Nutrigenetic Intervention on Blood Lipid Markers and Body Composition of Adults With Overweight and Obesity
- Conditions
- Overweight and ObesityDyslipidemias
- Interventions
- Other: CONVENTIONAL DIET INTERVENTIONOther: NUTRIGENETIC DIET INTERVENTION
- Registration Number
- NCT05210023
- Lead Sponsor
- Instituto Tecnológico y de Estudios Superiores de Occidente
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- Men and women
- 18-50 years old
- Mexican- Mexican ancestry (3 generations)
- Live in Guadalajara, Jalisco or metropolitan area.
- Being overweight or obese BMI 25> 40
- Waist circumference:
Women> 80 cm, Men> 94 cm.
-Availability to attend virtual nutritional consultations
- Not meeting the inclusion criteria.
- Pregnancy or breastfeeding
- Gastrointestinal disorders
- Endocrinopathies
- Cardiovascular events
- Diagnosed psychiatric illnesses.
- Diagnosed diabetes
- Take lipid-lowering drugs
- Autoimmune diseases.
- Covid +
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional Diet Group CONVENTIONAL DIET INTERVENTION Participants randomly included in this group will receive menus prepared following the international conventional guidelines set out by the WHO, AHA and Official Mexican Standards (NOM) for the treatment of obesity and dyslipidemia. Nutrigenetic Diet Group NUTRIGENETIC DIET INTERVENTION Participants randomly included in this group will receive nutrigenetic menus, i.e., considering the genotypes of the 11 variants analyzed.
- Primary Outcome Measures
Name Time Method Lipid profile change Baseline, week 4, week 8 Measurements of total cholesterol, LDL cholesterol, VLDL cholesterol, HDL cholesterol, and triglycerides will be evaluated to assess lipid profile change.
- Secondary Outcome Measures
Name Time Method Change in blood pressure Baseline, week 4, week 8 Systolic and diastolic pressure measurement will determine changes in blood pressure
Change in physical activity practice Baseline, week 8 Change in physical activity practice using International Physical Activity Questionnaire - Short Form
Visceral fat index change Baseline, week 4, week 8 Visceral fat index change will be evaluated to assess body composition change and fat loss. Measurement will be assessed using multifrequency bioelectrical impedance analysis (BIA)
Interleukins levels Baseline, week 4, week 8 Determination of serum levels of Interleukin (IL) 6, IL1, IL10 (pg/ml) will be evaluated as a markers of inflammation
Anthropometric measurements change Baseline, week 4, week 8 Waist circumference (cm) and hip circumference (cm) will be evaluated to assess anthropometric change.
tumor Necrosis factor- alfa (TNF-alfa) Baseline, week 4, week 8 Change in TNF-alfa (pg/ml) will be evaluated as a marker of inflammation
Change in food intake Baseline, Week 4, week 8 Change in food intake using Food Frequency Questionnaire
Body Weight change Baseline, week 4, week 8 Measurement of body weight (kg) will be evaluated to assess anthropometric change.
Body Mass Index (BMI) change Baseline, week 4, week 8 Body Mass Index (BMI) allows the identification of overweight and obesity in adults. Weight and height will be combined to report BMI in (kg/m\^2)
C-reactive protein (CRP) Baseline, week 4, week 8 Change in C-reactive protein (CRP)( mg/L) will be evaluated as a marker of inflammation
Change in glucose Baseline, week 4, week 8 Measuring glucose levels will determine changes in this parameter
Adherence to nutritional intervention Week 4, week 8 It will be evaluated through changes in food consumption (food frequency questionnaire)
Insulin Resistance (HOMA-IR) Baseline, week 4, week 8 Insulin resistance will be determined using HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) fasting serum glucose (mg/dL) x insulin (mIU /L) / 405
Body composition change Baseline, week 4, week 8 Body fat mass (% BFM), body fat percentage (%BF) and skeletal muscle mass (% SMM) will be evaluated to assess body composition change. Measurements will be assessed using multifrequency bioelectrical impedance analysis (BIA)
Change in insulin level Baseline, week 4, week 8 Measurement of insulin levels will determine changes in this parameter (microIU/ml)
Trial Locations
- Locations (1)
Institute of Translational Nutrigenetics and Nutrigenomics, Department of Molecular Biology and Genomics, Health Sciences University Center, University of Guadalajara,
🇲🇽Guadalajara, Jalisco, Mexico