index
  • Change from Baseline sleep quality at 12 months [ Time Frame: Baseline and 12 months ]
    Sleep information will be assessed by the Pittsburgh Sleep Quality Index
  • Change from Baseline Depressive symptoms at 6 months [ Time Frame: Baseline and 6 months ]
    Depressive symptoms will be assessed by the Beck Depression Inventory (BDI)
  • Change from 6 month Depressive symptoms at 12 months [ Time Frame: 6 months and 12 months ]
    Depressive symptoms will be assessed by the Beck Depression Inventory (BDI)
  • Change from Baseline Depressive symptoms at 12 months [ Time Frame: Baseline and 12 months ]
    Depressive symptoms will be assessed by the Beck Depression Inventory (BDI)
  • Change from Baseline Anxiety symptoms at 6 months [ Time Frame: Baseline and 6 months ]
    Anxiety symptoms will be assessed by State Anxiety test (STAI)
  • Change from 6 month Anxiety symptoms at 12 months [ Time Frame: 6 months and 12 months ]
    Anxiety symptoms will be assessed by State Anxiety test (STAI)
  • Change from Baseline Anxiety symptoms at 12 months [ Time Frame: Baseline and 12 months ]
    Anxiety symptoms will be assessed by State Anxiety test (STAI)
  • Single Nucleotide polymorphisms (SNPs) [ Time Frame: Baseline ]
    Single nucleotide polymorphisms will be determined by Genomic DNA from oral epithelial cells
  • Change from Baseline DNA methylation at 6 months [ Time Frame: Baseline and 6 months ]
    Epigenetics will be assessed by changes in DNA methylation of genes related with NAFLD development
  • Change from 6 month DNA methylation at 12 months [ Time Frame: 6 months and 12 months ]
    Epigenetics will be assessed by changes in DNA methylation of genes related with NAFLD development
  • Change from Baseline DNA methylation at 12 months [ Time Frame: Baseline and 12 months ]
    Epigenetics will be assessed by changes in DNA methylation of genes related with NAFLD development
  • Change from Baseline microRNAs at 6 months [ Time Frame: Baseline and 6 months ]
    Transcriptomic will be assessed by changes in miRNAs
  • Change from 6 month microRNAs at 12 months [ Time Frame: 6 months and 12 months ]
    Transcriptomic will be assessed by changes in miRNAs
  • Change from Baseline microRNAs at 12 months [ Time Frame: Baseline and 12 months ]
    Transcriptomic will be assessed by changes in miRNAs
  • Change from Baseline Gut microbiota composition at 6 months [ Time Frame: Baseline and 6 months ]
    Gut microbiota composition will be analyzed
  • Change from 6 month Gut microbiota composition at 12 month [ Time Frame: 6 months and 12 months ]
    Gut microbiota composition will be analyzed
  • Change from Baseline Gut microbiota composition at 12 month [ Time Frame: Baseline and 12 months ]
    Gut microbiota composition will be analyzed
  • Change from Baseline metabolites composition of urine at 6 months [ Time Frame: Baseline and 6 months ]
    Metabolites composition of urine will be analyzed
  • Change from 6 month metabolites composition of urine at 12 months [ Time Frame: 6 months and 12 months ]
    Metabolites composition of urine will be analyzed
  • Change from Baseline metabolites composition of urine at 12 months [ Time Frame: Baseline and 12 months ]
    Metabolites composition of urine will be analyzed
  • Change from Baseline metabolites composition of serum at 6 months [ Time Frame: Baseline and 6 months ]
    Metabolites composition of serum will be analyzed
  • Change from 6 month metabolites composition of serum at 12 months [ Time Frame: 6 months and 12 months ]
    Metabolites composition of serum will be analyzed
  • Change from Baseline metabolites composition of serum at 12 months [ Time Frame: Baseline and 12 months ]
    Metabolites composition of serum will be analyzed
  • Change from Baseline dietary intake at 6 months [ Time Frame: Baseline and 6 months ]
    Dietary intake will be assessed by means of food frequency questionnaire
  • Change from 6 month dietary intake at 12 months [ Time Frame: 6 months and 12 months ]
    Dietary intake will be assessed by means of food frequency questionnaire
  • Change from Baseline dietary intake at 12 months [ Time Frame: Baseline and 12 months ]
    Dietary intake will be assessed by means of food frequency questionnaire
  • Assessment of dietary adherence at Baseline [ Time Frame: Baseline ]
    Dietary adherence will be assessed by means of 3 day weighed food records
  • Assessment of dietary adherence at 6 months [ Time Frame: 6 months ]
    Dietary adherence will be assessed by means of 3 day weighed food records
  • Assessment of dietary adherence at 12 months [ Time Frame: 12 months ]
    Dietary adherence will be assessed by means of 3 day weighed food records
  • Change from Baseline satiety index at 6 months [ Time Frame: Baseline and 6 months ]
    Satiety index/appetite will be assessed by using the 100 mm Visual Analogue Scale
  • Change from 6 month satiety index at 12 months [ Time Frame: 6 months and 12 months ]
    Satiety index/appetite will be assessed by using the 100 mm Visual Analogue Scale
  • Change from Baseline satiety index at 12 months [ Time Frame: Baseline and 12 months ]
    Satiety index/appetite will be assessed by using the 100 mm Visual Analogue Scale
  • Change from Baseline life quality index at 6 months [ Time Frame: Baseline and 6 months ]
    Life quality index will be assessed by means of the Short Form 36 (SF-36) questionnaire
  • Change from 6 month life quality index at 12 months [ Time Frame: 6 months and 12 months ]
    Life quality index will be assessed by means of the Short Form 36 (SF-36) questionnaire
  • Change from Baseline life quality index at 12 months [ Time Frame: Baseline and 12 months ]
    Life quality index will be assessed by means of the Short Form 36 (SF-36) questionnaire
