INNUPREC (Nutrigenetic Intervention for the Prevention of Cardiovascular Disease)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorUniversity of Guadalajara

About this trial

Background: Abdominal obesity (AO) is a multifactorial disease that affects 81.6% of the Mexican population; it is characterized by the excessive accumulation of adipose tissue in abdominal region. Scientific evidence suggest that regional fat distribution plays a critical role in the development of cardiovascular diseases (CVD). The main processes involved in the increased risk of developing CVD in the presence of AO are alterations in insulin signaling, dyslipidemias, atherosclerosis, inflammation, and oxidative damage. On the last years has been reported genetic variations associated with AO and dyslipidemia. In addition, interactions have been found between these genetic variants and diet that may be influencing a differential response in metabolic, molecular, and phenotypic processes, which favor the development of CVD. Objective: Evaluate the effect of nutrigenetic intervention on cardiovascular biomarkers, oxidative stress and antioxidant capacity in subjects with abdominal obesity. Materials and methods: The present study is a simple randomized clinical trial. Participants will be randomized into one of two groups of intervention; Control group and Nutrigenetic group during a 2-month follow-up period. Anthropometric, dietary evaluation and biochemical markers assessments will be monitored at baseline, at 4 weeks (mid-intervention), and at 8 weeks (end of intervention). The dietary evaluation was analyzed by Nutritionist Pro software. Body composition was evaluated by electrical bioimpedance (InBody 370). All biochemical determinations were analyzed by dry chemistry (Vitros 350) and cardiometabolic markers by colorimetric immunoassay technology. Infrastructure: Institute of Translational Nutrigenomics and Nutrigenomics, University Center for Health Sciences, University of Guadalajara.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Currently consuming any of the following drugs: NSAIDs, anticoagulants, hypoglycemic, or hypolipemic drugs

Diagnosed autoimmune diseases

Diagnosed cancer

Pregnancy and breastfeeding

Trial design

Treatments tested in this trial

  • Nutrigenetic diet according the genetic test
  • Control intervention group

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators