Body Weight ChangesObekitNCT02737267
Development of a Nutrigenetic Test for Personalized Prescription of Body Weight Loss Diets (Obekit)
A study testing Moderately high protein diet and Low fat diet in people with Body Weight Changes, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes
- What is being tested?
- Moderately high protein diet and Low fat diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centre for Nutrition Research, University of Navarra
Pamplona, Navarre, 31008
About this study
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
- Body Weight Changes
- Being tested
- Moderately high protein diet, Low fat diet
- Keywords
- Genetics, Polymorphism, Epigenetics, Metagenomics, Metabolomics, Metabolic syndrome conditions, Precision nutrition
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderately high protein dietBehavioural
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 dietBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Moderately high protein diet | Experimental | 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 Receives: Behavioral: Moderately high protein diet |
| Low fat diet | Placebo comparator | 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 Receives: Behavioral: Low fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight at Week 16
Measured: Baseline and 16 Weeks
Change in body weight at Week 40
Measured: 16 Weeks and 40 Weeks
Secondary outcomes (92)
Height
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 16 Weeks and 40 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startNov 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Body Weight ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 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 SpainFernando J. Corrales, PhD, Principal investigator, CIMA, University of NavarraFemín 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 SpainJose Ignacio Riezu, PhD, Study chair, Centre for Nutrition Research, University of NavarraCarlos González-Navarro, PhD, Study chair, Centre for Nutrition Research, University of NavarraMarta Cuervo, PhD, Study chair, Centre for Nutrition Research, University of NavarraIosune Zubieta, Study chair, Centre for Nutrition Research, University of NavarraBlanca Esther Martínez de Morentin, MD, Study chair, Centre for Nutrition Research, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737267
- Sponsor's protocol ID
- 132/2015
- Acronym
- Obekit
- Status last verified
- Nov 2015
- First submitted
- 10 Mar 2016
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mogna-Pelaez P, Zhang N, Guasch-Ferre M, Milagro FI, Riezu-Boj JI, Herrero JI, Elorz M, Benito-Boillos A, Tobaruela-Resola AL, Marti Del Moral A, Tur JA, Martinez JA, Abete I, Zulet MA. Planetary Health Diet Adherence Improves Weight and Body Composition During Energy Restriction. Obesity (Silver Spring). 2026 Jun;34(6):1265-1276. doi: 10.1002/oby.70215. Epub 2026 May 20.
PubMed 42159409Alonso-Allende J, Riezu-Boj JI, Hualde AR, Milagro FI, Aranaz P. A novel obesity index reveals obesity-associated microbiota changes after weight loss intervention in a Spanish population. Nutr J. 2026 Mar 13;25(1):49. doi: 10.1186/s12937-026-01313-x.
PubMed 41827016Garcia-Alvarez NC, Riezu-Boj JI, Martinez JA, Garcia-Calzon S, Milagro FI. A Predictive Tool Based on DNA Methylation Data for Personalized Weight Loss through Different Dietary Strategies: A Pilot Study. Nutrients. 2023 Dec 6;15(24):5023. doi: 10.3390/nu15245023.
PubMed 38140282Cuevas-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 35777110Cuevas-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 33591390Ramos-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 31751449Ramos-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
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Nutrigenetic Test for Personalized Prescription of Body Weight Loss Diets (Obekit)
- ClinicalTrials.gov ID
- NCT02737267
- Acronym / sponsor ID
- Obekit / 132/2015
- Conditions
- Body Weight Changes
- Keywords
- Genetics, Polymorphism, Epigenetics, Metagenomics, Metabolomics, Metabolic syndrome conditions, Precision nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderately high protein diet | Experimental | Behavioral: Moderately high protein dietCaloric 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 |
| Low fat diet | Placebo comparator | Behavioral: Low fat dietCaloric 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderately high protein dietAfter 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. | Behavioural | Moderately high protein diet |
| Low fat dietAfter 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 | Behavioural | Low fat diet |
Primary outcome
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
92 secondary outcomes
Height
Time frame: Baseline
Change in waist and hip circumferences at 16 Weeks
Time frame: Baseline and 16 Weeks
