Status unknownNCT02737267ObekitUpdated Mar 29, 2017

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

An interventional study of Moderately high protein diet and Low fat diet in Body Weight Changes, sponsored by Clinica Universidad de Navarra, Universidad de Navarra. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-29.

Sponsored by Clinica Universidad de Navarra, Universidad de Navarra · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2015), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 260
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Body Weight Changes

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Keywords

Genetics
Polymorphism
Epigenetics
Metagenomics
Metabolomics
Metabolic syndrome conditions
Precision nutrition

In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.

This study's enrollment of 260 is above the median of 64 across 947 interventional studies indexed under Body Weight.

Browse Body Weight studies →

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra is the lead sponsor of 158 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 260 participants (actual)

Study arms

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
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

Interventions

BehavioralModerately 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.
BehavioralLow 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

What researchers measure

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

Study locations

1 site

Centre for Nutrition Research, University of Navarra
Pamplona, Navarra 31008, Spain

References and documents

Publications

Cuevas-Sierra A, Milagro FI, Guruceaga E, Cuervo M, Goni L, Garcia-Granero M, Martinez JA, Riezu-Boj JI. A weight-loss model based on baseline microbiota and genetic scores for selection of dietary treatments in overweight and obese population. Clin Nutr. 2022 Aug;41(8):1712-1723. doi: 10.1016/j.clnu.2022.06.008. Epub 2022 Jun 16. PubMed 35777110 ↗
Cuevas-Sierra A, Romo-Hualde A, Aranaz P, Goni L, Cuervo M, Martinez JA, Milagro FI, Riezu-Boj JI. Diet- and sex-related changes of gut microbiota composition and functional profiles after 4 months of weight loss intervention. Eur J Nutr. 2021 Sep;60(6):3279-3301. doi: 10.1007/s00394-021-02508-0. Epub 2021 Feb 16. PubMed 33591390 ↗
Ramos-Lopez O, Cuervo M, Goni L, Milagro FI, Riezu-Boj JI, Martinez JA. Modeling of an integrative prototype based on genetic, phenotypic, and environmental information for personalized prescription of energy-restricted diets in overweight/obese subjects. Am J Clin Nutr. 2020 Feb 1;111(2):459-470. doi: 10.1093/ajcn/nqz286. PubMed 31751449 ↗
Ramos-Lopez O, Riezu-Boj JI, Milagro FI, Goni L, Cuervo M, Martinez JA. Differential lipid metabolism outcomes associated with ADRB2 gene polymorphisms in response to two dietary interventions in overweight/obese subjects. Nutr Metab Cardiovasc Dis. 2018 Feb;28(2):165-172. doi: 10.1016/j.numecd.2017.11.006. Epub 2017 Dec 5. PubMed 29331538 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02737267
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Responsible party: Sponsor
First posted: Apr 13, 2016
Start date: Nov 2015
Primary completion: Dec 2017 (estimated)
Completion: Dec 2017 (estimated)
Last update: Mar 29, 2017

Study contacts

J. Alfredo Martínez, MD, PhD

principal investigator · Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III Madrid Spain

Fernando J. Corrales, PhD

principal investigator · CIMA, University of Navarra

Femín I Milagro, PhD

study chair · Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III Madrid Spain

Jose Ignacio Riezu, PhD