AzTrials
AzTrials

Non-Alcoholic Fatty Liver DiseaseFLiONCT03183193

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

A study testing FLiO diet in people with Non-Alcoholic Fatty Liver Disease and Obese, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 80 years
What is being tested?
FLiO diet
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteSpain
Study dates
Jun 2016to Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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.)

Trial locations and contacts

1 site in 1 country.

M. Angeles Zulet, PhD contact

+34948425600 ext. 806317

mazulet@unav.es

Itziar Abete, PhD contact

+34948425600 ext. 806357

iabetego@unav.es

Spain1 site, 1 recruiting

  • Centre for Nutrition Research, University of Navarra

    Pamplona, Navarre, 31008

    M. Angeles Zulet, PhD, +34948425600 ext. 806317, mazulet@unav.es

    Itziar Abete, PhD, +34948425600 ext. 806357, iabetego@unav.es

    Recruiting

Other trials in Spain

About this study

Official title: Non-alcoholic Fatty Liver Disease (NAFLD) in Overweight and Obese People Under Nutritional and Lifestyle Follow-up: a Randomized Controlled Trial

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.

Read the 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.
Being tested
Control diet, FLiO diet
Keywords
NAFLD, NASH, Obesity, AASLD, AHA, Energy-restricted diet, Lifestyle intervention, Mediterranean diet, Weight loss, Liver damage, Inflammation, Oxidative stress, Microbiota composition, Eating behaviour, Satiety, Physical activity, Sedentary behaviours, Sleep quality, Sleep duration, Psychological factors
Medical subject headings
Non-alcoholic Fatty Liver Disease, Obesity, Overweight, Weight Loss, Inflammation, Feeding Behavior, Motor Activity, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control dietOther

    Also called American Heart Association 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).

  • FLiO dietOther

    Also called Fatty Liver in Obesity 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.

Study groups in NCT03183193
Study groupRoleWhat they receive
Control dietPlacebo comparatorA 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.
Receives: Other: Control diet
FLiO dietExperimentalA 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.
Receives: Other: FLiO diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Weight at 6 months

    Weight will be measured by a digital scale

    Measured: Baseline and 6 months

  2. Change from 6 month Weight at 12 months

    Weight will be measured by a digital scale

    Measured: 6 months and 12 months

  3. Change from Baseline Weight at 12 months

    Weight will be measured by a digital scale

    Measured: Baseline and 12 months

Secondary outcomes (151)

