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Clinical Trials/NCT02737267
NCT02737267UnknownNot Applicable

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

Clinica Universidad de Navarra, Universidad de Navarra2 sites in 1 country260 target enrollmentStarted: November 1, 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
260
Locations
2
Primary Endpoint
Change in body weight at Week 40
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study evaluates the relationship between several genetic variants and the response to a hypocaloric diet, in order to design a genetic test which permits prescribe the more personalized diet for each individual according to her genotype. Half of the participants will assigned to a moderate high protein diet, while the other half will assigned to a high carbohydrate diet.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
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

  • •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
  • •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.

Outcomes

Primary Outcomes

Change in body weight at Week 40

Time Frame: 16 Weeks and 40 Weeks

Change in body weight at Week 16

Time Frame: Baseline and 16 Weeks

Secondary Outcomes

  • Change in body fat mass at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in metabolomic profile at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in lipidomic profile at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in gut microbiota composition at 16 Weeks(Baseline and 16 Weeks)
  • Single nucleotide polymorphisms (SNPs)(Baseline)
  • Changes in serum glucose levels at 16 Weeks(Baseline and 16 weeks)
  • Changes in serum insulin concentration at 16 Weeks(Baseline and 16 Weeks)
  • Height(Baseline)
  • Change in waist and hip circumferences at 16 Weeks(Baseline and 16 Weeks)
  • Changes in proteomic profile at 16 Weeks(Baseline and 16 Weeks)
  • Changes in proteomic profile at 40 Weeks(16 Weeks and 40 Weeks)
  • Change in waist and hip circumferences at 40 Weeks(16 Weeks and 40 Weeks)
  • Change in body fat mass at 16 Weeks(Baseline and 16 Weeks)
  • Changes in DNA methylation levels at 16 Weeks(Baseline and 16 Weeks)
  • Changes in DNA methylation levels at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in metabolic profiling at 16 Weeks(Baseline and 16 Weeks)
  • Changes in lipidomic profile at 16 Weeks(Baseline and 16 Weeks)
  • Changes in microARNs in exosomes at 16 weeks(Baseline and 16 Weeks)
  • Changes in DNA oxidation at 16 weeks(Baseline and 16 Weeks)
  • Changes in serum glucose levels at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in gut microbiota composition at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in messenger ribonucleic acid (mRNA) expression at 16 Weeks(Baseline and 16 Weeks)
  • Changes in mRNA expression at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in microARNs in exosomes at 40 weeks(16 Weeks and 40 Weeks)
  • Changes in DNA oxidation at 40 weeks(16 Weeks and 40 Weeks)
  • Changes in serum lipid metabolism markers at 16 Weeks(Baseline and 16 Weeks)
  • Changes in serum insulin concentration at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in serum lipid metabolism markers at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in serum uric acid levels at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in asymmetric dimethylarginine (ADMA) at 16 Weeks(Baseline and 16 Weeks)
  • Changes in asymmetric dimethylarginine (ADMA) at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in plasma IL-6 and IL-10 levels at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in plasma tumor necrosis factor-alpha (TNF-alpha) levels at 16 Weeks(Baseline and 16 Weeks)
  • Changes in serum total protein concentration at 16 Weeks(Baseline and 16 Weeks)
  • Changes in serum total protein concentration at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in serum uric acid levels at 16 Weeks(Baseline and 16 Weeks)
  • Changes in serum transaminases concentrations at 16 Weeks(Baseline and 16 Weeks)
  • Changes in serum transaminases concentrations at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in serum homocystein concentration at 16 Weeks(Baseline and 16 Weeks)
  • Changes in serum homocystein concentration at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in vascular endothelial growth factor (VEGF) at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in PAI-1 concentration at 16 Weeks(Baseline and 16 Weeks)
  • Changes in blood pressure at 16 Weeks(Baseline and 16 Weeks)
  • Changes in vascular endothelial growth factor (VEGF) at 16 Weeks(Baseline and 16 Weeks)
  • Changes in plasminogen activator inhibitor-1 (PAI-1) concentration at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in nitric oxide levels at 16 Weeks(Baseline and 16 Weeks)
  • Changes in plasma C-Reactive Protein levels at 16 Weeks(Baseline and 16 Weeks)
  • Changes in nitric oxide levels at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in blood pressure at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in plasma C-Reactive Protein levels at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in plasma interleukin-6 (IL-6) and interleukin-10 (IL-10) levels at 16 Weeks(Baseline and 16 Weeks)
  • Changes in adiponectin levels at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in plasma TNF-alpha levels at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in adiponectin levels at 16 Weeks(Baseline and 16 Weeks)
  • Changes in chemerin levels at 16 Weeks(Baseline and 16 Weeks)
  • Changes in chemerin levels at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in apelin levels at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in haptoglobin levels at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in amyloid A levels at 16 Weeks(Baseline and 16 Weeks)
  • Changes in amyloid A levels at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in leukocytes levels at 16 Weeks(Baseline and 16 Weeks)
  • Changes in apelin levels at 16 Weeks(Baseline and 16 Weeks)
  • Changes in haptoglobin levels at 16 Weeks(Baseline and 16 Weeks)
  • Changes in leptin levels at 16 Weeks(Baseline and 16 Weeks)
  • Changes in leptin levels at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in food intake at 16 Weeks(Baseline and 16 weeks)
  • Changes in glutathione peroxidase activity at 16 Weeks(Baseline and 16 Weeks)
  • Changes in monoamines levels at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in physical activity at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in depression degree at 16 Weeks(Baseline and 16 Weeks)
  • Changes in anxiety degree at 16 Weeks(Baseline and 16 Weeks)
  • Changes in anxiety degree at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in leukocytes levels at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in plasma LDL-ox levels at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in glutathione peroxidase activity at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in superoxide dismutase levels at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in plasma LDL-ox levels at 16 Weeks(Baseline and 16 Weeks)
  • Changes in reduced and oxidized glutathione levels at 16 Weeks(Baseline and 16 Weeks)
  • Changes in reduced and oxidized glutathione levels at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in superoxide dismutase levels at 16 Weeks(Baseline ant 16 Weeks)
  • Changes in serum isoprostanes levels at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in plasma malonyldialdehyde (MDA) concentration at 16 Weeks(Baseline and 16 Weeks)
  • Changes in serum isoprostanes levels at 16 Weeks(Baseline and 16 Weeks)
  • Changes in physical activity at 16 Weeks(Baseline and 16 Weeks)
  • Changes in plasma malonyldialdehyde (MDA) concentration at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in monoamines levels at 16 Weeks(Baseline and 16 Weeks)
  • Changes in depression degree at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in the chronotype at 40 Weeks(16 Weeks and 40 Weeks)
  • Changes in the chronotype at 16 Weeks(Baseline and 16 Weeks)
  • Changes in food intake at 40 Weeks(Baseline and 40 weeks)
  • Changes in satiety at 16 Weeks(Baseline and 16 Weeks)
  • Changes in satiety at 40 Weeks(16 Weeks and 40 Weeks)

Investigators

Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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