INNUPREC (Nutrigenetic Intervention for the Prevention of Cardiovascular Disease)

Condition(s) studied

Investigational drug(s) / intervention(s)

Nutrigenetic diet according the genetic test: Subjects within the nutrigenetic intervention group will be provided with a dietary plan according to nutrient intake characteristics by alghoritm genetic afinity.

Control intervention group: Subjects within the control intervention group will be provided with a dietary plan according to general nutrient recommendation by the AHA (American Hearth association) and national cholesterol education program

Study summary

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

Primary outcome measure(s)

• Changes in Waist Circumference between nutrigenetic and control group — At baseline, first month and second month (final)
  Waist circumference is used as a diagnostic criterion for abdominal obesity, which is why it is the main change to be evaluated among our study groups. Waist circumference will be measure at the narrowest point between the edge of the inner rib and the iliac crest, with the participant in an abducted and relaxed position, after expiration using a Lufkin Executive® tape.

Trial sites (1)

More University of Guadalajara trials in Mexico