  1. Change from Baseline Body fat at 6 months

    Fat mass will be measured by Dual X-ray absorptiometry

    Measured: Baseline and 6 months

  2. Change from 6 month Body fat at 12 months

    Fat mass will be measured by Dual X-ray absorptiometry

    Measured: 6 months and 12 months

  3. Change from Baseline Body fat at 12 months

    Fat mass will be measured by Dual X-ray absorptiometry

    Measured: Baseline and 12 months

  4. Change from Baseline Waist circumference at 6 months

    Waist circumference will be measured with a tape measure

    Measured: Baseline and 6 months

  5. Change from 6 month Waist circumference at 12 months

    Waist circumference will be measured with a tape measure

    Measured: 6 months and 12 months

  6. Change from Baseline Waist circumference at 12 months

    Waist circumference will be measured with a tape measure

    Measured: Baseline and 12 months

  7. Change from Baseline handgrip strength at 6 months

    Handgrip strength will be measured with a dynamometer

    Measured: Baseline and 6 months

  8. Change from 6 month handgrip strength at 12 months

    Handgrip strength will be measured with a dynamometer

    Measured: 6 months and 12 months

  9. Change from Baseline handgrip strength at 12 months

    Handgrip strength will be measured with a dynamometer

    Measured: Baseline and 12 months

  10. Change from Baseline Systolic blood pressure at 6 months

    Systolic blood pressure will be measured with a sphygmomanometer

    Measured: Baseline and 6 months

  11. Change from 6 month Systolic blood pressure at 12 months

    Systolic blood pressure will be measured with a sphygmomanometer

    Measured: 6 months and 12 months

  12. Change from Baseline Systolic blood pressure at 12 months

    Systolic blood pressure will be measured with a sphygmomanometer

    Measured: Baseline and 12 months

  13. Change from Baseline Diastolic blood pressure at 6 months

    Diastolic blood pressure will be measured with a sphygmomanometer

    Measured: Baseline and 6 months

  14. Change from 6 month Diastolic blood pressure at 12 months

    Diastolic blood pressure will be measured with a sphygmomanometer

    Measured: 6 months and 12 months

  15. Change from Baseline Diastolic blood pressure at 12 months

    Diastolic blood pressure will be measured with a sphygmomanometer

    Measured: Baseline and 12 months

  16. 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

    Measured: Baseline and 6 months

  17. 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

    Measured: 6 months and 12 months

  18. 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

    Measured: Baseline and 12 months

  19. Change from Baseline uric acid concentration at 6 months

    Serum uric acid will be measured in a fasting state

    Measured: Baseline and 6 months

  20. Change from 6 month uric acid concentration at 12 months

    Serum uric acid will be measured in a fasting state

    Measured: 6 months and 12 months

  21. Change from Baseline uric acid concentration at 12 months

    Serum uric acid will be measured in a fasting state

    Measured: Baseline and 12 months

  22. Change from Baseline homocysteine concentration at 6 months

    Serum homocysteine will be measured in a fasting state

    Measured: Baseline and 6 months

  23. Change from 6 month homocysteine concentration at 12 months

    Serum homocysteine will be measured in a fasting state

    Measured: 6 months and 12 months

  24. Change from Baseline homocysteine concentration at 12 months

    Serum homocysteine will be measured in a fasting state

    Measured: Baseline and 12 months

  25. Change from Baseline glucose metabolism at 6 months

    Serum glucose levels will be measured in a fasting state

    Measured: Baseline and 6 months

  26. Change from 6 month glucose metabolism at 12 months

    Serum glucose levels will be measured in a fasting state

    Measured: 6 months and 12 months

  27. Change from Baseline glucose metabolism at 12 months

    Serum glucose levels will be measured in a fasting state

    Measured: Baseline and 12 months

  28. Change from Baseline insulin concentration at 6 months

    Serum insulin levels will be measured in a fasting state

    Measured: Baseline and 6 months

  29. Change from 6 month insulin concentration at 12 months

    Serum insulin levels will be measured in a fasting state

    Measured: 6 months and 12 months

  30. Change from Baseline insulin concentration at 12 months

    Serum insulin levels will be measured in a fasting state

    Measured: Baseline and 12 months

  31. Change from Baseline Hemoglobin A1c concentration at 6 months

    Serum Hemoglobin A1c will be measured in a fasting state

    Measured: Baseline and 6 months

  32. Change from 6 month Hemoglobin A1c concentration at 12 months

    Serum Hemoglobin A1c will be measured in a fasting state

    Measured: 6 months and 12 months

  33. Change from Baseline Hemoglobin A1c concentration at 12 months

    Serum Hemoglobin A1c will be measured in a fasting state

    Measured: Baseline and 12 months

  34. 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

    Measured: Baseline and 12 months

  35. 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

    Measured: 6 months and 12 months

  36. 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

    Measured: Baseline and 12 months

  37. 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

    Measured: Baseline and 6 months

  38. 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

    Measured: 6 months and 12 months

  39. 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

    Measured: Baseline and 12 months

  40. 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

    Measured: Baseline and 6 months

  41. 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

    Measured: 6 months and 12 months

  42. 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

