INNUPREC (Nutrigenetic Intervention for the Prevention of Cardiovascular Disease) (INNUPREC)

February 26, 2025 updated by: ERIKA MARTINEZ-LOPEZ, University of Guadalajara

Effect of Nutrigenetic Intervention on Cardiovascular Biomarkers, Oxidative Stress and Antioxidant Capacity in Subjects with Abdominal Obesity

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nutrigenetic intervention
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.
Placebo Comparator: Control Intervention
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Waist Circumference between nutrigenetic and control group
Time Frame: 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.
At baseline, first month and second month (final)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Weight
Time Frame: At the baseline (0 Month) and 1st month, 2nd month (final)
The weight will be measure in kilograms on InBody 370
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)
The Fat Mass will be measure in kilograms by electrical bioimpedance on InBody 370
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)
Will be measure in mg/dL using a dry chemistry system in Vitros 350 equipment.
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)
Will be measure in mg/dL using a dry chemistry system in Vitros 350 equipment.
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)
Will be measure in mg/dL using a dry chemistry system in Vitros 350 equipment.
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)
Will be calculated using Friedewald formula, which uses the parameters of total cholesterol, HDL and VLDL and the result is reported in mg/dL
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)
Will be measure in mg/dL using a dry chemistry system in Vitros 350 equipment.
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)
It be measure by chemiluminescence immunoassay in DiaSorin Liaison equipment
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)
Serum glucose and Insulin levels were be combined to report HOMA-IR calculated as described by Matthews
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)
Will be measured in pg/dL. Serum oxLDL levels will be quantified according to the supplier's instructions by an enzyme linked immunosorbent assay (ELISA) kit provided by Cell Biolabs, Inc
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)
Will be measured in pg/dL. Serum oxHDL levels will be quantified according to the supplier's instructions by an enzyme linked immunosorbent assay (ELISA) kit provided by Cell Biolabs, Inc
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)
Will be measure from serum samples using an OxiSelect TAC Assay Kit, (Cell Biolabs) and reported in mM.
At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in serum Lipid peroxidation
Time Frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Will be measure in μM. Serum lipid peroxidation will be quantified according to the supplier's instructions by Lipid peroxidation assay kit, Oxford Biomedical
At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in hsPCR
Time Frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Serum levels will be measure using an automated biochemical analyzer, Mindray BS-120 chemistry analyzer, from Shenzhen Mindray Bio-Medical Electronics Co.
At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in ApoA1
Time Frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Serum levels will be measure using an automated biochemical analyzer, Mindray BS-120 chemistry analyzer, from Shenzhen Mindray Bio-Medical Electronics Co.
At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in ApoB
Time Frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Serum levels will be measure using an automated biochemical analyzer, Mindray BS-120 chemistry analyzer, from Shenzhen Mindray Bio-Medical Electronics Co.
At the baseline (0 Month) and 1st month, 2nd month (final)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guadalajara

Investigators

  • Study Chair: Wendy Campos-Perez, PhD, University of Guadalajara
  • Study Chair: Alondra Mora-Jiménez, Graduate, University of Guadalajara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI-05223

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data will not be shared to protect and safeguard the confidentiality data of the participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Abdominal Obesity

Clinical Trials on Nutrigenetic diet according the genetic test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe