Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Development of a Nutrigenetic Test for Personalized Prescription of Body Weight Loss Diets (Obekit) (Obekit)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02737267
Recruitment Status : Unknown
Verified November 2015 by Clinica Universidad de Navarra, Universidad de Navarra.
Recruitment status was:  Active, not recruiting
First Posted : April 13, 2016
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

Brief Summary:
This study evaluates the relationship between several genetic variants and the response to a hypocaloric diet, in order to design a genetic test which permits prescribe the more personalized diet for each individual according to her genotype. Half of the participants will assigned to a moderate high protein diet, while the other half will assigned to a high carbohydrate diet.

Condition or disease Intervention/treatment Phase
Body Weight Changes Behavioral: Moderately high protein diet Behavioral: Low fat diet Not Applicable

Detailed Description:

Obesity has reached epidemic proportions becoming a major global public health challenge since it is associated with an increased risk of type 2 diabetes, cardiovascular disease, stroke, arthritis and some forms of cancer. Therefore, a large number of strategies have been investigated in order to induce a negative energy balance and consequently body weight loss mainly inducing a low calorie diet and sometimes accompanied by an increase in physical activity. However, individual responses to body weight loss interventions vary widely and several studies have aimed to identify psychological, behavioral and personal predictors of this variability.

In this context, the hypothesis of the present study is that part of the interindividual variability in relation to the success of certain weight loss treatments is based on gene-diet interactions. Depending on the composition of the diet and the genotype of each individual, it is more or less easy to reduce and maintenance body weight.

After the recruitment and selection of the study participants, the study will consists of a 4-month hypocaloric diet ("body weight loss period") followed by a second 6-month period ("body weight maintenance period") in which the subjects of the study will continue with the diet, but without any energy restriction. The participants will assigned to one of the two hypocaloric diets (-30% of the studied requirements for each individual) with different macronutrient composition:

  • Moderately high protein diet: 40% of the energy derived from carbohydrates, 30% of the energy derived from protein and 30% of the energy derived from fat.
  • Low fat diet: 60% of the energy derived from carbohydrates, 30% of the energy derived from protein and 30% of the energy derived from fat.

A group of normal weight individuals (n 12) will be recruited in order to compare the different parameters obtained in the obese subjects with those of normal population. They will be not subjected to any intervention.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of a Nutrigenetic Test for Personalized Prescription of Body Weight Loss Diets (Obekit)
Study Start Date : November 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Moderately high protein diet
Caloric restriction (-30% total energy intake) Macronutrient distribution: 40% of the energy derived from carbohydrates, 30% of the energy derived from protein and 30% of the energy derived from fat
Behavioral: Moderately high protein diet
After the recruitment randomization of the study participants, the study will consists of a 4-month nutritional intervention ("body weight loss period") followed by a second 6-month period ("body weight maintenance period") in which the subjects of the study will continue with the assigned diet, but without any energy restriction.

Placebo Comparator: Low fat diet
Caloric restriction (-30% total energy intake) Macronutrient distribution: 60% of the energy derived from carbohydrates, 18% of the energy derived from protein and 22% of the energy derived from fat
Behavioral: Low fat diet
After the recruitment randomization of the study participants, the study will consists of a 4-month nutritional intervention ("body weight loss period") followed by a second 6-month period ("body weight maintenance period") in which the subjects of the study will continue with the assigned diet, but without any energy restriction.the energy derived from fat




Primary Outcome Measures :
  1. Change in body weight at Week 16 [ Time Frame: Baseline and 16 Weeks ]
  2. Change in body weight at Week 40 [ Time Frame: 16 Weeks and 40 Weeks ]

Secondary Outcome Measures :
  1. Height [ Time Frame: Baseline ]
  2. Change in waist and hip circumferences at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Waist and hip circumferences will be measured with a tape measure at baseline and at the end of the body weight loss period (16 weeks)

  3. Change in waist and hip circumferences at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Waist and hip circumferences will be measured with a tape measure at the end of the body weight loss period (16 weeks) and at the end of the body weight maintenance period (40 Weeks)

  4. Change in body fat mass at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Fat mass will be measured by bioelectric bioimpedance and Dual X-ray absorptiometry at baseline and at the end of the body weight loss period (16 Weeks)

  5. Change in body fat mass at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Fat mass will be measured by bioelectric bioimpedance and Dual X-ray absorptiometry at the end of the body weight loss period (16 weeks) and at the end of the body weight maintenance period (40 Weeks)

