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Trial record 50 of 55 for:    cancer AND energy restriction

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

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ClinicalTrials.gov Identifier: NCT03183193
Recruitment Status : 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

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.


Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Obese Overweight Other: Control diet Other: FLiO diet Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
Official Title: Non-alcoholic Fatty Liver Disease (NAFLD) in Overweight and Obese People Under Nutritional and Lifestyle Follow-up: a Randomized Controlled Trial
Actual Study Start Date : June 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. Change from Baseline Weight at 6 months [ Time Frame: Baseline and 6 months ]
    Weight will be measured by a digital scale

  2. Change from 6 month Weight at 12 months [ Time Frame: 6 months and 12 months ]
    Weight will be measured by a digital scale

  3. Change from Baseline Weight at 12 months [ Time Frame: Baseline and 12 months ]
    Weight will be measured by a digital scale


Secondary Outcome Measures :
  1. Change from Baseline Body fat at 6 months [ Time Frame: Baseline and 6 months ]
    Fat mass will be measured by Dual X-ray absorptiometry

  2. 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

  3. Change from Baseline Body fat at 12 months [ Time Frame: Baseline and 12 months ]
    Fat mass will be measured by Dual X-ray absorptiometry

  4. Change from Baseline Waist circumference at 6 months [ Time Frame: Baseline and 6 months ]
    Waist circumference will be measured with a tape measure

  5. 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

  6. Change from Baseline Waist circumference at 12 months [ Time Frame: Baseline and 12 months ]
    Waist circumference will be measured with a tape measure

  7. Change from Baseline handgrip strength at 6 months [ Time Frame: Baseline and 6 months ]
    Handgrip strength will be measured with a dynamometer

  8. Change from 6 month handgrip strength at 12 months [ Time Frame: 6 months and 12 months ]
    Handgrip strength will be measured with a dynamometer

  9. Change from Baseline handgrip strength at 12 months [ Time Frame: Baseline and 12 months ]
    Handgrip strength will be measured with a dynamometer

  10. Change from Baseline Systolic blood pressure at 6 months [ Time Frame: Baseline and 6 months ]
    Systolic blood pressure will be measured with a sphygmomanometer

  11. 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

  12. Change from Baseline Systolic blood pressure at 12 months [ Time Frame: Baseline and 12 months ]
    Systolic blood pressure will be measured with a sphygmomanometer

  13. Change from Baseline Diastolic blood pressure at 6 months [ Time Frame: Baseline and 6 months ]
    Diastolic blood pressure will be measured with a sphygmomanometer

  14. 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

  15. Change from Baseline Diastolic blood pressure at 12 months [ Time Frame: Baseline and 12 months ]
    Diastolic blood pressure will be measured with a sphygmomanometer

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. Change from Baseline homocysteine concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Serum homocysteine will be measured in a fasting state

  23. 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

  24. Change from Baseline homocysteine concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Serum homocysteine will be measured in a fasting state

  25. Change from Baseline glucose metabolism at 6 months [ Time Frame: Baseline and 6 months ]
    Serum glucose levels will be measured in a fasting state

  26. 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

  27. Change from Baseline glucose metabolism at 12 months [ Time Frame: Baseline and 12 months ]
    Serum glucose levels will be measured in a fasting state

  28. Change from Baseline insulin concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Serum insulin levels will be measured in a fasting state

  29. 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

  30. Change from Baseline insulin concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Serum insulin levels will be measured in a fasting state

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

  44. 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

  45. 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

  46. 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

  47. 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

  48. 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

  49. 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

  50. 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

  51. 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

  52. Change from Baseline leptin concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Plasma leptin will be assessed to determine inflammatory status

  53. 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

  54. Change from Baseline leptin concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Plasma leptin will be assessed to determine inflammatory status

  55. Change from Baseline adiponectin concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Plasma leptin will be assessed to determine inflammatory status

  56. Change from 6 month adiponectin concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Plasma adiponectin will be assessed to determine inflammatory status