    Measured: Baseline and 12 months

  43. Change from Baseline C-reactive protein (CRP) concentration at 6 months

    Plasma CRP will be assessed to determine inflammatory status

    Measured: Baseline and 6 months

  44. Change from 6 month C-reactive protein (CRP) concentration at 12 months

    Plasma CRP will be assessed to determine inflammatory status

    Measured: 6 months and 12 months

  45. Change from Baseline C-reactive protein (CRP) concentration at 12 months

    Plasma CRP will be assessed to determine inflammatory status

    Measured: Baseline and 12 months

  46. Change from Baseline interleukin 6 (IL-6) concentration at 6 months

    Plasma IL-6 will be assessed to determine inflammatory status

    Measured: Baseline and 6 months

  47. Change from 6 month interleukin 6 (IL-6) concentration at 12 months

    Plasma IL-6 will be assessed to determine inflammatory status

    Measured: 6 months and 12 months

  48. Change from Baseline interleukin 6 (IL-6) concentration at 12 months

    Plasma IL-6 will be assessed to determine inflammatory status

    Measured: Baseline and 12 months

  49. Change from Baseline tumor necrosis factor-α (TNFα) concentration at 6 months

    Plasma TNF-alpha will be assessed to determine inflammatory status

    Measured: Baseline and 6 months

  50. Change from 6 month tumor necrosis factor-α (TNFα) concentration at 12 months

    Plasma TNF-alpha will be assessed to determine inflammatory status

    Measured: 6 months and 12 months

  51. Change from Baseline tumor necrosis factor-α (TNFα) concentration at 12 months

    Plasma TNF-alpha will be assessed to determine inflammatory status

    Measured: Baseline and 12 months

  52. Change from Baseline leptin concentration at 6 months

    Plasma leptin will be assessed to determine inflammatory status

    Measured: Baseline and 6 months

  53. Change from 6 month leptin concentration at 12 months

    Plasma leptin will be assessed to determine inflammatory status

    Measured: 6 months and 12 months

  54. Change from Baseline leptin concentration at 12 months

    Plasma leptin will be assessed to determine inflammatory status

    Measured: Baseline and 12 months

  55. Change from Baseline adiponectin concentration at 6 months

    Plasma leptin will be assessed to determine inflammatory status

    Measured: Baseline and 6 months

  56. Change from 6 month adiponectin concentration at 12 months

    Plasma adiponectin will be assessed to determine inflammatory status

    Measured: Baseline and 12 months

  57. Change from Baseline adiponectin concentration at 12 months

    Plasma adiponectin will be assessed to determine inflammatory status

    Measured: Baseline and 12 months

  58. Change from Baseline LDL-oxidized concentration at 6 months

    LDL-ox will be assessed to determine oxidative status

    Measured: Baseline and 6 months

  59. Change from 6 month LDL-oxidized concentration at 12 months

    LDL-ox will be assessed to determine oxidative status

    Measured: 6 months and 12 months

  60. Change from Baseline LDL-oxidized concentration at 12 months

    LDL-ox will be assessed to determine oxidative status

    Measured: Baseline and 12 months

  61. Change from Baseline Malondialdehyde concentration at 6 months

    Plasma malondialdehyde will be assessed to determine oxidative status

    Measured: Baseline and 6 months

  62. Change from 6 month Malondialdehyde concentration at 12 months

    Plasma malondialdehyde will be assessed to determine oxidative status

    Measured: 6 months and 12 months

  63. Change from Baseline Malondialdehyde concentration at 12 months

    Plasma malondialdehyde will be assessed to determine oxidative status

    Measured: Baseline and 12 months

  64. Change from Baseline plasma antioxidant capacity at 6 months

    Plasma antioxidant capacity will be assessed by measuring the ferric reducing ability of plasma (FRAP)

    Measured: Baseline and 6 months

  65. 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)

    Measured: 6 months and 12 months

  66. Change from Baseline plasma antioxidant capacity at 12 months

    Plasma antioxidant capacity will be assessed by measuring the ferric reducing ability of plasma (FRAP)

    Measured: Baseline and 12 months

  67. Change from Baseline Hepatic echography at 6 months

    Echography will be carried out to analyze liver steatosis

    Measured: Baseline and 6 months

  68. Change from 6 month Hepatic echography at 12 months

    Echography will be carried out to analyze liver steatosis

    Measured: 6 months and 12 months

  69. Change from Baseline Hepatic echography at 12 months

    Echography will be carried out to analyze liver steatosis

    Measured: Baseline and 12 months

  70. Change from Baseline Hepatic elastography at 6 months

    Elastography will be carried out to analyze liver fibrosis

    Measured: Baseline and 6 months

  71. Change from 6 month Hepatic elastography at 12 months

    Elastography will be carried out to analyze liver fibrosis

    Measured: 6 months and 12 months

  72. Change from Baseline Hepatic elastography at 12 months

    Elastography will be carried out to analyze liver fibrosis

    Measured: Baseline and 12 months

  73. Change from Baseline Hepatic Magnetic Resonance Imaging at 6 months

    Magnetic Resonance Imaging will be carried out to analyze liver status

    Measured: Baseline and 6 months

  74. Change from 6 month Hepatic Magnetic Resonance Imaging at 12 months

    Magnetic Resonance Imaging will be carried out to analyze liver status

    Measured: 6 months and 12 months

  75. Change from Baseline Hepatic Magnetic Resonance Imaging at 12 months

    Magnetic Resonance Imaging will be carried out to analyze liver status

    Measured: Baseline and 12 months

  76. Change from Baseline White blood cell count at 6 months

    White blood cell count includes: Leucocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophil, Basophils.

