Development of a Nutrigenetic Test for Personalized Prescription of Body Weight Loss Diets (Obekit)
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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:
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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.
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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.
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Change in body weight at Week 16 [Baseline and 16 Weeks]
- Change in body weight at Week 40 [16 Weeks and 40 Weeks]
Secondary Outcome Measures
- Height [Baseline]
- Change in waist and hip circumferences at 16 Weeks [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)
- Change in waist and hip circumferences at 40 Weeks [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)
- Change in body fat mass at 16 Weeks [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)
- Change in body fat mass at 40 Weeks [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)
- Single nucleotide polymorphisms (SNPs) [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
- Changes in DNA methylation levels at 16 Weeks [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)
- Changes in DNA methylation levels at 40 Weeks [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)
- Changes in metabolic profiling at 16 Weeks [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)
- Changes in metabolomic profile at 40 Weeks [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)
- Changes in lipidomic profile at 16 Weeks [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)
- Changes in lipidomic profile at 40 Weeks [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)
- Changes in proteomic profile at 16 Weeks [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)
- Changes in proteomic profile at 40 Weeks [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)
- Changes in gut microbiota composition at 16 Weeks [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)
- Changes in gut microbiota composition at 40 Weeks [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)
- Changes in messenger ribonucleic acid (mRNA) expression at 16 Weeks [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)
- Changes in mRNA expression at 40 Weeks [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)
- Changes in microARNs in exosomes at 16 weeks [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)
- Changes in microARNs in exosomes at 40 weeks [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)
- Changes in DNA oxidation at 16 weeks [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)
- Changes in DNA oxidation at 40 weeks [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)
- Changes in serum glucose levels at 16 Weeks [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)
- Changes in serum glucose levels at 40 Weeks [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)
- Changes in serum insulin concentration at 16 Weeks [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)
- Changes in serum insulin concentration at 40 Weeks [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)
- Changes in serum lipid metabolism markers at 16 Weeks [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)
- Changes in serum lipid metabolism markers at 40 Weeks [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)
- Changes in serum total protein concentration at 16 Weeks [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)
- Changes in serum total protein concentration at 40 Weeks [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)
- Changes in serum uric acid levels at 16 Weeks [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)
- Changes in serum uric acid levels at 40 Weeks [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)
- Changes in serum transaminases concentrations at 16 Weeks [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)
- Changes in serum transaminases concentrations at 40 Weeks [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)
- Changes in serum homocystein concentration at 16 Weeks [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)
- Changes in serum homocystein concentration at 40 Weeks [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)
- Changes in vascular endothelial growth factor (VEGF) at 16 Weeks [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)
- Changes in vascular endothelial growth factor (VEGF) at 40 Weeks [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)
- Changes in asymmetric dimethylarginine (ADMA) at 16 Weeks [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)
- Changes in asymmetric dimethylarginine (ADMA) at 40 Weeks [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)
- Changes in PAI-1 concentration at 16 Weeks [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)
- Changes in plasminogen activator inhibitor-1 (PAI-1) concentration at 40 Weeks [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)
- Changes in nitric oxide levels at 16 Weeks [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)
- Changes in nitric oxide levels at 40 Weeks [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)
- Changes in blood pressure at 16 Weeks [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)
- Changes in blood pressure at 40 Weeks [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)
- Changes in plasma C-Reactive Protein levels at 16 Weeks [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)
- Changes in plasma C-Reactive Protein levels at 40 Weeks [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)
- Changes in plasma interleukin-6 (IL-6) and interleukin-10 (IL-10) levels at 16 Weeks [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)
- Changes in plasma IL-6 and IL-10 levels at 40 Weeks [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)
- Changes in plasma tumor necrosis factor-alpha (TNF-alpha) levels at 16 Weeks [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)
- Changes in plasma TNF-alpha levels at 40 Weeks [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)
- Changes in adiponectin levels at 16 Weeks [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)
- Changes in adiponectin levels at 40 Weeks [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)
- Changes in chemerin levels at 16 Weeks [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)
- Changes in chemerin levels at 40 Weeks [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)
- Changes in leptin levels at 16 Weeks [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)
- Changes in leptin levels at 40 Weeks [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)
- Changes in apelin levels at 16 Weeks [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)
- Changes in apelin levels at 40 Weeks [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)
- Changes in haptoglobin levels at 16 Weeks [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)
- Changes in haptoglobin levels at 40 Weeks [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)
- Changes in amyloid A levels at 16 Weeks [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)
- Changes in amyloid A levels at 40 Weeks [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)
- Changes in leukocytes levels at 16 Weeks [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)
- Changes in leukocytes levels at 40 Weeks [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)
- Changes in plasma LDL-ox levels at 16 Weeks [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)
- Changes in plasma LDL-ox levels at 40 Weeks [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)
- Changes in glutathione peroxidase activity at 16 Weeks [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)
- Changes in glutathione peroxidase activity at 40 Weeks [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)
- Changes in reduced and oxidized glutathione levels at 16 Weeks [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)
- Changes in reduced and oxidized glutathione levels at 40 Weeks [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)
- Changes in superoxide dismutase levels at 16 Weeks [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)
- Changes in superoxide dismutase levels at 40 Weeks [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)
- Changes in serum isoprostanes levels at 16 Weeks [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)
- Changes in serum isoprostanes levels at 40 Weeks [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)
- Changes in plasma malonyldialdehyde (MDA) concentration at 16 Weeks [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)
- Changes in plasma malonyldialdehyde (MDA) concentration at 40 Weeks [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)
- Changes in monoamines levels at 16 Weeks [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)
- Changes in monoamines levels at 40 Weeks [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)
- Changes in physical activity at 16 Weeks [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)
- Changes in physical activity at 40 Weeks [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)
- Changes in depression degree at 16 Weeks [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)
- Changes in depression degree at 40 Weeks [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)
- Changes in anxiety degree at 16 Weeks [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)
- Changes in anxiety degree at 40 Weeks [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)
- Changes in the chronotype at 16 Weeks [Baseline and 16 Weeks]
Chronotype will be defined by two questionnaires at baseline and at the end of the intervention period (16 Weeks)
- Changes in the chronotype at 40 Weeks [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)
- Changes in food intake at 16 Weeks [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)
- Changes in food intake at 40 Weeks [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)
- Changes in satiety at 16 Weeks [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)
- Changes in satiety at 40 Weeks [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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Body Mass Index (BMI) between 25 and 40 kg/m2
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Physical examination and vital signs normal, or is considered abnormal, but clinically insignificant by researcher.
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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:
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BMI less than 25 or higher than 40 kg/m2
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Pregnant women
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Breastfeeding period. If artificial feeding until 6 months after birth.
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Type 1 diabetes
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Severe kidney diseases
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Severe digestive system diseases
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Electrolyte disorders (disorders of sodium, potassium, calcium, chlorine, phosphorus, magnesium)
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Acute cardiovascular diseases
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Cancer
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Anemia
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Eating disorders
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Recent prescription drug treatment (without stable doses scheduled)
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Drug therapy that can influence weight loss as corticosteroids.
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Some type of cognitive impairment and / psychic
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Subjects in which poor collaboration or, in the investigator's opinion, have difficulty following the procedures of the study is foreseen
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre for Nutrition Research, University of Navarra | Pamplona | Navarra | Spain | 31008 |
Sponsors and Collaborators
- Clinica Universidad de Navarra, Universidad de Navarra
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 132/2015