Nutrigenetic Intervention on Blood Lipid Markers and Body Composition of Adults With Overweight and Obesity
Condition: Dyslipidemias; Overweight and Obesity
MeSH terms: Obesity; Overweight; Dyslipidemias
Study type: Interventional

Summary: 
      Obesity is defined as the accumulation of excessive fat, attributed to the maintenance of a
      positive energy imbalance between calorie intake and expenditure. Obesity contributes to the
      development of many comorbidities such as type 2 diabetes, cardiovascular diseases,
      hypertension, metabolic syndrome, and dyslipidemias, among others. Dyslipidemias indicate a
      high concentration of lipids in the blood. Dyslipidemias cause more than 4 million premature
      deaths per year.

      The pathogenesis of obesity is complex as it involves environmental, sociocultural,
      physiological, medical, behavioral, genetic, epigenetic, and many other factors. On the other
      hand, the causes of dyslipidemias can be: genetic / hereditary (primary dyslipidemias) or an
      inadequate lifestyle (secondary dyslipidemias).

      Sufficient evidence indicates that lifestyle, mainly diet, plays a decisive role in the
      development of diseases such as obesity and dyslipidemias, in addition to that, recent
      research shows the importance of individual genetic predisposition to suffer from diseases.
      Data based on genome-wide association studies suggest a genetic predisposition for obesity
      and dyslipidemias with identification of various genes and genetic variations associated with
      these conditions. In this sense, the postulates of nutrigenetics as applied science are
      emphasized, since it states that food components can act on the human genome, directly or
      indirectly, to alter the expression of genes and gene products; diet can potentially
      compensate or accentuate the effects of genetic polymorphisms; and the consequences of a
      certain diet depend on the balance of health and disease states and the genetic background of
      an individual.

      Therefore, when advising a change in diet and lifestyle as prevention and as part of the
      treatment for obesity and dyslipidemias, it is considered that a nutrigenetic intervention,
      that is, the administration of a diet designed according to genotypic characteristics and
      personal phenotypic, will have a much greater positive impact on the health status of people
      with detected genetic variations that make them susceptible to these pathologies.

      For this reason, the implementation of nutrigenetic interventions could be a timely and
      successful avant-garde treatment to mitigate various cardiometabolic diseases such as
      dyslipidemias and others that are highly prevalent worldwide.
    

Detailed description: 
      After the selection of the population, the patients undergo a molecular diagnosis: DNA will
      be extracted from peripheral blood with the High Pure PCR (Polymerase Chain Reaction)
      Template Preparation Kit (Roche). Then certain polymorphisms will be determined by allelic
      discrimination with TaqMan® probes with real-time PCR.

      The polymorphisms under study will be the following:

      ABCA1 (ATP-binding cassette transporter ABCA1) rs9282541 PPARG (Peroxisome Proliferator
      Activated Receptor Gamma) rs1801282 LIPC (hepatic lipase) rs1800588 CETP (Cholesteryl ester
      transfer protein) rs708272 LPL (Lipoprotein lipase) rs13702 FABP2 (fatty acid binding protein
      2) rs1799883 APOA5 (Apolipoprotein A-V) rs662799 APOC3 (Apolipoprotein C-III) rs5128 APOA1
      (Apolipoprotein A-I) rs670 APOE (Apolipoprotein E) rs429358 and rs7412

      Patients will be randomized into two different treatment groups. Randomization will be
      stratified according to age, BMI and sex. The allocation ratio will be 1: 1 and parallel
      intervention.Then, trained nutritionists will deliver the intervention according to the
      patient group and they will be followed-up for 8 weeks, which includes 3 face-to-face
      evaluations (baseline, 1st month and final) and 5 remote consultations, via zoom, every 15
      days

      Interventions will be provided as follows:

      NUTRIGENETIC DIET INTERVENTION Weekly, personalized meal plans (menus) will be provided,
      prepared based on the anthropometric needs of the patients, with a caloric reduction (-500
      kcal). These weekly menus (Sunday to Monday) consist of 5 meal times (breakfast, snack,
      lunch, snack and dinner). The distribution of the macronutrients: carbohydrates, proteins and
      fats, as well as the percentages of polyunsaturated, monounsaturated and saturated fatty
      acids, will be established according to certain nutrigenetic recommendations identified in
      the reference bibliography.