    Measured: Baseline and 6 months

  77. Change from 6 month White blood cell count at 12 months

    White blood cell count includes: Leucocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophil, Basophils.

    Measured: 6 months and 12 months

  78. Change from Baseline White blood cell count at 12 months

    White blood cell count includes: Leucocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophil, Basophils.

    Measured: Baseline and 12 months

  79. 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

    Measured: Baseline and 6 months

  80. 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

    Measured: 6 months and 12 months

  81. 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

    Measured: Baseline and 12 months

  82. Change from Baseline Physical activity level at 6 months

    Physical activity will be assessed by accelerometers

    Measured: Baseline and 6 months

  83. Change from 6 months Physical activity level at 12 months

    Physical activity will be assessed accelerometers

    Measured: 6 months and 12 months

  84. Change from Baseline Physical activity level at 12 months

    Physical activity will be assessed by accelerometers

    Measured: Baseline and 12 months

  85. Change from Baseline Minnesota Physical Activity test at 6 months

    Physical activity assessed by Minnesota Physical Activity test

    Measured: Baseline and 6 months

  86. Change from 6 month Minnesota Physical Activity test at 12 months

    Physical activity assessed by Minnesota Physical Activity test

    Measured: 6 months and 12 months

  87. Change from Baseline Minnesota Physical Activity test at 12 months

    Physical activity assessed by Minnesota Physical Activity test

    Measured: Baseline and 12 months

  88. Change from Baseline number of steps at 6 months

    Physical activity assessed by Pedometers

    Measured: Baseline and 6 months

  89. Change from 6 month number of steps at 12 months

    Physical activity assessed by Pedometers

    Measured: 6 months and 12 months

  90. Change from Baseline number of steps at 12 months

    Physical activity assessed by Pedometers

    Measured: Baseline and 12 months

  91. Change from Baseline chair test at 6 months

    Physical activity assessed by the chair test

    Measured: Baseline and 6 months

  92. Change from 6 month chair test at 12 months

    Physical activity assessed by the chair test

    Measured: 6 months and 12 months

  93. Change from Baseline chair test at 12 months

    Physical activity assessed by the chair test

    Measured: Baseline and 12 months

  94. Change from Baseline sleep quality at 6 months

    Sleep information will be assessed by the Pittsburgh Sleep Quality Index

    Measured: Baseline and 12 months

  95. Change from 6 month sleep quality at 12 months

    Sleep information will be assessed by the Pittsburgh Sleep Quality Index

    Measured: 6 months and 12 months

  96. Change from Baseline sleep quality at 12 months

    Sleep information will be assessed by the Pittsburgh Sleep Quality Index

    Measured: Baseline and 12 months

  97. Change from Baseline Depressive symptoms at 6 months

    Depressive symptoms will be assessed by the Beck Depression Inventory (BDI)

    Measured: Baseline and 6 months

  98. Change from 6 month Depressive symptoms at 12 months

    Depressive symptoms will be assessed by the Beck Depression Inventory (BDI)

    Measured: 6 months and 12 months

  99. Change from Baseline Depressive symptoms at 12 months

    Depressive symptoms will be assessed by the Beck Depression Inventory (BDI)

    Measured: Baseline and 12 months

  100. Change from Baseline Anxiety symptoms at 6 months

    Anxiety symptoms will be assessed by State Anxiety test (STAI)

    Measured: Baseline and 6 months

  101. Change from 6 month Anxiety symptoms at 12 months

    Anxiety symptoms will be assessed by State Anxiety test (STAI)