  57. Change from Baseline adiponectin concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Plasma adiponectin will be assessed to determine inflammatory status

  58. Change from Baseline LDL-oxidized concentration at 6 months [ Time Frame: Baseline and 6 months ]
    LDL-ox will be assessed to determine oxidative status

  59. 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

  60. Change from Baseline LDL-oxidized concentration at 12 months [ Time Frame: Baseline and 12 months ]
    LDL-ox will be assessed to determine oxidative status

  61. Change from Baseline Malondialdehyde concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Plasma malondialdehyde will be assessed to determine oxidative status

  62. 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

  63. Change from Baseline Malondialdehyde concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Plasma malondialdehyde will be assessed to determine oxidative status

  64. 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)

  65. 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)

  66. 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)

  67. Change from Baseline Hepatic echography at 6 months [ Time Frame: Baseline and 6 months ]
    Echography will be carried out to analyze liver steatosis

  68. 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

  69. Change from Baseline Hepatic echography at 12 months [ Time Frame: Baseline and 12 months ]
    Echography will be carried out to analyze liver steatosis

  70. Change from Baseline Hepatic elastography at 6 months [ Time Frame: Baseline and 6 months ]
    Elastography will be carried out to analyze liver fibrosis

  71. 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

  72. Change from Baseline Hepatic elastography at 12 months [ Time Frame: Baseline and 12 months ]
    Elastography will be carried out to analyze liver fibrosis

  73. 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

  74. 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

  75. 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

  76. 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.

  77. 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.

  78. 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.

  79. 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

  80. 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

  81. 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

  82. Change from Baseline Physical activity level at 6 months [ Time Frame: Baseline and 6 months ]
    Physical activity will be assessed by accelerometers

  83. Change from 6 months Physical activity level at 12 months [ Time Frame: 6 months and 12 months ]
    Physical activity will be assessed accelerometers

  84. Change from Baseline Physical activity level at 12 months [ Time Frame: Baseline and 12 months ]
    Physical activity will be assessed by accelerometers

  85. Change from Baseline Minnesota Physical Activity test at 6 months [ Time Frame: Baseline and 6 months ]
    Physical activity assessed by Minnesota Physical Activity test

  86. 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

  87. Change from Baseline Minnesota Physical Activity test at 12 months [ Time Frame: Baseline and 12 months ]
    Physical activity assessed by Minnesota Physical Activity test

  88. Change from Baseline number of steps at 6 months [ Time Frame: Baseline and 6 months ]
    Physical activity assessed by Pedometers

  89. Change from 6 month number of steps at 12 months [ Time Frame: 6 months and 12 months ]
    Physical activity assessed by Pedometers

  90. Change from Baseline number of steps at 12 months [ Time Frame: Baseline and 12 months ]
    Physical activity assessed by Pedometers

  91. Change from Baseline chair test at 6 months [ Time Frame: Baseline and 6 months ]
    Physical activity assessed by the chair test

  92. Change from 6 month chair test at 12 months [ Time Frame: 6 months and 12 months ]
    Physical activity assessed by the chair test

  93. Change from Baseline chair test at 12 months [ Time Frame: Baseline and 12 months ]
    Physical activity assessed by the chair test

  94. 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

  95. 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

  96. 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

  97. 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)

  98. 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)

  99. 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)

  100. Change from Baseline Anxiety symptoms at 6 months [ Time Frame: Baseline and 6 months ]
    Anxiety symptoms will be assessed by State Anxiety test (STAI)

  101. 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)

  102. Change from Baseline Anxiety symptoms at 12 months [ Time Frame: Baseline and 12 months ]
    Anxiety symptoms will be assessed by State Anxiety test (STAI)

  103. Single Nucleotide polymorphisms (SNPs) [ Time Frame: Baseline ]
    Single nucleotide polymorphisms will be determined by Genomic DNA from oral epithelial cells

