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

N/AUnknownNCT02737267
Clinica Universidad de Navarra, Universidad de Navarra260 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

260

Conditions

Body Weight Changes

Interventions

Moderately high protein dietBEHAVIORAL

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.

Low fat dietBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:
Medical Language ↔ Plain English
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.

Locations (1)

Centre for Nutrition Research, University of Navarra

Pamplona, Navarre, Spain

Outcomes

Primary Outcomes

Change in body weight at Week 16

Time frame: Baseline and 16 Weeks

Change in body weight at Week 40

Time frame: 16 Weeks and 40 Weeks

Secondary Outcomes

Height

Time frame: Baseline

Change in waist and hip circumferences at 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)

Time frame: Baseline and 16 Weeks

Change in waist and hip circumferences at 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)

Time frame: 16 Weeks and 40 Weeks

Change in body fat mass at 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)

Time frame: Baseline and 16 Weeks

Change in body fat mass at 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)

Time frame: 16 Weeks and 40 Weeks

Single nucleotide polymorphisms (SNPs)

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

Time frame: Baseline

Changes in DNA methylation levels at 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)

Time frame: Baseline and 16 Weeks

Changes in DNA methylation levels at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in metabolic profiling at 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)

Time frame: Baseline and 16 Weeks

Changes in metabolomic profile at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in lipidomic profile at 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)

Time frame: Baseline and 16 Weeks

Changes in lipidomic profile at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in proteomic profile at 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)

Time frame: Baseline and 16 Weeks

Changes in proteomic profile at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in gut microbiota composition at 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)

Time frame: Baseline and 16 Weeks

Changes in gut microbiota composition at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in messenger ribonucleic acid (mRNA) expression at 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)

Time frame: Baseline and 16 Weeks

Changes in mRNA expression at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in microARNs in exosomes at 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)

Time frame: Baseline and 16 Weeks

Changes in microARNs in exosomes at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in DNA oxidation at 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)

Time frame: Baseline and 16 Weeks

Changes in DNA oxidation at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in serum glucose levels at 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)

Time frame: Baseline and 16 weeks

Changes in serum glucose levels at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in serum insulin concentration at 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)

Time frame: Baseline and 16 Weeks

Changes in serum insulin concentration at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in serum lipid metabolism markers at 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)

Time frame: Baseline and 16 Weeks

Changes in serum lipid metabolism markers at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in serum total protein concentration at 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)

Time frame: Baseline and 16 Weeks

Changes in serum total protein concentration at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in serum uric acid levels at 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)

Time frame: Baseline and 16 Weeks

Changes in serum uric acid levels at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in serum transaminases concentrations at 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)

Time frame: Baseline and 16 Weeks

Changes in serum transaminases concentrations at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in serum homocystein concentration at 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)

Time frame: Baseline and 16 Weeks

Changes in serum homocystein concentration at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in vascular endothelial growth factor (VEGF) at 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)

Time frame: Baseline and 16 Weeks

Changes in vascular endothelial growth factor (VEGF) at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in asymmetric dimethylarginine (ADMA) at 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)

Time frame: Baseline and 16 Weeks

Changes in asymmetric dimethylarginine (ADMA) at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in PAI-1 concentration at 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)

Time frame: Baseline and 16 Weeks

Changes in plasminogen activator inhibitor-1 (PAI-1) concentration at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in nitric oxide levels at 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)

Time frame: Baseline and 16 Weeks

Changes in nitric oxide levels at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in blood pressure at 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)

Time frame: Baseline and 16 Weeks

Changes in blood pressure at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in plasma C-Reactive Protein levels at 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)

Time frame: Baseline and 16 Weeks

Changes in plasma C-Reactive Protein levels at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in plasma interleukin-6 (IL-6) and interleukin-10 (IL-10) levels at 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)

Time frame: Baseline and 16 Weeks

Changes in plasma IL-6 and IL-10 levels at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in plasma tumor necrosis factor-alpha (TNF-alpha) levels at 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)

Time frame: Baseline and 16 Weeks

Changes in plasma TNF-alpha levels at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in adiponectin levels at 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)

Time frame: Baseline and 16 Weeks

Changes in adiponectin levels at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in chemerin levels at 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)

Time frame: Baseline and 16 Weeks

Changes in chemerin levels at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in leptin levels at 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)

Time frame: Baseline and 16 Weeks

Changes in leptin levels at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in apelin levels at 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)

Time frame: Baseline and 16 Weeks

Changes in apelin levels at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in haptoglobin levels at 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)

Time frame: Baseline and 16 Weeks

Changes in haptoglobin levels at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in amyloid A levels at 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)

Time frame: Baseline and 16 Weeks

Changes in amyloid A levels at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in leukocytes levels at 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)

Time frame: Baseline and 16 Weeks

Changes in leukocytes levels at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in plasma LDL-ox levels at 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)

Time frame: Baseline and 16 Weeks

Changes in plasma LDL-ox levels at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in glutathione peroxidase activity at 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)

Time frame: Baseline and 16 Weeks

Changes in glutathione peroxidase activity at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in reduced and oxidized glutathione levels at 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)

Time frame: Baseline and 16 Weeks

Changes in reduced and oxidized glutathione levels at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in superoxide dismutase levels at 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)

Time frame: Baseline ant 16 Weeks

Changes in superoxide dismutase levels at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in serum isoprostanes levels at 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)

Time frame: Baseline and 16 Weeks

Changes in serum isoprostanes levels at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in plasma malonyldialdehyde (MDA) concentration at 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)

Time frame: Baseline and 16 Weeks

Changes in plasma malonyldialdehyde (MDA) concentration at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in monoamines levels at 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)

Time frame: Baseline and 16 Weeks

Changes in monoamines levels at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in physical activity at 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)

Time frame: Baseline and 16 Weeks

Changes in physical activity at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in depression degree at 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)

Time frame: Baseline and 16 Weeks

Changes in depression degree at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in anxiety degree at 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)

Time frame: Baseline and 16 Weeks

Changes in anxiety degree at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in the chronotype at 16 Weeks

Chronotype will be defined by two questionnaires at baseline and at the end of the intervention period (16 Weeks)

Time frame: Baseline and 16 Weeks

Changes in the chronotype at 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)

Time frame: 16 Weeks and 40 Weeks

Changes in food intake at 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)

Time frame: Baseline and 16 weeks

Changes in food intake at 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)

Time frame: Baseline and 40 weeks

Changes in satiety at 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)

Time frame: Baseline and 16 Weeks

Changes in satiety at 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)

Time frame: 16 Weeks and 40 Weeks

Data from ClinicalTrials.gov

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