    Measured: 6 months and 12 months

  102. Change from Baseline Anxiety symptoms at 12 months

    Anxiety symptoms will be assessed by State Anxiety test (STAI)

    Measured: Baseline and 12 months

  103. Single Nucleotide polymorphisms (SNPs)

    Single nucleotide polymorphisms will be determined by Genomic DNA from oral epithelial cells

    Measured: Baseline

  104. Change from Baseline DNA methylation at 6 months

    Epigenetics will be assessed by changes in DNA methylation of genes related with NAFLD development

    Measured: Baseline and 6 months

  105. Change from 6 month DNA methylation at 12 months

    Epigenetics will be assessed by changes in DNA methylation of genes related with NAFLD development

    Measured: 6 months and 12 months

  106. Change from Baseline DNA methylation at 12 months

    Epigenetics will be assessed by changes in DNA methylation of genes related with NAFLD development

    Measured: Baseline and 12 months

  107. Change from Baseline microRNAs at 6 months

    Transcriptomic will be assessed by changes in miRNAs

    Measured: Baseline and 6 months

  108. Change from 6 month microRNAs at 12 months

    Transcriptomic will be assessed by changes in miRNAs

    Measured: 6 months and 12 months

  109. Change from Baseline microRNAs at 12 months

    Transcriptomic will be assessed by changes in miRNAs

    Measured: Baseline and 12 months

  110. Change from Baseline Gut microbiota composition at 6 months

    Gut microbiota composition will be analyzed

    Measured: Baseline and 6 months

  111. Change from 6 month Gut microbiota composition at 12 month

    Gut microbiota composition will be analyzed

    Measured: 6 months and 12 months

  112. Change from Baseline Gut microbiota composition at 12 month

    Gut microbiota composition will be analyzed

    Measured: Baseline and 12 months

  113. Change from Baseline metabolites composition of urine at 6 months

    Metabolites composition of urine will be analyzed

    Measured: Baseline and 6 months

  114. Change from 6 month metabolites composition of urine at 12 months

    Metabolites composition of urine will be analyzed

    Measured: 6 months and 12 months

  115. Change from Baseline metabolites composition of urine at 12 months

    Metabolites composition of urine will be analyzed

    Measured: Baseline and 12 months

  116. Change from Baseline metabolites composition of serum at 6 months

    Metabolites composition of serum will be analyzed

    Measured: Baseline and 6 months

  117. Change from 6 month metabolites composition of serum at 12 months

    Metabolites composition of serum will be analyzed

    Measured: 6 months and 12 months

  118. Change from Baseline metabolites composition of serum at 12 months

    Metabolites composition of serum will be analyzed

    Measured: Baseline and 12 months

  119. Change from Baseline dietary intake at 6 months

    Dietary intake will be assessed by means of food frequency questionnaire

    Measured: Baseline and 6 months

  120. Change from 6 month dietary intake at 12 months

    Dietary intake will be assessed by means of food frequency questionnaire

    Measured: 6 months and 12 months

  121. Change from Baseline dietary intake at 12 months

    Dietary intake will be assessed by means of food frequency questionnaire

    Measured: Baseline and 12 months

  122. Assessment of dietary adherence at Baseline

    Dietary adherence will be assessed by means of 3 day weighed food records

    Measured: Baseline

  123. Assessment of dietary adherence at 6 months

    Dietary adherence will be assessed by means of 3 day weighed food records

    Measured: 6 months

  124. Assessment of dietary adherence at 12 months

    Dietary adherence will be assessed by means of 3 day weighed food records

    Measured: 12 months

  125. Change from Baseline satiety index at 6 months

    Satiety index/appetite will be assessed by using the 100 mm Visual Analogue Scale

    Measured: Baseline and 6 months

  126. Change from 6 month satiety index at 12 months

    Satiety index/appetite will be assessed by using the 100 mm Visual Analogue Scale

    Measured: 6 months and 12 months

  127. Change from Baseline satiety index at 12 months

    Satiety index/appetite will be assessed by using the 100 mm Visual Analogue Scale