  • Change from Baseline Ghrelin concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Serum Active Ghrelin will be determined to assess satiety
  • Change from 6 month Ghrelin concentration at 12 months [ Time Frame: 6 months and 12 months ]
    Serum Active Ghrelin will be determined to assess satiety
  • Change from Baseline Ghrelin concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Serum Active Ghrelin will be determined to assess satiety
  • Change from Baseline glucagon-like peptide-1 (GLP-1) concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Serum active glucagon-like peptide-1 will be determined to assess satiety
  • Change from 6 month glucagon-like peptide-1 (GLP-1) concentration at 12 months [ Time Frame: 6 months and 12 months ]
    Serum active glucagon-like peptide-1 will be determined to assess satiety
  • Change from Baseline glucagon-like peptide-1 (GLP-1) concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Serum active glucagon-like peptide-1 will be determined to assess satiety
  • Change from Baseline Dopamine concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Peripheral Dopamine concentration will be analysed using high-performance liquid chromatography (HPLC)
  • Change from 6 month Dopamine concentration at 12 months [ Time Frame: 6 months and 12 months ]
    Peripheral Dopamine concentration will be analysed using high-performance liquid chromatography (HPLC)
  • Change from Baseline Dopamine concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Peripheral Dopamine concentration will be analysed using high-performance liquid chromatography (HPLC)
  • Change from Baseline Dopac concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Peripheral Dopac concentration will be analysed using high-performance liquid chromatography (HPLC)
  • Change from 6 month Dopac concentration at 12 months [ Time Frame: 6 months and 12 months ]
    Peripheral Dopac concentration will be analysed using high-performance liquid chromatography (HPLC)
  • Change from Baseline Dopac concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Peripheral Dopac concentration will be analysed using high-performance liquid chromatography (HPLC)
  • Change from Baseline Serotonin (5-HT) concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Peripheral Serotonin concentration will be analysed using high-performance liquid chromatography (HPLC)
  • Change from 6 month Serotonin (5-HT) concentration at 12 months [ Time Frame: 6 months and 12 months ]
    Peripheral Serotonin concentration will be analysed using high-performance liquid chromatography (HPLC)
  • Change from Baseline Serotonin (5-HT) concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Peripheral Serotonin concentration will be analysed using high-performance liquid chromatography (HPLC)
  • Change from Baseline Noradrenaline concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Peripheral Noradrenaline concentration will be analysed using high-performance liquid chromatography (HPLC)
  • Change from 6 month Noradrenaline concentration at 12 months [ Time Frame: 6 months and 12 months ]
    Peripheral Noradrenaline concentration will be analysed using high-performance liquid chromatography (HPLC)
  • Change from Baseline Noradrenaline concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Peripheral Noradrenaline concentration will be analysed using high-performance liquid chromatography (HPLC)
  • Change from Baseline 5-hydroxyindoleacetic acetic (5-HIAAC) concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Peripheral 5-hydroxyindoleacetic acetic concentration will be analysed using high-performance liquid chromatography (HPLC)
  • Change from 6 month 5-hydroxyindoleacetic acetic (5-HIAAC) concentration at 12 months [ Time Frame: 6 months and 12 months ]
    Peripheral 5-hydroxyindoleacetic acetic concentration will be analysed using high-performance liquid chromatography (HPLC)
  • Change from Baseline 5-hydroxyindoleacetic acetic (5-HIAAC) concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Peripheral 5-hydroxyindoleacetic acetic concentration will be analysed using high-performance liquid chromatography (HPLC)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fatty Liver in Obesity: Long-lifestyle Follow-up (FLiO)
Official Title  ICMJE Non-alcoholic Fatty Liver Disease (NAFLD) in Overweight and Obese People Under Nutritional and Lifestyle Follow-up: a Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The participants are randomly assigned to Control or FLiO strategy.
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-Alcoholic Fatty Liver Disease
  • Obese
  • Overweight
Intervention  ICMJE
  • 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 Name: American Heart Association diet
  • 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.
    Other Name: Fatty Liver in Obesity diet
Study Arms  ICMJE
  • Placebo Comparator: Control diet
    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.
    Intervention: Other: Control diet
  • Experimental: FLiO diet
    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.
    Intervention: Other: FLiO diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 7, 2017)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03183193
Other Study ID Numbers  ICMJE FLiO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Marian Zulet, University of Navarra
Study Sponsor  ICMJE Clinica Universidad de Navarra, Universidad de Navarra
Collaborators  ICMJE Complejo Hospitalario de Navarra
Investigators  ICMJE
Principal Investigator: 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
Study Director: 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
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 Chair: 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
PRS Account Clinica Universidad de Navarra, Universidad de Navarra
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP