Skip to main content
OpenTrials
Completed

NCT Number: NCT05210023

Nutrigenetic Intervention on Blood Lipid Markers and Body Composition of Adults With Overweight and Obesity

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dyslipidemias Body Weight Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Translational Nutrigenetics and Nutrigenomics, Department of Molecular Biology and Genomics, Health Sciences University Center, University of Guadalajara,

Guadalajara, Jalisco, 44340, Mexico

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 +

Treatment and study plan

NUTRIGENETIC DIET INTERVENTION

Other

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.

Other names: Nutrigenetic diet group

CONVENTIONAL DIET INTERVENTION

Other

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 names: Conventional diet group

Primary outcomes

  1. Lipid profile change

    Time frame: 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 outcomes

  1. Body composition change

    Time frame: 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)

  2. Visceral fat index change

    Time frame: 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)

  3. Body Weight change

    Time frame: Baseline, week 4, week 8

    Measurement of body weight (kg) will be evaluated to assess anthropometric change.

  4. Anthropometric measurements change

    Time frame: Baseline, week 4, week 8

    Waist circumference (cm) and hip circumference (cm) will be evaluated to assess anthropometric change.

  5. Body Mass Index (BMI) change

    Time frame: 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)

  6. tumor Necrosis factor- alfa (TNF-alfa)

    Time frame: Baseline, week 4, week 8

    Change in TNF-alfa (pg/ml) will be evaluated as a marker of inflammation

  7. C-reactive protein (CRP)

    Time frame: Baseline, week 4, week 8

    Change in C-reactive protein (CRP)( mg/L) will be evaluated as a marker of inflammation

  8. Interleukins levels

    Time frame: 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

  9. Change in glucose

    Time frame: Baseline, week 4, week 8

    Measuring glucose levels will determine changes in this parameter

  10. Change in blood pressure

    Time frame: Baseline, week 4, week 8

    Systolic and diastolic pressure measurement will determine changes in blood pressure

  11. Adherence to nutritional intervention

    Time frame: Week 4, week 8

    It will be evaluated through changes in food consumption (food frequency questionnaire)

  12. Change in food intake

    Time frame: Baseline, Week 4, week 8

    Change in food intake using Food Frequency Questionnaire

  13. Change in physical activity practice

    Time frame: Baseline, week 8

    Change in physical activity practice using International Physical Activity Questionnaire - Short Form

  14. Change in insulin level

    Time frame: Baseline, week 4, week 8

    Measurement of insulin levels will determine changes in this parameter (microIU/ml)

  15. Insulin Resistance (HOMA-IR)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Instituto Tecnológico y de Estudios Superiores de Occidente

Other

Collaborators

  • Instituto Tecnológico de Tepic
  • University of Guadalajara

Registry information

Official study title

Effect of a Nutrigenetic Intervention on Blood Lipid Markers and Body Composition of Adults With Overweight and Obesity

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2022
Registry last updated
Jan 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.