Change in waist and hip circumferences at 40 Weeks
Time frame: 16 Weeks and 40 Weeks
Change in body fat mass at 16 Weeks
Time frame: Baseline and 16 Weeks
Change in body fat mass at 40 Weeks
Time frame: 16 Weeks and 40 Weeks
Single nucleotide polymorphisms (SNPs)
Time frame: Baseline
Changes in DNA methylation levels at 16 Weeks
Time frame: Baseline and 16 Weeks
Changes in DNA methylation levels at 40 Weeks
Time frame: 16 Weeks and 40 Weeks
Changes in metabolic profiling at 16 Weeks
Time frame: Baseline and 16 Weeks
Changes in metabolomic profile at 40 Weeks
Time frame: 16 Weeks and 40 Weeks
Changes in lipidomic profile at 16 Weeks
Time frame: Baseline and 16 Weeks
Changes in lipidomic profile at 40 Weeks
Time frame: 16 Weeks and 40 Weeks
Changes in proteomic profile at 16 Weeks
Time frame: Baseline and 16 Weeks
Changes in proteomic profile at 40 Weeks
Time frame: 16 Weeks and 40 Weeks
Changes in gut microbiota composition at 16 Weeks
Time frame: Baseline and 16 Weeks
Changes in gut microbiota composition at 40 Weeks
Time frame: 16 Weeks and 40 Weeks
Changes in messenger ribonucleic acid (mRNA) expression at 16 Weeks
Time frame: Baseline and 16 Weeks
Changes in mRNA expression at 40 Weeks
Time frame: 16 Weeks and 40 Weeks
Changes in microARNs in exosomes at 16 weeks
Time frame: Baseline and 16 Weeks
Changes in microARNs in exosomes at 40 weeks
Time frame: 16 Weeks and 40 Weeks
Changes in DNA oxidation at 16 weeks
Time frame: Baseline and 16 Weeks
Changes in DNA oxidation at 40 weeks
Time frame: 16 Weeks and 40 Weeks
Changes in serum glucose levels at 16 Weeks
Time frame: Baseline and 16 weeks
Changes in serum glucose levels at 40 Weeks
Time frame: 16 Weeks and 40 Weeks
Changes in serum insulin concentration at 16 Weeks
Time frame: Baseline and 16 Weeks
Changes in serum insulin concentration at 40 Weeks
Time frame: 16 Weeks and 40 Weeks
Changes in serum lipid metabolism markers at 16 Weeks
Time frame: Baseline and 16 Weeks
Changes in serum lipid metabolism markers at 40 Weeks
Time frame: 16 Weeks and 40 Weeks
Changes in serum total protein concentration at 16 Weeks
Time frame: Baseline and 16 Weeks
Changes in serum total protein concentration at 40 Weeks
Time frame: 16 Weeks and 40 Weeks
Changes in serum uric acid levels at 16 Weeks
Time frame: Baseline and 16 Weeks
Changes in serum uric acid levels at 40 Weeks
Time frame: 16 Weeks and 40 Weeks
Changes in serum transaminases concentrations at 16 Weeks
Time frame: Baseline and 16 Weeks
Changes in serum transaminases concentrations at 40 Weeks
Time frame: 16 Weeks and 40 Weeks
Changes in serum homocystein concentration at 16 Weeks
Time frame: Baseline and 16 Weeks
Changes in serum homocystein concentration at 40 Weeks
Time frame: 16 Weeks and 40 Weeks
Changes in vascular endothelial growth factor (VEGF) at 16 Weeks
Time frame: Baseline and 16 Weeks
Changes in vascular endothelial growth factor (VEGF) at 40 Weeks
Time frame: 16 Weeks and 40 Weeks
Changes in asymmetric dimethylarginine (ADMA) at 16 Weeks
Time frame: Baseline and 16 Weeks
Changes in asymmetric dimethylarginine (ADMA) at 40 Weeks
Time frame: 16 Weeks and 40 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Derived from this study: PubMed 42159409Mogna-Pelaez P, Zhang N, Guasch-Ferre M, Milagro FI, Riezu-Boj JI, Herrero JI, Elorz M, Benito-Boillos A, Tobaruela-Resola AL, Marti Del Moral A, Tur JA, Martinez JA, Abete I, Zulet MA. Planetary Health Diet Adherence Improves Weight and Body Composition During Energy Restriction. Obesity (Silver Spring). 2026 Jun;34(6):1265-1276. doi: 10.1002/oby.70215. Epub 2026 May 20.
- Derived from this study: PubMed 41827016Alonso-Allende J, Riezu-Boj JI, Hualde AR, Milagro FI, Aranaz P. A novel obesity index reveals obesity-associated microbiota changes after weight loss intervention in a Spanish population. Nutr J. 2026 Mar 13;25(1):49. doi: 10.1186/s12937-026-01313-x.
- Derived from this study: PubMed 38140282Garcia-Alvarez NC, Riezu-Boj JI, Martinez JA, Garcia-Calzon S, Milagro FI. A Predictive Tool Based on DNA Methylation Data for Personalized Weight Loss through Different Dietary Strategies: A Pilot Study. Nutrients. 2023 Dec 6;15(24):5023. doi: 10.3390/nu15245023.
- Derived from this study: PubMed 35777110Cuevas-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.
- Derived from this study: PubMed 33591390Cuevas-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.
- Derived from this study: PubMed 31751449Ramos-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.
- Derived from this study: PubMed 29331538Ramos-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderately high protein diet and Low fat diet in people with Body Weight Changes, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight at Week 16 (time frame: Baseline and 16 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02737267, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.