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
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.
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
Centre for Nutrition Research, University of Navarra
Pamplona, Navarre, Spain
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
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
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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