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

January 13, 2022 updated by: Instituto Tecnológico y de Estudios Superiores de Occidente

Effect of a 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Institute of Translational Nutrigenetics and Nutrigenomics, Department of Molecular Biology and Genomics, Health Sciences University Center, University of Guadalajara,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 +

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutrigenetic Diet Group
Participants randomly included in this group will receive nutrigenetic menus, i.e., considering the genotypes of the 11 variants analyzed.
Other: 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.

Participants included in this group will receive remote (virtual) nutritional counseling every 15 days.

Other Names:
  • Nutrigenetic diet group
Experimental: Conventional Diet Group
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.
Other: 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.

Participants included in this group will receive remote (virtual) nutritional counseling every 15 days.

Other Names:
  • Conventional diet group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, week 4, week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, week 4, week 8
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)
Baseline, week 4, week 8
Body Weight change
Time Frame: Baseline, week 4, week 8
Measurement of body weight (kg) will be evaluated to assess anthropometric change.
Baseline, week 4, week 8
Anthropometric measurements change
Time Frame: Baseline, week 4, week 8
Waist circumference (cm) and hip circumference (cm) will be evaluated to assess anthropometric change.
Baseline, week 4, week 8
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)
Baseline, week 4, week 8
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
Baseline, week 4, week 8
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
Baseline, week 4, week 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
Baseline, week 4, week 8
Change in glucose
Time Frame: Baseline, week 4, week 8
Measuring glucose levels will determine changes in this parameter
Baseline, week 4, week 8
Change in blood pressure
Time Frame: Baseline, week 4, week 8
Systolic and diastolic pressure measurement will determine changes in blood pressure
Baseline, week 4, week 8
Adherence to nutritional intervention
Time Frame: Week 4, week 8
It will be evaluated through changes in food consumption (food frequency questionnaire)
Week 4, week 8
Change in food intake
Time Frame: Baseline, Week 4, week 8
Change in food intake using Food Frequency Questionnaire
Baseline, Week 4, week 8
Change in physical activity practice
Time Frame: Baseline, week 8
Change in physical activity practice using International Physical Activity Questionnaire - Short Form
Baseline, week 8
Change in insulin level
Time Frame: Baseline, week 4, week 8
Measurement of insulin levels will determine changes in this parameter (microIU/ml)
Baseline, week 4, week 8
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
Baseline, week 4, week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Tecnológico y de Estudios Superiores de Occidente

Collaborators

University of Guadalajara
Instituto Tecnológico de Tepic

Investigators

  • Study Director: Edgar J Mendivil, PhD, Instituto Tecnologico y de Estudios Superiores de Occidente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2021

Primary Completion (Actual)

December 22, 2021

Study Completion (Actual)

December 22, 2021

Study Registration Dates

First Submitted

December 31, 2021

First Submitted That Met QC Criteria

January 13, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

January 27, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUTRIGENETIC_INTERV07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

All information provided by participant is strictly confidential, will be used only by the project's research team and will not be available for any other purpose. The results obtained from this study will be published for scientific purposes but the confidentiality of the participants will never be violated. The information or evidence obtained will be eliminated after fulfilling the scientific purposes for which this intervention was proposed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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