  6. Single nucleotide polymorphisms (SNPs) [ Time Frame: Baseline ]
    Single nucleotide polymorphisms will be measured from Genomic DNA from oral epithelial cells (collected in ORAcollect DNA, DNAGenotek) and from peripheral blood mononuclear cells (PBMC) by using massive sequencing in a Ion Torrent sequencer

  7. Changes in DNA methylation levels at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    DNA methylation levels will be measured in PBMC by Microarray (Illumina. 450k methylation array) and validation specific sites by Sequenom (MassArray) and Methylationsensitive High-Resolution Melting (MS-HRM) (Real Time PCR) at baseline and at the end of the body weight loss period (16 Weeks)

  8. Changes in DNA methylation levels at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    DNA methylation levels will be measured in PBMC by Microarray (Illumina 450k methylation array) and validation specific sites by Sequenom (MassArray) and MS-HRM (Real Time PCR) at the end of the body weight loss period (16 weeks) and at the end of the maintenance body weight period (40 Weeks)

  9. Changes in metabolic profiling at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Metabolic profiling will be measured in urine by High Performance Liquid Chromatography-Mass Spectrometry (HPLC-MS) at baseline and at the end of the body weight loss period (16 Weeks)

  10. Changes in metabolomic profile at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Metabolomic profile will be measured in urine by HPLC-MS at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  11. Changes in lipidomic profile at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Lipidomic profile will be measured in plasma by HPLC-MS at baseline and at the end of the body weight loss period (16 Weeks)

  12. Changes in lipidomic profile at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Lipidomic profile will be measured in plasma by HPLC-MS at the end of the body weight loss period (16 weeks) and at the end of the body weight maintenance period (40 Weeks)

  13. Changes in proteomic profile at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Proteomic profile will be measured in plasma by Two-Dimensional Fluorescence Difference Gel Electrophoresis (2D-DIGE) and Liquid Chromatography Electrospray Ionization with Tandem Mass Spectrometry (LC-ESI-MS/MS) at baseline and at the end of the body weight loss period (16 Weeks)

  14. Changes in proteomic profile at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Proteomic profile will be measured in plasma by 2D-DIGE and LC-ESI-MS/MS at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  15. Changes in gut microbiota composition at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Gut microbiota composition will be measured by Pyrosequencing 16SR RNA at baseline and at the end of the body weight loss period (16 Weeks)

  16. Changes in gut microbiota composition at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Gut microbiota composition will be measured by Pyrosequencing 16SR RNA at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  17. Changes in messenger ribonucleic acid (mRNA) expression at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    mRNA expression will be measured by GeneChip Human Transcriptome Array 2.0 (Affimetrix) at baseline and at the end of the body weight loss period (16 Weeks)

  18. Changes in mRNA expression at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    mRNA expression will be measured by GeneChip Human Transcriptome Array 2.0 (Affimetrix) at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  19. Changes in microARNs in exosomes at 16 weeks [ Time Frame: Baseline and 16 Weeks ]
    microARNs levels in exosomes will be measured by NGS Illumina Myseq at baseline and at the end of the body weight loss period (16 Weeks)

  20. Changes in microARNs in exosomes at 40 weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    microARNs levels in exosomes will be measured by next-generation sequencing (NGS) Illumina Myseq at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  21. Changes in DNA oxidation at 16 weeks [ Time Frame: Baseline and 16 Weeks ]
    DNA oxidation will be measured by 8-hydroxy-deoxyguanosine at baseline and at the end of the body weight loss period (16 Weeks)

