INNUPREC (Nutrigenetic Intervention for the Prevention of Cardiovascular Disease)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nutrigenetic diet according the genetic test, Control intervention group.
- Who it may be relevant to
- Registry conditions: Abdominal Obesity. Basic parameters: 30 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Nutrigenetic Intervention on Cardiovascular Biomarkers, Oxidative Stress and Antioxidant Capacity in Subjects with Abdominal Obesity
Overview
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.
Detailed description
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
Interventions
- Diagnostic test 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. - Other 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
Primary outcome measures
- Changes in Waist Circumference between nutrigenetic and control group [Time frame: At baseline, first month and second month (final)]
Secondary outcome measures (12)
- Changes in Weight [Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)]
- Changes in Fat Mass [Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)]
- Changes in Total Cholesterol [Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)]
- Changes in Triglycerides [Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)]
- Changes in High-density lipoprotein (c-HDL) [Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)]
- Changes in Low-density lipoprotein (c-LDL) [Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)]
- Changes in serum glucose [Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)]
- Changes in serum insulin [Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)]
- Changes in homeostatic model assessment - insulin resistance (HOMA-IR) [Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)]
- Changes in serum Oxidized low-density lipoprotein (oxLDL) [Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)]
- Changes in serum Oxidized high-density lipoprotein (oxHDL) [Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)]
- Changes in serum Total antioxidant capacity [Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Mexico · 1 center
- University of Guadalajara — Guadalajara
Identifiers
NCT: NCT06847243 · CI-05223