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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Nutrigenetic diet according the genetic test

    Diagnostic 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

    Other intervention

    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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Nutrigenetic interventionActive comparator 1 intervention
Group B: Control InterventionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in Waist Circumference between nutrigenetic and control group

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.

Time frame
At baseline, first month and second month (final)

Secondary outcomes

1

Changes in Weight

The weight will be measure in kilograms on InBody 370

Time frame
At the baseline (0 Month) and 1st month, 2nd month (final)
2

Changes in Fat Mass

The Fat Mass will be measure in kilograms by electrical bioimpedance on InBody 370

Time frame
At the baseline (0 Month) and 1st month, 2nd month (final)
3

Changes in Total Cholesterol

Will be measure in mg/dL using a dry chemistry system in Vitros 350 equipment.

Time frame
At the baseline (0 Month) and 1st month, 2nd month (final)
4

Changes in Triglycerides

Will be measure in mg/dL using a dry chemistry system in Vitros 350 equipment.

Time frame
At the baseline (0 Month) and 1st month, 2nd month (final)

Other outcomes

Sponsors and contacts

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