  104. 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

  105. 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

  106. 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

  107. Change from Baseline microRNAs at 6 months [ Time Frame: Baseline and 6 months ]
    Transcriptomic will be assessed by changes in miRNAs

  108. Change from 6 month microRNAs at 12 months [ Time Frame: 6 months and 12 months ]
    Transcriptomic will be assessed by changes in miRNAs

  109. Change from Baseline microRNAs at 12 months [ Time Frame: Baseline and 12 months ]
    Transcriptomic will be assessed by changes in miRNAs

  110. Change from Baseline Gut microbiota composition at 6 months [ Time Frame: Baseline and 6 months ]
    Gut microbiota composition will be analyzed

  111. Change from 6 month Gut microbiota composition at 12 month [ Time Frame: 6 months and 12 months ]
    Gut microbiota composition will be analyzed

  112. Change from Baseline Gut microbiota composition at 12 month [ Time Frame: Baseline and 12 months ]
    Gut microbiota composition will be analyzed

  113. Change from Baseline metabolites composition of urine at 6 months [ Time Frame: Baseline and 6 months ]
    Metabolites composition of urine will be analyzed

  114. 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

  115. Change from Baseline metabolites composition of urine at 12 months [ Time Frame: Baseline and 12 months ]
    Metabolites composition of urine will be analyzed

  116. Change from Baseline metabolites composition of serum at 6 months [ Time Frame: Baseline and 6 months ]
    Metabolites composition of serum will be analyzed

  117. 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

  118. Change from Baseline metabolites composition of serum at 12 months [ Time Frame: Baseline and 12 months ]
    Metabolites composition of serum will be analyzed

  119. 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

  120. 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

  121. 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

  122. Assessment of dietary adherence at Baseline [ Time Frame: Baseline ]
    Dietary adherence will be assessed by means of 3 day weighed food records

  123. Assessment of dietary adherence at 6 months [ Time Frame: 6 months ]
    Dietary adherence will be assessed by means of 3 day weighed food records

  124. Assessment of dietary adherence at 12 months [ Time Frame: 12 months ]
    Dietary adherence will be assessed by means of 3 day weighed food records

  125. 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

  126. 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

  127. 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

  128. 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

  129. 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

  130. 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

  131. Change from Baseline Ghrelin concentration at 6 months [ Time Frame: Baseline and 6 months ]
    Serum Active Ghrelin will be determined to assess satiety

  132. 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

  133. Change from Baseline Ghrelin concentration at 12 months [ Time Frame: Baseline and 12 months ]
    Serum Active Ghrelin will be determined to assess satiety

  134. 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

  135. 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

  136. 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

  137. 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)

  138. 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)

  139. 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)

  140. 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)

  141. 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)

  142. 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)

  143. 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)

  144. 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)

  145. 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)

  146. 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)

  147. 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)

  148. 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)

  149. 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)

  150. 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)

  151. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183193


Contacts
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Contact: M. Angeles Zulet, PhD +34948425600 ext 806317 mazulet@unav.es
Contact: Itziar Abete, PhD +34948425600 ext 806357 iabetego@unav.es

Locations
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Spain
Centre for Nutrition Research, University of Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Contact: M. Angeles Zulet, PhD    +34948425600 ext 806317    mazulet@unav.es   
Contact: Itziar Abete, PhD    +34948425600 ext 806357    iabetego@unav.es   
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Complejo Hospitalario de Navarra
Investigators
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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

Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marian Zulet, Principal Investigator, University of Navarra
ClinicalTrials.gov Identifier: NCT03183193     History of Changes
Other Study ID Numbers: FLiO
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Marian Zulet, University of Navarra:
Energy-restricted diet
NAFLD
NASH
Obesity
AASLD
AHA
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

Additional relevant MeSH terms:
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Overweight
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Body Weight
Signs and Symptoms
Digestive System Diseases
Liver Extracts
Nutrients
Hematinics
Growth Substances
Physiological Effects of Drugs