  22. Changes in DNA oxidation at 40 weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    DNA oxidation will be measured by 8-hydroxy-deoxyguanosine at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  23. Changes in serum glucose levels at 16 Weeks [ Time Frame: Baseline and 16 weeks ]
    Serum glucose levels will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  24. Changes in serum glucose levels at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Serum glucose levels will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  25. Changes in serum insulin concentration at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Serum insulin concentration will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  26. Changes in serum insulin concentration at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Serum insulin concentration will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  27. Changes in serum lipid metabolism markers at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Serum free fatty acids, triglycerides, total cholesterol, LDL cholesterol and HDL cholesterol concentrations will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  28. Changes in serum lipid metabolism markers at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Serum free fatty acids, triglycerides, total cholesterol, LDL cholesterol and HDL cholesterol concentrations will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  29. Changes in serum total protein concentration at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Serum total protein concentration will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  30. Changes in serum total protein concentration at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Serum total protein concentration will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  31. Changes in serum uric acid levels at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Serum uric acid levels will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  32. Changes in serum uric acid levels at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Serum uric acid levels will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  33. Changes in serum transaminases concentrations at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Serum transaminases (AST & ALT) concentrations will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  34. Changes in serum transaminases concentrations at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Serum transaminases (AST & ALT) concentrations will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  35. Changes in serum homocystein concentration at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Serum homocystein concentration will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  36. Changes in serum homocystein concentration at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Serum homocystein concentration will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  37. Changes in vascular endothelial growth factor (VEGF) at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    VEGF levels will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  38. Changes in vascular endothelial growth factor (VEGF) at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    VEGF levels will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  39. Changes in asymmetric dimethylarginine (ADMA) at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    ADMA levels will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  40. Changes in asymmetric dimethylarginine (ADMA) at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    ADMA levels will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  41. Changes in PAI-1 concentration at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    PAI-1 concentration will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  42. Changes in plasminogen activator inhibitor-1 (PAI-1) concentration at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    PAI-1 concentration will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  43. Changes in nitric oxide levels at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Nitric oxide levels will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  44. Changes in nitric oxide levels at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Nitric oxide levels will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  45. Changes in blood pressure at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Changes in diastolic and systolic blood pressure will be measured at baseline and at the end of the body weight loss period (16 Weeks)

  46. Changes in blood pressure at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Changes in diastolic and systolic blood pressure will be measured at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  47. Changes in plasma C-Reactive Protein levels at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    C-Reactive Protein levels will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  48. Changes in plasma C-Reactive Protein levels at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    C-Reactive Protein levels will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  49. Changes in plasma interleukin-6 (IL-6) and interleukin-10 (IL-10) levels at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    IL-6 and IL-10 levels will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  50. Changes in plasma IL-6 and IL-10 levels at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    IL-6 and IL-10 levels will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  51. Changes in plasma tumor necrosis factor-alpha (TNF-alpha) levels at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    TNF-alpha levels will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  52. Changes in plasma TNF-alpha levels at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    TNF-alpha levels will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  53. Changes in adiponectin levels at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Adiponectin levels will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  54. Changes in adiponectin levels at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Adiponectin levels will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  55. Changes in chemerin levels at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Chemerin levels will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  56. Changes in chemerin levels at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Chemerin levels will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  57. Changes in leptin levels at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Leptin levels will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  58. Changes in leptin levels at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Leptin levels will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  59. Changes in apelin levels at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Apelin levels will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  60. Changes in apelin levels at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Apelin levels will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  61. Changes in haptoglobin levels at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Haptoglobin levels will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  62. Changes in haptoglobin levels at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Haptoglobin levels will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  63. Changes in amyloid A levels at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Amyloid A levels will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  64. Changes in amyloid A levels at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Amyloid A levels will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  65. Changes in leukocytes levels at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Leukocytes levels will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  66. Changes in leukocytes levels at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Leukocytes levels will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  67. Changes in plasma LDL-ox levels at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Levels of LDL-ox in plasma will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  68. Changes in plasma LDL-ox levels at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Levels of LDL-ox in plasma will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  69. Changes in glutathione peroxidase activity at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Glutathione peroxidase activity will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  70. Changes in glutathione peroxidase activity at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Glutathione peroxidase activity will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  71. Changes in reduced and oxidized glutathione levels at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Reduced and oxidized glutathione levels will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  72. Changes in reduced and oxidized glutathione levels at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Reduced and oxidized glutathione levels will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  73. Changes in superoxide dismutase levels at 16 Weeks [ Time Frame: Baseline ant 16 Weeks ]
    Superoxide dismutase levels will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  74. Changes in superoxide dismutase levels at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Superoxide dismutase levels will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  75. Changes in serum isoprostanes levels at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Serum isoprostanes levels will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  76. Changes in serum isoprostanes levels at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Serum isoprostanes levels will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  77. Changes in plasma malonyldialdehyde (MDA) concentration at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    MDA concentration will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  78. Changes in plasma malonyldialdehyde (MDA) concentration at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    MDA concentration will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  79. Changes in monoamines levels at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Plasma monoamines (dopamine, dopac, homovalic acid, serotonin, noradrenalin) levels will be measured in a fasting state at baseline and at the end of the body weight loss period (16 Weeks)

  80. Changes in monoamines levels at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Plasma monoamines (dopamine, dopac, homovalic acid, serotonin, noradrenalin) levels will be measured in a fasting state at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  81. Changes in physical activity at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Physical activity level will be measured by a validated physical activity questionnaire and by a pedometer at baseline and at the end of the body weight loss period (16 Weeks)