    Measured: Baseline and 12 months

  128. 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

    Measured: Baseline and 6 months

  129. 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

    Measured: 6 months and 12 months

  130. 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

    Measured: Baseline and 12 months

  131. Change from Baseline Ghrelin concentration at 6 months

    Serum Active Ghrelin will be determined to assess satiety

    Measured: Baseline and 6 months

  132. Change from 6 month Ghrelin concentration at 12 months

    Serum Active Ghrelin will be determined to assess satiety

    Measured: 6 months and 12 months

  133. Change from Baseline Ghrelin concentration at 12 months

    Serum Active Ghrelin will be determined to assess satiety

    Measured: Baseline and 12 months

  134. 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

    Measured: Baseline and 6 months

  135. 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

    Measured: 6 months and 12 months

  136. 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

    Measured: Baseline and 12 months

  137. Change from Baseline Dopamine concentration at 6 months

    Peripheral Dopamine concentration will be analysed using high-performance liquid chromatography (HPLC)

    Measured: Baseline and 6 months

  138. Change from 6 month Dopamine concentration at 12 months

    Peripheral Dopamine concentration will be analysed using high-performance liquid chromatography (HPLC)

    Measured: 6 months and 12 months

  139. Change from Baseline Dopamine concentration at 12 months

    Peripheral Dopamine concentration will be analysed using high-performance liquid chromatography (HPLC)

    Measured: Baseline and 12 months

  140. Change from Baseline Dopac concentration at 6 months

    Peripheral Dopac concentration will be analysed using high-performance liquid chromatography (HPLC)

    Measured: Baseline and 6 months

  141. Change from 6 month Dopac concentration at 12 months

    Peripheral Dopac concentration will be analysed using high-performance liquid chromatography (HPLC)

    Measured: 6 months and 12 months

  142. Change from Baseline Dopac concentration at 12 months

    Peripheral Dopac concentration will be analysed using high-performance liquid chromatography (HPLC)

    Measured: Baseline and 12 months

  143. Change from Baseline Serotonin (5-HT) concentration at 6 months

    Peripheral Serotonin concentration will be analysed using high-performance liquid chromatography (HPLC)

    Measured: Baseline and 6 months

  144. Change from 6 month Serotonin (5-HT) concentration at 12 months

    Peripheral Serotonin concentration will be analysed using high-performance liquid chromatography (HPLC)

    Measured: 6 months and 12 months

  145. Change from Baseline Serotonin (5-HT) concentration at 12 months

    Peripheral Serotonin concentration will be analysed using high-performance liquid chromatography (HPLC)

    Measured: Baseline and 12 months

  146. Change from Baseline Noradrenaline concentration at 6 months

    Peripheral Noradrenaline concentration will be analysed using high-performance liquid chromatography (HPLC)

    Measured: Baseline and 6 months

  147. Change from 6 month Noradrenaline concentration at 12 months

    Peripheral Noradrenaline concentration will be analysed using high-performance liquid chromatography (HPLC)

    Measured: 6 months and 12 months

  148. Change from Baseline Noradrenaline concentration at 12 months

    Peripheral Noradrenaline concentration will be analysed using high-performance liquid chromatography (HPLC)

    Measured: Baseline and 12 months

  149. 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)

    Measured: Baseline and 6 months

  150. 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)

    Measured: 6 months and 12 months

  151. 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)

    Measured: Baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2017
  2. Study startJun 2016
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The participants are randomly assigned to Control or FLiO strategy.
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03183193
Sponsor's protocol ID
FLiO
Acronym
FLiO
Status last verified
Jun 2017
First submitted
31 Mar 2017
Last updated
12 Jun 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25937862

  • 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.

    PubMed 23968597

  • 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.

    PubMed 23535332

  • 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.

    PubMed 23406163

  • 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.

    PubMed 24587653

  • 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.

    PubMed 22656328

  • 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.

    PubMed 42159409

  • 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.

    PubMed 39549213

  • 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.

    PubMed 38861890

  • 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.

    PubMed 33550706

  • 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.

    PubMed 33474638

  • 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.

    PubMed 32857176

  • 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.

    PubMed 30662331

Questions about this trial

What is this clinical trial studying?

A study testing FLiO diet in people with Non-Alcoholic Fatty Liver Disease and Obese, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact M. Angeles Zulet, PhD (+34948425600 ext. 806317, mazulet@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Weight at 6 months (time frame: Baseline and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03183193, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.

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