Clinical trial NCT05210023: Nutrigenetic Intervention on Blood Lipid Markers and Body Composition of Adults With Overweight and Obesity
Official title: Effect of a Nutrigenetic Intervention on Blood Lipid Markers and Body Composition of Adults With Overweight and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemias
Overweight and Obesity
Keywords: nutrigenetic
polymorphisms
dietetic intervention
lipid levels
Lead sponsor: Instituto Tecnológico y de Estudios Superiores de Occidente
Sponsor class: OTHER
Collaborators: name: Instituto Tecnológico de Tepic
name: University of Guadalajara
First posted: 2022-01-27
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial, parallel, with 2 study groups
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 +

Primary outcomes:
measure: Lipid profile change
timeFrame: Baseline, week 4, week 8
Secondary outcomes:
measure: Body composition change
timeFrame: Baseline, week 4, week 8
measure: Visceral fat index change
timeFrame: Baseline, week 4, week 8
measure: Body Weight change
timeFrame: Baseline, week 4, week 8
measure: Anthropometric measurements change
timeFrame: Baseline, week 4, week 8
measure: Body Mass Index (BMI) change
timeFrame: Baseline, week 4, week 8
measure: tumor Necrosis factor- alfa (TNF-alfa)
timeFrame: Baseline, week 4, week 8
measure: C-reactive protein (CRP)
timeFrame: Baseline, week 4, week 8
measure: Interleukins levels
timeFrame: Baseline, week 4, week 8
measure: Change in glucose
timeFrame: Baseline, week 4, week 8
measure: Change in blood pressure
timeFrame: Baseline, week 4, week 8
measure: Adherence to nutritional intervention
timeFrame: Week 4, week 8
measure: Change in food intake
timeFrame: Baseline, Week 4, week 8
measure: Change in physical activity practice
timeFrame: Baseline, week 8
measure: Change in insulin level
timeFrame: Baseline, week 4, week 8
measure: Insulin Resistance (HOMA-IR)
timeFrame: Baseline, week 4, week 8
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Institute of Translational Nutrigenetics and Nutrigenomics, Department of Molecular Biology and Genomics, Health Sciences University Center, University of Guadalajara,
state: Jalisco
Study officials:
affiliation: Instituto Tecnológico y de Estudios Superiores de Occidente
name: Edgar J Mendivil, PhD
role: STUDY_DIRECTOR
References:
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