NCT05210023

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

Completed NA Last updated 27 January 2022

What this trial tests

NA trial testing NUTRIGENETIC DIET INTERVENTION in Dyslipidemias in 101 participants. Completed in 22 December 2021.

Timeline

9 June 2021

Primary endpoint
22 December 2021

22 December 2021

Quick facts

Lead sponsor	Instituto Tecnológico y de Estudios Superiores de Occidente
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	101
Start date	9 June 2021
Primary completion	22 December 2021
Estimated completion	22 December 2021
Sites	1 location across Mexico

Drugs / interventions tested

• NUTRIGENETIC DIET INTERVENTION
• CONVENTIONAL DIET INTERVENTION

Conditions studied

• Dyslipidemias — all drugs for Dyslipidemias →
• Overweight and Obesity — all drugs for Overweight and Obesity →

Sponsor

Instituto Tecnológico y de Estudios Superiores de Occidente

Who can join

Adults 18 to 50, any sex, with Dyslipidemias or Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Nutrigenetic Strategy for Reducing Blood Lipids and Low-Grade Inflammation in Adults with Obesity and Overweight.
   Pérez-Beltrán YE, González-Becerra K, Rivera-Iñiguez I, Martínez-López E, et al · · 2023 · cited 8× · PMID 37892400 · DOI 10.3390/nu15204324
2. Interaction of CETP rs708272 Polymorphism on Trans Fatty Acid Intake and Glucose Metabolism Markers.
   Mendivil EJ, Barcenas-Rivera G, Ramos-Lopez O, Hernández-Guerrero C, et al · · 2024 · cited 1× · PMID 39519516 · DOI 10.3390/nu16213683