  82. Changes in physical activity at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Physical activity level will be measured by a validated physical activity questionnaire and by a pedometer at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  83. Changes in depression degree at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Depression degree will be measured by the Beck Depression Inventory at baseline and at the end of the body weight loss period (16 Weeks)

  84. Changes in depression degree at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Depression degree will be measured by the Beck Depression Inventory at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  85. Changes in anxiety degree at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Anxiety degree will be measured by the State-Trait Anxiety Inventory (STAI) at baseline and at the end of the body weight loss period (16 Weeks)

  86. Changes in anxiety degree at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Anxiety degree will be measured by the State-Trait Anxiety Inventory (STAI) at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  87. Changes in the chronotype at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Chronotype will be defined by two questionnaires at baseline and at the end of the intervention period (16 Weeks)

  88. Changes in the chronotype at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Chronotype will be defined by two questionnaires at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)

  89. Changes in food intake at 16 Weeks [ Time Frame: Baseline and 16 weeks ]
    Food intake will be evaluated by a 72 hours dietary record at baseline and at the end of the body weight loss period (16 Weeks)

  90. Changes in food intake at 40 Weeks [ Time Frame: Baseline and 40 weeks ]
    Food intake will be evaluated by a 72 hours dietary record and by a validated Food Frequency Questionnaire at baseline and at the end of the body weight maintenance period (40 Weeks)

  91. Changes in satiety at 16 Weeks [ Time Frame: Baseline and 16 Weeks ]
    Satiety will be evaluated by the Visual Analogue Scale (VAS) at baseline and at the end of the body weight loss period (16 Weeks)

  92. Changes in satiety at 40 Weeks [ Time Frame: 16 Weeks and 40 Weeks ]
    Satiety will be evaluated by the Visual Analogue Scale (VAS) at the end of the body weight loss period (16 Weeks) and at the end of the body weight maintenance period (40 Weeks)



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI) between 25 and 40 kg/m2
  • Physical examination and vital signs normal, or is considered abnormal, but clinically insignificant by researcher.
  • In the case of individuals with chronic stable dose drug treatment and during the last 3 previous months at baseline, the investigator will assess their possible inclusion.

Exclusion Criteria:

  • BMI less than 25 or higher than 40 kg/m2
  • Pregnant women
  • Breastfeeding period. If artificial feeding until 6 months after birth.
  • Type 1 diabetes
  • Severe kidney diseases
  • Severe digestive system diseases
  • Electrolyte disorders (disorders of sodium, potassium, calcium, chlorine, phosphorus, magnesium)
  • Acute cardiovascular diseases
  • Cancer
  • Anemia
  • Eating disorders
  • Recent prescription drug treatment (without stable doses scheduled)
  • Drug therapy that can influence weight loss as corticosteroids.
  • Some type of cognitive impairment and / psychic
  • Subjects in which poor collaboration or, in the investigator's opinion, have difficulty following the procedures of the study is foreseen
  • Lack of commitment (at the discretion of the investigator) with the intervention, suspected non-compliance, or real difficulties to follow the development of the study.

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): NCT02737267


Locations
Layout table for location information
Spain
Centre for Nutrition Research, University of Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
Layout table for investigator information
Principal Investigator: J. Alfredo Martínez, MD, PhD Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III Madrid Spain
Principal Investigator: Fernando J. Corrales, PhD CIMA, University of Navarra
Study Chair: Femín 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: Jose Ignacio Riezu, PhD Centre for Nutrition Research, University of Navarra
Study Chair: Carlos González-Navarro, PhD Centre for Nutrition Research, University of Navarra
Study Chair: Marta Cuervo, PhD Centre for Nutrition Research, University of Navarra
Study Chair: Iosune Zubieta Centre for Nutrition Research, University of Navarra
Study Chair: Blanca Esther Martínez de Morentin, MD Centre for Nutrition Research, University of Navarra
Study Chair: Leticia Goñi Centre for Nutrition Research, University of 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT02737267     History of Changes
Other Study ID Numbers: 132/2015
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: November 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
Genetics
Polymorphism
Epigenetics
Metagenomics
Metabolomics
Metabolic syndrome conditions
Precision nutrition
Additional relevant MeSH terms:
Layout table for MeSH terms
Body Weight
Weight Loss
Body Weight Changes
Signs and Symptoms