Clinical trial NCT06847243: INNUPREC (Nutrigenetic Intervention for the Prevention of Cardiovascular Disease)
Official title: Effect of Nutrigenetic Intervention on Cardiovascular Biomarkers, Oxidative Stress and Antioxidant Capacity in Subjects with Abdominal Obesity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Abdominal Obesity
Keywords: Abdominal obesity
Nutrigenetic intervention
Cardiometabolic biomarkers
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized parallel clinical trial
Primary purpose: TREATMENT

Brief 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.

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

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

Primary outcomes:
measure: Changes in Waist Circumference between nutrigenetic and control group
timeFrame: At baseline, first month and second month (final)
Secondary outcomes:
measure: Changes in Weight
timeFrame: At the baseline (0 Month) and 1st month, 2nd month (final)
measure: Changes in Fat Mass
timeFrame: At the baseline (0 Month) and 1st month, 2nd month (final)
measure: Changes in Total Cholesterol
timeFrame: At the baseline (0 Month) and 1st month, 2nd month (final)
measure: Changes in Triglycerides
timeFrame: At the baseline (0 Month) and 1st month, 2nd month (final)
measure: Changes in High-density lipoprotein (c-HDL)
timeFrame: At the baseline (0 Month) and 1st month, 2nd month (final)
measure: Changes in Low-density lipoprotein (c-LDL)
timeFrame: At the baseline (0 Month) and 1st month, 2nd month (final)
measure: Changes in serum glucose
timeFrame: At the baseline (0 Month) and 1st month, 2nd month (final)
measure: Changes in serum insulin
timeFrame: At the baseline (0 Month) and 1st month, 2nd month (final)
measure: Changes in homeostatic model assessment - insulin resistance (HOMA-IR)
timeFrame: At the baseline (0 Month) and 1st month, 2nd month (final)
measure: Changes in serum Oxidized low-density lipoprotein (oxLDL)
timeFrame: At the baseline (0 Month) and 1st month, 2nd month (final)
measure: Changes in serum Oxidized high-density lipoprotein (oxHDL)
timeFrame: At the baseline (0 Month) and 1st month, 2nd month (final)
measure: Changes in serum Total antioxidant capacity
timeFrame: At the baseline (0 Month) and 1st month, 2nd month (final)
measure: Changes in serum Lipid peroxidation
timeFrame: At the baseline (0 Month) and 1st month, 2nd month (final)
measure: Changes in hsPCR
timeFrame: At the baseline (0 Month) and 1st month, 2nd month (final)
measure: Changes in ApoA1
timeFrame: At the baseline (0 Month) and 1st month, 2nd month (final)
measure: Changes in ApoB
timeFrame: At the baseline (0 Month) and 1st month, 2nd month (final)
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: University of Guadalajara
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: Wendy Campos-Perez, PhD
role: STUDY_CHAIR
affiliation: University of Guadalajara
name: Alondra Mora-Jiménez, Graduate
role: STUDY_CHAIR
References: