INNUPREC (Nutrigenetic Intervention for the Prevention of Cardiovascular Disease)

A total of 60 subjects will be invited to enroll in a clinical trial of nutrigenetic or control intervention. Prior to randomization and the start of the intervention, all subjects will be scheduled for a first appointment where their medical history will be taken and a blood sample will be taken for DNA extraction and their genetic profile will be performed (including 21 SNV (single nucleotide variation) involved in cardiometabolic disorders). The assignment to the intervention group will be done through a random permuted block assignment. In the case of the subjects of the nutrigenetic intervention group, with the help of an algorithm designed for the purposes of this study, their genetic profile of the variants of interest will be entered, in order to determine the dietary pattern to which they have the greatest affinity. Once this data is available, they will be given their eating plan. Regarding the control group, the characteristics of their menu will adhere to what is established in a correct diet and the recommendations of the American Heart Association.

This clinical trial will consist in a 8-week intervention with recurrent visits every 4 weeks. Subjects will be required to follow the dietary plan provided in a menu produced and edited by our research group. In every visit, all subjects will undergo a body composition analysis as well as blood tests that include: total cell count, glucose and lipid homeostasis, serum oxidative and antioxidant markers. In total, they will be evaluated anthropometrically and biochemically on 3 occasions, at baseline, 1 month and 2 months (final).

This study proposes three distinct but closely related approaches to gain a better understanding of nutrigenetics and its impact on precision nutrition.

• To compare the effect and impact of personalized nutritional interventions on nutritional diets with general recommendations.
• See the impact of a personalized diet in improving parameters involved in the development of cardiovascular diseases
• Develop new personalized nutritional treatment strategies for subjects with chronic diseases

Once the project is finished, new research strategies will be proposed for future studies, seeking to have an evaluation beyond the anthropometric and biochemical, such as microbiota or gene regulation. In addition to this, the application of the knowledge generated in the project to the health care of patients with obesity who may come to our service in the future will be encouraged. Finally, the knowledge generated will be disseminated in our institutional community, which would increase the impact and significance of the project.

In summary, the impact of this study is divided into the following points:

• Design of new strategys as nutrigenetic intervention´s for the treatment and prevention metabolic disease such as obesity and cardiovascular
• Identification of some cardiovascular biomarkers relevant to the treatment of abdominal obesity and its comorbidities
• Useful information on gene-nutrient interaction for the public and private sector in the field of genetic testing
• Study population benefited from the results of the intervention and the information of their genetic and biochemical profiles

Inclusion criteria

• 30-65 years of age
• Subjects who agree to participate in the study and all signed informed consent
• Women with a waist circumference ≥ 88 cm and men ≥ 102 cm according to NCEP/ATPIII.

Exclusion criteria

• Currently consuming any of the following drugs: NSAIDs, anticoagulants, hypoglycemic, or hypolipemic drugs
• Diagnosed autoimmune diseases
• Diagnosed cancer
• Pregnancy and breastfeeding
• Subjects who have undergone a dietary intervention at the time or up to 3 months prior
• Subjects who wish to abandon the study