      CONVENTIONAL DIET INTERVENTION Weekly, personalized meal plans (menus) will be provided,
      prepared based on the anthropometric needs of the patients, with a caloric reduction (-500
      kcal). These weekly menus (Sunday to Monday) consist of 5 meal times (breakfast, snack,
      lunch, snack and dinner). The distribution of the macronutrients: carbohydrates, proteins and
      fats, as well as the percentages of polyunsaturated, monounsaturated and saturated fatty
      acids, will be in accordance with the recommendations made by the WHO (World Health
      Organization), the AHA (American Heart Association) and the NOM (Official Mexican Standards)
      for the treatment of obesity and dyslipidemias

      The 3 face-to-face evaluations (baseline, 1st month, final) will include anthropometric and
      biochemical evaluations. Therefore, the following criteria will be measured:

      Weight (kg) Height (cm) BMI(kg/m2) Waist circumference and hip circumference (cm) Blood
      pressure Body composition determination

      Blood will be obtained from the antecubital vein, it will be centrifuged to obtain the serum
      and later it will determine:

      Glucose (mg / dL) Total cholesterol (mg / dL) Triglycerides (mg / dL) HDL-c (mg / dL) LDL-c
      (mg / dL) VLDL-c (mg / dL) Insulin (microIU/mL) C-reactive protein (mg/L) Interleukins, among
      other parameters

      Every 15 days there will be virtual remote consultations, through the zoom platform. In these
      sessions, the nutritional clinical history and various medical and dietary questionnaires
      will be applied to evaluate secondary results. In addition, a new food plan will be
      delivered, according to the needs of the participant and taking into account the
      characteristics of the experimental treatment to which they belong.

      This research will be conducted at The Institute of Translational Nutrigenetics and
      Nutrigenomics, Department of Molecular Biology and Genomics, Health Sciences University
      Center, University of Guadalajara, Guadalajara, Mexico
    

Intervention name(s): NUTRIGENETIC DIET INTERVENTION; CONVENTIONAL DIET INTERVENTION
Intervention type(s): Other; Other
Intervention description(s): Weekly, personalized meal plans (menus) will be provided, prepared based on the anthropometric needs of the patients, with a caloric reduction (-500 kcal). These weekly menus (Sunday to Monday) consist of 5 meal times (breakfast, snack, lunch, snack and dinner). The distribution of the macronutrients: carbohydrates, proteins and fats, as well as the percentages of polyunsaturated, monounsaturated and saturated fatty acids, will be established according to certain nutrigenetic recommendations identified in the reference bibliography.
Participants included in this group will receive remote (virtual) nutritional counseling every 15 days.; Weekly, personalized meal plans (menus) will be provided, prepared based on the anthropometric needs of the patients, with a caloric reduction (-500 kcal). These weekly menus (Sunday to Monday) consist of 5 meal times (breakfast, snack, lunch, snack and dinner). The distribution of the macronutrients: carbohydrates, proteins and fats, as well as the percentages of polyunsaturated, monounsaturated and saturated fatty acids, will be in accordance with the recommendations made by the WHO (World Health Organization), the AHA (American heart association) and the NOM (Official Mexican Standards) for the treatment of obesity and dyslipidemias.
Participants included in this group will receive remote (virtual) nutritional counseling every 15 days.
Other intervention name(s): Nutrigenetic diet group; Conventional diet group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled clinical trial, parallel, with 2 study groups
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: nutrigenetic; polymorphisms; dietetic intervention; lipid levels